Moderna’s BA.4/BA.5 Omicron-targeting COVID-19 booster – mRNA-1273.222 – has been granted Emergency Use Authorisation (EUA) by the US Food and Drug Administration (FDA), the company announced.
The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the US and are predicted to circulate in the autumn and winter, the FDA reported.
The approval is specifically for a 50µg booster dose for adults 18 years and older, and is based on preclinical data and clinical trial data available from a phase 2/3 study evaluation the company’s BA.1 Omicron-targeting bivalent booster candidate, mRNA-1273.214.
In the study, mRNA-1273.214 met all primary endpoints, including superior neutralising antibody response against Omicron when compared to a 50µg dose of the currently authorised booster – mRNA-1273 – in previously uninfected participants, as well as potent neutralising antibody responses against the Omicron subvariants BA.4 and BA.5 when compared against mRNA-1273 regardless of age or prior infection status.
Additionally, the company said in a statement: ‘a vast and growing body of real-world evidence provides strong evidence for the effectiveness and safety of mRNA-1273, the original Moderna COVID-19 vaccine which is the basis for the company’s updated, bivalent vaccines’.
A phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year, Moderna outlined.
In July, Moderna announced the advancement of two bivalent candidates for autumn based on different population health security strategies in different countries. mRNA-1273.222 contains the BA.4/5 Omicron strain and is being developed in accordance with recent recommendations from the FDA, while mRNA-1273.214 contains the BA.1 Omicron strain. Both bivalent candidates contain 25µg of mRNA-1273 and 25µg of an Omicron subvariant.
Stéphane Bancel, chief executive officer of Moderna, said: “The FDA’s authorisation of our updated bivalent booster, mRNA-1273.222, provides Americans with access to broader protection against Omicron variants.
“Receiving a booster that specifically targets the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, is an important public health measure that people can take to help protect themselves, especially as we head into a season filled with indoor gatherings. We are grateful to the FDA for their decisive leadership.”
Moderna’s updated bivalent booster is expected to be available at vaccination sites nationwide in the coming days, with doses of mRNA-1273-222 having been purchased by the US government.