Moderna Approved For Emergency Use, 4th Vaccine Okayed By India
NEW DELHI, June 29: The government today cleared the fourth vaccine for emergency use in the country, the US-made Moderna.
Mumbai-based pharma major Cipla has been allowed to import Moderna's Covid vaccine for restricted emergency use in India, where the vaccines used so far were Bharat Biotech's Covaxin and Serum Institute of India's Covishield. Russia's Sputnik was also cleared recently.
Details of a rollout plan are not out yet. It is not clear how many doses will be available in India and when. Sources say for now, Cipla is only looking at receiving donated vaccines; commercial agreements are still being processed.
"Cipla Limited is supporting Moderna Inc with the regulatory approval and importation of vaccines to be donated to India. At this stage, there is no definitive agreement on commercial supplies," Cipla said in a statement.
Out of all four, Moderna has the highest effectiveness - it is 94 per cent effective compared to Sputnik (91 per cent), Covaxin (77.8 per cent) and Covishield (74 per cent).
"I am pleased to inform that application received from Moderna through their Indian partner Cipla has been granted. This opens up the possibility of the vaccine being imported in the near future. Other formalities to follow. But important that licensure has been given," said VK Paul, who heads the Covid task force.
Dr Paul said only regulatory clearance had been given to Moderna for now.
Both Pfizer and Moderna have asked for an important concession - they want indemnity from liability in case of any adverse effect of the vaccine. India has, so far, not granted indemnity to any vaccine-maker.
Dr Paul said the government had "multiple sessions" with Pfizer and the company has to make the next move.
"We are going through talks. There has been an exchange of information and inputs. There has been a back-and-forth on that. Intensive meetings were held last week. We are awaiting feedback from Pfizer," he told reporters.
Recently, Pfizer CEO Albert Bourla had said that the company's vaccine may soon be available in India as the process of its approval is in the "final stages".
"Pfizer is now in the final stages to get approval for COVID-19 vaccine in India. I hope very soon we will finalise an agreement with the government," Mr Bourla had said.
Like Pfizer, Moderna is an mRNA vaccine that has fragments of the genetic material known as messenger RNA.
The vaccine works by giving cells temporary instructions to make the coronavirus spike protein. The protein is found on the surface of the COVID-19 virus.
Cipla received clearance to import Moderna vaccines within 24 hours of its application, due to the government's revised policy on accelerated approvals for foreign vaccines. It had taken Sputnik two months for the same approval.
Cipla, in its application to the drug regulator, had referred to the government's decision to waive bridging trials for foreign vaccines if it is cleared for emergency use in countries like the US and if the safety assessment data of the first 100 beneficiaries is submitted before mass rollout.
Rectal bleeding reported in 5 Covid-19 patients in Delhi, one dead
NEW DELHI, June 29: In a first such post Covid-19 complication in India, five cases of Cytomegalovirus (CVM) related rectal bleeding in patients diagnosed with Covid-19 have been reported from Delhi's Sir Ganga Ram Hospital on Tuesday. Patients with Cytomegalovirus have complained of bleeding in stools and abdominal pain, officials said.
The cases have emerged in the second wave of infections this year, officials said.
One of the patients has succumbed to massive bleeding and Covid chest disease, officials from Sir Ganga Ram Hospital confirmed.
"During the second wave of the Covid-19 in April-May 2021, we have seen five cases of CMV infection in otherwise immunocompetent patients with Covid-19. These patients presented with pain abdomen and bleeding in stools with a mean of 20 to 30 days after the diagnosis of Covid-19," a statement released by the hospital read.
None of them had other predisposing immunosuppressed states accounting for this viral infection, the statement added.
The cases have been seen in the age group of 30-70 years from Delhi-NCR. Four patients have complained of lower gastrointestinal bleed which is bleeding in stools and one patient presented with intestinal obstruction. Of the five patients, two reported massive bleed, with one requiring emergency life-saving surgery in which the side of the colon has been removed.
Three patients have been successfully treated with antiviral therapy with ganciclovir, Dr. Arora said in a statement.
The officials explained that Covid infection itself and the medicines used for its treatment (Steroids) do suppress the immunity of patients and make them susceptible to uncommon infections with varied presentations. One such opportunistic infection is (CMV) virus.
Cytomegalo virus exists in 80 to 90% of the Indian population in asymptomatic form due to inherent immunity which makes it strong enough to be clinically asymptomatic.
Three patients have been successfully treated with antiviral therapy with ganciclovir, Dr. Arora said in a statement.
Doctors have suggested early diagnosis and effective antiviral therapy as a way of treatment to handle the cases of CMV infection in Covid-19 patients.
"In such cases of high index of suspicion and timely intervention in the form of an early diagnosis and effective antiviral therapy can save many precious lives, says Dr. Praveen Sharma of Sir Ganga Ram Hospital said.
Low vitamin D can raise death risk from Covid by 20%
JERUSALEM, June 27: People with low vitamin D levels are at least 20 per cent more likely to die from Covid-19 than people who are not, according to a new study.
The study by researchers from the Azrieli Faculty of Medicine of Bar-Ilan University in Safed and the Galilee Medical Center (GMC) in Nahariya, Israel, found that being deficient in vitamin D before contracting Covid-19 has a direct impact on the disease's severity and mortality. The findings have been published on the medical sharing site MedRxiv and is also being submitted to a peer-reviewed journal, The Jerusalem Post reported.
The study revealed that 26 per cent of people who had a pre-infection level of vitamin D of 20 ng/mL died, compared to 3 per cent of those who had higher levels of vitamin D -- a difference of 23 per cent, said Amir Bashkin, director of the Endocrinology and Diabetes Unit at GMC.
While the study falls short of pinpointing vitamin D as the cause of death, "we know that people who had low vitamin D died more," according to Bashkin.
Further "we found that if vitamin D was low, it was correlated with severe disease and mortality in an independent manner," Bashkin said.
When the team tested all other known comorbidities that might cause severity, they found vitamin D was an independent predictor, the report said.
Early this month, a study at McGill University in Quebec, Canada, showed no evidence for an association between genetically predicted vitamin D levels and Covid-19 susceptibility, hospitalisation, or severe disease.
It is because previous studies looked only at vitamin D levels only once people were sick, which could make the studies inaccurate, said the new study researchers.
"It is very important that people take vitamin D, especially older people," said lead author Amiel Dror from the varsity.
The recommended dose is around 1,200 mg per day, but people should consult with their healthcare provider before taking any supplement to be sure not to take too much or too little, Bashkin said.
"If you are going to encounter Covid-19 next time, perhaps in a next wave, you better have a sufficient level of vitamin D in your body," Dror said.
'Delta plus' variant evades vaccines? Experts flag major concerns
NEW DELHI, June 25: The emergence of the Delta and Delta plus variants of the coronavirus disease (Covid-19), has once again put India, and by extension the world, in a state of high alert.
Delta plus, reportedly a variant with increased transmissibility, is the latest in a long list of new mutant forms of the Delta Covid-19 strain which was first detected in India. While the earlier version had largely been blamed for the second wave of the Covid-19 pandemic in India, the new, more virulent variant is being feared ahead of a potential third wave.
With the Delta plus Covid-19 variant being detected in as many as 11 countries so far, here's everything that the public health experts are currently talking about.
What is the 'Delta plus' Covid-19 variant?
First things first, one ought to know what exactly is 'Delta plus', the new coronavirus mutant strain that's got the world worried ahead of a potential third wave of the Covid-19 pandemic.
Delta plus (B.1.617.2.1/(AY.1) is a new variant of the SARS-CoV-2 coronavirus formed due to a mutation in the Delta strain of the virus (B.1.617.2 variant). Since it is still technically a new mutant strain, not much is known about its severity or resistance to antibodies. Some reports claim that the Delta plus (AY.1) is resistant to monoclonal antibodies cocktail, but more research is required in this area.
How dangerous is 'Delta plus' from the earlier Covid-19 variant?
Additionally, one of the emerging variants of the Delta plus mutant strain has also acquired the K417N mutation, found in Beta variants in South Africa. Some scientists fear that the mutation combined with other existing features of the Delta variant could make it more transmissible, but again, further studies are needed to ascertain this idea.
Efficacy of vaccines on 'Delta plus' variants
One of India's top virologists and a former member of the Indian Sars-CoV-2 Genomic Consortia (INSACOG), Professor Shahid Jameel, expressed concerns regarding the Delta plus variant earlier this week. He said that the new mutant variant may just be capable of dodging immunities, both from Covid-19 vaccines as well as from earlier infections. This is because the Delta plus variant not only has all the symptoms that the original Delta variant had, but also carries symptoms from its partner Beta variant (K417N mutation), Professor Jameel explained. We already know that the Beta variant evades Covid-19 vaccines much better than the Alpha or the Delta variants, as evidenced by the fact that the South African government had returned a consignment of AstraZeneca vaccines, reasoned the virologist.
However, the central government, on the other hand, has quoted studies as saying the Covishield and Covaxin are 'broadly effective' on the Delta plus variant. Further studies are required in this area to properly ascertain the claims on either side.
Major concerns around the variant
Multiple studies are ongoing in India and globally to test the effectiveness of vaccines against the Delta plus Covid-19 mutation. India's health ministry warned that regions where it has been found "may need to enhance their public health response by focusing on surveillance, enhanced testing, quick contact-tracing, and priority vaccination." Authorities have spotlighted that Delta Plus can likely inflict another wave of infections on India after it emerged from the world's worst surge in cases only recently.
"WHO is tracking this variant as part of the Delta variant, as we are doing for other Variants of Concern with additional mutations," according to the World Health Organization (WHO).
Around 200 cases of the new Delta plus variant had been found in as many as 11 countries till June 16 -- Britain (36), Canada (1), India (8), Japan (15), Nepal (3), Poland (9), Portugal (22), Russia (1), Switzerland (18), Turkey (1), and the United States (83).
In India alone, around 40 cases of the Delta plus variant have been detected sporadically in Maharashtra, Kerala, and Madhya Pradesh. However, no deaths have yet been reported of the new variant in India and the UK. Britain said its first 5 cases were sequenced on April 26 and they were contacts of individuals who had travelled from or transited through Nepal and Turkey.
Delta plus a Covid-19 'variant of concern' in India: Health ministry
NEW DELHI, June 22: The Union health ministry on Tuesday alerted Maharashtra, Kerala and Madhya Pradesh governments on the Delta Plus variant of Covid-19 after certain districts reported the presence of the virus in some of the samples tested from these states.
It advised the authorities to strictly enforce the Covid-19 protocols and intensify containment measures in the districts where the variant has been found.
“In India, 16 of the 22 cases of Delta Plus variant have been found in Ratnagiri and Jalgaon (Maharashtra) and some cases in Kerala and Madhya Pradesh,” Union health secretary Rajesh Bhushan said during the daily Covid-19 press briefing.
The health ministry has advised the chief secretaries of these states to take up immediate containment measures in the districts and clusters on a priority basis. The health ministry’s advisory comes after Indian SARS-CoV-2 Genome Sequencing Consortia (INSACOG) found Delta Plus variant in genome sequenced samples from Ratnagiri and Jalgaon Districts of Maharashtra; Palakkad and Pathanamthitta Districts of Kerala; and Bhopal and Shivpuri districts of Madhya Pradesh.
The health ministry also said that India is among the nine countries where the Delta Plus variant has been detected. It said that the variant has been detected in the US, UK, Portugal, Switzerland, Japan, Poland, Nepal, China and Russia.
