Covaxin gets emergency use nod for children aged 2-18 years
NEW DELHI, Oct 12: The Subject Expert Committee (SEC) of the drug regulator has recommended granting an emergency use authorisation to Bharat Biotech's Covaxin for children aged between 2-18. The SEC has submitted its recommendation to the Drugs Controller General of India (DCGI) for final approval.
“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," the expert panel said in a statement.
It said that the emergency use authorisation, however, is subject to four conditions.
"The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol," SEC added.
Other conditions listed by the expert panel are: The firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet; the firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials Rules, 2019; and the firm should submit risk management plan.
Bharat Biotech had last week submitted Phase 2/3 clinical trials data of children's trials to the DCGI for its verification and subsequent approval for emergency use authorisation (EUA) for the jab.
Bharat Biotech, in a statement, said that this represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.
"Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children," it said.
Two doses of Covaxin will be administered to children with a gap of 28 days. For adults, the government has set a gap of 4-6 weeks between the two shots.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing COVID-19 vaccination drive.
This is the second COVID-19 vaccine to get approved for children in India. DGCI had, in August, approved ZyCoV-D for children aged 12 and above as well as adults. However, the rollout has not yet begun.
Loss of Appetite And Other Side Effects Linked With AstraZeneca Vaccine Shot
LONDON, Sept 10: In a recent development, experts have added 4 new side effects that a receipt of AstraZeneca also known as Covishield in India might experience post-vaccination. Side effects of vaccines against deadly coronavirus have been in the limelight ever since the vaccines were first pushed into usage for the common people.
With AstraZeneca's COVID-19 vaccine, these side effects have always been a little more concerning since some of them can actually turn fatal and lead to the urgent need for hospitalisation.
Earlier, some of the recipients of the AstraZeneca vaccine had complained about blood clotting and brain fogging post jab. Now, reports have surfaced which show there are some new side effects that are also linked with AstraZeneca's COVID shots. Let's look at each one of them:
One of the newer side effects of AstraZeneca's is a pain in the arms and legs. Although not everyone who got the jab experienced this uncommon side effect, only a few reports have been registered where the recipients of the Covisheild vaccine jab complained about sudden pain in their joints in the arms and legs.
Another side effect that has been recently added to the already existing list is loss of appetite. According to the reports, some of the AstraZeneca vaccine recipients have reportedly complained about not being able to eat properly after taking the jab or feeling a sense of losing their appetite for a couple of days after getting the vaccine shot.
Experiencing nausea or sudden abdominal pain is also among the 4 new side effects of the Covisheild vaccine dose. According to the experts, a recipient of the Covishield or AstraZeneca COVID-19 vaccine shot may feel certain discomfort in their chest after taking the vaccine shot which can lead to the feeling of vomiting or nausea. This particular side effect is most likely to occur with the first vaccine dose of Covishield or AstraZeneca, rather than the second one.
Flu-like symptoms such as a fever, chills, and body aches are also very common after taking the vaccine shot, but experts have now warned that a Covisheild recipient may also experience symptoms associated with viral influenza.
Above listed side effects linked with the Covishield vaccine are not considered as serious or life-threatening. However, the persistency of these common symptoms can be a bad sign. What are some of the severe side effects of the AstraZeneca vaccine shot or Covishield? Expert says, watch out for these blood clots, seizures, intense headaches, and allergic reactions, post-vaccination.