Moderna’s bivalent booster vaccine candidate shows a significantly higher neutralizing antibody response against the BA.4 and BA.5 subvariants of Omicron than the currently licensed booster vaccine. That was announced by the company through the release of new clinical data on its mRNA-1273.214 vaccine.
Specifically, after one month of administration in previously vaccinated participants with a first booster dose, a second booster dose of 50 mg of mRNA-1273.214 elicited significantly higher neutralizing antibody responses against the Omicron BA.4 and BA.5 subvariants; compared to the currently licensed booster (mRNA-1273) and irrespective of prior infection status or age.
Moderna bivalent vaccine resulted in significantly higher neutralizing titers against BA.4/5 subvariants.
In addition, among participants without prior infection, the bivalent vaccine resulted in significantly higher neutralizing titers against BA.4/5 compared to the currently licensed booster; with a geometric mean ratio of 1.69. One month after the booster, neutralizing titers against BA.4/5 were 776 for mRNA-1273.214 and 458 for the currently licensed booster.
On the other hand, the geometric mean fold increase (GMFR) of BA.4/5 relative to pre-boost levels was 6.3-fold for mRNA-1273.214 recipients, and 3.5-fold for mRNA-1273 recipients. Consistent results were also demonstrated across all subgroups, including those over 65 years of age. The full data have been submitted for peer-reviewed publication and shared with regulators.
Stéphane Bancel: “This superior breadth and durability of the immune response following a bivalent boost has already been demonstrated in multiple Phase 2/3 studies with thousands of participants.”
“This update extends the remarkable performance of mRNA-1273.214, demonstrating significantly higher titers against all variants tested, including BA.4/5 and BA.1 Omicron subvariants, and adds to the larger body of data confirming the superiority of a bivalent approach. This superior breadth and durability of the immune response following a bivalent booster has already been demonstrated in multiple Phase 2/3 studies with thousands of participants,” said Stéphane Bancel, CEO of Moderna.
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Two bivalent vaccine candidates
Moderna’s CEO highlighted that “we are working with regulatory agencies to advance two bivalent vaccine candidates, mRNA-1273.214 and mRNA-1273.222, based on different market preferences for Omicron subvariants; as well as clinical data requirements and the urgency of starting fall booster campaigns for vulnerable populations.”
These data add to results shared last month from the company’s ongoing Phase 2/3 study in approximately 800 participants. Earlier results showed that a 50 mg mRNA-1273,214 mRNA booster dose met all pre-specified primary endpoints. In addition, it was generally well-tolerated, with a reactogenicity and safety profile that was consistent with the currently licensed booster.
Moderna is advancing two bivalent candidates for the fall, based on differing market preferences for subvariants of Omicron
Moderna is now advancing two bivalent candidates for fall, based on differing market preferences for Omicron subvariants. The bivalent booster mRNA-1273.214 is the only candidate that is expected to have demonstrated significantly higher titers against the BA.4/5 strain in a clinical trial prior to the fall booster season compared to the currently licensed booster.
The second bivalent booster candidate, mRNA 1273.222, is based on the BA.4/5 strain. It is being developed in accordance with recent FDA recommendations. Both bivalent candidates contain 25 mg of the currently licensed booster (mRNA-1273) and 25 mg of a subvariant of Omicron.
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