The health ministry said based on data received from the INSACOG so far it found that the Delta Plus variants have three main characteristics -- increased transmissibility, stronger binding to receptors of lung cells, potential reduction in monoclonal antibody response.
“The states’ chief secretaries have been advised to take up immediate containment measures in the districts and clusters (as identified by INSACOG) including preventing crowds and intermingling of people, conduct widespread testing, prompt tracing as well as vaccine coverage on a priority basis,” the health ministry said in a press release.
“They were also advised to ensure that adequate samples of positive persons are promptly sent to the designated laboratories of INSACOG so that clinical epidemiological correlations can be made for further guidance to be provided to the states,” the release further added.
The health ministry on Tuesday said that the variant has not yet been categorised as ‘variant of concern’ but it is currently accorded the ‘variant of interest’ status.
Covaxin, Covishield effective against Delta variant: Health Secretary
NEW DELHI, June 22: The Union Health Ministry on Tuesday said that both the Indian vaccines — Covaxin and Covishield — are effective against Delta Plus variant of Covid-19. He, however, said that to what extent these vaccines are effective will be shared shortly.
"What impact different vaccines have in terms of anti-body titers - that information is available, which we would be sharing very shortly with you," Union Health Secretary Rajesh Bhushan said while responding to a question on impact of Covid vaccines against Delta Plus.
"However, broadly speaking, both the Indian vaccines which we are currently using in Covid vaccination programme - we are using three but Sputnik V came quite later - so Covishield and Covaxin both are effective against Delta variant. But to what extent and what's the proportion of antibody titers that they produce, that we would share with you shortly," the union secretary said.
He also informed that Delta variant has been found in 80 nations, including India.
"It's considered 'variant of concern'. Delta Plus found in 9 nations - US, UK, Portugal, Switzerland, Japan, Poland, Nepal, China and Russia; 22 cases found in India. Variant is in category of 'variant of interest'," Bhushan said.
In India, 16 of the 22 cases of Delta Plus variant have been found in Ratnagiri and Jalgaon (Maharashtra) and some cases in Kerala and Madhya Pradesh, the secretary informed.
Delta variant is highly infectious and now it has mutated into Delta Plus. With new mutation, people are curious to know whether the existing vaccines are effective against the new variant.
Pfizer CEO Says In Final Stages To Get Approval For COVID-19 Vaccine In India: Report
NEW DELHI, June 22: US pharmaceutical company Pfizer is in the final stages of an agreement with India to supply Covid vaccines, Chief Executive Officer Albert Bourla said today.
"My hope is that very soon we will finalise the approval of the product in India by the Indian health care authorities and the agreement with the government so that we can also start sending vaccines, on our side," said Dr Bourla. He was addressing the 15th edition of the India-US Bio Pharma & Healthcare Summit organised by the US-India Chamber of Commerce.
He added that Pfizer has planned that mid and low-income countries, which include India, will receive at least two billion such doses.
The Pfizer CEO said that a significant local manufacturing of vaccines that is happening at the Serum Institute of India will provide the "backbone of vaccinating" the Indian people.
"But getting the additional mRNA vaccines from us and also from Moderna will contribute significantly," he said.
This comes weeks after the Drug Controller General of India (DCGI) paved the way for foreign vaccines like Pfizer and Moderna to be used in India by doing away with the requirement of India-specific trials. The move had come amid a shortage of vaccine doses across the country and was aimed at speeding up their import.
Earlier, manufacturers of vaccines were required to carry out "bridging trials" or limited clinical trials on the Indian population to know how the drug works on people here.
But earlier this month, DCGI chief V G Somani said in a letter that it has waived the requirement "in the light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines".
The letter said the foreign vaccines would only require approval from specific countries or health bodies.
The move came following a recommendation by the National Expert Group on Vaccine Administration for COVID-19.
"It has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL) and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin," Dr Somani had said in the letter.
The Pfizer vaccine is developed using the mRNA technology and is a double-dose vaccine, like the other vaccines currently available in India.
A go-ahead to the Pfizer vaccine will make it the second foreign vaccine to be cleared for use in India, after Sputnik V. The nod is expected to further boost the immunisation exercise in the country.
India yesterday administered a record 86.16 lakh doses of Covid vaccines, as per data on the CoWIN portal. The jump in jabs administered came on Day One of the new vaccine policy.
Reversing a policy enforced a month ago, Prime Minister Narendra Modi announced on June 7 that the Centre would provide vaccines for free all above 18, starting June 21, and take back control of vaccination from states.
Delta Covid-19 Variant Becoming Globally Dominant: WHO
GENEVA, June 18: The Delta variant of Covid-19, first identified in India, is becoming the globally dominant variant of the disease, the World Health Organization’s (WHO) chief scientist Soumya Swaminathan said on Friday.
Swaminathan also voiced disappointment in the failure of CureVac's vaccine candidate in a trial to meet the WHO's efficacy standard, in particular as highly transmissible variants boost the need for new, effective shots.
Britain has reported a steep rise in infections with the Delta variant, while Germany's top public health official predicted it would rapidly become the dominant variant there despite rising vaccination rates.
The Kremlin blamed a surge in Covid-19 cases on reluctance to have vaccinations and "nihilism" after record new infections in Moscow, mostly with the new Delta variant, fanned fears of a third wave.
"The Delta variant is well on its way to becoming the dominant variant globally because of its increased transmissibility," Swaminathan told a news conference.
Coronavirus variants were cited by CureVac when the German company this week reported its vaccine proved only 47% effective at preventing disease, shy of the WHO's 50% benchmark.
The company said it documented at least 13 variants circulating within its study population.
Given that similar mRNA vaccines from Pfizer and BioNTech and Moderna posted efficacy rates topping 90%, Swaminathan said the world had been expecting more from CureVac's candidate.
"Just because it's another mRNA vaccine, we cannot presume all mRNA vaccines are the same, because each one has a slightly different technology," Swaminathan said, adding the surprise failure underscored the value of robust clinical trials to test new products.
WHO officials said Africa remains an area of concern, even though it accounts for only around 5% of new global infections and 2% of deaths.
New cases in Namibia, Sierra Leone, Liberia and Rwanda have doubled in the last week, WHO emergencies programme head Mike Ryan said, while vaccine access remains miniscule.
"It's a trajectory that is very, very concerning," Ryan said. "The brutal reality is that in an era of multiple variants, with increased transmissibility, we have left vast swathes of the population, the vulnerable population of Africa, unprotected by vaccines."
Over 10,000 Daily UK Covid Cases For First Time In 4 Months
LONDON, June 17: Britain on Thursday recorded 11,007 new daily coronavirus cases, with the emergence of the Delta variant pushing the figure above 10,000 for the first time since late February.
The government on Monday announced it was delaying steps to lift restrictions due to concern over the spread of the new strain, first detected in India.
The government said a four-week delay would give it time to fully vaccinate millions more.
The death rate remains low, with 19 fatalities recorded on Thursday.
The vaccines are believed to be highly effective against preventing serious illness from the variant.
But there is concern whether rising case numbers will turn into death tolls similar to previous waves, which combined have seen 127,945 people lose their lives.
A government report published on Thursday found that cases are "rising exponentially" across England, driven by mostly unvaccinated age groups.
The data suggested cases were doubling every 11 days.
'Delta' Variant Of COVID-19 Mutates Into 'Delta Plus'
NEW DELHI, June 15: The 'delta' variant of COVID-19 - a version first detected in India - has evolved to form the 'delta plus' or AY.1 variant. Scientists say it has acquired a mutation associated with escaping immunity but stress there is "no cause for concern yet".
The 'delta plus' variant is a mutated version of the more aggressive B.1.617.2 strain that drove the second wave of infections in India. It is characterised by the K417N mutation in the spike protein of the SARS-CoV2 virus that causes the COVID-19 disease.
The spike protein is what helps the virus enter and infect human cells, and the K417N mutation has been associated with immune escape, or evasion, that leaves it less susceptible, or more immune, to the vaccine or any form of drug therapy.
The government on Tuesday said the 'delta plus' variant had been around since March this year. It is not, however, a variant of concern at this point, Dr VK Paul, Member (Health), NITI Aayog, said. "Its presence had been detected and submitted to global data system," he added.
According to Public Health England, 63 B.1.617.2 genomes with the K417N mutation have been identified so far, six of which are from India. There are 36 confirmed 'delta plus' cases in the UK and it accounts for around six per cent of cases in the US. Two UK cases were registered more than 14 days after the second vaccine dose, making them 'breakthrough' infections.
However, there is no cause for concern as reports of the new variant are still low and there is no indication, as yet, about the severity of the disease, Anurag Agrawal, Director of Delhi's CSIR-Institute of Genomics and Integrative Biology (IGIB), said. He also said blood plasma from a number of fully vaccinated individuals would have to be tested against this variant to establish if it shows any significant level of immune escape.
Vinod Scaria, another CSIR-IGIB scientist, said the K417N variant was more frequent in Europe, America and other Asian countries at this time. He also said travel histories were not immediately available, meaning it is unwise to assume how far it may have spread.
The 'delta plus' variant is resistant to the monoclonal antibody cocktail recently authorised in India. These cocktails - Casirivimab and Imdevimab - are designed to block the virus from attaching to human cells and entering the body, and are similar to antibodies that the human body naturally produces to defend itself against the disease.
As a counterpoint, Vineeta Bal, a guest faculty at Pune's Institute of Science Education and Research, said resistance to therapy did not indicate severity. She also said the quality and quantity of neutralising antibodies generated by an individual infected with the new variant is unlikely to be affected because of the mutation.
The 'delta' variant of COVID-19 - first reported in India in October last year - is already between 40 and 50 per cent more infectious than the 'alpha' version first reported from the UK and is, according to a (not yet peer-reviewed) study by AIIMS, likely behind the majority of breakthrough infections in India.
Studies differ on just how effective vaccines currently in India - Covishield and Covaxin - are in protecting against the 'delta' variant. The AIIMS study indicated it might not protect people even after the second dose, while a research letter published in The Lancet said Covishield (the AstraZeneca shot) provided 79 per cent protection after two doses.
Sputnik covid vaccine more efficient against Delta variant: Study
NEW DELHI, June 15: The Russia-developed Sputnik V vaccine has been found to more efficient against the highly transmissible Delta variant of coronavirus disease (Covid-19), which was found in India, according to a study.
The drug has been found to be more efficient against the variant than any other vaccine used to fight the viral contagion in the study, Sputnik V's official handle posted on Twitter.
“#SputnikV is more efficient against the Delta variant of coronavirus, first detected in India than any other vaccine that published results on this strain so far - the Gamaleya Center study submitted for publication in an international peer-reviewed journal,” said a tweet shared by Sputnik V.
Developed in Russia by Gamaleya Institute, Sputnik V is reported to show over 91.6% efficacy against coronavirus. The drug has been authorised in 67 countries across the world. The Russian Direct Investment Fund (RDIF) on June 10 announced that the efficacy of the Sputnik V was estimated at 94.3% during a vaccination campaign by Bahrain's ministry of health. However, the World Health Organization (WHO) has not yet approved Sputnik V as an emergency vaccine.
Sputnik V is set to make its entry in India after a rollout is expected in Delhi's Indraprastha Apollo Hospital, based on the number of consignments received by the hospital, it is reported.
The first phase of the Sputnik V rollout by Apollo Hospitals and Dr Reddy's Laboratories started on a pilot basis on May 17 in Hyderabad and the next day in Visakhapatnam. Sputnik V is also available at Hyderabad’s Continental Hospitals.
