Centers for Disease Control and Prevention (CDC) approved the release of COVID-19 booster shots ,on September 12, designed to provide protection against emerging strains of the virus. These booster shots will be available in the United States in a matter of days.
CDC Director Mandy Cohen officially endorsed the use of these new shots, aligning with the recommendations put forth by a panel of vaccine and health experts. This panel voted with a 13-1 decision, to recommend the booster shots from Moderna Inc., Pfizer Inc., and BioNTech SE for individuals aged six months and older.
In an email statement, the agency said, “CDC recommends everyone 6 months and older get an updated Covid-19 vaccine to protect against the potentially serious outcomes of Covid-19 illness this fall and winter.” Bloomberg reported, the statement further added, “Updated Covid-19 vaccines from Pfizer-BioNTech and Moderna will be available later this week.”
Cohen’s final green light means the shots can be administered across the US. The Food and Drug Administration has already approved them.
Distribution of these boosters could be especially helpful for Pfizer, which has struggled amid a sharp decline in sales of its Covid vaccine and antivirals after a surge 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 EG.5 variant, dubbed Eris, are gaining ground. Hospitalizations are also rising for the first time this year, though they are still less frequent than in previous waves.
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In June, US health officials told drugmakers to reformulate their boosters in time for the fall season that would protect against another subvariant, the XBB.1.5, that accounted for some 40% of infections at the time. But the new Eris strain has since become the most widely 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 its booster increased antibodies to Pirola almost ninefold in a human clinical trial. Pfizer said its vaccine elicited a “strong neutralizing antibody response” to the same strain in a pre-clinical study. Both companies said trials showed their products also offered some protection against Eris.
Those early findings, and others showing that antibodies from prior infection and vaccination still offer protection against Pirola, are reassuring, the CDC said Friday.
Members of the advisory panel said they endorsed a universal recommendation to allow for broad access to the shot. A couple raised questions about a lack of data on children for this particular 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 School of Public Health at the University of Washington in Seattle, said there needs to be messaging that clarifies that some individuals are at a much higher risk. “A lot of people with underlying medical conditions and who are older, are dying, and they really need to get a booster,” she said.
Pfizer intends to price their COVID-19 booster at $120 per dose, while Moderna intends to charge $129 for theirs. Additionally, Novavax Inc. has reported that their COVID-19 booster is currently under review by the FDA for individuals aged 12 and above. If approved by the FDA, it will likely fall under recommendations of the CDC advisory panel without necessitating a separate vote.
(With inputs from Bloomberg)
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Updated: 13 Sep 2023, 09:08 AM IST