BIO member Moderna’s bivalent Omicron-targeting boosters (mRNA-1273.214 and mRNA-1273.222) “trigger a superior antibody response” against Omicron (BA.4/BA.5) compared to its predecessor and also “met non-inferiority immunogenicity criteria to the original strain,” the company said in a release on Monday.
“Both of our bivalent booster vaccine candidates offer superior protection against Omicron BA.4/BA.5 variants compared to our original booster … which persisted for at least three months after the mRNA-1273.214 booster,” said Stéphane Bancel, Moderna’s Chief Executive Officer.
Bancel added that both bivalent boosters “also show neutralizing activity” against the emerging Covid subvariant BQ.1.1, which is increasingly dominant in the United States, demonstrating its potential to strengthen the immune response against subvariants as SARS-CoV-2 continues to evolve rapidly to escape people’s immunity.
Study results published in the New England Journal of Medicine (NEJM), show that 50 μg of mRNA-1273.214 or mRNA-1273 as a second booster dose triggered 5.11 and 6.29 times more antibodies against Omicron BA.5 “for participants with and without SARS-CoV-2 infection pre-booster, respectively.”
The boosters results also showed “a 15.1-fold increase” in Omicron BA.4/BA.5 antibody levels from pre-booster levels in all participants.
The study summary also noted that “in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster.”
The US Food and Drug Administration (FDA) authorized Moderna’s updated booster for “use as a single booster dose at least two months following primary or booster vaccination,” back in September after calling in June “for the fall booster campaign to target Omicron,” and advising manufacturers to “add an Omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine.”
Moderna’s bivalent booster mRNA-1273.222 contains Moderna’s original vaccine and a vaccine specifically designed against the BA.4 and BA.5 subvariants.