Moderna Clinical Trial Data Shows It’s Updated COVID Vaccine Is Efficient Against ba.2.86

Moderna, Inc. announced September 6th that clinical trial data from its research assay confirm its updated COVID-19 vaccine, which is pending approval by the U.S. Food and Drug Administration for the fall 2023 vaccination season, generates an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola), a variant under monitoring. 

The Centers for Disease Control (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.

Clinical trial data from a research confirmed Moderna’s updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants.

With governments accelerating the timing of COVID-19 vaccination campaigns due to the potential risk of BA.2.86, Moderna has shared this data with regulators and is ready to supply its updated COVID-19 vaccine pending regulatory approval.

“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,” said Stephen Hoge, M.D., President of Moderna. “Moderna will continue to rapidly assess global public health threats and is committed to leveraging our mRNA platform against COVID-19.”

The BA.2.86 variant, a highly-mutated strain of COVID-19, closely monitored by health authorities

Public health authorities are vigilantly monitoring the BA.2.86 variant, a highly-mutated strain of COVID-19 with over 30 mutations as compared to prior Omicron strains, with some governments accelerating COVID-19 vaccination campaigns due to its potential to break through protective immunity generated from previous COVID-19 vaccination or infection. The emergence of BA.2.86, in addition to the growing prevalence of the EG.5 and FL1.5.1 variants, underscores the need for vaccination with an updated COVID-19 vaccine, which can help reduce severe disease and hospitalizations caused by current circulating strains.

Moderna’s clinical trial data around its updated COVID-19 vaccine’s effectiveness against BA.2.86 have been shared with regulators and submitted for peer review publication.

Moderna, Inc. announced August 17th that preliminary clinical trial data confirmed its updated COVID-19 vaccine for the fall 2023 vaccination season showed a significant boost in neutralizing antibodies against EG.5 and FL.1.5.1 variants. 

These results suggested that Moderna’s updated COVID-19 vaccine may effectively target the expected circulating variants of COVID-19 during the upcoming vaccination season.

The clinical trial data for the updated COVID vaccine, the golden ticket for Moderna

The company really needs its updated vaccine to work against new mutations, if it is to have any hope of recovering from previous losses. In the second quarter, Moderna’s COVID vaccine sales plummeted 94% to $293 million.

Earlier last month, Moderna forecasted $6-8 billion in revenue from its COVID-19 vaccine from both government contracts and selling to a private market this year. Moderna is expecting demand to grow further in 2024 and match the market for flu shots.

Moderna expects 2023 COVID-19 vaccine sales of $6 billion to $8 billion, with approximately $4 billion from previously announced COVID-19 vaccine Advance Purchase Agreements (APAs) and $2 billion to $4 billion in signed and anticipated commercial contracts in the U.S., as well as other markets. The range for product sales is primarily driven by the U.S. fall 2023 COVID-19 market size, which is dependent on vaccination rates and is likely to be 50 to 100 million doses, the company’s forecast says. So, the vaccine maker anticipates $4 billion in sales to governments this year, and between $2 and $4 billion in a private market for the shot in the United States and other countries. It had previously expected sales of $5 billion from government contracts.  

The new clinical trial data might prove to be the golden ticket for Moderna, if the potential risk presented by the new COVID variant would accelerate authorisation for the company’s updated vaccine.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years.