First Omicron Booster Submitted to FDA By Pfizer-BioNTech

All COVID-19 vaccines used in the U.S. are based on the same strain of SARS CoV-2. However, there may soon be boosters to defend against Omicron subvariants.

Pfizer BioNTech, a subsidiary of Pfizer Inc. submitted a request for authorization to U.S. Food and Drug Administration. It targets BA.4 (or BA.5), which account for most new infections in the U.S.

Pfizer BioNTech announced that it had requested an emergency authorization to use a booster vaccine. This vaccine contains both the genetic material, mRNA, from the original virus which circulated when the vaccine was approved for the first time in August 2021 and the mRNA of newer subvariants BA.4 and BA.5. This vaccine is for people aged 12 and older.

These companies submitted data to FDA for approval after they had conducted animal studies on the BA.4/BA.5 vaccine. 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 states that it has ramped up the production of BA.4/BA.5 vaccine, and will begin shipping as soon as the FDA approves. Although the FDA does not have a timeline for when this might occur, it has stated that they requested vaccine manufacturers develop a booster BA.4/BA.5 in order to provide protection during the winter and fall months when viruses such as SARS-CoV-2 are more prevalent. The FDA will most likely take action as soon as the situation permits. If the agency authorizes the booster, the White House’sCOVID-19 response coordinator Dr. Ashish Jha predicted on Aug. 16 that the shot could be available “by early to mid September.”

There are no data yet on the safety or efficacy Omicron-specific shots in humans. These studies will start in August. The animal data are not the only ones available.,The request was based upon limited human data Pfizer BioNTech obtained with a similar vaccine that targeted an Omicron variant called BA.1. In June, an FDA panel made up of independent experts examined the data and rejected it from authorization. Instead they asked companies to create a vaccine that targets the BA.4 or BA.5 subvariants.

Other vaccine makers are also developing Omicron-specific vaccines and likely won’t be far behind in requesting FDA authorization. Moderna (which makes the second mRNA COVID-19 vaccination approved by FDA) released data promising in June that it produced more Omicron-fighting antibodies than its original vaccine. At the FDA’s request, Moderna is also developing a BA.4/BA.5-specific version of its Omicron vaccine.

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