The FDA refused to put a timeline for approval.

The Food and Drug Administration (FDA) is set to approve the use of Pfizer-BioNTech’s two-dose COVID-19 mRNA vaccine for children 12 to 15 years old according to US press reports. Deployment could begin as early as next week. More than 131 million injections of the Pfizer vaccine have been used to date in the United States, and the extension to adolescents could help the school reopen later this year.

The Pfizer-BioNTech vaccine – one of two mRNA vaccines (the other is from Moderna) that have an Emergency Use Clearance (EUA) in the United States for use in people 16 years of age and older – is likely to be cleared for EUA for adolescents as early as this week, according to reports, which were based on comments from FDA officials. The day after the expected FDA approval, the US Center for Disease Control and Prevention (CDC) will likely meet to green light the vaccine for use in adolescents, the New York Times reported.

The FDA refused to put a timeline for approval.

The FDA’s review of Pfizer’s request to amend its Emergency Use Authorization (EUA) to expand the age range of its COVID-19 vaccine to include people aged 12 to 15 is ongoing, ”said Stephanie Caccomo, spokesperson for the FDA. , according to the Washington Post.

Of 2,260 adolescents who took part in a Pfizer clinical study, none of those who were fully vaccinated contracted COVID-19, compared with 18 cases in the group who received placebos, the company reported in March.

Although children can contract COVID-19, data available over the past year indicates that they are significantly less susceptible than adults. However, the proportion of children in all infections has increased in the United States, in part because older adults are getting vaccinated.

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

Pfizer not yet available in India

Pfizer was seeking a “fast-track approval path” for its vaccine in India, Pfizer CEO Albert Bourla said in a May 3 post on social media. The vaccine is not currently approved for any age group in India.

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

In April, the government eased conditions for the use of foreign vaccines in the country, allowing foreign vaccine makers to conduct clinical trials in India within 30 days of EUA administration (rather than before the fact). Pfizer announced in February that it had withdrawn an earlier EUA application in India, where it failed to meet drug testing requirements in place at the time.

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