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The panel voted 17 to 0 to recommend that FDA grant Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 vaccine in children aged 5 to 11 years old.
Pfizer announced that the FDA Vaccines and Related Biological Products Advisory (VRBPAC) Committee voted to recommend that FDA grant Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine in children aged 5 to 11 years old. The committee voted 17 to 0, with one member abstaining.
The committee reviewed results from a Phase II/III randomized, controlled trial that included approximately 4500 children aged 5 years to less than 11 years. According to a Pfizer press release, the vaccine efficacy rate was 90.7% in participants who were given a two-dose regimen of 10-µg of the Pfizer-BioNTech vaccine administered 21 days apart (one-third of the dosage given to individuals aged 12 years and older).
If approved, this would make the Pfizer-BioNTech vaccine the first available for the 5 years to under 12 years age demographic. FDA is expected to make a decision on the EUA in the coming days.
“We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our COVID-19 vaccine in children 5 to under 12 years of age,” said Kathrin U. Jansen, senior vice-president and head of Vaccine Research & Development, Pfizer, in the press release. “COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the US, as they remain at risk for this infection. About 10% of all weekly US cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner. We thank the FDA advisory committee for their review and positive recommendation in support of [EUA] to help protect this young population.”
“We are committed to support the ongoing efforts to reduce infections and COVID-19 cases around the world by expanding the population of people protected against COVID-19,” said Özlem Türeci, co-founder and chief medical officer of BioNTech, in the press release. “The clinical data reviewed underline that our vaccine induces a strong immune response in children when Delta was the prevalent strain and thus may contribute to help address this public health crisis.”