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Citing the need to see more data as part of its rolling application process, the Food and Drug Administration (FDA) announced on Friday, Feb. 11 that it would be delaying the planned meeting, raising questions about how soon children should get the COVID-19 shot.
The FDA’s outside experts had been set to meet on Tuesday, Feb. 15 to discuss if children under the age of 5 could safely receive a low dose of the vaccine safely.
Pfizer said on Friday that it will be waiting for new data on a three-dose series of the vaccine for children between 6 months and 5 years old, the only age group in the US still not eligible to receive the vaccine.
The trial in children 6 months through 4 years of age is still in progress and data on the first two doses in that age group are being shared with the FDA on an ongoing basis, officials noted.
Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
“The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and supports a potential three-dose regimen,” they said.
“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.”
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