Has the US jumped the gun with new vaccines targeting omicron?

Last month, the U.S. Food and Drug Administration (FDA) authorized Omicron vaccines, accompanied by a breathless press release from science and media blitzkrieg. A few days after the FDA’s action, the Centers for Disease Control and Prevention followed suit, recommending updated boosters for anyone 12 or older who received at least two doses of the original Covid vaccines. The message to a nation still struggling with the COVID-19 pandemic: Cavalry — in the form of a shot — approaches the hill.

But for those familiar with the workings of the pharmaceutical industry, those copious messages — combined with the incompleteness of studies — caused significant heartburn and raised a host of unanswered concerns.

The updated footage easily scans the “Safe and Effective” bar for government permission. But in the real world, are Omicron’s vaccines significantly more protective – and in what ways – than the original Covid vaccines that many have already taken? If so, who would benefit most from the new picks? As the federal government buys these new vaccines—and many of the original ones already purchased may never find their way into the arms of taxpayers— $3.2 billion worth Worth the non-obvious benefit? Especially when that money had to be pulled from other Covid response efforts, such as testing and treatment.

multiple members of the CDC advisory committee that voted 13-1 for the recommendation expressed similar questions and concerns, one said Only “reluctantly” voted in the affirmative.

Some said they had put aside their desire for more information and better data and voted yes for fear of the possible further spread of the coronavirus in the winter. They hoped that new vaccines – or at least the vaccination campaign that would accompany their release – would limit the number of future cases, hospitalizations, and deaths.

Perhaps this calculation is understandable at a time when the average was more than 300 Americans They die from covid every day.

But it leaves health care providers on the front lines in the impossible position of trying to advise individual patients on whether and when to take the hot new vaccines, without complete data and in the face of marketing hype.

Don’t get us wrong. We are grateful and amazed that Pfizer-BioNTech and Moderna (with help from the National Institutes of Health and Operation Warp Speed) 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 yet, but vaccines are largely credited with enabling most of America to return to a semblance of normalcy. We are both up to date on our Covid vaccinations and don’t understand why anyone would choose not to participate, playing Russian roulette with their health.

But as society moves into the next phase of the pandemic, the pharmaceutical industry may move into more familiar territory: developing small products that may be better than they used to be, and selling — sometimes selling — their increased efficacy in the absence of adequate control. Published studies or data, and advertising them as desirable to all when only some will benefit greatly, and in all likelihood raise the price later.

This last point is worrisome because the government no longer has money to buy coronavirus vaccines after this fall. Funding to cover immunization provider fees and community outreach for those who will benefit most from immunization has already run out. So the upgrades now and in the future will more likely go to “good concern” who have good insurance rather than those at risk of infection and progression to severe disease.

The FDA’s job is simply to determine if a new drug is safe and effective. However, the FDA could have requested more clinical vaccine efficacy data from Pfizer and Moderna before authorizing the omicron BA.5 updates.

Yet the FDA can’t think of important follow-up questions: How effective are updated boosters than vaccines already on the market? In which population? And what is the increase in effectiveness sufficient to merit an increase in price (so-called cost-benefit analysis)? Other countries, such as United kingdomConduct such analysis before allowing new drugs to enter the market 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 virus BA.5. Studies by Pfizer have shown that the updated omicron BA.1 booster provides a 1.56 times A higher increase in neutralizing antibody titer against BA.1 compared to the booster with its original vaccine. Modern Studies From the updated omicron BA.1 booster, it showed very similar results. but, others expect that a 1.5-fold higher antibody titer would result in only a slight improvement in vaccine efficacy against symptomatic and severe disease, with bumps of about 5% and 1%, respectively. Pfizer and Moderna are just beginning to study the updated omicron BA.5 enhancers in human trials.

Although studies of the updated omicron BA.5 boosters were conducted only in mice, the agency’s statement is in line with precedent: The FDA clears updated influenza vaccines for new strains each year. without requiring human testing. But with flu vaccines, scientists have decades of experience and a better understanding of how increases in neutralizing antibody titers correlate with improvements in vaccine efficacy. This is not the case with Covid vaccines. And if the mice data are a good indication of clinical efficacy, we’ll get an HIV vaccine now.

As population immunity builds up through vaccination and infection, it is unclear whether additional vaccine boosters, whether updated or not, would benefit all ages equally. In 2022, the United States saw hospitalization rates for the virus among people 65 and older a plus For younger age groups. And while it seems that the boosters for the Covid vaccine are, as well Cost-effective in the elderlyThey may not be in the younger age groups. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices considered limiting the updated boosters to people 50 and older, but ultimately decided that doing so would be too complex.

Unfortunately, history shows – as with other pharmaceutical products – that once a vaccine arrives and marketing accompanies it, salesmanship trumps science: many people with money and insurance will ask whether or not the data ultimately proves necessary to them individually. .

We will likely encounter SARS-CoV-2 over and over again, and the virus will continue to mutate, giving rise to new variants year after year. In a country where large portions of the vulnerable population remain vulnerable and unvaccinated, the fear of an increase in winter is legitimate.

But will a vaccine be widely adopted — in this case? Yearly updated covid boosters Do you end up boosting protection for those who really need it or just boosting pharmaceutical companies’ profits? Will the money well be spent?

The federal government was paying a negotiated price of $15 to $19.50 for a dose of the mRNA vaccine under a purchase agreement signed during the height of the pandemic. When those government agreements expire, Analysts expect Price to triple or quadruple, and maybe more for the updated annual Covid multiples, which Moderna’s CEO said it will evolve “like the iPhone.” To spread these snapshots and these dollars wisely, a little hype and a lot of information might help.

Kaiser Health NewsThis article was reprinted from khn.org Courtesy of the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization not affiliated with Kaiser Permanente.

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