Infectious Disease

Pfizer-BioNTech applies for FDA approval for COVID-19 booster dose

August 25, 2021

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Pfizer and BioNTech announced on Wednesday that they are filing for FDA approval for a booster dose of their Messenger RNA COVID-19 vaccine for people 16 years and older.

The companies said they filed an application with the FDA for a supplemental biologics license that should be completed by the end of the week.

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The application includes data from a Phase 3 study involving 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, the 50% neutralizing titers after the third dose were 3.3 times higher than after the second dose and thus met the pre-determined 1.5 times non-inferiority criteria for success and superiority, according to the companies.

“In addition, 99.5% of participants had a four-fold response after the third dose compared to 98% after the second dose,” the companies reported. “The titers after the third dose met the pre-determined non-inferiority margin of 10% for the difference of four times the seroreaction rates.”

The side effects after the third dose were mild to moderate, the companies said. The most common events were injection site pain, fatigue, headache, muscle and joint pain, and chills. Serious adverse events were minor.

The vaccine received full FDA approval on Monday. A third dose of the vaccine is currently only approved for use in certain immunocompromised patients in the United States. However, beginning September 20, the US will offer booster doses of Pfizer BioNTech and Moderna vaccines to fully vaccinated Americans 8 months after their second dose, pending FDA approval.

Pfizer and BioNTech also plan to submit the data to a peer-reviewed journal and to file the information with the European Medicines Agency and other global regulatory agencies in the coming weeks.

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