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COVID-19 Vaccine for Kids: Covaxin Gets Emergency Use Approval for Children Above 2 Years of Age

The Subject Expert Committee (SEC) on Covid-19 has given emergency use approval to Covaxin, a COVID-19 vaccine developed by Bharat Biotech, for children 2-18 years of age. This represents one of the first approvals globally for COVID-19 vaccines for the 2-18 age group.

Covaxin is the second COVID-19 vaccine to be approved for emergency use among children in India. Earlier in August 2021, India granted emergency use approval to ZyCov-D, the COVID-19 vaccine developed by pharmaceutical firm Zydus Cadila, for children aged 12 to 18. The vaccine is the first DNA vaccine to be approved in the world.

Other vaccine candidates being considered for children include Covovax and Corbevex. Both the vaccines have been given the go-ahead to conduct mid-stage trials on children aged 7-14 years old.

Bharat Biotech announced the completion of Phase-2 and Phase-3 trials of Covaxin on children below 18 years in September 2021. Bharat Biotech submitted the trial data to the DCGI (Drugs and Comptroller General of India) for verification and consequent approval for emergency use authorization for the jab in the beginning of this month.

The Central Drugs Standard Control Organization (CDSCO) and the SEC on COVID-19 reviewed the submitted data, which provided recommendations to grant market authorization of this vaccine for the age group of 2 – 18 years for restricted use in emergency situations.

The vaccine will be administered in two doses, with a 20-day gap between the first and the second dose.

The developer of Covaxin will continue the study as per the approved clinical trial protocol and provide updated prescribing information/package.

The company is now waiting for further regulatory approvals from the CDSCO before launching the product in the market for children.

In addition, as per requirement of New Drugs & Clinical Trials Rules, 2019; the company has to submit safety data including the data on AESI and AEFI, with due analysis, every 15 days for the first two months and every month afterwards.

Frequently Asked Questions

  • Do children need the COVID-19 vaccine?

Yes, the vaccine helps to prevent or reduce the spread of the COVID-19. While children are unlikely so far to develop serious complications or severe disease due to COVID-19, they may spread the infection to adults who are more prone to develop severe complications or severe disease due to COVID-19.

COVID-19 vaccine can protect the child and help reduce the spread of COVID-19 infection.

  • When Can Children Get the COVID-19 vaccine?

The SEC (Subject Expert Committee) recently approved Covaxin, a COVID-19 vaccine developed by Bharat Biotech for emergency use in children between 2-18 years of age. While the SEC recommended authorizing the vaccine to be used in kids sparking a big relief for parents and educational institutions, there is yet no official confirmation on the likely date.

  • What other vaccines would be available for kids?

While Covaxin is the first vaccine officially approved for use in children between 2-18 years of age, other vaccines are also being planned to vaccinate kids in India. Earlier, ZyCov-D, a COVID-19 vaccine developed by Zydus Cadila, has been considered for use in children aged 12 to 18 years. While the trials are still underway, it may take some time before the vaccine hits the market.

Other vaccine candidates being considered for children include Covovax and Corbevex. Both the vaccines have been given the go-ahead to conduct mid-stage trials on children aged 7-14 years old.

  • What Does Emergency Use Authorization (EUA) mean for Children?

Emergency Use Authorization (EUA) refers to a mechanism in which the authorities allow the use of certain medications and vaccines in a life-threatening emergency, such as COVID, after reviewing the clinical trials and laboratory-based data. Covaxin has currently been granted emergency use authorization in India- and not full access. While Covaxin is still undergoing an important last stage study, the necessary EUA was granted based on a risk vs benefit evaluation.

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