Albert Bourla, Pfizer CEO (Patrick Semansky/AP Images)

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.

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