Pfizer told the FDA on Friday that it wants a delay on the company’s EUA request for a two-dose Covid vaccine for children under five. . .
BREAKING: Pfizer postpones application to the FDA to expand use of its Covid vaccine for kids under 5. https://t.co/oSBVViwVqm
— NBC News (@NBCNews) February 11, 2022
. . .and that’s because Pfizer thinks three doses “may provide a higher level of protection in this age group”:
BREAKING: Pfizer pulls FDA request for Covid vaccine for kids under 5
👉The company believes three doses "may provide a higher level of protection in this age group." Data on the third dose is expected in early April.https://t.co/Rus7OwA5NX via @nbcnews
— Heidi Przybyla (@HeidiReports) February 11, 2022
Here’s the statement from the FDA:
The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
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Something just doesn’t add up here, right?
Pfizer/BioNTech first submitted this application at the FDA's request — an unusual step, as I reported for the Guardian at the time. Now it seems the companies have pulled the request. https://t.co/tb7XPRqwO8
— Melody Schreiber (@m_scribe) February 11, 2022
The FDA was going to meet on February 15 to discuss the authorization for this age group:
JUST IN: @US_FDA has postponed its Feb. 15 advisory committee meeting on an EUA request for the use of the Pfizer-BioNTech Covid-19 vaccine in children 6 months through 4 years old, citing the need for more time to review additional findings from Pfizer's ongoing clinical trial.
— Celine Castronuovo (@cecelou18) February 11, 2022
Pfizer expects to have data from the three-dose vaccine in April:
Pfizer, which has been sharing trial data with the FDA on an ongoing basis, has decided to wait until data from the three-dose trial is complete, which the company expects to have in early April.https://t.co/MefTZ3uyOo
— WDTN (@WDTN) February 11, 2022
In other words, “back to the drawing board”:
FDA and Pfizer postpone review of #covid19 vaccine for kids under 5 to await three-dose data (back to the drawing board), noting additional findings from ongoing clinical trial. FDA statement on delay of advisory committee meeting: pic.twitter.com/Fxw6SFZDg1
— Meg Tirrell (@megtirrell) February 11, 2022
Do you mean to tell us our health experts have a messaging problem?
What a nightmare. I get the decision, but why tell Pfizer to submit and then change their minds?
The FDA and CDC messaging around Covid have been simply pathetic. https://t.co/ZnVoZNm44w
— Tim Fullerton (@TimFullerton) February 11, 2022
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