Covaxin Approval Requested In US For Minors

After the approval of Pfizer’s Covid-19 Vaccine shot in the US for children between ages 5-11, US firm Ocugen who partners with Bharat Biotech to develop Covaxin has announced that it has asked authorities for the emergency use authorisation of the vaccine for ages 2 to 18.

“Ocugen’s data, gathered from clinical trials conducted outside of the United States with only a small group of children, may not be enough for the Food and Drug Administration (FDA) to grant the request,” an Agence France Presse report stated.

Covaxin, gained emergency approval from the World Health Organization on Wednesday and has already been cleared for use in 17 countries.

The approval request is based on results from a study of 526 kids between ages 2 and 18 who received two doses of Covaxin 28 days apart.

You might also like