The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
Pictured: Syringe drawing up vaccine/iStock, Diy13
The FDA approved two updated COVID-19 booster shots from Pfizer-BioNTech and Moderna Monday afternoon, just in time for the fall vaccination season.
The reformulated mRNA vaccines are specifically tailored to provide protection against circulating Omicron-related variants, including subvariant XBB.1.5, which the FDA had recommended vaccines be updated to cover in June 2023.
The CDC is anticipated to release its recommendation guidance on the boosters Tuesday. A positive endorsement by the agency could see boosters available at pharmacies and doctors’ offices by the end of the week, The New York Times reported. CDC Director Mandy Cohen is expected to recommend the updated vaccines and sign off on their use, having previously made remarks favoring an updated booster.
The approval for both boosters covers individuals ages 12 years and up, with Emergency Use Authorization granted for individuals ages six months to 11 years. The FDA says that anyone aged five or older can get an updated booster shot from either Pfizer or Moderna regardless of previous vaccination.
Preclinical data from Pfizer has shown that the updated booster shot generates improved neutralizing antibody responses against subvariants XBB.1.5, BA.2.86 and EG.5.1 which are currently driving infections in the U.S., according to CDC data.
Moderna’s booster contains spike proteins for the XBB.1.5 sublineage of COVID-19, with preclinical data supporting immune responses to multiple XBB variants, as well as EG.5, FL.1.5.1 and BA.2.86.
A non-mRNA vaccine candidate put forth by Novavax is still pending approval by the FDA, with the company responding to the regulator’s requests to facilitate final review. The company stated that its updated protein-based vaccine is ready for distribution this fall in a press release. If approved, the updated XBB version of Novavax’s vaccine would be available to individuals ages 12 and older.
Hospital admissions and COVID-19 related deaths have been trending upwards in the U.S. over the past week, according to the CDC COVID Data Tracker. Over 1.4 million new COVID-19 cases were reported to the World Health Organization from July to August, a 38% increase compared to previous months. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that “vaccination remains critical” against the consequences of COVID-19 in a press release.
The purchase of updated vaccines will not come from federal dollars. The U.S. Government COVID-19 Vaccine Distribution Program will end this fall, although most health insurance policies and Medicare will cover the cost of the shot.
Free COVID-19 boosters are planned to be provided by the CDC’s Bride Access Program, which will distribute no-cost vaccines through local healthcare providers, health centers and pharmacies to adults who are without insurance or whose insurance will not provide free COVID-19 vaccines.
Hayley Shasteen is a freelance science writer based in northeastern Ohio. You can reach her at hayleyshasteen@gmail.com, or follow her on LinkedIn.
