Pfizer submits application for updated COVID-19 vaccine booster to FDA

Pfizer said Monday that it has submitted its application to the Food and Drug Administration (FDA) for an updated COVID-19 vaccine targeting the omicron subvariant currently circulating.  

The application comes ahead of a fall booster shot campaign. Assuming the FDA signs off, the shots are expected to begin in September.  

The application, per instructions previously given by FDA, is for a “bivalent” vaccine that targets the BA.4 and BA.5 subvariants of omicron currently circulating, as well as the original form of the virus.  

The vaccine is designed to be more effective against the current form of the virus, given there has been significant evolution. In addition, protection from the initial shots wanes over time.  

“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,” Albert Bourla, Pfizer’s CEO, said in a statement.  

“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,” he added.  

The application is for everyone 12 years of age and older.  

“The vaccines that are coming in a few short weeks are specifically designed for the virus that’s out there, and I believe it’s going to be available and every American over the age of 12 will be eligible,” White House COVID-19 response coordinator Ashish Jha said last week on “NBC Nightly News.” 

Pfizer said the first doses are available to ship immediately pending authorization from the FDA.  

The company said that, following FDA guidance, it had submitted clinical data from a slightly different vaccine, targeting the BA.1 strain of omicron, as well as more preliminary data from the BA.4/BA.5 vaccine itself. 

The BA.1 vaccine was “was well-tolerated with a favorable safety profile,” Pfizer said.  

It remains unclear how many people will get the new boosters, despite the potential for a surge of COVID-19 over the fall and winter, given that uptake for the first booster shot has been lagging.  

Only about half of people who got the first two shots received the first booster shot, according to Centers for Disease Control and Prevention data.