Moderna is vigorously advocating for the expedited approval of its updated COVID-19 vaccine in preparation for the upcoming fall vaccination season. The company is now emphasizing the vaccine’s efficacy against the recently emerged pirola variant.
On September 6, Moderna disclosed that its vaccine, known as mRNA-1273.815, exhibited an impressive 8.7-fold increase in neutralizing antibodies against the pirola variant. Although not as widely recognized as the omicron variant that gained notoriety in the winter of 2021, the pirola variant, also identified as BA.2.86, has been under close monitoring by the Centers for Disease Control and Prevention (CDC). By August 30, cases of this variant had been reported in “at least” four US states.
The CDC has noted that the highly mutated BA.2.86 variant may have an increased ability to cause infection in individuals who have previously had COVID-19 or received earlier vaccines. As a response, Moderna is advocating for the swift approval of updated COVID-19 vaccines, emphasizing their potential effectiveness in reducing severe illness and hospitalization. While Moderna did not provide in-depth details about its findings, it described the 8.7-fold increase in neutralizing antibodies as indicative of a “strong human immune response.” The company has already shared clinical trial data related to the pirola variant with regulatory authorities and submitted it for peer-reviewed publication.
This recent development follows Moderna’s announcement last month that its mRNA-1273.815 vaccine also exhibited effectiveness against two other variants categorized as “current strains of concern,” namely eris and fornax. Combined clinical trial data, derived from research assays, indicated that the vaccine generates an “8.7 to 11-fold increase in neutralizing antibodies against circulating variants,” as outlined by the company.
Moderna is under significant pressure to perform well in the upcoming vaccination season after experiencing a decline in sales during the second quarter. The company has raised its sales guidance for the approved Spikevax vaccine to a range of $6 billion to $8 billion, up from the previous projection of $5 billion. Moderna anticipates approximately 100 million COVID vaccine doses to be administered in the US during the fall, which is below the average of 150 million doses administered during an average flu season.