FDA Greenlights Moderna and Pfizer-BioNTech’s Enhanced COVID-19 Vaccines for Battle Against Variants

In a timely move for the upcoming fall vaccination season, the FDA has given the green light to updated COVID-19 booster shots from Pfizer-BioNTech and Moderna. These reformulated mRNA vaccines are custom-tailored to defend against the ever-evolving Omicron-related variants, including the formidable subvariant XBB.1.5, which the FDA had recommended be covered since June 2023.

The eagerly awaited guidance from the CDC on these boosters is expected to drop tomorrow. If the agency gives its nod of approval, we could see these boosters hitting the shelves at pharmacies and doctors’ offices by the end of the week, as reported by The New York Times. CDC Director Mandy Cohen is anticipated to endorse the updated vaccines, given her prior statements favoring booster updates.

What’s even more reassuring is that this approval extends to individuals aged 12 and up, with Emergency Use Authorization for those as young as six months to 11 years. The FDA has even broadened the eligibility, stating that anyone aged five or older can now receive an updated booster shot from either Pfizer or Moderna, regardless of their vaccination history.

The science behind these boosters is promising. Pfizer’s preclinical data demonstrates enhanced neutralizing antibody responses against the prevalent XBB.1.5, BA.2.86, and EG.5.1 subvariants currently fueling infections in the U.S., according to CDC data. Moderna, on the other hand, has packed its booster with spike proteins tailored to the XBB.1.5 sublineage, with preclinical studies showing robust immune responses to various XBB variants, as well as EG.5, FL.1.5.1, and BA.2.86.

But the story doesn’t end there. Novavax is in the race too, awaiting FDA approval for its protein-based vaccine. They’ve responded promptly to regulatory requests and declared their readiness to distribute the updated XBB version of their vaccine this fall for those aged 12 and older.

The urgency for these boosters is palpable as hospital admissions and COVID-19-related deaths are on the rise in the U.S. According to the CDC COVID Data Tracker, the past week has seen an alarming upward trend. Worldwide, the World Health Organization reported a 38% spike in new COVID-19 cases from July to August, totaling over 1.4 million. In the words of Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, “vaccination remains critical.”

And here’s the icing on the cake: you won’t have to dig into your pockets for these updated vaccines. The U.S. Government COVID-19 Vaccine Distribution Program is concluding this fall, but fear not, as most health insurance policies and Medicare will cover the cost of your booster shot.

For those without insurance or those whose insurance won’t foot the bill, the CDC’s Bride Access Program has your back. They’ll be distributing free COVID-19 boosters through local healthcare providers, health centers, and pharmacies, ensuring that everyone has access to these crucial vaccinations.

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