In time for respiratory virus season this fall and winter, the US Food and Drug Administration (FDA) approved updated COVID vaccines from Pfizer/BioNTech and Moderna last week, followed by an endorsement from the Centers for Disease Control and Prevention (CDC) a day later.
Last week, a CDC advisory committee voted 13-1 in favor of recommending the updated shots for individuals six months of age and older.
CDC director Mandy Cohen, MD, MPH, then signed off on the committee’s recommendation, which gave the green light for the vaccines to be made available to the public within the next day or two.
“We have more tools than ever to prevent the worst outcomes from COVID-19,” Dr. Cohen said in a statement.
The updated COVID vaccines target the XBB.1.5 Omicron subvariant, which is the dominant version in circulation in the US. It is thought that any offshoots of the Omicron subvariant, such as EG.5 (Eris), which began dominating in August, should be covered by the new vaccines.
The shots are monovalent, meaning that they only target one strain of SARS-CoV-2. This is in contrast to the bivalent shots that were rolled out last fall.
COVID-19 cases have been on the rise in recent months, including increases in both hospitalizations and deaths.
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Pfizer, BioNTech and Moderna redesigned their mRNA-based COVID vaccines based on FDA guidance for the 2023-2024 season.
The FDA gave the nod to a single dose of either Pfizer’s or Moderna’s new shots for individuals five years of age and older, irrespective of prior vaccination status, but at least two months since receiving the last dose of any COVID vaccine.
Children six months to four years of age who have received previous COVID-19 vaccines are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine, with the timing and number of doses depending on the previous vaccine received.
In June, FDA advisors endorsed updating the shots to target the XBB strain. Data from clinical and preclinical trials showed that the shots produced antibodies against the variant as well as newer subtypes of it like BA.2.86.
There was some debate among committee members about whether the recommendation should focus on groups most at risk from COVID complications, such as older adults. Except for one vote against a universal recommendation from Pablo Sanchez, a professor of pediatrics at Ohio State University, the CDC advisory committee opted to offer the updated COVID vaccine to all age groups for whom a COVID vaccine is currently approved.
Other committee members argued that a restrictive recommendation could worsen vaccine inequities. Despite this, the members did agree that vaccination was most important for those at highest risk.
The updated COVID vaccines will not be bought by the government like before. They will instead be purchased and paid for by pharmacies and insurers. Moderna’s updated COVID vaccine will go for $129 per dose, while Pfizer’s will be priced at $120. These are higher per-dose costs than what the US government paid for previously.
Another COVID booster from Novavax is currently under FDA review. The company said it will make its vaccine available for $130 per dose pending the FDA’s decision.
This fall will mark the first time vaccines will be rolled out for three major respiratory viruses: influenza, SARS-CoV-2 and respiratory syncytial virus (RSV).
This year, GSK’s Arexvy became the very first FDA-approved RSV vaccine, which was approved in May for adults 60 years of age and older. Pfizer followed suit just a couple of weeks later, winning FDA approval for its RSV vaccine Abrysvo for adults 60 years of age and older as well. In August, Pfizer scored approval for Abrysvo for pregnant women, making it the first approved maternal RSV vaccine for the protection of infants from RSV.