Did the US Jump the Gun With the New Omicron-Targeted Vaccines?

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Yves here. It’s noteworthy for a publication like Kaiser Health News say in a not very coded manner that the testing and approval process for the new omicron vaccines (which are available only as boosters; you have to get the original Covid shots to get the tweaked vaccines) sucked and might be unduly influenced by money.

By Céline Gounder, Senior Fellow and Editor-at-Large for Public Health at Kaiser Health News, as well as an internist, infectious disease specialist, epidemiologist, who volunteers on the wards at NYC Health + Hospitals’ Bellevue Hospital,affiliated with NYU Grossman School of Medicine, and Elisabeth Rosenthal, Editor-in-Chief at Kaiser Health News. Originally published at Kaiser Health News

Last month, the FDA authorized omicron-specific vaccines, accompanied by breathless science-by-press release and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed, recommending updated boosters for anyone age 12 and up who had received at least two doses of the original covid vaccines. The message to a nation still struggling with the covid-19 pandemic: The cavalry — in the form of a shot — is coming over the hill.

But for those familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — combined with the lack of completed studies — has caused considerable heartburn and raised an array of unanswered concerns.

The updated shots easily clear the “safe and effective” bar for government authorization. But in the real world, are the omicron-specific vaccines significantly more protective — and in what ways — than the original covid vaccines so many have already taken? If so, who would benefit most from the new shots? Since the federal government is purchasing these new vaccines — and many of the original, already purchased vaccines may never find their way into taxpayers’ arms — is the $3.2 billion price tag worth the unclear benefit? 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 voiced similar questions and concerns, one saying she only “reluctantly” voted in the affirmative.

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

That calculus is, perhaps, understandable at a time when an average of more than 300 Americans are dying of covid each day.

But it leaves front-line health care providers in the impossible position of trying to advise individual patients 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’re grateful and amazed that Pfizer-BioNTech and Moderna (with assists 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 each day. The pandemic isn’t over, but the vaccines are largely credited for enabling most of America to return to a semblance of normalcy. We’re both up-to-date with our covid vaccinations and 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 a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness in the absence of adequate controlled studies or published data, advertising them as desirable for all when only some stand to benefit significantly, and in all likelihood raising the price later.

This last point is concerning because the government no longer has funds to purchase covid vaccines after this autumn. Funding to cover the provider fees for vaccinations and community outreach to those who would most benefit from vaccination has already run out. So updated boosters now and in the future will likely go to the “worried well” who have good insurance rather than to those at highest risk for infection and progression to severe disease.

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

Yet 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 populations? And what increase in effectiveness is enough to merit an increase in price (a so-called cost-benefit analysis)? Other countries, such as the United Kingdom, perform such an analysis before allowing new medicines onto the market, to negotiate a fair national price.

The updated booster vaccine formulations are identical to the original covid vaccines except for a tweak in the mRNA code to match the omicron BA.5 virus. Studies by Pfizer showed that its updated omicron BA.1 booster provides a 1.56 times higher increase in neutralizing antibody titers against the BA.1 virus as compared with a booster using its original vaccine. Moderna’s studies of its updated omicron BA.1 booster demonstrated very similar results. However, others predict that a 1.5 times higher antibody titer would yield only slight improvement in vaccine effectiveness against symptomatic illness and severe disease, with a bump of about 5% and 1% respectively. Pfizer and Moderna are just starting to study their updated omicron BA.5 boosters in human trials.

Though the studies of the updated omicron BA.5 boosters were conducted only in mice, the agency’s authorization is in line with precedent: The FDA clears updated flu shots for new strains each year without demanding 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. That’s not the case with covid vaccines. And if mouse data were a good predictor of clinical effectiveness, we’d have an HIV vaccine by now.

As population immunity builds up through vaccination and infection, it’s unclear whether additional vaccine boosters, updated or not, would benefit all ages equally. In 2022, the U.S. has seen covid hospitalization rates among people 65 and older increaserelative to younger age groups. And while covid vaccine boosters seem to be cost-effective in the elderly, they may not be in younger populations. The CDC’s Advisory Committee on Immunization Practices considered limiting the updated boosters to people 50 and up, but eventually decided that doing so would be too complicated.

Unfortunately, history shows that — as with other pharmaceutical products — once a vaccine arrives and is accompanied by marketing, salesmanship trumps science: Many people with money and insurance will demand it whether data ultimately proves it is necessary for them individually or not.

