Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have received emergency use authorization for BNT162b2 mRNA COVID-19 vaccine for individuals at least 16 years old.
To coincide with the announcement, CDC Director Dr. Rochelle Walensky recommended that everyone 16 and older receive a booster. “Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants,” Walensky said. Recipients need to wait at least six months after completing the primary vaccination series.
The Pfizer-BioNTech is now the only COVID-19 vaccine to win authorization for adolescents between 16 and 17.
“Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus,” said Albert Bourla, Pfizer CEO, in a press release.
In related news, Pfizer also said that the Omicron variant could spur interest in a fourth COVID-19 vaccine booster earlier than anticipated — perhaps six months after dose three, Bourla said in a Bloomberg interview.
Pfizer and its partner BioNTech are developing a variant-specific booster but are uncertain whether it is necessary. The companies anticipate that such a booster would be ready in March, according to a Bloomberg interview with Bourla. An Omicron-specific variant could be less protective against the Delta variant, but having boosters available for both Delta and Omicron variants would give health authorities greater flexibility in fighting the pandemic.
Bourla anticipates that more data will be available in the coming weeks concerning the performance of the BNT162b2 vaccine against the Omicron variant.
Filed Under: clinical trials, Drug Discovery