Apart from Apollo Hospitals, Madhukar Rainbow Children’s Hospital in Delhi will also start administering the Sputnik V Covid-19 vaccine to people by the end of this week. The Centre has fixed the price of the vaccine at ₹1,145 per dose.
The use of single-dose Sputnik V in India is expected to significantly boost the country's vaccination drive, which faced hiccups in several states amid a crippling shortage of doses. India, the world's biggest vaccine manufacturer, has been able to vaccinate around 3% of its population.
AstraZeneca shots should be halted for over-60s: EMA official
MILAN, June 13: Countries should avoid giving the AstraZeneca coronavirus vaccine to people over 60 in addition to younger age groups, the head of the EU drug regulator's COVID-19 task force was quoted on Sunday as saying, amid fears over rare blood clotting and as alternative vaccines become available.
The European Medicines Agency's (EMA) position is that the AstraZeneca shot is safe and can be used for all age groups over 18. However several European Union member states have restricted its use to those in the age range 50 to 65, due to rare cases of blood clotting, mainly among young people.
"In a pandemic context, our position was and is that the risk-benefit ratio remains favourable for all age groups," COVID-19 task force chief Marco Cavaleri told the Italian newspaper La Stampa.
However, Cavaleri said that as the number of COVID-19 cases is falling and taking into account that the younger population is less exposed to COVID-19 related risks, it could be better to use vaccines based on messenger RNA (mRNA) technology, such as Moderna and the Pfizer-BioNTech vaccines, on the younger population.
Asked whether health authorities should also avoid giving the AstraZeneca vaccine to people aged over 60, Cavaleri said: "Yes, and many countries, such as France and Germany, are considering it in the light of greater availability of mRNA vaccines."
Earlier this week the Italian government said it would restrict the use of the AstraZeneca vaccine to people aged over 60, after a teenager who had received the shot died from a rare form of blood clotting.
Italian Health minister Roberto Speranza told reporters on Sunday that Italy will continue to use the AstraZeneca vaccine on the over 60s, including those who have not received a first jab.
Like many European countries, Italy briefly halted AstraZeneca inoculations in March over concerns about the rare blood clotting problems.
It resumed them the following month with the recommendation that the product be "preferably" used for people over the age of 60, after the EMA said its benefits outweighed any risks.
Amid row, Bharat Biotech says it will conduct phase 4 trial of Covaxin, phase 3 data to be out in July
NEW DELHI, June 9: Amid the Twitter war between Bharat Biotech's Raches Ella and Kolkata researcher Dr Aswadhesh Kumar Singh over Covaxin versus Covishield, Bharat Biotech on Wednesday informed that the company will conduct a phase 4 trial of its vaccine to check the real-world effectiveness of Covaxin. Its phase 3 trial data will be published in July, the company said, after which it will apply for full licensure.
While the Centre has said that these two vaccines can not be compared as they are made differently, researchers have not stopped finding out the answer to the question: which vaccine is better between Covaxin and Covishield.
A pre-print study, which is yet to peer-reviewed, has recently claimed that both the vaccines showed a good immune response after two doses. But Serum Institute of India's Covishield produced more antibodies than Covaxin.
Opposing the reporting of the study, Bharat Biotech's business development head Dr Raches Ella took to social media and said the study has its limitations.
Dr Aswadhesh Kumar Singh, one of the researchers, pointed to the fact that the "whole country is getting vaccinated even without a preprint phase 3 result — lest forget published one".
The company officially issued a statement on Wednesday against the study. "A recent comparative report on an evaluation of immunogenicity responses to spike protein after the first and second dose of Indian manufactured vaccines study had lots of flaws. The journal that stated the comparative report said more antibodies produced by Covishield than COVAXIN®. This is not a peer-reviewed publication, nor do it a statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis," the company said.
The company on Wednesday said that the data will be out by July. First, the data will be submitted to the Central Drugs Standard Control Organisation, followed by peer-reviewed journals. Then Bharat Biotech will apply for full licensure, the company said.
So far, the vaccine's overall efficacy on 78 per cent and its efficacy against hospitalisation is 100 per cent.
The 4th phase trials will be also be conducted to ensure that Covaxin met every rigorous standard, the company said.
Covishield produced more antibodies than Covaxin, claims study
NEW DELHI, June 6: Covishield triggered more antibodies than Covaxin, claims a preprint of the first Indian study involving doctors and nurses who received both doses of either of the two Covid-19 vaccines. The study by Dr AK Singh and his colleagues states that both vaccines elicited a good immune response.
Unpublished data had earlier indicated that Covishield was found to be 70 per cent effective after the first dose. At the same time, preliminary data from its phase 3 trial put Covaxin's efficacy rate at 81 per cent.
"Among 515 healthcare workers (305 male, 210 female), 95 per cent showed seropositivity (higher antibodies) after two doses of both vaccines. Of the 425 Covishield and 90 Covaxin recipients, 98.1 per cent and 80 per cent, respectively, showed seropositivity," says the study.
The study shows that while both Covishield and Covaxin prompted good immune response after two doses, seropositivity rates and median anti-spike antibody titre were significantly higher in the Covishield arm when compared to the Covaxin arm.
Antibody titer was 115 AU/ml (arbitrary units per millilitre) for Covishield and 51 AU/ml for Covaxin. A type of blood test, an antibody titer determines the presence and level (titer) of antibodies in the blood.
It goes on to add, "However, both the seropositivity rate and the average rise in anti-spike antibody were significantly higher in Covishield versus Covaxin recipients."
Anti-spike antibody level is not the same as neutralising antibody titers (NAb). The two are not known to reliably correlate. In fact, neutralising antibody titers form only a fraction of the total anti-spike antibodies produced.
Gastroenterologist and former chief of the IMA's Kochi unit, Dr Rajeev Jayadevan adds, "The percentage or level of anti-spike antibody measured in the study cannot be taken as a percentage of protection delivered to the recipient."
A total of 27 breakthrough infections (4.9 per cent) were recorded among respondents who had received both doses of either of the vaccines. Out of these, 25 were mild and two were moderate cases of breakthrough infections. No deaths were recorded as a result of breakthrough infections.
The study puts the risk of breakthrough infections in the case of Covishield at 5.5 per cent compared with 2.2 per cent for Covaxin.
While no difference was observed in relation to gender, body mass index, blood group and any comorbidities, people aged 60 years and above or those with type 2 diabetes had a significantly lower seropositivity rate, indicating a comparatively lower antibody response.
Both vaccines were seen to be providing excellent protection on the ground, according to reports from doctors across the country. The exact percentage, say the authors, will only be seen in a head-to-head trial.
The study also shows a good safety profile for both vaccines. By and large, the study shows that the vaccines are working. It further underscores the need to speed up vaccinations to avert a potential third wave of infections by expanding the coverage of vaccinations.
At present, less than four per cent of the Indian population has received both doses of either of the vaccines, while less than 15 per cent have received at least one dose.
Some 2,000 people had 'severe adverse reactions' to Pfizer, Moderna vaccine: MOH
SINGAPORE, June 5: There are some 2,000 individuals who have experienced severe adverse reactions after the first dose of the Pfizer-BioNTech or Moderna vaccine and they should not receive an mRNA vaccine again, said the Ministry of Health (MOH).
In a Facebook post on Saturday (5 June), the MOH said it is evaluating other suitable non-mRNA vaccines. "We expect to make such vaccines available before the end of this year for use in our national vaccination programme, after the vaccines have been rigorously assessed and approved by the HSA (Health Sciences Authority)," the ministry said.
In a press release on Friday, the MOH said that these 2,000 individuals are those who had developed "anaphylaxis or allergic reactions (hives, face/ eyelid/ lip/ throat swelling, generalised rash within 7 days after vaccination)".
The individuals can consider taking vaccines under the Special Access Route (SAR), such as the Sinovac vaccine, if they cannot wait, the ministry added in its post.
The ministry is also awaiting "some outstanding data on the Sinovac vaccine to complete our evaluation" for the vaccine to be part of the national vaccination programme.
In the meantime, private healthcare providers can apply to draw on Singapore's existing stock of the Sinovac vaccine. The Republic received its first shipment of the vaccine, also known as CoronaVac, in February, with some 200,000 doses delivered.
Those who were previously rejected from taking the mRNA vaccines because of severe allergies or were allergic to the first dose – over 30,000 of them in total, said Health Minister Ong Ye Kung at a virtual press conference on Monday – are able to be vaccinated with the Sinovac vaccine for free at approved private clinics, the ministry said.
"For all other individuals who prefer Sinovac for non-medical reasons, it will be a private arrangement with the vaccine provider, and (they) will have to pay an admin fee to the private providers," the MOH added.
Scientists make a major breakthrough in breast cancer treatment
LONDON, June 5: A group of scientists say they are "thrilled" at the results of a breast cancer treatment clinical trial, which has identified a possible new treatment for women with early-stage breast cancer who have BRCA1 or BRCA2 gene mutations.
People with such mutations have increased risk of several cancers, most notably breast and ovarian cancer (but others too), and are more likely to develop cancer at younger ages than people who do not have the gene variant.
The trial tested the effectiveness of a drug called olaparib, which until now has only been used for patients with advanced cancer. In this study, which was conducted by numerous bodies including London’s Institute of Cancer Research (ICR) and has just been published in the New England Journal of Medicine, 1,836 patients took part. All had previously received chemotherapy treatment for breast cancer, and half the group were then given olaparib, while the other half were given a placebo.
The results of the study – which has been named the OlympiA trial – showed that after a median 2.5 years of follow-up, 85.9% of patients who had taken the drug remained free of their cancer, where just 77.1% who had received a placebo had the same outcome. This equates to a 42% overall drop in the risk of cancer returning.
The research also concluded that use of the olaparib drug following chemotherapy reduced risk of the risk of cancer spreading by 43%. It shows that it could be an effective treatment for the "curative" and not just the advanced stage of cancer, say the scientists involved.
Professor Andrew Tutt, who's a professor of oncology at the ICR and chairs the OlympiA study steering committee, spoke about the study's results in a statement. "We are thrilled that our global academic and industry partnership in OlympiA has been able to help identify a possible new treatment option for women with early-stage breast cancer who have inherited mutations in their BRCA1 or BRCA2 genes," he said.
"Women with early-stage breast cancer who have inherited BRCA1 or BRCA2 mutations are typically diagnosed at a younger age. Up to now, there has been no treatment that specifically targets the unique biology of these cancers to reduce the rate of recurrence, beyond initial treatment such as surgery, hormone treatment, radiotherapy and chemotherapy.
It's definite cause for celebration, and hopefully in future the drug can be used to save many more women's lives.
After first infection, Covid-19 risk reduces for up to 10 months: Study
LONDON, June 4: The risk of contracting the coronavirus disease after a previous infection will substantially reduce for up to 10 months, according to a new study published in the Lancet medical journal.
The research, which published in The Lancet Healthy Longevity on Thursday, looked at rates of Covid-19 infections between October last year and February this year among over 2000 care home residents and staff in England.
The study conducted by the researchers at the University College London found that care home residents, who were infected with the viral disease in the past, were approximately 85 per cent less likely to catch it again than those who had not been infected. While the staff with past infections were 60 per cent less likely to be infected again. The study involved 1429 staff members of care homes and 682 residents with a median age of 86.
