Wednesday, September 06, 2023

Moderna Press Release: Clinical Trial Data Confirm Updated Vaccine Generates A Strong Immune Response Against BA.2.86

 

Credit ACIP/CDC

#17,559

With the dual caveats that laboratory findings don't always translate into real-world results, and that the BA.2.86.x variant continues to evolve in unpredictable ways, we have an encouraging finding this morning by Moderna on the immune response generated by its upcoming vaccine against recently emerged COVID variants, including BA.2.86. 

Exactly how much protection the vaccine will provide, and for how long, is still unknown.

At this point, we don't even know if BA.2.86 can compete against EG.5.1, or other XBB variants.  Some recent studies have suggested BA.2.86 may not be quite the game-changer than many initially feared (see last night's CIDRAP Report).

But once again, data is quite limited, and this remains a rapidly evolving situation. 

The link, and excerpts from the Moderna press release follow.  I'll have a brief postscript after the break.

MODERNA CLINICAL TRIAL DATA CONFIRM ITS UPDATED COVID-19 VACCINE GENERATES STRONG IMMUNE RESPONSE IN HUMANS AGAINST BA.2.86
September 6, 2023
CDC notes that the BA.2.86 (Pirola) variant may be more likely to break through existing immunity from previous vaccination or infection, highlighting the need for vaccination with an updated COVID-19 vaccine for the fall 2023 season

Clinical trial data from research assay 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

CAMBRIDGE, MA / ACCESSWIRE / September 6, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced 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.

"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."

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.


While I'm hopeful this fall's vaccines will provide some additional protection against BA.2.86, EG.5.1, and the plethora of other XBB variants in waiting, I'm not expecting a miracle.

For the past couple of years,  vaccines have done a good job reducing severe illness, hospitalizations, and deaths . . . but have proven less effective at preventing breakthrough infection. 

Which is why I'll get the vaccine when its offered, but I'll also continue to take other precautions, including wearing a face mask in public, using hand sanitizer, and avoiding crowds whenever possible.   

Granted, everyone has to make their own risk/reward calculation, but this is where mine falls.