In a major reversal from its previous push to get kids under 5 vaccinated against COVID, Pfizer has withdrawn its application from the FDA for its COVID vaccinations for kids under 5 yrs old.

The company said it “did not have enough data” to recommend it for young kids.

MSNBC reported about the stunning reversal:

 

CNET reports – Last week, Pfizer and BioNTech submitted data to the FDA for authorization of their COVID-19 vaccine for children 6 months through 4 years old. While the vaccine for children under 5 is expected to be a three-dose vaccine series (it’s one-tenth the volume of Pfizer’s vaccine for people 12 and up), the FDA asked the companies to submit data on the first two doses as part of a “rolling submission” process.

In December, Pfizer announced that while two doses of the vaccine were effective in children ages 6 months to 2 years, two shots failed to promote a strong enough immune response in children ages 2 through 4 years. This prompted the company to start testing a three-dose version of the vaccine for children under 5.

New York Post reports – Pfizer unexpectedly announced Friday that it had scrapped its bid to have its COVID-19 vaccine approved for children ages 6 months to up to 5 years old.

The pharmaceutical giant and its partner, BioNTech, had at the beginning of the month applied for emergency use authorization with the Food and Drug Administration based on a quicker timeline of research on just two shots.

But the companies announced Friday that they were going to “extend their rolling submission” to the FDA to await fuller testing on three-shot doses.

Pfizer’s decision coincides with an FDA report that was scheduled to be released today.

The FDA, which had been expected to release the latest data from studies Friday, also confirmed the decision to delay.

FDA STATEMENT:

Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study. The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group. Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness. Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.

 

 

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