Researchers conducted the antibody blood tests in June and July last year and the results showed that around a third were positive for the presence of Covid-19 antibodies. The research also covered the emergency of Alpha strain, a more contagious variant of Covid-19 which was first detected in the UK last year. The researchers said the antibodies provided a good level of protection against the Alpha variant.
"It’s really good news that natural infection protects against reinfection in this time period. The risk of being infected twice appears to be very low," a news agency quoted the study's lead researcher, Maria Krutikov of the UCL Institute of Health Informatics, saying.
"The fact that prior COVID-19 infection gives a high level of protection to care home residents is also reassuring, given past concerns that these individuals might have less robust immune responses associated with increasing age," Krutikov also said.
The study, meanwhile, excluded the impact of vaccination as the scientists are planning to look at its effectiveness in separate research.
Not Just Adults, Pfizer Coming in India for Kids Too: AIIMS Chief
NEW DELHI, June 4: Granting indemnity to Pfizer and Moderna will boost Covid-19 vaccination for not just children, but also adults, said AIIMS director Dr Randeep Guleria in an interview with CNN-News18.
The Centre may grant indemnity from liability to Pfizer and Moderna to speed up approvals for the vaccines in India, health ministry sources indicated on Wednesday. A top official with the government has said that “there is no issue” in granting indemnity to the two giants in India and the approval will be in line with the approach taken by US and other countries administering both vaccines.
On the Government of India granting indemnity for bridging trials for Pfizer, Dr Guleria said, “It’ll help for not only children but adults also”.
“This has been done in the past too when the government gave emergency approvals to all vaccines that had been approved by agencies of US, UK or EU and WHO. Based on that, emergency approvals have already been given de-facto to vaccines with approvals from these agencies and the issue of indemnity also seems to be resolved. So, I think we will have Pfizer vaccine coming in for children and adults shortly,” the top pulmonologist said.
Responding to why norms were not eased before, Dr Guleria said, “There are two things here. First, to look at emerging data. There wasn’t enough data to be comfortable with. I am not the part of the group that decides this, but there wasn’t enough data for the vaccine to be given comfortably to Indians. There have been side-affects with European population so you have to be really careful. The first principle is you don’t want to cause more harm than good. As the vaccine rollout happened it became clear that a large number of vaccinated in UK and the US were of Indian origin and in them there were no side-effects and therefore we felt now we have enough data globally to say that we can approve the vaccines.
Amid reports that the Indian government may grant indemnity to Pfizer and Moderna to hasten the vaccination process in India, the Serum Institute of India on Thursday also asked for indemnity from liability, saying all vaccine makers, whether Indian or foreign, should be granted the same protection. The government has so far not given any manufacturer indemnity or protection against legal action for any severe side effects. As the issue gains traction, here’s what indemnity means and how it will aid the vaccination process in India.
Indemnity means protection to vaccine makers from legal proceedings, which ensures they can’t be sued in India. No other vaccine maker in India enjoys this clause. However, Pfizer and Moderna have said they will export to India only if the transaction is with the Centre and the company is protected from legal cases.
While Pfizer and Moderna have raised the demand, the Serum Institute of India on Thursday said the same protection should be provided to all vaccine makers. Pfizer and Moderna, which are among the best shots in the international market and more than 90 per cent effective, have been approved by more than 40 countries, including US and Britain.
As per Niti Ayog member VK Paul, “They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now.”
Delta Variant Of Covid Prominently Found In Varanasi: Study
HYDRABAD, June 4: The Banaras Hindu University (BHU), Varanasi, and CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad, have collaboratively sequenced genomes of coronavirus variants in the temple town and adjoining areas.
Their study reports at least seven major strains of coronavirus circulating in these regions, a press release from the CCMB said on Friday.
The multi-disciplinary research unit headed at BHU collected samples from Varanasi and areas around the city, mostly in April 2021, it said. The team at CCMB sequenced these samples and found out that there were at least seven major variants circulating in the region.
As many as 130 samples were sequenced in this study.
"Among the variants of concern (VoC), the most predominant variant we found in our study was B.1.617. This variant was also reported to be one of the major drivers of the second COVID-19 wave in the country," Prof Singh, who heads the multi-disciplinary research Unit at BHU, said.
"Just as in most of the country, the B.1.617.2 variant (also know as Delta variant) was the most common one in the samples we studied. They were found among 36 per cent of the total samples. Other VoCs such as the B.1.351, detected in South Africa for the first time, were also found in this area," said Dr Rakesh Mishra, Advisor, CCMB.
The study confirms yet again that the Delta variant is the most widespread coronavirus variant in the country right now.
But at the same time, it is imperative to keep an eye on the other emerging variants in the country to prevent another unprecedented surge of cases, he added.
Bharat Biotech’s Covaxin Shows 78 Percent Efficacy In Phase 3 Analysis
NEW DELHI, May 29: The final phase 3 analysis of Covaxin, the Covid-19 jab developed by Bharat Biotech, has shown the efficacy of 78 per cent in preventing symptomatic coronavirus caused disease, a report said.
Officials familiar with the development said that the Hyderabad-based vaccine maker is likely to announce the results in June.
As per previous reports, while the first interim efficacy analysis had shown the efficacy of nearly 81 per cent, the second interim analysis results showed it to be about 78 per cent.
Dr Sanjay Rai, professor, community medicine department, All India Institute of Medical Sciences (AIIMS), Delhi said "The final analysis was done at 130 confirmed case and it was found to be 78 per cent.”
“The interim analysis may be over, the analysed data needs to be peer-reviewed and published in a medical journal now,” added Dr Rai who is also the principal investigator of the study site at AIIMS.
While confirming the news about the vaccine, another official in the central government said: “We have been made to understand that the interim analysis results for Covaxin phase 3 trials are almost done and they are in the process of publishing the data.”
This analysis comes at a time when Bharat Biotech has applied for emergency use listing (EUL) from the World Health Organization (WHO) and the company is expecting a nod from the UN health agency by July-September.
The researchers have analysed Covaxin’s efficacy at several, pre-set interval—known as endpoints.
The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 per cent.
The results were released in March 2021.
The second interim analysis result, released in April, was based on accruing more than 87 symptomatic Covid-19 cases.
It showed that the efficacy of the vaccine against the coronavirus caused disease was 100 per cent and a reduction of hospitalization numbers was also noted.
Even though Bharat Biotech has not yet revealed any details about the final analysis, in April the company said that the safety and efficacy details will be available by June.
The vaccine maker also stated that the final results will be submitted to a peer-reviewed publication.
How rare are blood clots after the AstraZeneca vaccine?
MELBOURNE, May 28: With COVID-19 community transmission on the rise once again, those aged over 50 are weighing up the benefits of being vaccinated against the virus with the very rare risk of blood clotting induced by the AstraZeneca vaccine.
Since the first reports of blood clotting after the AstraZeneca vaccine emerged in March 2021, our understanding of the clotting disorder, called vaccine-induced thrombotic thrombocytopaenia (VITT) or thrombosis with thrombocytopenia syndrome (TTS), has grown.
We now know how to diagnose and treat it, so we’re likely to see better outcomes for patients with the condition.
How common and deadly is it? Thankfully, developing blood clots after the AstraZeneca vaccine is very rare.
So far in Australia, out of 2.1 million doses of the AstraZeneca vaccine, 24 cases of TTS have been reported. So the risk of TTS is approximately one in 88,000.
These figures are similar to those reported in the UK, Europe, the Middle East and Canada.
Although early reports from Europe indicated approximately 20 per cent of cases of TTS were fatal, in Australia, to date, one out of 24 TTS cases has been fatal, so just over 4 per cent.
What exactly is thrombosis with thrombocytopenia syndrome? Although we don’t yet have the full explanation, it appears that the AstraZeneca vaccine can activate platelets, which are small cells in our blood important for forming blood clots that prevent bleeding.
In some people, activated platelets can release a protein called platelet factor 4 (PF4), which binds to the AstraZeneca vaccine. It is thought that this binding of PF4 can induce the immune system to activate more platelets, making them stick together and thereby diminishing their numbers.
This leads to blood clotting (thrombosis) and a low platelet count (thrombocytopaenia).
Having blood clots with a reduced number of platelets is a key feature of TTS.
Different to other blood clots This mechanism is quite different to the usual process by which blood clots occur.
TTS appears to result from an irregular immune response, so current evidence suggests people with a history of heart attack, stroke, deep vein thrombosis, pulmonary embolism (a clot in the lung) or on regular blood thinners aren’t at any increased risk of TTS.
However, as a precautionary measure, the Pfizer vaccine is currently recommended for people aged under 50 years, or those with a history of clots in the brain, in the abdomen or previous low platelet count after taking the blood-thinning drug heparin.
Testing and treatment has improved A key development is diagnostic tests and guidelines to recognise and treat cases of TTS. In most cases, patients will have a low platelet count, evidence of a blood clot, and antibodies directed against PF4. Many of these tests can be done quickly.
Treatment can now begin immediately, with specific blood thinners and medications to dampen the immune system.
As of May 20 when the latest vaccine safety report was released, 21 of the 24 Australians with TTS had recovered and been discharged from hospital and two were stable and recovering in hospital.
So what side effects are normal, and what might indicate a clot? General side effects are common after any vaccine.
In the case of the AstraZeneca vaccine, these occur in the first two days after vaccination and include: headache fever (chills) muscle and joint aches nausea fatigue pain at the site of injection, which tends to resolve with simple measures such as paracetamol. In many cases, the blood clots in TTS occur in unusual locations such as the veins in the abdomen (splanchnic vein thrombosis) and brain (cerebral venous sinus thrombosis). They typically occur four to 30 days days after vaccination.
Therefore, symptoms that could indicate TTS after getting the AstraZeneca vaccine include: persistent or severe headache blurred or double vision shortness of breath severe abdominal, back or chest pain swelling, redness, pain in a leg unusual bleeding or bruising.
If you experience any of these symptoms four to 30 days after your vaccination, seek urgent medical attention. Balancing the risk and benefits While TTS is very rare, some people will have concerns and will want to discuss them with their doctor. This is essential to allow people to make an informed choice.
However, with the ongoing risk of COVID outbreaks in Australia and their potential deadly consequences, as well as the potentially severe long-term effects of COVID-19, for the vast majority of people, the benefits of vaccination against COVID-19 as soon as possible outweigh the risks.
UK Approves Single Shot Johnson & Johnson Covid-19 Vaccine
LONDON, May 28: Britain on Friday approved the use of the single shot Johnson & Johnson coronavirus vaccine, the Medicines and Healthcare products Regulatory Agency (MHRA) announced.
“This is a further boost to the UK’s hugely successful vaccination programme, which has already saved over 13,000 lives, and means that we now have four safe and effective vaccines approved to help protect people from this awful virus,” said Health Secretary Matt Hancock.
The government hopes the single-dose jab “will play an important role in the months to come”, he added, as young people come forward for their vaccinations amid concern over the rise of variant, first found in India.
Britain has ordered 20 million doses of the vaccine.
The European Medicines Agency said in April that a warning about unusual blood clots with low blood platelet count should be added to its product information following cases in the United States.
The vaccine was found to be 72 per cent effective in preventing moderate to severe coronavirus infection, according to a US trial.
Britain has administered more than 62 million shots so far, mainly using the Pfizer and AstraZeneca vaccines. It has also approved the use of the Moderna vaccine.
After months of falling cases, infections have started to rise again due to the emergence of the Indian variant, which has put in doubt plans for a full reopening of the country on June 21.
