U.S. FDA to approve Pfizer-BioNTech vaccine in adolescents

U.S. FDA to approve Pfizer-BioNTech vaccine in adolescents


The FDA declined to put a timeline to the approval.

The Food and Drug Administration (FDA) is set to approve the use of the Pfizer-BioNTech two-dose mRNA COVID-19 vaccine for children 12-15 years old according to reports in the American press. The rollout could begin as early as next week. More than 131 million shots of the Pfizer vaccine have been used to date in the U.S., and the extension to adolescents could assist with school re-opening later this year.

The Pfizer-BioNTech vaccine — one of two mRNA vaccines (the other is from Moderna) that have Emergency Use Authorisation (EUA) fin the U.S. for use in people 16 years and older — is likely to be cleared for EUA for adolescents as early as this week, as per reports, which were based on comments from FDA officials. The day after the FDA’s expected approval, the U.S. Centre for Disease Control and Prevention (CDC) will likely meet to give the vaccine the go ahead for use in adolescents, the New York Times reported.

The FDA declined to put a timeline to the approval.

“The FDA’s review of Pfizer’s request to amend its emergency use authorization (EUA) in order to expand the age range for its COVID-19 vaccine to include individuals 12-15 years of age is ongoing,” Stephanie Caccomo, an FDA spokesperson, said, as per the Washington Post.

Of 2,260 adolescents who participated in a Pfizer clinical study, none who were fully vaccinated got COVID-19 , compared to 18 cases in the group that got placebos, the company had reported in March.

While children can get COVID-19, data available over the past year indicates that they are significantly less susceptible than adults. However, the proportion of children in overall infections has been rising in the U.S. , partly because older adults are getting vaccinated.

Moderna is also expected to release the results of a U.S. vaccine study on 12-17 year olds in the summer. Moderna, Pfizer-BioNTech trials for children 6 months and older are also underway. Another company, Novavax , which expects to seek approval for its vaccine in the second quarter of this year, has also expanded its clinical trials to include children in the 12-17 age group.

Pfizer not yet available in India

Pfizer was seeking an “expedited approval pathway” for its vaccine in India, Pfizer CEO Albert Bourla said in a May 3 social media post. The vaccine is currently not approved for any age group in India.

“Unfortunately our vaccine is not registered in India, although our application was submitted months ago, “ Mr Bourla said in the post.

In April, the government relaxed conditions for foreign vaccine use in the country, by permitting foreign vaccine manufactures to conduct clinical trials in India within 30 days of being given EUA (rather than before the fact). Pfizer announced in February that it had withdrawn an earlier application for EUA in India where it had not met the drug trial requirements in place at the time .



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