Pfizer Seeks FDA Authorization For Updated COVID Booster Shot

Pfizer and BioNTech announced they have completed their submission to the U.S. Food and Drug Administration requesting an emergency use authorization of their updated COVID-19 vaccine for individuals 12 years and older.

The new vaccines will provide protection against the original strain of the virus and the Omicron sublineages BA.4 and BA.5, which have become the leading causes of COVID infections in the country.

Pfizer said the data from pre-clinical trials showed that the bivalent vaccine "generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants."

"The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test, and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges."

The FDA's Vaccines and Related Biological Products Advisory Committee will review the data and decide whether to authorize the updated vaccine. If they approve the vaccine, a committee with the Centers for Disease Control and Prevention will then meet to discuss the vaccine. If they also authorize it, CDC Director Dr. Rochelle Walensky will then make the final decision before the vaccine is distributed.

Health officials have previously said they hope the new vaccines will be approved in the early fall. The FDA committee is scheduled to meet next on September 22.