Pfizer doses could come to India in July
NEW DELHI, May 28: The head of the country’s Covid-19 Task Force on Thursday said that Pfizer has indicated that it would be able to make available a “certain amount” of its mRNA Covid-19 vaccine to India, “possibly starting in July”.
However, the government is still examining the American pharma giant’s request for indemnity against the cost of compensation for any severe side effects, Dr V K Paul said.
The ongoing discussions with Pfizer are also taking place around issues related to the cold chain, as the vaccine — developed by Pfizer along with the German biotechnology company BioNTech — requires ultra-low temperatures during transport and storage, he said.
“Yes, we are engaged with Pfizer because they have indicated availability of a certain amount and volume of vaccines in the coming months, possibly starting in July.
“We are looking at what Pfizer’s expectations from the government are, and they are looking at what our expectations from them are. That is the process in which it will move because they have to come into India; they have to apply for licensure, that is one part…
“There are imperatives of the cold chain that are being looked at,” Dr Paul, who also heads the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), said.
The Indian drug regulator has not granted indemnity against the costs of compensation for severe side effects to the manufacturers of any of the three Covid-19 vaccines to which it has issued emergency use authorisation (EUA).
However, Pfizer, which has received EUA in several countries, obtained indemnity before rolling out its vaccine. “…They have requested indemnity from all nations. It is their expectation that liability should be indemnified. They have expressed this in legal language. We are examining this request and we will take a decision in the larger interest of the people and on merits. This is under discussion, but there is no decision as of now,” Paul said.
Hours before he made these statements at the media briefing, Paul had issued a separate, written statement on “Myths & Facts on India’s Vaccination Process”.
“Myth 1”, the statement said, was that “Centre is not doing enough to buy vaccines from abroad.” However, the statement said, “The Central Government has remained engaged continuously with all the major international vaccine manufacturers right from mid-2020. Multiple rounds of discussions have happened with Pfizer, J&J & Moderna. The government offered all assistance to have them supply and /or manufacture their vaccines in India. However, it is not that their vaccines are available in free supply.”
“We need to understand that buying vaccines internationally is not similar to buying ‘off the shelf’ items. Vaccines are in limited supply globally, and companies have their own priorities, game-plans and compulsions in allocating finite stocks. They also give preference to countries of their origin just as our own vaccine makers have done unhesitatingly for us,” Paul said in the statement.
At the media briefing, Paul was asked whether any vaccine manufacturer had cited “preference to countries of their origin” as the reason to deny vaccines to India.
Paul replied: “The context of that observation is that the vaccines developed in other countries, a large part of those vaccines were supplied to the same country. The US-made vaccines went in a big way to the US; that was taken for them as a priority. This is nothing surprising because when we look upon our vaccine manufacturers, they also unhesitatingly offered the vaccines to our nation.”
However, “Now that the vaccine availability for the country of origin has been met to a large extent, and their own production capacities are rising because they are aware of the market and the success of the vaccine, there will be vaccine for others to take, partly through Covax and partly through bilateral arrangements,” Paul said.
Bharat Biotech holds talks with US FDA for phase-3 clinical trial of Covaxin: Report
NEW DELHI, May 24: The Hyderabad-based Bharat Biotech is in the final stages of submission of required documents for regulatory approvals to Covaxin in Brazil and Hungary.
Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90% of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine, sources said on Monday.
The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion on obtaining the World Health Organisation's authorisation for emergency use listing for Covaxin, sources said.
"BBIL is confident about obtaining WHO's emergency use listing," said a source.
Sources also said that no country has instituted a 'vaccine passport' and that countries around the world have their own requirements for approval which, in most cases, involves travel by carrying a COVID-19 negative RT-PCR report.
Noting that Covaxin has already received regulatory approval from 11 countries, sources said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.
The company is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the United States, sources said.
Sources also said that BBIL is in the final stages of submission of required documents for regulatory approvals to Covaxin in Brazil and Hungary.
They said the meeting with BBIL on the EUL was attended by the company's managing director V Krishna Mohan and his colleagues besides senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs.
Roche's Antibody Cocktail Launched in India at Rs 59,750/Dose
NEW DELHI, May 24: Drug majors Roche India and Cipla on Monday announced launch of Roche’s Antibody Cocktail in India priced at Rs 59,750 per dose for the treatment of mild to moderate COVID-19 in patients who are at high risk.
“The first batch of the Antibody Cocktail (Casirivimab and Imdevimab) is now available in India while a second batch will be made available by mid-June. In total they can potentially benefit 2,00,000 patients as each of the 1,00,000 packs that will be available in India offers treatment for two patients,” Cipla and Roche said in a joint statement.
Cipla will distribute the product by leveraging its strong distribution strengths across the country, it added.
The price for each patient dose [a combined dose of 1,200 mg (600 mg of Casirivimab and 600 mg of Imdevimab)] will be Rs 59,750 inclusive of all taxes. The maximum retail price for the multi dose pack (each pack can treat two patients) is Rs 1,19,500 inclusive of all taxes.
As per the statement, the drug will be available through leading hospitals and COVID treatment centers. The Central Drugs Standards Control Organisation (CDSCO) had recently provided an emergency use authorisation (EUA) for the Antibody Cocktail (Casirivimab and Imdevimab) in India. It has also received a EUA in the US and several EU countries.
“We are optimistic that the availability of Antibody Cocktail (Casirivimab and Imdevimab) in India can help in minimising hospitalisation, ease the burden on healthcare systems and play a key role in treatment of high risk patients before their condition worsens," said V Simpson Emmanuel, Managing Director and CEO, Roche Pharma India.
Umang Vohra, MD and Global CEO Cipla said, “We look forward to leveraging our solid marketing and distribution strengths in India to provide broader, equitable access to this innovative treatment option in the country."
The antibody cocktail is to be administered for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease and do not require oxygen.
Vohra said it has been shown to help these high-risk patients before their condition worsens, reducing the risk of hospitalization and fatality by 70 per cent and shortening the duration of symptoms by four days.
Made-in-India Nasal Vaccines Could be Game Changer for Kids: WHO Top Scientist
NEW DELHI, May 23: Nasal vaccines, which are being made in India, could be game changers for children. However, it may not be available this year, said World Health Organization’s chief scientist Soumya Swaminathan. The hope comes amid concerns over a probable third wave of the coronavirus pandemic hitting the children.
“Some of the nasal vaccines that are going to be made in India could be game changers for children — easy to administer, will give you local immunity in the respiratory tract,” said Swaminathan, a paediatrician.
She, however, insisted that till then more and more adults, especially teachers, need to be vaccinated and schools be reopened only when risk of community transmission is low.
“I am very hopeful that ultimately we’ll have vaccine for children. But that’s not going to happen this year, and we should open schools when community transmission is down. That’s what rest of the countries have done, with other precautions. And if teachers are vaccinated, that would be a big step forward,” WHO’s top scientist added.
The Centre on Saturday said children are not immune from the infection, but stressed that the impact is minimal. “If children get affected by Covid, either there will be no symptoms or there will be minimal symptoms. They do not require hospitalisation generally,” Niti Aayog (health) member VK Paul said during the press briefing of the Union health ministry.
He added that health infrastructure should be ramped up to treat Covid-19 among children, but it is most important to not let them become a part of the transmission chain in the first place.
Children account for about 3-4 per cent of hospital admission, in both India and the rest of the world, Paul said, adding special attention should be on those between the age of 10 and 12 years as they are very mobile.
Prime Minister Narendra Modi, in a recent meeting with state and district officials, had asked them to collect data on the infection transmission and severity among youth and children.
The US Food and Drug Administration also already given emergency authorization to the Pfizer-BioNTech vaccine for young people aged 12 to 17. Reports said two other vaccines are likely to be given emergency authorization for children in the coming months. Moderna is testing its vaccine in 3,000 children ages 12 to 17 and may have results for that age group within weeks. Johnson & Johnson in April also began studying 12- to 17-year-olds, a report in New York Times stated.
“There are many vaccine developers who have already started their paediatric trials, like the Pfizer vaccine is now approved for children over the age of 12 and trials in younger children are ongoing. It is expected that in a couple of months, Pfizer and Moderna vaccines will get approval. The AstraZeneca and other vaccines for younger people — there’s a slower development there because of the rare side effects noted in younger generation given the adenoviral vaccines. But certainly other classes of vaccine are coming on board,” Swaminathan said.
Pfizer also has plans to seek emergency authorization in US in September for children between the ages of 2 and 11, and results from Moderna’s clinical trial in children as young as 6 months are expected by the end of the year.
Recently, Canada, Singapore and the United Arab Emirates too approved the Pfizer-BioNTech Covid-19 vaccine for emergency use in the 12-15 age group.
Study suggests lipid droplets protect kidney cells from being damaged
LONDON, May 22: During a recent study, researchers from the Francis Crick Institute discovered how microscopic structures called lipid droplets may help to prevent a high-fat diet causing damage to the kidneys.
The work published in PLoS Biology opens up a new research avenue for developing better treatments for chronic kidney disease.
Eating foods high in fats can cause inflammation and metabolic stress in the kidneys, leading to chronic disease, which in severe cases requires dialysis or a transplant. And with obesity on the rise globally, it's a growing problem- around 10 per cent of people in the UK are living with chronic kidney disease.
Scientists at the Crick have been studying a common characteristic of the disease, the appearance of lipid droplets inside kidney cells, to solve a long-standing mystery of whether this protects or harms kidney function.
Working with electron microscopy experts at the Crick, the team used the sophisticated genetic methods available in the fruit fly (Drosophila) to show that lipid droplets protect the renal system against damage from excess dietary fats.
When fed a high-fat diet, lipid droplets accumulate inside nephrocytes, the flies' equivalent of human kidney cells called podocytes. Here, the droplets act as a 'safe haven' for storing excess fats away from the rest of the cell.
An enzyme called ATGL sits on the surface of lipid droplets and helps to dispose of the stored fats in a safe way. ATGL does this by feeding the fats in a digestible form to nearby mitochondria, where they can be broken down into less toxic molecules.
Lipid droplets are essential for the protective process as when the scientists used genetic methods to prevent their formation, the fats left free inside the nephrocytes caused substantial damage and impaired kidney function.
Alex Gould, head of the Physiology and Metabolism Laboratory at the Crick and lead researcher of the study says: "It has been known for many years that lipid droplets pop up in a wide range of diseases, all the way from diabetes to brain cancer. What's been far less clear is whether they are making things better or worse."
"It's exciting to find that lipid droplets are an essential part of the kidney's fight back against fat overload. These fascinating structures are turning out to be so much more than tiny balls of fat, and we now want to find out whether their protective role in the kidney also applies to other disease contexts."
The scientists also found that boosting the expression of the ATGL enzyme in fruit flies was able to repair most of the damage caused by a high-fat diet, restoring normal function to the kidney cells.
Fruit flies are a useful model for understanding the biology of kidney disease in humans because there are important similarities in the renal systems of both species, including the presence of the ATGL enzyme.
Ola Lubojemska, who carried out much of this work in the Physiology and Metabolism Laboratory at the Crick, explains: "These findings are at an early stage but open up a new direction for clinical research into chronic kidney disease."
Ola further gave an example saying, "It may be possible to develop a drug that boosts the ATGL enzyme in renal patients. This would allow excess dietary fats to be more efficiently detoxified by kidney cells, thus improving kidney function."
Can people without Covid get black fungus?
