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Moderna Asks FDA to Authorize Variant-Specific COVID Vaccine


June 22, 2022 – Moderna released study results today showing its new Omicron-specific booster increased antibodies against the coronavirus by a factor of 5, even against some of the newer and more worrisome variants.

The company also today asked the FDA to authorize the use of the vaccine. The company said shipments of this vaccine could begin as early as this summer.

The booster in development contains both Moderna’s original COVID-19 vaccine and one specifically designed to target the more recent BA.4 and BA.5 Omicron subvariants.

The announcement comes at a time when the proportion of BA.4 and BA.5 subvariants in the United States is growing. These two strains now account for about 35% of those circulating in the U.S., according to CDC data.

BA.4 and BA.5 “represent an emergent threat to global public health,” Stéphane Bancel, chief executive officer of Moderna, stated in a news release. “We will submit these data to regulators urgently and are preparing to supply our next generation bivalent booster starting in August, ahead of a potential rise in SARS-CoV-2 infections due to Omicron subvariants in the early fall.”

The combination vaccine was not as strong against all Omicron variants though, showing that antibodies against BA.4 and BA.5 were approximately three times lower than against the older BA.1 variant.

The late-stage study shows that 1 month after giving the shot to people already vaccinated and boosted, this new booster created “potent neutralizing antibody responses” against BA.4 and BA.5 in all who got the shot, regardless of prior infection, the company reported.

Today’s findings build on prior results released earlier this month showing the company’s original vaccine booster had a strong antibody response against the earlier BA.1 Omicron variant.



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