Pfizer and BioNTech Secure FDA Authorization for Fourth Dose of COVID-19 Vaccine as Second Booster

On March 29, Pfizer and BioNTech announced that the U.S. FDA had expanded the emergency use authorization of their COVID-19 vaccine to include a second booster dose for individuals aged 50 and older.

Additionally, the FDA has authorized the vaccine for a second booster dose in individuals aged 12 and above who have been identified as having certain immunocompromised conditions and have already received any of the approved COVID-19 booster shots. The additional booster will be administered at least four months after the first booster, with the same formulation and dosage strength as the previous Pfizer and BioNTech COVID-19 vaccine doses.

This EUA expansion is based on clinical trial data provided by the two companies, one of which was an open-label trial conducted at a medical center in Israel involving 154 participants aged 18 and above. During the Omicron wave, participants received two booster doses within specified timeframes. Results showed that, compared to the neutralizing antibody concentrations five months after the first booster dose, the average neutralizing antibody levels against both the Delta and Omicron variants increased approximately 11-fold two weeks after the second booster dose. No new safety concerns were identified among participants. The effectiveness of the COVID-19 vaccine significantly declines 3-6 months after the initial booster dose. Evidence from Israel suggests that an additional booster dose can effectively reduce the number of severe cases and deaths.

Previously, the Pfizer-BioNTech COVID-19 vaccine had received EUA authorization as a single booster dose for individuals aged 12 and above who have completed the primary vaccination series.

It is reported that the vaccination in the United States is divided into primary and booster series. The primary series is administered as a 2-dose regimen, 3 weeks apart, to individuals aged 5 years and above. For the booster series, the first booster dose can be administered 5 months after receiving the Pfizer-BioNTech COVID-19 vaccine or COMIRNATY to individuals aged 12 years and above, and the first booster dose can also be administered to individuals aged 18 years and above who have received any approved primary COVID-19 vaccine.

Reference Source: Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older

Editor: Liuli

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