NEW DELHI, May 23: Amid the sharp rise of the cases of mucormycosis or black fungus among Covid-19 patients in India, experts have warned that this fungal infection can happen even without Covid and so those who have high blood sugar level should be on alert.
"This is an infection which was present before Covid too. What medical students are taught about black fungus is that this infects diabetic people — those who have uncontrolled diabetes. The combination of uncontrolled diabetes and some other significant disease may lead to black fungus," Niti Aayog (health) member VK Paul said.
Explaining the severity of diabetes which makes one vulnerable to black fungus, Dr Paul said blood sugar level reaches 700-800, a situation medically known as diabetic ketoacidosis, attack of black fungus, be in among children or older people, is common.
"Any other diseases like pneumonia aggravate the situation. Now, there is Covid which itself has its impacts. Then comes the use of the steroid. All these have compounded the situation, but in short people without Covid can also get mucormycosis, if the other conditions are present," Dr Paul said.
Healthy people have no need to worry about this infection, AIIMS' Dr Nikhil Tandon has said adding that those who have weakened immunity are only at a greater risk.
"It may have happened that the Covid variant in the second wave of the pandemic has attacked the immunity more than the first wave which is why so many cases of mucormycosis are being reported. In addition to this, there has been rampant use of steroids in this wave. But nothing can be said with certainty without proper investigation," Dr Tandon said.
On Sunday, the total number of black fungus cases in Haryana rose to 398, with Gurugram reporting the maximum of 147 cases. Kerala reported four black fungus deaths, whle Uttarakhand declared mucormycosis as an epidemic. In Madhya Pradesh's Jabalpur, one case of white fungus was reported on Saturday, which doctors said is curable and common.
Researchers find new, effective treatment for Vitamin D deficiency
BOSTON, May 22: A new study demonstrates 25-hydroxyvitamin D3 is an effective treatment for vitamin D deficiency in some specific patients.
There are several million people worldwide with various fat malabsorption syndromes including those who have undergone gastric bypass surgery and those with obesity. These patients often have a difficult time absorbing vitamin D and both groups of patients are at an increased risk for vitamin D deficiency and therefore at higher risk for osteoporosis and osteomalacia (softening of the bones).
Patients with obesity are also susceptible to vitamin D deficiency as vitamin D derived from intestinal absorption and cutaneous synthesis is diluted in a larger body pool of fat. These findings appear online in the American Journal of Clinical Nutrition.
According to the researchers, approximately one-third of adults are obese and require much larger doses of vitamin D to satisfy their requirements.
"This vitamin D metabolite is better absorbed in patients with fat malabsorption syndromes and since it is not as fat-soluble, it does not gets diluted in the body fat and is effective in raising and maintaining blood levels of 25-hydroxyvitamin D in obese people," explained corresponding author Michael F. Holick, PhD, MD, professor of medicine, physiology and biophysics and molecular medicine at Boston University School of Medicine.
Healthy adults, adults with a fat malabsorption syndrome and obese adults were compared to evaluate if a more water-soluble form of vitamin D3 known as 25-hydroxyvitamin D3 was more effective than the same dose of vitamin D3 in improving their vitamin D status. The researchers observed that compared to healthy adults only about 36 percent of orally ingested vitamin D3 was found in the blood of patients with fat malabsorption syndromes including patients who had gastric bypass surgery.
When the same adults ingested 25-hydroxyvitamin D3 the patients with fat malabsorption syndromes were able to absorb it as well as the healthy adults thereby raising their vitamin D status to the same degree. A similar observation was made in the obese subjects compared to the healthy controls. "Therefore using 25-hydroxyvitamin D3 could be a novel approach for treating vitamin D deficiency in patients with fat malabsorption syndromes and obese adults," added Holick.
Vitamin D deficiency not only results in bone loss increasing risk for fracture but causes the painful bone disease osteomalacia. Patients who are vitamin D deficient with osteomalacia have unrelenting achiness in their bones and muscles.
Vitamin D deficiency has been associated with an increased risk of many chronic illnesses including multiple sclerosis, type 1 diabetes, heart disease, type 2 diabetes, depression, neurocognitive dysfunction and Alzheimer's disease as well as infectious diseases including COVID.
After black fungus, reports of white fungus infections surface
NEW DELHI, May 20: Mucormycosis or black fungus cases in India are on a massive surge. After coronavirus disease (Covid-19), the biggest healthcare concern is the fungal infection for India presently.
The Central government on Thursday urged the states and Union territories (UTs) to make black fungus a notifiable disease under the Epidemic Diseases Act, 1897. A notifiable disease requires the medical practitioners to notify the government about the disease in a prescribed format within three days or 24 hours, in case of urgency.
However, a new threat is an emerging white fungus that is concerning medical experts. Though there has been no official confirmation about such cases, various media reports claimed Bihar has reported around four cases of white fungus, which according to the health experts is more dangerous than Mucormycosis.
Director general of the Indian Council of Medical Research, Dr Balram Bhargava on Thursday said the colour of the fungus depends on its growth. Fungal infections are common when there is dampness, Dr Bhargava said, without specifically mentioning anything about white fungus.
White fungus is being suggested to be more dangerous than black fungus by health experts as it can affect other parts of the body like skin, stomach, kidney, brain, private parts and mouth besides lungs, according to the reports.
Not much evidence has been found of the white fungus spreading to other states, but experts feel that it can be as virulent as the virus, as per the reports. The mortality rate of white fungus is currently unknown.
The patients infected with white fungus showed Covid-like symptoms, however, were tested negative. The medical experts believe an HRCT scan may be required to trace the fungal infection, as the reports claimed.
An HRCT scan is an additional diagnosis done in patients suffering from severe Covid-19.
Much like Covid-19 and black fungus, people with low immunity, pre-existing medical issues, people with diabetes and people on or using steroids are at a high risk of contracting the infection, according to the reports.
Aerosols Can Travel 10 Metres: Government's New Pointers On Covid
NEW DELHI, May 20: Smaller aerosol particles can be carried in the air for 10 metres, the government warned today as it shared a set of "easy to follow" guidelines on fighting Covid, which includes double masks, social distancing and well-ventilated spaces.
Use of proper ventilation can prevent the spread of coronavirus, the Union government's principal scientific adviser K VijayRaghavan's office said in the new advisory which also warns against running air conditioners while keeping windows and doors shut.
"Running ACs traps infected air inside the room and increases risk of transmission from an infected carrier to others," it said.
"Always Remember: People who show no symptoms can also spread the virus," the document, titled "Stop the Transmission, Crush the Pandemic" said, urging people to rigorously follow Covid appropriate behaviour. While droplets fall within two meters from an infected person, smaller aerosol particles are carried in the air up to 10 metres, it said.
Saliva and nasal discharged in the form of droplets and aerosols by an infected person is the primary mode of virus transmissions, the document said, adding that an infected person without symptoms also transmit the virus.
"Just as smells can be diluted by ventilation, the dangerous concentration of the virus can be reduced by ensuring that outdoor air flows in," it said.
Droplets emitted by an infected person land on various surfaces (where they can survive for a long time), the advisory said, calling for frequent cleaning of high contact points such as door handles, light switches, tables, chairs and the floor with disinfectants like bleach and phenyl.
People should wear a double layer mask or an N95 mask, which offers maximum protection, the new guidelines said. For double masking, wear a surgical mask, then wear another tight fitting cloth mask over it, the advisory said, adding that those who do not have a surgical mask can wear two cotton masks together.
"Ideally, surgical mask should be used only once, but when pairing, you can use it up to 5 times by leaving it in a dry place for 7 days after one use (ideally give it some sun exposure)," it said.
The document also highlighted the important role well-ventilated spaces play in diluting the risk of transmission from one infected person to the other.
"Just as smells can be diluted from the air through opening windows and doors and using exhaust systems, ventilating spaces with improved directional air flow decreases the accumulated viral land in the air, reducing the risk of transmission," the document, titled "Stop the Transmission, Crush the Pandemic" says.
Simple strategic placement of fans, open windows and doors, even slightly open windows can introduce outdoor air and improve the air quality inside, it added.
"In buildings with central air-management systems, improving central air filtration /increased filtration efficiency is especially helpful when enhanced outdoor air delivery options are limited. In offices, auditoriums, shopping malls etc. use of gable fan systems and roof ventilators are recommended. Frequent cleaning and replacement of fiters is highly recommended," the advisory noted.
People entering rural/semi-urban areas should undertake Rapid Antigen Test, the document said. "ASHA/Anganwadi/health workers must be trained and protected for conducting the Rapid Antigen Test. These health workers must be given a certified N95 mask even if they are vaccinated. ASHA/Anganwadi/Health Workers to also be provided oximeters to monitor infected person," it said.
The support and cooperation of individuals, communities, local bodies and authorities was necessary to stop the transmission of the virus and decrease the infection rate to a level where it can eventually die, the guidelines said, adding, that "with the use of masks, ventilation, distancing, and sanitation, the battle against the virus can be won".
At least 2.57 crore people in India have been infected with Covid, which has also led to death of 2.87 lakh people since the pandemic began early last year.
Vaccines to be ‘at least partially’ protective against variant from India: Fauci
WASHINGTON, May 18: Top US infectious disease expert Dr Anthony Fauci on Tuesday said that the vaccines currently being used by the United States would be “at least partially and probably quite protective” against coronavirus variants first detected in India.
Citing recent studies published in medical journals, Dr Fauci, the director of the National Institute of Allergy and Infectious Diseases, said that the results are very encouraging regarding protection against the known SARS-CoV-2 variants.
“The modest neutralization resistance of B.1.617.1 variant to vaccine-elicited antibodies suggests that current vaccines will be protective,” according to the slide shared by the White House Covid-19 response team as Fauci spoke.
“The spike proteins of SARS-CoV-2 B.1.617 and B.1.618 variants identified in India provide partial resistance to vaccine-elicited and therapeutic monoclonal antibodies,” the presentation further read.
The United States is using vaccines developed by Pfizer-BioNTech and Moderna, both based on mRNA technology. Health experts have been closely following the studies regarding the efficacy of Covid-19 vaccines against variants of concern.
Pfizer-BioNTech Covid-19 vaccine showed that it can neutralise SARS-CoV-2 dominant variants which remain susceptible to neutralising antibodies, said Fauci.
He added that most individuals vaccinated with Moderna’s Covid-19 vaccine maintained binding and functional antibodies against a wide range of variants.
“This is just another example of the scientific data accruing, and as I have shown you here...indicating another very strong reason why we should be vaccinated,” said Dr Fauci.
The B.1.617 variant, believed to be driving the deadly second wave of coronavirus disease (Covid-19) pandemic, is the fourth variant that has been classified as a variant of global concern. India on Monday registered 263,533 cases of Covid-19 and 4,329 related deaths, the Union ministry of health and family welfare (MoHFW) dashboard showed on Tuesday morning.
Share excess COVID-19 vaccines now, UNICEF chief says ahead of G7 summit
By Deepak Arora
NEW YORK, May 16: The deadly increase in COVID-19 cases in India could potentially occur elsewhere if vulnerable countries do not have access to vaccines, the head of the UN Children’s Fund, UNICEF, warned on Monday in a bid to get richer nations to share their excess doses.
Henrietta Fore, the agency’s Executive Director, issued the statement from New York as G7 leaders gear up for their summit next month in the United Kingdom, and as vaccine producer India continues to confront the rapid surge.
UNICEF is a partner in COVAX, the global vaccine equity mechanism, which is set to deliver its 65 millionth dose this week. However, Ms Fore said “it should have been at least its 170 millionth.”
