Moderna’s mRNA Vaccine Shows Promise Against the Pirola Variant of COVID-19

mRNA-1273.815 (Moderna Inc) generated an 8.7-fold increase in neutralizing antibodies against BA.2.86, the Pirola variant of COVID-19 that is currently being monitored. The vaccine is currently awaiting approval by the FDA for the fall 2023 vaccination season.¹

"These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. Taken together with our previously communicated results showing a similarly effective response against EG.5 and FL.1.5.1 variants, these data confirm that our updated COVID-19 vaccine will continue to be an important tool for protection as we head into the fall vaccination season," Stephen Hoge, MD, president of Moderna, said in a statement. "Moderna will continue to rapidly assess global public health threats and is committed to leveraging our mRNA platform against COVID-19."¹

According to Moderna, the CDC has said that BA.2.86 is highly mutated and is more capable of causing infections in those who have previously had COVID-19 or those immunized with other vaccines. The CDC also added that the updated COVID-19 vaccines could be effective at reducing severe disease as well as hospitalizations.¹

Currently, the CDC stated that existing tests and medication for COVID-19 have been effective with the variant but could still be more capable of causing infection than previous variants. The CDC also said that there is no evidence to support more serious disease caused by BA.2.86 than previous COVID-19 variants.² The anticipated impact on molecular and antigen-based tests is low, according to the CDC.²

Furthermore, the statement says that public health authorities are monitoring the variant, noting that it contains more than 30 mutations compared to the prior Omicron strains. The company also stated that some governments are accelerating COVID-19 vaccination development due to the variant’s ability to break through protective immunity by a previous infection or vaccination.¹ However, the CDC noted that the antibodies from current vaccination, previous infection, or both, could still provide protection against the variant.²

The CDC recommends the same actions to protect against infection as the other COVID-19 variants, such as getting vaccinated, getting tested, washing hands, seeking treatment due to COVID-19 infection, etc.²

As of August 23, 2023, there have been 9 reports of the variant across the world, including Denmark, South Africa, Israel, the United States, and the United Kingdom.² The CDC also reported that the locations in which the variants were detected have not seen an increase in cases, emergency department visits, or hospitalizations, but the agency said it is still too soon to determine the impacts of the variant.²

With the emergence of BA.2.86, as well as the growing prevalence of EG.5 and FL1.5.1, there is a need for updated vaccines against COVID-19 to help decrease severe disease and hospitalizations.¹ The clinical trial data from Moderna that supports the efficacy of the vaccine has been shared with regulators and for peer review publication.¹

mRNA-1273.815 has not been authorized or approved by the FDA, according to the company statement.¹

The CDC will continue to monitor and update the documentation on the variant as well as its impacts on therapeutics when the data become available.²

References

1. Moderna clinical trial data confirm its updated COVID-19 vaccine generates strong immune response in humans against BA.2.86. News release. Moderna. September 6, 2023. Accessed September 7, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Clinical-Trial-Data-Confirm-Its-Updated-Covid-19-Vaccine-Generates-Strong-Immune-Response-in-Humans-Against-BA.2.86/default.aspx
2. Centers for Disease Control and Prevention. Risk assessment summary for SARS CoV-2 sublineage BA.2.86. August 23, 2023. September 7, 2023. https://www.cdc.gov/respiratory-viruses/whats-new/covid-19-variant.html