Moderna Follows Pfizer With Their Own Omicron BA.4/BA.5 Application to the FDA

One day after Pfizer and BioNTech submitted their emergency use authorization (EUA) for their bivalent COVID-19 Omicron BA.4/BA.5 vaccine, Moderna announced they completed their own submission of their version of the vaccine to the United States Food and Drug Administration (FDA). This completion follows a deal struck between Moderna and the US government for the manufacturing and delivering of the bivalent vaccines earlier this year. 

Related Article: Moderna to Supply 66 Million COVID-19 Boosters to US

Getting the Bivalent Vaccine Rolled out to the Public

mRNA-1273.222 is a bivalent vaccine, which are vaccines protecting against multiple antigens. In the case of mRNA-1273.222, it protects against the original SARS-CoV-2 strain and the subvariants of the Omicron strain BA.4/BA.5. First identified around May of this year, the BA.5 subvarient causes around 65% of current COVID-19 cases, while BA.4 causes around 17%.

In July of this year, Modern announced a secured deal with the US government to develop and purchase mRNA-1273.222 doses. In exchange for 66 million doses, the government provided Moderna with $1.74 billion. At the time, the bivalent vaccine was still under development per FDA regulations. Since then, mRNA-1273.222 moved to evaluation under a Phase ⅔ clinical trial. Despite not having the trial results, Moderna based its emergency use authorization application on prior clinical data from a previous bivalent vaccine. 

Previous Omicron Vaccine Supports Updated Candidate

mRNA-1273.214 is another bivalent vaccine developed by Moderna. However, it targets the BA.1 subvarient of the COVID-19 Omicron strain. In June of this year, a Phase ⅔ clinical trial demonstrated the candidate’s effective defense against the omicron strain. 

In addition to preclinical data of mRNA-1273.222, this data formed the basis of Moderna’s application for the vaccine’s emergency use authorization.

On Moderna’s collaboration with the FDA, Stéphane Bancel, Chief Executive Officer of Moderna, said, “We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster.”

Moderna’s submission marks yet another application to the FDA for an Omicron BA.4/BA.5 vaccine. A day before this announcement, Pfizer and BioNTech submitted their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine to the FDA for an emergency use authorization. In comparison to Moderna, clinical data of the companies’ Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data show that the Pfizer/BioNTech BA.4/BA.5 vaccine dose generated an effective and safe response to Omicron strains BA.1, BA.2 and BA.4/BA.5 in addition to the original COVID-19 strain. 

While Moderna and Pfizer/BioNTech continuously compete for success in the vaccine market, other companies like AstraZeneca may drop out of the market. With their COVID-19 vaccine still not gaining US approval, the CEO of AstraZeneca, Pascal Soriot, stated he ‘can’t be sure’ they’ll stay in the market.

Should the FDA approve Moderna’s application, the company is rapidly upscaling the manufacturing of mRNA-1273.222, preparing to deliver their orders in September. 

Author

Max Heirich