The shortfall will be closer to 190 million doses by the time the G7 meet, she added, and as a deadly second wave of COVID-19 will likely continue to sweep across India and many of its neighbours.
“We have issued repeated warnings of the risks of letting down our guard and leaving low- and middle-income countries without equitable access to vaccines, diagnostics and therapeutics. We are concerned that the deadly spike in India is a precursor to what will happen if those warnings remain unheeded,” she said.
Although tragic, Ms Fore said the situation in India “is not unique”. Countries such as Nepal, Sri Lanka, the Maldives, Argentina and Brazil have seen an explosion in cases, and health systems are struggling. She also pointed to the threat of the emergence of more deadly or contagious variants if the virus continues to spread unchecked.
While COVAX represents a pathway out of the pandemic, it is undersupplied, in part due to the crisis in India. The country is a leader in vaccine production, but the situation at home has led to a severe reduction in supplies for the solidarity scheme.
“Soaring domestic demand has meant that 140 million doses intended for distribution to low- and middle-income countries through the end of May cannot be accessed by COVAX. Another 50 million doses are likely to be missed in June,” she said.
“This, added to vaccine nationalism, limited production capacity and lack of funding, is why the roll-out of COVID vaccines is so behind schedule.”
Ms Fore said G7 leaders will be meeting in June "with a potential emergency stop-gap measure readily available."
New data analysis indicates that the bloc, together with European Union countries, could donate around 153 million vaccine doses if they shared just 20 per cent of their available supply over June, July and August. Governments would still be able to vaccinate their populations.
“While some G7 members have greater supplies than others, and some have further advanced domestic rollouts, an immediate collective commitment to pool excess supplies and share the burden of responsibility could buttress vulnerable countries against becoming the next global hotspot,” Ms Fore said.
The UNICEF chief stated that “the global vaccination race” will only be won when countries fully fund and supply COVAX, while also supporting vaccine production through Intellectual Property licensing and technology transfers.
“These measures are critical, but they won’t change anything overnight,” she said. “Sharing immediately available excess doses is a minimum, essential and emergency stop-gap measure, and it is needed right now.”
India's Covid Situation Hugely Concerning, Says WHO Chief
UNITED NATIONS, May 15: India's COVID-19 situation remains hugely concerning, with several states continuing to see a worrying number of cases, hospitalisations and deaths, WHO chief Tedros Adhanom Ghebreyesus said on Friday, warning that the pandemic's second year will be "far more deadly" than the first for the world.
Ghebreyesus added that the WHO is responding to the COVID-19 surge in India and has shipped thousands of oxygen concentrators, tents for mobile field hospitals, masks and other medical supplies.
"India remains hugely concerning, with several states continuing to see a worrying number of cases, hospitalisations and deaths," he said at the daily media briefing.
"And we thank all the stakeholders who are supporting India," the WHO Director-General said.
India is in the midst of a deadly wave of the coronavirus pandemic, with 3,43,144 people testing positive for the virus on Friday, taking the country's caseload to 2,40,46,809. The death count stands at 2,62,317.
India's COVID-19 tally crossed the 10 million mark on December 19 and in under six months it has doubled, surpassing the grim milestone of 20 million cases on May 4.
Ghebreyesus pointed out that the emergency-like situation was not restricted to India.
"Nepal, Sri Lanka, Vietnam, Cambodia, Thailand and Egypt are just some of the countries that are dealing with spikes in cases and hospitalisations," he said adding that some countries in the Americas still have high numbers of cases and as a region, the Americas accounted for 40 per cent of all COVID-19 deaths last week.
There are also spikes in some countries in Africa. "These countries are in heightened response mode and WHO will continue to provide support in all ways possible," he said.
Noting that COVID-19 has already cost more than 3.3 million lives across the world, Ghebreyesus said, "We're on track for the second year of this pandemic to be far more deadly than the first."
He lamented that vaccine supply remains a key challenge and that saving lives and livelihoods with a combination of public health measures and vaccination - not one or the other - is the only way out of the pandemic.
WHO Warns Against Use Of Ivermectin For COVID-19 Treatment
NEW DELHI, May 11: The World Health Organization on Tuesday recommended against the general use of 'ivermectin' - an orally-administered drug used to treat parasitic infections - for treatment of COVID-19 patients.
"Safety and efficacy are important when using any drug for a new indication. WHO recommends against use of 'ivermectin' for COVID-19 except within clinical trials," Dr Soumya Swaminathan, the global health body's chief scientist, tweeted.
A similar warning has also been issued by 'ivermectin' manufacturer MSD, or Merck & Co., Inc, whose statement Dr Swaminathan attached to her tweet. Merck said its scientists continue to "carefully examine findings of all available and emerging studies of 'ivermectin' for treatment of COVID-19".
"...to-date, our analysis has identified: No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; No meaningful evidence for clinical activity or efficacy in patients with COVID-19 disease, and; A concerning lack of safety data in the majority of studies," it said.
This is the second WHO warning against 'ivermectin' in the past two months.
In March it said there is "very low certainty of evidence" of the drug's effect on mortality or hospital admission.
"We currently lack persuasive evidence of a mechanism of action for 'ivermectin' in COVID-19, and any observed clinical benefit would be unexplained," the WHO said then.
Dr Swaminathan's tweet today comes a day after Goa approved use of 'ivermectin' as preventive treatment for all adults against the SARS-CoV2 virus that causes the COVID-19 disease.
Goa Health Minister Vishwajit P Rane said the state's green-lighting of the drug was after expert panels from the United Kingdom, Italy, Spain and Japan found a "statistically significant reduction in mortality, time to recovery, and viral clearance in COVID-19 patients treated with 'ivermectin'".
Rane said treatment - 12 mg for five days - would be available for everyone over 18.
Last month the Union Health Ministry, while issuing revised guidelines for home isolation of asymptomatic Covid cases, indicated use of 'ivermectin' to control fevers.
The WHO chief scientist's tweet today is important given growing debate over the efficacy of 'ivermectin', which is approved - in specific doses - for infections caused by some parasitic worms.
It is not, at this stage, viewed as an antiviral drug; which is something the United States' Food and Drug Administration has stressed, saying, "Ivermectin is not approved for COVID-19 treatment."
There are, however, some studies that suggest the opposite.
A review of available data - published in the May-June issue of the American Journal of Therapeutics - claims 'ivermectin' can help end the pandemic.
"We conducted the most comprehensive review of the available data on ivermectin," Pierre Kory, President and Chief Medical Officer of the Front Line COVID-19 Critical Care Alliance (FLCCC) - a group of medical and scientific experts that led the study - said.
The authors have claimed a large and statistically significant reduction in mortality, time to recovery, and viral clearance in COVID-19 patients treated with 'ivermectin'.
'Ivermectin' is one of a number of drugs, antiviral or otherwise, being studied for and offered as COVID-19 treatment options. Others include Remdesivir - which is in great demand in India - and anti-malaria drug hydroxychloroquine - large quantities of which were exported by India last year.
The WHO has still not approved hydroxychloroquine and, last month, the centre said remdesivir is not a life-saving drug and its "unnecessary or irrational" use on Covid patients is unethical.
Remdesivir is, however, routinely recommended for treatment in India.
Medication to treat or lessen the impact of COVID-19 continue to make headlines in India and around the world, as many countries battle devastating waves of the infection.
This morning India, the current epicentre of the pandemic, reported over 3.2 lakh new cases and 3,876 deaths in the past 24 hours. The number of active cases is now over 37.15 lakh.
WHO Labels Coronavirus Strain In India As 'Variant Of Concern'
GENEVA, May 10: A Covid-19 variant spreading in India, which is facing an explosive outbreak, appears to be more contagious and has been classified as being "of concern", the World Health Organization said Monday.
The UN health agency said the B.1.617 variant of Covid-19 first found in India last October seemed to be transmitting more easily than the original version of the virus, and might possibly have some increased resistance to vaccine protections.
"There is some available information to suggest increased transmissibility of the B.1.617," Maria Van Kerkove, the WHO's lead on Covid-19, told reporters, also pointing to early studies "suggesting that there is some reduced neutralisation".
"As such we are classifying this as a variant of concern at the global level," she said, adding that more details would be provided in the WHO's weekly epidemiological update on Tuesday.
India, suffering from one of the worst outbreaks in the world, reported nearly 370,000 fresh infections and more than 3,700 new deaths on Monday.
The devastating wave has overwhelmed country's healthcare system, and experts have said official figures for cases and fatalities are much lower than the actual numbers.
It has for some time been feared that B.1.617 -- which counts several sub-lineages with slightly different mutations and characteristics -- might be contributing to the alarming spread.
But until now, WHO has listed it merely as a "variant of interest".
Now it will be added to the list containing three other variants of Covid-19 -- those first detected in Britain, Brazil and South Africa -- which the WHO has classified as being "of concern".
They are seen as more dangerous than the original version of the virus by being more transmissible, deadly or able to get past vaccine protections.
When it comes to the B.1.617 variant, Van Kerkove stressed that for the time being "we don't have anything to suggest that our diagnostics or therapeutics and our vaccines don't work".
The WHO's chief scientist Soumya Swaminathan agreed.
"What we know now is that the vaccines work, the diagnostics work, the same treatments that are used for the regular virus work," she told the news conference.
"So there's really no need to change any of those, and in fact... people should go ahead and get whatever vaccine is available to them and that they are eligible for."
France detects 20 cases of Indian COVID variant: Health minister
PARIS, May 10: The coronavirus variant first detected in India appears to be on the rise in France, which has now recorded at least 20 cases, according to the country’s health minister.
On Monday, Olivier Veran told French news channel LCI that people affected had been identified in five small clusters, local media reported.
Veran did not specify where the cases had been recorded but said the variant, formally known as B.1.617, was “not spreading rapidly” in the country.
France first detected a handful of instances of the variant late last month.
Veran’s comments came as concerns grow over the strain as B.1.617 is linked to a devastating wave of infections in India.
It has since spread outwards to about 20 other countries, including several European nations, prompting fresh travel restrictions with India.
The World Health Organization (WHO) has described B.1.617 as a “variant of interest”, suggesting it may have mutations that would make the virus more transmissible, cause more severe disease, or evade vaccine immunity.
Other strains with known risks, such as those first detected in the United Kingdom, Brazil and South Africa, have been categorised as “variants of concern” – a higher threat level.
B.1.617 contains two notable mutations – formally known as E484Q and L452R.
This has led to it sometimes being dubbed the “double mutant” strain, though this is something of a misnomer as it actually carries more than a dozen mutations altogether.
France began its third national lockdown at the end of March, but faced pressure from businesses and a COVID-weary public.
Despite the rise in cases, Veran confirmed that France will continue with plans to reopen bars and restaurants for outdoor service on May 19, as the third wave of the pandemic appears to be easing.
Authorities will also start relaxing a nightly curfew.
“The prospects look rather good but we must not let down our guard,” Veran told LCI television.
The moves come as France attempts to speed up its mass immunisation programme following a sluggish start.
As of Sunday, 17.8 million people had received at least one dose of vaccine, accounting for 26.6 percent of the total population, the health ministry said. Some 7.8 million people had been fully inoculated with two doses.
Meanwhile, the number of COVID-19 patients in French intensive care units fell below 5,000 for the first time since March 29 on Sunday, health ministry data showed.
