Moderna ( MRNA Quick Quote MRNA - Free Report) reported clinical data from its research assay, which confirmed that its updated COVID-19 vaccine mRNA-1273.815 generated an 8.7-fold increase in neutralizing antibodies against the BA.2.86 variant (also known as ‘Pirola’). The vaccine is yet to be authorized/approved by the FDA.
Pirola was recently designated as a variant under the World Health Organization (“WHO”) monitoring. Though not prevalent in the United States, the CDC has indicated that the variant may be more capable of causing infection in people who previously had COVID-19 or were vaccinated with previous vaccines.
A highly mutated strain of the virus, the CDC believes that the Pirola variant carries more than 35 mutations compared to the XBB.1.5 variant, the previously dominant variant.
Last month, Moderna reported preliminary data from a clinical study that showed that mRNA-1273.815
generated a robust immune response against the EG.5 (also known as ‘Eris’) and FL.1.5.1 variants (also known as ‘Fornax’), which are currently the dominating variants in the United States. Per the latest data from the Centers for Disease Control and Prevention (“CDC”), the two variants combined are responsible for around 36% of COVID-19 infections in the country.
A regulatory filing is currently under the agency’s review
seeking authorization for mRNA-1273.815. A final FDA decision is expected in the coming weeks for the vaccine’s launch for the upcoming fall season. A similar regulatory submission is currently under review in Europe. Management has also shared the above data with health regulators worldwide.
Shares of Moderna have lost 39.7% year to date compared with the
industry’s 13.2% decline. Image Source: Zacks Investment Research
Management claims it has built an ample supply for mRNA-1273.815 and is ready to ship the same doses for the upcoming fall vaccination season, provided the FDA authorizes the vaccine.
With rising COVID-19 hospitalizations, the CDC recommends U.S. citizens inoculate themselves with the updated vaccines, likely to be available in the coming weeks. Health officials believe vaccinations can effectively help reduce severe disease and hospitalizations caused by the currently circulating COVID-19 variants.
Apart from Moderna, other COVID vaccine makers like
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech ( BNTX Quick Quote BNTX - Free Report) and Novavax ( NVAX Quick Quote NVAX - Free Report) have also updated their vaccines to target the newer COVID-19 virus variants and, like Moderna, also expect to launch their respective vaccines during the fall season.
Last month, Pfizer/BioNTech’s updated vaccine was authorized in the European Union. This authorization was based on preclinical data which showed that the vaccine was effective against the Eris variant and multiple other XBB variants, including XBB.1.5, XBB.1.16, and XBB.2.3. A regulatory filing for this updated Pfizer/BioNTech vaccine is currently under FDA’s review. Pfizer and BioNTech expect to prepare their updated COVID-19 vaccine for supply immediately after regulatory approval.
Last month, Novavax
reported preclinical data showing that its updated protein-based COVID-19 vaccine was effective against the Eris and XBB.1.16.6 variants. Alongside its second-quarter 2023 results, Novavax announced that it had initiated a filing with the FDA for this updated COVID-19 vaccine and intends to submit one in Europe in the coming weeks. The company has stated that it is manufacturing the updated vaccine commercially and is planning to launch it in the fall. Novavax aims to make its updated vaccine available and accessible on par with mRNA-based COVID-19 vaccines. Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold). You can see
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