FDA Set to Authorize New Covid Booster As Early As This Week

Moderna has reported that their most recent Covid booster seems to be effective against the BA.2.86 omicron subvariant, as disclosed in a press release on Wednesday.

According to Moderna, this updated booster has elicited a robust antibody response against BA.2.86. This particular variant has not yet become widespread in the United States, but it has garnered attention from experts and health officials due to its high number of mutations.

It’s important to note that the data provided by Moderna, which is based on blood samples, has not yet undergone scrutiny by external scientists. Nevertheless, Moderna is the first manufacturer of Covid vaccines to share data regarding the performance of the updated booster against this new variant.

Moderna notes “mRNA-1273.815 has not yet been authorized or approved by the FDA. Emergency uses of the Moderna COVID-19 Vaccine, Bivalent, have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19).”

NBC News reported that the “updated booster is expected to be authorized by the FDA as early as this week.”

The Biden administration formally ended the national Covid emergency earlier this year.

However, as the U.S. witnesses a surge in Covid cases and hospitalizations driven by the spread of several new variants, the Centers for Disease Control and Prevention (CDC) has raised concerns that BA.2.86, sometimes referred to as “Pirola” on social media, may have a heightened ability to infect individuals who have had Covid or have been vaccinated. However, the agency clarified that there is currently no evidence suggesting that it leads to more severe illness.

Interestingly, recent laboratory studies have suggested that BA.2.86 might be less contagious and less capable of evading the immune response than initially feared.

The ongoing increases in Covid cases and hospitalizations in the U.S. are likely attributable to infections with XBB lineage viruses, rather than the BA.2.86 variant, according to the CDC.

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Moderna’s updated booster, anticipated to receive authorization from the Food and Drug Administration this week, is designed to target the XBB.1.5 omicron subvariant. Although this particular strain is no longer the dominant one, recent laboratory studies in the U.S. have indicated that the updated boosters should still offer protection against all currently circulating subvariants, including BA.2.86.

Last month, Moderna also shared data demonstrating that its latest booster seemed to provide protection against the EG.5 omicron subvariant, known as the “Eris” variant, as well as the omicron subvariant FL.1.5.1.

According to the CDC, EG.5 accounts for approximately 22% of all new Covid cases in the U.S., while FL.1.5.1 makes up around 15% of new cases.

By Melinda Davies
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8 months ago

I wonder when the cumulative vaxx damage will reach a critical point for a death cascade?

8 months ago
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When no one is left alive to record it!

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