Pfizer has pulled its FDA request to authorize a 2-dose shot for kids under 5, saying it will 'wait for the 3-dose data'
AP Photo/Nam Y. Huh
- Parents of kids aged 0-5 will have to wait until at least April for a COVID-19 vaccine from Pfizer.
- On Friday the company said it was going to "wait for the 3-dose data" before requesting FDA authorization.
- Pfizer says a 3-dose regimen may provide better protection than 2 doses.
No COVID-19 vaccine for kids under 5 is going to be available this month after all.
Pfizer announced on Friday that the company will continue to "wait for the three-dose data" from its COVID-19 vaccine trial in kids 6 months to 5 years of age, before submitting for an Emergency Use Authorization with the US Food and Drug Administration this spring.
"Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," the pharmaceutical company said in a release. "The companies expect to have three-dose protection data available in early April."
The FDA's independent advisory group on vaccines was set to meet on February 15 to review Pfizer's two-dose data, but that meeting will likely be put on hold until Pfizer's three-dose data is ready in a few months.
"The extension allows the FDA time to receive updated data on the two- and three-dose regimen, conduct a thorough evaluation of it, and facilitate a robust, public discussion," Pfizer said.
Dr. Anthony Fauci, the president's chief medical advisor, predicted to Insider in November that a vaccine for babies and toddlers might be ready by this spring.
But, he also said "can't guarantee it, you've got to do the clinical trial."
Pfizer's vaccine dose for kids under 5 is tiny, and it's not clear if its enough to do the job
Pfizer is testing a very small 3 microgram doses for kids under 5, which is 10% of the amount of mRNA adults get with Pfizer vaccines, and a third of the Pfizer mRNA dose for 5-11 year olds.
The company announced in December that 2 doses of that size were effective for the youngest children in the trial those 6 months to 2 years old, but it didn't seem to be enough to stimulate a good immune response in the 2 to 5-year-olds.
"A vaccine that doesn't work (but is safe) won't generate a ton of interest," Dr. Jeremy Faust, an emergency physician at Brigham and Women's Hospital, and a parent of a 3-year-old, said in a recent newsletter, pressing for more "solid" data on the Pfizer vaccine for children under 5.
Pfizer hasn't shared any efficacy data on this age group publicly yet, but The New York Times reported earlier this month that an anonymous source who was "familiar with the data" on two doses shared that 2 to 4 year olds in Pfizer's trial "were infected at a rate 57% lower" than their unvaccinated counterparts in the study, while the COVID-19 rate in babies 6 months to 2 years old was 50% lower for those with Pfizer on board.
Moderna is testing out larger vaccine doses than Pfizer in its KidCove study, but the company has yet to report any pediatric results.
from Business Insider https://ift.tt/RK1no57
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