FDA Postpones Committee Meeting to Approve Pfizer Vaccine for Children 6mos to 4 Years at Company Request
“This is sketchy. Despite them calling the upcoming February 15th meeting of the FDA vaccine advisory committee an approval review, everyone knows the meetings are just formalities as the FDA has rubber stamped all Big Rx requests throughout the COVID-19 effort.
As a result, the FDA was only a few days away from authorizing the Pfizer vaccine for children 6months to 4-years old. However, according to an FDA press release [SEE HERE] Pfizer asked the FDA to wait for authorization until more clinical trial data could be gathered. Additionally, Pfizer plans on presenting the findings of a three-dose vaccine regime.
FDA Press Release – 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.
Therefore, the FDA is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15.
This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.
We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation.” (read more)