, Pfizer-BioNTech requested emergency use authorization for a booster dose of the vaccine, which contains a combination of the genetic material mRNA from the original virus circulating when the vaccine was initially approved in August 2021, and mRNA from the newer BA.4 and BA.5 subvariants. The vaccine is intended for anyone 12 years or older.
The companies have been studying the BA.4 and BA.5 vaccine in animal models and submitted that data to the FDA for review. Those studies showed the vaccine was safe and produced a “strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5,” the companies said in the statement. Pfizer-BioNTech says it has scaled up production of the BA.4/BA.5 vaccine and is ready to begin shipping immediately if the FDA authorizes the shot.
Other vaccine makers are also developing Omicron-specific vaccines and likely won’t be far behind in requesting FDA authorization. Moderna, which makes the other mRNA COVID-19 vaccine approved by the FDA, releasedin June showing its vaccine, which also targeted the BA.1 subvariant, produced higher levels of virus-fighting antibodies against Omicron in people compared to the original vaccine. At the FDA’s request, Moderna is also developing a BA.4/BA.5-specific version of its Omicron vaccine.