FDA Approves Both Moderna’s and Pfizer/BioNTech’s Omicron Bivalent Vaccines in One Day

On August 31, the United States Food and Drug Administration (FDA) granted Emergency Use Authorizations (EUA) for both Pfizer/BioNTech’s and Moderna’s Omicron BA.4/BA.5 Bivalent Vaccines. The basis of the FDA’s decision was preclinical data for the BA.4/BA.5 vaccine and data from clinical studies around each company’s Omicron BA.1 vaccine. The authorizations come at a time after Moderna filed a lawsuit against Pfizer. 

Related Article: Moderna’s Lawsuit Against Pfizer/BioNTech: What Does This Mean for Their Vaccine’s future?

Updated Vaccines Are Now Available

Since Omicron subvariant strains BA.4/BA.5 emerged in May this year, they quickly became the most dominant strains of COVID-19. Together, they account for over 80% of new COVID-19 infections, with BA.5 causing 65% alone.  

Incensed into action, pharmaceutical companies swiftly developed updates to their established vaccines. Chief among these were Pfizer/BioNTech and Moderna. Both companies already possessed an Omicron BA.1 bivalent vaccine tested in separate Phase ⅔ clinical studies. Moderna and Pfizer combined their study’s data with preclinical data for the new Omicron BA.4/BA.5 Bivalent Vaccines in their submissions to the FDA. 

Pfizer/BioNTech submitted their EUA to the FDA on August 22. The authorization granted today approves its use in individuals ages 12 years and older as a 30-µg booster dose. Two days after Pfizer/BioNTech’s submission, Moderna submitted their own updated bivalent booster, mRNA-1273.222. Their EUA outlines mRNA-1273.222’s use as a 50 µg booster dose for adults over 18 years of age.

What Does This Mean for the Supply of Vaccines?

Anticipating this authorization, Moderna struck a deal with the U.S. government in July. In exchange for 66 million doses of mRNA-1273.222, the U.S. government paid Moderna $1.74 billion for manufacturing and delivering the doses. The deal also left room for the additional purchasing of 234 million doses. 

On today’s authorization, Stéphane Bancel, Chief Executive Officer of Moderna, said, “The FDA’s authorization of our updated bivalent booster, mRNA-1273.222, provides Americans with access to broader protection against Omicron variants. We are grateful to the FDA for their decisive leadership.”

Conversely, Pfizer/BioNTech’s previous and updated bivalent vaccine will remain available under their continuous deal with the U.S. government. However, they intend to withdraw their supplemental Biologics Application (sBLA) for their original vaccine in exchange for a new filling for their updated bivalent vaccine. However, the original vaccine will remain the primary series for those six months of age and older.

On the authorization, Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said, “With today’s approval, a vaccine will shortly become available that addresses the currently prevalent Omicron sublineages with the aim of preserving protection against COVID-19.”

Despite the lawsuit filed by Moderna against Pfizer/BioNTech, vaccine supply is expected to be unaffected. This is due to Moderna seeking payment for what they claim is their mRNA technology used in Pfizer/BioNTech’s COVID-19 vaccines. 

Going forward, Pfizer/BioNTech intends to submit applications for the bivalent vaccine’s use in children 5 through 11 in October and six months through 4 years afterward. 

As for Moderna, a phase ⅔ clinical study is currently underway evaluating mRNA-1273.222. Moderna expects the initial data from this trial sometime in late 2022. 

Author

Max Heirich