Has the US jumped the gun with a new Omicron-targeted vaccine?

Last month, the FDA approved the Omicron-specific vaccine, accompanied by breathless science-by-press releases and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed suit, recommending the updated booster for anyone age 12 and older who has received at least two doses of the original Covid vaccine. Message to a Nation Struggling with the Covid-19 Pandemic: The cavalry – in the form of a bullet – is coming over the hill.

But for those familiar with the pharmaceutical industry’s business tactics, that bullish messaging — combined with a lack of thorough studies — has caused considerable uneasiness and raised an array of unanswered concerns.

The updated shots easily clear the “safe and effective” bar for government approval. But in the real world, are Omicron-specific vaccines significantly more protective — and in what way — than the original Covid vaccines many have already received? If so, who will benefit most from the new shot? Since the federal government is buying these new vaccines — and many of the original, already-purchased vaccines will never find their way into taxpayer arms — is the $3.2 billion price tag worth the intangible benefits? Especially when these funds had to be pulled from other Covid response efforts like testing and treatment.

Several members of the CDC advisory committee that voted 13-1 for the recommendation expressed similar questions and concerns, with one saying he only “reluctantly” voted affirmatively.

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

That calculus, perhaps, makes sense at a time when, on average, more than 300 Americans are dying of Covid every day.

But that leaves front-line health care providers in the impossible position of trying to advise individual patients when to receive 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 the help of National Institutes of Health and Operation Warp Speed) developed an effective vaccine in record time, freeing the nation from the worst phase of the Covid pandemic, when thousands of people were dying every day. The epidemic is not over, but vaccines are largely credited with enabling most of America to return to normal. We are both up-to-date on our covid vaccinations and don’t understand why anyone would choose not to play Russian roulette with their health.

But as society moves into the next phase of the pandemic, the drug industry may be moving into more familiar territory: developing products that may be better than what came before, selling — sometimes overselling — their effectiveness in the absence of adequate regulation. Studies or published data, advertising them as desirable to all when only a few benefit significantly and subsequently likely to drive up prices.

This last point is worrisome because the government no longer has funds to purchase a Covid vaccine after this fall. Provider fees for vaccination and funding for community outreach have already been exhausted to those who would benefit most from vaccination. So updated boosters now and in the future will likely go to the “worried good” who have better insurance than the highest risk of infection and serious disease progression.

The only mandate of the FDA is to determine whether a new drug is safe and effective. However, the FDA could have requested more clinical vaccine efficacy data from Pfizer and Moderna before approving their updated omicron BA.5 booster.

Yet the FDA can’t weigh in on important follow-up questions: How effective are updated boosters compared to vaccines already on the market? In which population? And what increase in effectiveness is sufficient to justify the increase in price (a so-called cost-benefit analysis)? Other countries, such as the UK, carry out such analyzes before allowing new drugs on the market to negotiate a fair national price.

The updated booster vaccine formulations are identical to the original Covid vaccines except for a change in the mRNA code to match the Omicron BA.5 virus. Pfizer’s study showed that its updated omicron BA.1 booster provided a 1.56-fold increase in neutralizing antibody titers against the BA.1 virus compared to using the original vaccine with a booster. Studies of Moderna’s updated omicron BA.1 booster demonstrated very similar results. However, others have predicted that a 1.5-fold higher antibody titer would result in a modest improvement in vaccine efficacy against symptomatic illness and severe disease, about 5% and 1%, respectively. Pfizer and Moderna have begun studying their updated omicron BA.5 boosters in human trials

Although studies of the updated omicron BA.5 boosters were conducted only in mice, the agency’s approval follows precedent: The FDA clears updated flu shots 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 effectiveness. Not so with the covid vaccine. And if the mouse data is a good predictor of clinical efficacy, we’ll have an HIV vaccine by now.

Because population immunity builds up through vaccination and infection, it is unclear whether additional vaccine boosters, updated or not, would benefit all age groups equally. In 2022, the rate of Covid hospitalizations in the United States increased among people aged 65 and older compared to younger age groups. And while Covid vaccine boosters appear to be cost-effective in the elderly, they may not be in younger populations. The CDC’s Advisory Committee on Immunization Practices considered restricting updated boosters to people age 50 and older, but ultimately decided that would be too complicated to do.

Unfortunately, history shows that — as with other pharmaceutical products — once a vaccine comes along and is marketed, salesmanship trumps science: the data will ultimately demand it, with money and insurance, for many people who individually prove it necessary or not.

All of us are likely to be repeatedly exposed to the SARS-CoV-2 virus, and the virus will continue to mutate, giving rise to new forms year after year. In a country where a significant portion of the vulnerable population remains unvaccinated and unprepared, fears of an increased winter are valid.

But will mass adoption of a vaccine — in this case the annually updated Covid booster — increase protection for those who really need it, or increase profits for drugmakers? And will it cost good money?

The federal government is paying $15 to $19.50 a dose of the mRNA vaccine under a purchase agreement signed at the height of the pandemic. When those government contracts expire, analysts expect prices to triple or quadruple and possibly even more for updated annual Covid boosters, which Moderna’s CEO said will evolve “like the iPhone.” To place these shots and these dollars wisely, a lot less hype and a lot more information can help.

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