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Moderna's bivalent COVID-19 booster candidate was safe and well tolerated, with a better immune response against Omicron versus a booster dose of the company's approved vaccine (Spikevax), .

The 50-μg vaccine, mRNA-1273.214, which contains Spikevax and a vaccine candidate that targets Omicron specifically, met all its primary endpoints, including "superior neutralizing antibody response" against Omicron a month later. Adverse events (AEs) were comparable to a booster dose of Spikevax, Moderna noted.

Stéphane Bancel, CEO of Moderna, said in a statement that this was the second bivalent booster candidate, joining mRNA-1273.211, which showed superiority compared with a booster dose of Spikevax against Beta, Delta, and Omicron 1 month later, and superiority against Beta and Omicron 6 months later.

However, mRNA-1273.214 is the lead candidate for a fall 2022 booster, he added, with the company anticipating that antibody titers "will be more durable over time against Omicron."

"We are submitting our preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer," Bancel said.

The preliminary data were from a phase II/III trial of seronegative participants; safety data from 437 individuals showed comparable safety and reactogenicity to a second booster dose of Spikevax.

As for immunogenicity, Moderna noted that a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers against Omicron by approximately eight-fold above baseline, and was noninferior against ancestral SARS-CoV-2 strains. Binding antibody titers were also significantly higher against other variants of concern versus Spikevax, they added.

Moderna said it will report data from day 91 after vaccination later in the summer, and submit the interim analysis to regulators "in the coming weeks."

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