FDA takes a rare step and asks Pfiz­er to sub­mit a Covid-19 vac­cine EUA for the youngest chil­dren

What does the FDA know that we don’t? Hope­ful­ly a lot.

With­out of­fer­ing much de­tail, the FDA yes­ter­day af­ter­noon asked Pfiz­er to send over a rolling sub­mis­sion to amend its Covid-19 vac­cine EUA to in­clude chil­dren 6 months to un­der 5 years of age.

The tricky part in mak­ing such a re­quest is that last month, Pfiz­er an­nounced that its vac­cine (a 3 µg dose for the youngest pop­u­la­tion) demon­strat­ed non-in­fe­ri­or­i­ty for the 6- to 24-month-old pop­u­la­tion, when com­pared to the 16- to 25-year-old pop­u­la­tion in which high ef­fi­ca­cy was demon­strat­ed, but not for the 2- to un­der 5-year-old pop­u­la­tion.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER