Pfizer, Moderna COVID booster shots for new strains get approval from CDC panel

In an emailed statement, the agency said: “CDC recommends everyone six months and older receive an updated Covid-19 vaccine to protect against the potentially serious consequences of Covid-19 disease this fall and winter .” Bloomberg reported, and the statement added: “Updated Covid-19 vaccines from Pfizer-BioNTech and Moderna will be available later this week.”

Cohen’s latest green light means the shots can be administered across the US. The Food and Drug Administration has already approved them.

The distribution of these boosters could be especially helpful for Pfizer, which has struggled with a sharp decline in sales of its Covid vaccine and antivirals after surging during the pandemic. The company is waiting to see how purchases of both products perform this quarter before deciding on cost-cutting measures.

The BA.2.86 strain, known as Pirola, and the EG.5 variant, called Eris, are gaining ground. The number of hospital admissions is also increasing this year for the first time, although they are still less frequent than in previous waves.

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In June, U.S. health officials told drugmakers to reformulate their boosters in time for the fall season, which would protect against another subvariant, the XBB.1.5, which was responsible for about 40% of infections at the time. But the new Eris strain has since become the most circulating variant, and the highly mutated Pirola is also spreading, raising questions about how effective the new boosters will be.

Moderna said earlier this month that the booster increased antibodies against Pirola nearly ninefold in a human clinical trial. Pfizer said its vaccine elicited a “strong neutralizing antibody response” against the same strain in a preclinical study. Both companies said studies showed their products also provided some protection against Eris.

These early findings, and others showing that antibodies from previous infections and vaccinations still protect against Pirola, are reassuring, the CDC said Friday.

Members of the advisory panel said they endorsed a universal recommendation to allow widespread access to the shot. A few raised questions about the lack of data on children for this specific booster, while others said the public needs to be informed about the increased risk for certain ages and populations.

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Beth Bell, a clinical professor at the University of Washington School of Public Health in Seattle, said there needs to be messaging that makes it clear that some individuals are at much greater risk. “A lot of people with underlying medical conditions and who are older are dying, and they really need a booster,” she said.

Pfizer plans to price their COVID-19 booster at $120 per dose, while Moderna plans to charge $129 for theirs. In addition, Novavax Inc. reported that their COVID-19 booster is currently under FDA review for those ages 12 and older. If approved by the FDA, it would likely fall under the CDC advisory panel’s recommendations without the need for a separate vote.

(With input from Bloomberg)

Updated: Sep 13, 2023 09:08 IST