Pfizer-BioNTech seek FDA approval for COVID-19 booster dose
Pfizer and BioNTech announced Wednesday that they are seeking FDA approval for a booster dose of their messenger RNA COVID-19 vaccine for people aged 16 years or older.
The companies said they have initiated a supplemental biologics license application with the FDA that should be finished by the end of the week.
The application includes data from a phase 3 trial of 306 participants aged 18 to 55 years who received a third dose of the vaccine between 4.8 and 8 months after completing the initial two-dose regimen.
According to the companies, 50% neutralizing titers were 3.3 times higher after the third dose than the second dose, meeting the prespecified 1.5-fold noninferiority criterion for success and superiority, the companies said.
“Moreover, 99.5% of participants had a fourfold response after the third dose compared to 98% after the second dose,” the companies reported. “The titers after dose three met the prespecified 10% noninferiority margin for the difference in the fourfold seroresponse rates.”
Adverse events following the third dose were mild to moderate, the companies stated. The most common events were injection site pain, fatigue, headache, muscle and joint pain and chills. Severe adverse events were low.
The vaccine received full FDA approval on Monday. Currently, a third dose of the vaccine is authorized only for certain immunocompromised patients in the United States. However, starting Sept. 20, the U.S. will begin offering booster doses of the Pfizer-BioNTech and Moderna vaccines to fully vaccinated Americans 8 months following their second dose, pending FDA authorization.
Pfizer and BioNTech also intend to submit the data to a peer-reviewed journal and file the information with the European Medicines Agency, as well as other global regulatory authorities, in the coming weeks.
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