The number was down for a sixth day in a row at 4,971, against 5,005 the previous day, the ministry said.The health ministry also said a total of 106,392 people had died from COVID-19 as of Sunday, up 115.
The number of new infections rose by 9,128, compared with 9,888 a week earlier, taking the total to 5.78 million.
Black Fungus Infection Seen In Some Covid Patients Can Maim, Kill: Report
NEW DELHI, May 10: Health officials in India warned about a fungal infection seen in some COVID-19 patients which can disfigure facial features and even kill, as the country continues to grapple with the world's fastest-growing coronavirus outbreak.
Mucormycosis, also called the "black fungus" infection, can damage the sinuses or lungs when the spores are inhaled, the Indian Council of Medical Research said in a health advisory issued on Sunday. Patients who have been on medication for some time or had prolonged stays in the ICU are particularly susceptible, the ICMR said. The rare but deadly infection can kill and maim patients, with some Covid sufferers losing their upper jaws and eyes after contracting it, according to local media reports.
With India reporting more than 300,000 new virus infections for the past 19 days straight, doctors across emergency rooms are seeing a rash of such cases -- an unintended consequence of intensive medical intervention that sometimes includes oxygen tubes through the nose.
The fungus can attack through the respiratory tract, and was present in India before the Covid pandemic, according to the New York Times.
The health system has been stretched to breaking point by a second virus wave that is proving more lethal and harder to control than the first.
Warning signs for the fungal infection include pain and redness around the eyes and nose, shortness of breath, bloody vomiting and an altered mental state, the ICMR said. Doctors were advised to monitor the afflicted person's blood glucose levels and to use clean, sterile water in humidifiers used for oxygen therapy. The ICMR warned against overuse of steroids, indicating they could worsen the infection.
The fungal infection is the latest complication in India's virus fight, with the country continuing to run short of hospital beds, oxygen cylinders, Covid medicines and vaccine doses as cases rise. Experts have warned that the sheer size of India's outbreak is bound to generate new virus mutations and after-effects from the virus that may not have been seen elsewhere.
With 4.14 Lakh Fresh Covid Cases, India Sees Biggest Daily Surge
NEW DELHI, May 7: India's Covid cases - which have sparked a global concern - rose by a record 4,14,188 infections, taking the active caseload to 36,45,164; 3,915 people died in a day. Shortage of resources to tackle a deadly second wave remains big concern.
This the second straight day that India has reported over 4 lakh cases. Last week, the country had hit a grim global record as daily cases passed the 4 lakh-mark in a first.
The country, which recorded just 15,510 fresh infections on March 1, has been reporting over 3 lakh new Covid cases every day for the last two weeks. More than 2.34 lakh people have died since the pandemic broke. Earlier this week, India's overall cases breached the two crore-mark.
Rajasthan and Kerala have also announced lockdown to tackle the Covid surge. While Rajasthan has announced a lockdown between May 10 and May 24, Kerala has announced strict restrictions between May 8 and May 16. Several states have imposed stringent measures to curb the spread of the virus.
India expanded the vaccination drive to all adults above 18 last week even as many states flagged shortage. Prime Minister Narendra Modi on Thursday said the pace of vaccination should not be slowed down.
"PM spoke about the need to sensitise states that the speed of vaccination doesn't come down. Citizens should be facilitated for vaccination despite lockdowns and healthcare workers involved in vaccination must not be diverted for other duties," a note from his office said.
Delhi must get at least 700 tonnes of oxygen every day, as requested by the government, to meet the needs of the city's patients, the Supreme Court told the centre on Thursday, in an important ruling.
Chief Minister Arvind Kejriwal had said the city is getting roughly half its allocation of oxygen, while neighbouring BJP-ruled states were prioritised.
Delhi's positivity rate has dropped below 25 - to 24.29 per cent for the first time since April 18. On April 22 it hit a record high of 36.3 per cent, meaning one in three tests were returning Covid positive results. The national capital on Thursday night reported 19,133 new cases and 335 deaths in the previous 24 hours. That was the third time in four days daily new cases were below 20,000.
On Thursday night Mumbai civic authorities said the city would have more drive-in vaccination centres in each administrative zone, posssibly within 24 hours. Maharashtra got its first drive-in vaccination centre this week at Dadar, and its success has persuaded Mumbai to adopt the model. The Dadar centre can vaccinate around 5,000 people a day with minimum risk of infection.
Stories of patients struggling to get medical attention have been making global headlines. Yesterday, a coronavirus patient's family in Bengaluru had to sit on a protest outside the Karnataka assembly before they managed to get a hospital bed.
International support has been pouring in with the United States, the United Kingdom among other nations sending medical supplies.
American civil rights Reverend Jesse Jackson has urged US President Joe Biden to release 60 million doses of the AstraZeneca vaccine for India.
Covid third wave inevitable… we should be prepared: India’s top scientific advisor
NEW DELHI, May 5: Even as India grapples with the ferocious second wave of Covid-19, the government Wednesday warned that a third wave of the pandemic was “inevitable”, although a time-frame for it could not be predicted.
“Phase three is inevitable given the higher levels of circulating virus, but it is not clear on what time-scale this phase three will occur. We should be prepared for new waves,” K Vijay Raghavan, the principal scientific advisor to the Centre, said during a press briefing.
On Wednesday, India reported a record 3,780 fresh Covid fatalities in the last 24 hours, taking the overall death toll to 2,26,188. As many as 3,82,315 new coronavirus infections were also recorded at the same time.
Raghavan further pointed out that vaccines are effective against the current variants. “New variants will arise all over the world, as well as India, but variants that increase transmission will likely plateau,” he said, adding that immune-evasive variants and those which lower or increase disease severity will arise going ahead.
“Scientists in India and all over the world are working to anticipate these kinds of variants and act against them rapidly by issuing early warnings and developing modified tools,” he said.
The Health Ministry officials also said that the long Covid wave of such “ferocity” that the country was experiencing currently “was not predicted”.
On being asked if a nationwide lockdown was the only solution to rise in cases, NITI Aayog member Dr V K Paul said there was already a guideline issued to states to impose restrictions to suppress the chain of transmission. He added that more options will be discussed in case of a necessity.
The Health Ministry, meanwhile, said 12 states, including Maharashtra, Karnataka, Kerala and Uttar Pradesh have over 1 lakh active cases. It further said that Karnataka, Kerala, Andhra Pradesh, Tamil Nadu, West Bengal, Rajasthan and Bihar are among the states that have shown an increasing trend in daily cases.
The government also said that 24 states and Union Territories show more than 15 per cent Covid positivity rate. A rise in Covid deaths has also been reported in a few states including Maharashtra, Karnataka, Andhra Pradesh, Delhi, and Haryana, the government said.
The Health Ministry also said that the liberalised policy for vaccination started on May 1, under which, 1, 6.71 lakh people in the age group of 18-44 years in nine states have been administered the vaccines.
Plan to increase Sputnik V vaccine production up to 850 million doses per year in India: Russian envoy
NEW DELHI, May 1: Expressing his happiness at the delivery of the first batch of Sputnik V vaccine to India, Russian envoy Nikolay Kudashev on Saturday said that the local production is about to start soon and is planned to be gradually increased up to 850 million doses per year.
Earlier today, a flight carrying the first lot of Russian vaccines landed in Hyderabad, Telangana.
"Happy to share that the first batch of the Sputnik V vaccine was delivered in Hyderabad today! As Russia and India continue dedicated joint efforts to combat the #COVID19, this move is especially important to support the Indian Government's endeavours to mitigate the deadly second wave and save lives," said Ambassador Kudashev
The Russian envoy also said that the efficacy of the Sputnik V in among the highest in the world, and this vaccine will also be effective against new strains of COVID-19,
"Its local production is about to start soon and is planned to be gradually increased up to 850 million doses per year. Look forward to further expand our bilateral and multilateral cooperation with India to stop the pandemic," he added.
Last month, the Drug Controller General (DCGI) had issued permission for Dr Reddy's Laboratories to import the Russian vaccine to India for emergency use.
The rollout of the Russian vaccine is expected to augment India's third phase of the vaccination drive which commenced today amid a record rise in COVID-19 cases.
Sputnik V is the third vaccine India has given the go-ahead to after 'Covishield', developed by Oxford University and AstraZeneca and 'Covaxin', the indigenous vaccine manufactured by Bharat Biotech. Covishield is manufactured by the Serum Institute of India.
Diplomatic sources had said that India will get a substantive number of vaccines in the first tranche and the supply will continue in instalments. India is expecting 5 million vials of Sputnik vaccines by the next month.
India first country to record 400,000 daily Covid cases
NEW DELHI, May 1: India has reported a staggering 400,000 new coronavirus infections in 24-hours – adding to a week-long streak of world record breaking numbers.
To battle the devastating second wave, Saturday should have marked the start of a vaccine rollout for hundreds of millions of over-18s in India. But most states are not taking part, because there are not nearly enough vaccines to go around.
Plans to begin vaccinating all adults are in disarray. Many states simply don't have any doses to give out. Only around one in ten of India's vast population has had even a first jab – the lack of doses made worse by administrative inefficiencies.
Oxygen and medicines are also in short supply. Pharmacies say there has been panic buying and hoarding and they are restricting supplies - only giving out oxygen cylinders to people who can prove they really need them.
Emergency care facilities are being set up. Sports halls, religious sites and catering facilities are being turned into makeshift COVID-19 isolation wards.
And the awful task of dealing with the dead goes on. In the capital Delhi, volunteers put themselves at risk collecting the bodies of those who've died.
An international relief effort is underway to help India fight its devastating second wave, but deaths and infections are still rising remorselessly and with not enough vaccines to go round.
WHO Lists Moderna Covid Vaccine For Emergency Use
GENEVA, May 1: The World Health Organization on Friday said it had listed the anti-Covid-19 Moderna vaccine for emergency use.
The listing procedure helps countries unable to assess a vaccine's effectiveness themselves have access as quickly as possible and allow the Covax vaccine sharing scheme and other partners to distribute it to poorer countries.
The US vaccine is the fifth jab to earn WHO's emergency listing.
The US Food and Drug Administration issued an emergency use authorization for the Moderna vaccine on 18 December 2020 and a marketing authorisation valid throughout the European Union was granted by the European Medicines Agency on 6 January 2021.
WHO said in a statement that its Strategic Advisory Group of Experts on Immunization (SAGE) had found the Moderna vaccine to have an efficacy of 94.1 percent.
The other vaccines listed for emergency use by WHO are Pfizer BioNTech; AstraZeneca; Serum Institute of India; and Janssen.
Moderna on Thursday said it expected to produce up to three billion doses of its vaccine in 2022 through new funding commitments to boost supply at manufacturing sites in Europe and the US.
India gets first consignment of SputnikV vaccine from Russia
NEW DELHI, May 1: India on Saturday received the first consignment of Russia's SputnikV COVID-19 vaccine, according to the Central Board of Indirect Taxes and Customs (CBIC).
The CBIC in a tweet said that Hyderabad customs expedited the clearance of the COVID-19 vaccine imported from Russia. "Hyderabad Customs, @cgstcushyd facilitated expeditious clearance of #SputnikV Vaccine imported from Russia," the CBIC tweeted.
Finance Minister Nirmala Sitharaman in tweet said: "Appropriate timely response @cgstcushyd. Need of the hour." The government last month allowed emergency use of imported vaccines to curb the spread of coronavirus infection and waived customs duty on their imports.
On August 11, 2020, Russia became the world's first country to register a coronavirus vaccine, dubbed as SputnikV.