“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.
“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 release says. “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.”
Pfizer and BioNTech expect to have three-dose protection data available in early April. The extension will give the FDA the time to examine data on the two- and three-dose regimens.
Pfizer said the study’s independent Data Monitoring Committee supports the continuation of the trial. It believes that the data collected indicates that the vaccine is well-tolerated and supports a potential three-dose regimen.
This is a developing story and will be updated.
