Moderna Wins the First Regulatory Approval for an Omicron Bivalent Vaccine

On August 30, Moderna announced that the Therapeutic Goods Administration (TGA) in Australia granted provisional approval for the company’s bivalent Omicron vaccine. This approval marks the first granted worldwide by a regulatory body. 

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

The Wave of Pending Bivalent Omicron Vaccines

Bivalent vaccines grant protection against two different strains of a disease. With the onset of the Omicron strain of COVID-19 in November of 2021, the previously approved vaccines did not provide as effective defense as they did against the original COVID-19 strain. As a result, pharmaceutical companies began developing updated vaccines to protect against these new strains. 

Moderna developed mRNA-1273.214, an improvement on their original Spikevax vaccine, now containing mRNA code for protection against Omicron subvariants BA.1. Omicron BA.1 is the original Omicron strain, having since further mutated to four other distinct subvarants. 

This August saw various submissions to regulatory bodies for the approval of the bivalent Omicron vaccine. Not only did Moderna submit mRNA-1273.214 to the United States Food and Drug Administration (FDA), but Pfizer also submitted their own vaccine. The vaccines co-produced by Pfizer and BioNTech provide defense against Omicron subvariants BA.4/BA.5. These two strains are further mutations of the original Omicron strain, BA.1. Since their emergence in May of this year, together, they caused over 80% of new COVID-19 cases. 

However, today marks the first approval granted by a regulatory agency for any bivalent omicron vaccine.

The First Approved Omicron Bivalent Vaccine

Australia’s TGA granted provisional approval for Moderna’s mRNA-1273.214 protecting against Omicron BA.1. The basis of the approval was the results found in a phase ⅔ clinical trial. The trial demonstrated that mRNA-1273.214 met all of its primary endpoints. Namely, the bivalent vaccine showed an eight-fold improvement in killing Omicron than Moderna’s original vaccine, mRNA-1273, had. In addition, the bivalent Omicron vaccine’s safety profile matched that of mRNA-1273.

This approval comes just days after Moderna filled lawsuits against Pfizer and BioNTech for allegedly copying their mRNA technology

On the approval, Arpa Garay, Chief Commercial Officer at Moderna, said, “We are delighted to receive provisional approval from the TGA for our next-generation bivalent vaccine, mRNA-1273.214. Australia becomes one of the first countries in the world to approve an Omicron-containing vaccine, highlighting its continued stewardship in the fight against COVID-19. This is a vital step in helping to keep the Australian people safe from the ongoing threat that COVID-19 represents to global public health.”

The TGA’s approval marks a positive milestone for the approval of Moderna’s Bivalent Omicron Vaccine. In the coming weeks, other regulatory bodies will likely follow suit and grant approval for the new vaccine.

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Author

Max Heirich