Pfizer Delays FDA Request For Its COVID Vaccine For Children Under 5

Pfizer has postponed its rolling application for FDA authorization for its COVID-19 vaccine for children under the age of five. The pharmaceutical company said it wants to wait for the results of a study testing a three-dose course of the vaccine.

In December, Pfizer said the two-dose series didn’t generate a strong immune response in children between the ages of two and four. Those children were given a three microgram dose. Children between the ages of five and 11 are given a 10 microgram dose.

“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,” Pfizer said in a statement. “This is also supported by recent observations of three-dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real-world vaccine protection for omicron compared to the two-dose regimen.”

As a result, the Food and Drug Administration announced it was postponing a February 15 meeting of its Vaccines and Related Biological Products Advisory Committee.

“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,” acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Pfizer said it hopes to have data on the efficacy of the three-dose series by April.

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