Moderna, hoping for swift approval, shows updated COVID shot can defend against pirola variant

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来源: FierceBiotech

Moderna has already shared the clinical trial data in relation to the pirola variant with regulators.

Moderna is continuing to make the case for why its updated COVID-19 shot needs a speedy approval in time for the fall vaccination season, now pointing to its effectiveness against the so-called pirola variant.

The vaccine, dubbed mRNA-1273.815, demonstrated an 8.7-fold increase in neutralizing antibodies against the variant, Moderna said in a Sept. 6 release. While not yet a household name to the extent that the omicron variant became in the winter of 2021, the Centers for Disease Control and Prevention (CDC) has been keeping a close eye on the pirola variant, also known as BA.2.86, with cases recorded in “at least” four U.S. states as of Aug. 30.

“The CDC indicates that the highly mutated BA.2.86 variant may be more capable of causing infection in people who previously had COVID-19 or were vaccinated with previous vaccines, noting that updated COVID-19 vaccines may be effective in reducing severe disease and hospitalization,” Moderna said in the release.

The company didn’t go into more detail about its findings in this morning’s release, beyond describing the 8.7-fold increase in neutralizing antibodies as a “strong human immune response.” However, Moderna said the clinical trial data in relation to the pirola variant have already been shared with regulators, and it has been submitted for peer review publication.

This follows Moderna’s announcement last month that the mRNA-1273.815 vaccine also held its own against two other variants considered “current strains of concern,” namely eris and fornax. Taken together, the clinical trial data from a research assay showed that the vaccine induces an “8.7 to 11-fold increase in neutralizing antibodies against circulating variants,” the company outlined today.

Moderna has a lot riding on this vaccination season after sales cratered in the second quarter. But the mRNA-focused company raised sales guidance for the approved Spikevax vaccine to a range of $6 billion to $8 billion, up from a previous forecast of $5 billion. Moderna expects around 100 million COVID vaccine doses to be administered in the U.S. this fall, below the average of 150 million doses for an average flu season.

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