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Did the US get ahead of itself with the new vaccines targeting Omicron?

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Last month, the FDA licensed specific omicron vaccines, accompanied by a breathless scientific press release and media blitz. Just days after the FDA move, the Centers for Disease Control and Prevention followed suit, recommending updated boosters for anyone age 12 and older who has received at least two doses of the original covid vaccines. The message to a nation still battling the covid-19 pandemic: Cavalry, in gunshot form, is coming down the hill.

But for those familiar with the pharmaceutical industry’s business tactics, that exuberant message, combined with a lack of comprehensive studies, has caused considerable heartburn and raised a number of unanswered concerns.

The updated shots easily pass the “safe and effective” bar for government clearance. But in the real world, are omicron’s specific vaccines significantly more protective, and in what ways, than the original covid vaccines that so many have already taken? If so, who would benefit most from the new vaccines? Since the federal government is buying these new vaccines, and many of the original vaccines already purchased may never make it into the arms of taxpayers, is the $3.2 billion price tag worth the unclear benefit? Especially when these funds had to be drawn from other covid response efforts, like testing and treatment.

several members of the CDC advisory committee that voted 13-1 in favor of the recommendation raised similar questions and concerns, one of which said that only voted “reluctantly” in the affirmative.

Some said they put aside their desire for more information and better data and voted yes out of fear of a possible rise in covid in the winter. They expressed the hope that the new vaccines, or at least the vaccination campaign that would accompany their launch, would reduce the number of cases, hospitalizations and deaths in the future.

That estimate is perhaps understandable at a time when an average of more than 300 americans They die of covid every day.

But it leaves front-line healthcare providers in the impossible position of trying to advise individual patients whether and when to take the new vaccines without comprehensive data and in the face of marketing hype.

Don’t get us wrong. We are grateful and amazed that Pfizer-BioNTech and Moderna (with assistance from the National Institutes of Health and Operation Warp Speed) have developed an effective vaccine in record time, freeing the nation from the deadliest phase of the COVID pandemic. , when thousands were dying. every day. The pandemic isn’t over, but vaccines are largely credited with allowing most of the United States to return to a semblance of normalcy. We are both up to date on our covid vaccinations and we don’t understand why anyone would choose not to be, playing Russian roulette with their health.

But as society moves into the next phase of the pandemic, the pharmaceutical industry may be moving into more familiar territory: developing products that may be slightly better than the last, selling, sometimes overselling, its biggest efficacy in the absence of adequate control. Published studies or data, heralding them as desirable to all when only a few benefit significantly, and in all likelihood driving the price up later.

This last point is concerning because the government no longer has the funds to buy covid vaccines after this fall. Funding has already been depleted to cover provider fees for vaccines and community outreach to those who would benefit most from vaccination. So updated boosters now and in the future will likely go to the “concerned” who have good insurance rather than those at higher risk of infection and progression to serious disease.

The FDA’s task is simply to determine whether a new drug is safe and effective. However, the FDA could have requested more clinical data on the vaccine’s efficacy from Pfizer and Moderna before authorizing their updated omicron BA.5 boosters.

However, the FDA cannot weigh in on important follow-up questions: How much more effective are the updated boosters than vaccines already on the market? In which towns? And what increase in effectiveness is enough to merit an increase in price (so-called cost-benefit analysis)? Other countries, like the United Kingdomcarry out this analysis before allowing new drugs to enter the market, in order to negotiate a fair national price.

The updated booster vaccine formulations are identical to the original covid vaccines, except for a modification in the mRNA code to match the omicron BA.5 virus. Studies conducted by Pfizer have shown that their updated omicron BA.1 booster provides a 1.56 times greater increase in neutralizing antibody titers against the BA.1 virus compared to a booster using its original vaccine. Modern studios of their upgraded omicron BA.1 booster showed very similar results. Nevertheless, others predict that a 1.5-fold higher antibody titer would produce only a slight improvement in vaccine efficacy against symptomatic disease and severe disease, with an increase of about 5% and 1%, respectively. Pfizer and Moderna are just beginning to study their updated BA.5 omicron boosters in human trials.

Although studies of the updated omicron BA.5 boosters were done only in mice, the agency’s authorization is in line with precedent: FDA approves updated flu vaccines for new strains each year without requiring human testing. But with influenza vaccines, scientists have decades of experience and a better understanding of how increases in neutralizing antibody titers correlate with improvements in vaccine effectiveness. That is not the case with covid vaccines. And if mouse data were a good predictor of clinical efficacy, we would already have an HIV vaccine.

As population immunity increases through vaccination and infection, it is unclear whether additional vaccine boosters, up-to-date or not, would benefit all ages equally. In 2022, the US has seen Covid hospitalization rates among people 65 and older increase relative to the younger age groups. And although the covid vaccine boosters seem to be profitable in the elderly, they may not be found in younger populations. The CDC’s Advisory Committee on Immunization Practices considered limiting catch-up boosters to people age 50 and older, but ultimately decided doing so would be too complicated.

Unfortunately, history shows that, as with other pharmaceuticals, once a vaccine arrives and is accompanied by marketing, salesmanship trumps science: many people with money and insurance will demand it, whether the data finally show that it is necessary for them individually or not.

We are all likely to encounter the SARS-CoV-2 virus over and over again, and the virus will continue to mutate, giving rise to new variants year after year. In a country where a significant part of the populations at risk are still not vaccinated or receiving boosters, the fear of a winter increase is legitimate.

But does widespread adoption of a vaccine, in this case yearly updated covid drivers — Will it end up improving protection for those who really need it, or will it simply improve profits for drugmakers? And will it be money well spent?

The federal government has been paying a negotiated price of $15 to $19.50 for a dose of mRNA vaccine under a purchase agreement signed during the height of the pandemic. When those government agreements expire, analysts expect the price to triple or quadruple, and maybe even more for updated yearly covid boosters, which Moderna’s CEO said it would evolve “like an iPhone.” To implement these injections and these dollars wisely, a lot less hype and a lot more information could help.

KHN (Kaiser Health News) is a national newsroom that produces detailed journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the top three operating programs in KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization that provides information on health issues to the nation.

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