Food and Drug Administration advisers have been grappling with how to modify dosages right now when there’s no way of knowing how quickly the mutated virus will evolve in the fall – especially when as those who are given today’s recommended boosters are still strongly protected against the worst outcome of COVID-19.
Ultimately, the FDA panel voted on February 19 that the COVID-19 booster should contain some version of the super-infectious omicron variant, in readiness for an expected fall boost campaign.
One adviser, Dr Mark Sawyer of the University of California, San Diego, said: “We’ll go after round eight if we wait any longer.
The FDA will have to decide on the exact formulation, but expect a combination shot that adds protection against omicron or some of its newer relatives to the parent vaccine.
“None of us have a crystal ball” for the next threatening variant, said FDA vaccine director Dr. Peter Marks. But “we can at least bring the immune system closer to being able to respond to what’s circulating” than far older strains of the virus.
It’s not clear who will be offered a tweaked booster – they may only be recommended for older adults or those at high risk of contracting the virus. But the FDA is expected to decide on the formula change within a few days, and then Pfizer and Moderna will have to get permission for the appropriate updated dosages, time for the health authorities to settle a strategy. autumn comb.
The current COVID-19 vaccine has saved millions of lives globally. At enhanced doses, those used in the US were still strongly protected from hospitalization and death, but their ability to prevent infection was markedly reduced when omicrons were present. And the omicron mutant that caused the winter spike has been replaced by its genetically distinct relatives. According to the Centers for Disease Control and Prevention, the two newest omicron cousins, known as BA.4 and BA.5, now account for half of all cases in the United States.
Pfizer and Moderna produced boosters to add protection to the first omicron mutant. Their combined shots, which scientists call a “bivalent” vaccine, essentially boosted levels of antibodies that are resistant to that variant, rather than simply injecting one. different doses of the vaccine today.
Both companies found that the tweaked photos also provided some cross-protection against those worrisome BA.4 and BA.5 spikes, but not nearly as much.
Many scientists favor the combined approach because it preserves the proven benefits of the parent vaccine, including some cross-protection against other mutations that have emerged during the pandemic.
The question the FDA faces is the exact formulation change. Both companies have said they’ll have more omicron-targeting combo footage in October, but Moderna said a move to targeting omicron’s newest relative could delay its release by another month.
Further complicating this decision is that only half of vaccinated Americans received that important first booster shot. And while the CDC says protection against hospitalization has dropped some for older adults, a second boost recommended for people 50 and older seems to restore that. . But only a quarter of those eligible for the extra booster received one.
Marks says that by tailoring the injections, “we hope to be able to convince people to use that booster to boost their immune response and help prevent another wave.”
Logistics will be challenging. Many Americans still haven’t gotten their first vaccine, including young children who are newly eligible — and it’s unclear whether the tweaked booster could eventually lead to a major vaccine change. But FDA advisors say it’s important to continue and study up-to-date vaccine formulations in children.
And another complication: A third company, Novavax, is awaiting FDA approval for a more traditional COVID-19 vaccine, protein-based injections. Novavax argued on Tuesday that routine vaccine boosters promise a good immune response against new omicron mutations without needing to change the formulation.
World Health Organization advisors recently said omicron-tuned injections would only be most beneficial as a booster, because they would increase people’s range of cross-protection against multiple variables. body.
“We don’t want the world to lose confidence in the vaccines currently available,” said Dr Kanta Subbarao, a virologist who chaired the WHO committee.
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https://6abc.com/covid-shots-fda-coronavirus-boosters-pfizer/12002205/ FDA advisors recommend updating COVID booster shots to better accommodate newer coronavirus variants