💥Breaking News !!💥
✔️ Pfizer initiated a request for FDA emergency use authorization of their vaccine in kids aged 6 months to <5 years today!
Back in December, Pfizer announced that 2, 3 µg doses given 3 weeks apart in kids aged 6 months to <5 years, was *SAFE*, but did not produce as strong of an immune response in kids aged 2 to <5 years as they had been aiming for (though it *DID* produce a strong immune response in kids aged 6 months – 2 years!). They decided to test a third 3 µg dose given 2 months after the second, to see if this would produce a more robust immune response in the 2 to <5 age group.
This week the U.S. Food and Drug Administration (FDA) urged Pfizer to request an emergency use authorization (EUA) for the 2-dose regimen for kids aged 6 months to <5 years *NOW* and then request additional authorization for a third dose, once the 3-dose trial data is available.
💥Pfizer listened and initiated the request to amend the EUA to include this age group today!
This means that if authorized by the FDA, kids in this age group will be able to start the vaccine series sooner (likely in a matter of weeks), even if a 3-dose regimen will ultimately be needed! A huge relief to parents everywhere that have been anxiously waiting to be able to protect their kids aged < 5 years against COVID-19!
We will report out any news on the FDA review of Pfizer’s request as soon as we see it break!