FDA approves updated COVID vaccines

Covid-19 pandemic

The U.S. Food and Drug Administration (FDA) on Sept. 11 approved updated Pfizer-BioNTech and Moderna vaccines for people over 12. In addition, FDA authorized their emergency use for children ages 6-11.

The approval comes amid a new surge in infections. According to the Centers for Disease Control and Prevention (CDC), as of late August, wastewater monitoring is revealing another rise in COVID-19 infections across the United States. “A U.S. wastewater sample that was collected as part of routine monitoring in the National Wastewater Surveillance System (NWSS) has preliminarily indicated the presence of the BA.2.86 variant. Scientists are investigating this sample and will continue to closely monitor wastewater for further or more widespread evidence of BA.2.86, said a recent CDC report.

And though lower than throughout the initial wave of infections, there has been a subsequent increase in related hospitalizations, too.

The impact of COVID variants

The virus responsible for COVID-19—SARS-CoV-2—is continuously mutating. Since its societal introduction, the variants include Alpha, Beta, Delta, and Omicron. The Omicron strain, which peaked between January and mid-February of 2022, is now being replaced by a highly mutated strain known as BA.2.86, or the Pirola variant. This variant is unique in that it encompasses approximately 30 different mutations.

The concerns associated with BA.2.86 relate to its potential to break through existing immunity from prior vaccinations or infection.  However, the CDC has been clear to explain that current increases in COVID-19 cases and hospitalizations are not due to the highly mutated strain of BA.2.86, but rather to a variety of other circulating viruses.

Subvariants of the COVID-19 Omicron variant, or XBB.1.5, include EG.5 and FL.1.5.1. In August, according to the CDC, the more dominant of the two variants causing COVID within the United States was EG.5 and responsible for approximately 20% of new infections.  FL.1.5.1 was a close second, at 13%.

The good news is that mRNA-based vaccines are highly effective, and are likely to be effective against the worst impacts of this new variant. But what are the current steps in place to ensure global safety in the upcoming months?

Updated vaccines are arriving

The newly approved Pfizer and Moderna vaccines are designed to target the Omicron XBB.1.5 mutation of the virus, per the request in January from FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). But both shots also have proven effective against the now-dominant EG.5 (Eris) variant and newer BA.2.86 (Pirola) variant. In addition, Novavax’s updated vaccine, made with protein-based technology, awaits FDA approval, which is anticipated soon.

“This approval is yet another example of what our mRNA platform can accomplish with incredible speed, scale and flexibility,” said Moderna CEO Stéphane Bancel. “This timely approval helps ensure everyone will have the tools they need to do their part in protecting themselves and slowing the spread of the virus as we head into the fall and winter months in the U.S.”

CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on September 12. The ACIP is expected to recommend the use of the new vaccines.

Moderna and Pfizer said they are ready to ship their vaccines to pharmacies, doctors, and hospitals pending CDC recommendation.

“In the U.S., we expect Spikevax to be at pharmacies and care settings in the coming days,” continued Bancel. “Once available, we encourage the public to get both their updated COVID-19 vaccine and flu vaccine this fall. Outside of the U.S., regulatory applications for our updated COVID-19 vaccine are under review and we expect to share an update in the coming weeks.”

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