We are all likely to encounter the SARS-CoV-2 virus again and again, and the virus will continue to mutate, giving rise to new variants year after year. In a country where significant portions of at-risk populations remain unvaccinated and unboosted, the fear of a winter surge is legitimate.

But will the widespread adoption of a vaccine — in this case yearly updated covid boosters — end up enhancing protection for those who really need it or just enhance drugmakers’ profits? And will it be money well spent?

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

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    1. Randall Flagg

      5th shot?
      I’m still waiting on better results before I get my first shot.
      But everyone should do what they feel is best for themselves or their loved ones.

      1. Pat

        As so many in NY say: “You be You!” /s

        Not how Hochul and her PR and advertising team meant it but what the heck. I stopped at one dose, and will be using that line at any suggestion I take a vaccine which hasn’t been tested whose efficacy is questionable.

        1. Randall Flagg

          Long term side effects from the shots, etc., etc
          Writing that Recognizing that there will always be some unknowns even many years from now. So, balancing that against possible disastrous long term effects from getting Covid in the first place
          You’re on your own.

          1. LifelongLib

            I’ve had 4 shots (Moderna). At 66, I’m at higher risk from covid and (somewhat) less concerned about long-term vaccine side effects. And yes, I do feel on my own.

            1. Randall Flagg

              That is completely understandable,
              My mother At 79 is getting all the shots and fine by me. Long term side effects are not the issue. Hopefully not passing away in a most miserable manner is all that matters.
              Best wishes to you.

            2. Anthony G Stegman

              Just because you are 66 years of age does not automatically make you at higher risk from COVID effects. That’s government propaganda as there is no data to support such a blanket statement.

        2. tegnost

          The end of the EUA would be one of many
          Until then I’ll be vaccinating with an n95…
          Throughout the pandemic I used homemade doubled up two layer masks, so 4 layers, which on the end of covid I upgraded to n95 or better exclusively.

  1. ambrit

    The “Vaccines to the Rescue” propaganda is a major subtext of this “article.”
    The statement in the body of the work that; “As population immunity builds up through vaccination and infection…” is not established science. The data suggests that any “immunity” to the coronavirus arising from infection or immunization is short lived at best. What is being spun as “population immunity” might just be the result of the more vulnerable populations dieing off. Statistics does the rest.
    No mention of treatments and precautions.
    Mr. Strether mentions “Our Democidal Elites.” I am now fully in agreement with him on this point.
    The funny sad part of all this is that the Elites might well avoid messy complications like guillotines simply because the prime demographics that could lead the charge in that direction will be either dead or so debilitated that effective offensive actions will be beyond their physical capabilities.
    Stay safe!

  2. Just An Analog girl

    What is this “immunity” of which they speak? I do not think it means what they think it means.

    1. Arizona Slim

      For me, my immunity to pharma industry propaganda has soared off the charts. Especially during the past two years.

      Thank you, Naked Capitalism, for helping me get to this point. Hit that Tip Jar, people! Or be retro like me and mail Yves a check!

    2. Lee

      Are there any vaccines that confer sterilizing immunity? Protection from disease, not from infection, is usually as good as it gets, isn’t it?

      I was recently surprised to learn that the oral polio vaccine, while conferring immunity in the vaccinated, then causes them for a time to potentially infect others. Evidently, the attenuated virus reverts to wild type in the gut of the vaccinated person, not harming them but can, through oral-fecal transmission, cause the disease in others. This does not occur with the polio jab.

      Also, the incidence of disease from being infectied by polio is relatively low: 1 of 100 or 1 of 2000 depending on the strain. So, there is a high rate of natural immunity to the disease in the gen pop.

  3. Mark K

    Yves commented that it was noteworthy for KHN to be opining that the development of the new COVID vaccines “might be unduly influenced by money.” That the article would assert this seemed much less surprising to me when I saw that its co-author (and Editor-in-Chief of KHN) is Elisabeth Rosenthal. Her book An American Sickness went methodically through every component of our healthcare industry, pointing out all of the profiteering that goes on in each.

  4. Silent Bob

    “We’re both up-to-date with our covid vaccinations and don’t understand why anyone would choose not to be, playing Russian roulette with their health.”
    And vice-versa.

    1. pjay

      This quote caught my attention as well. So I assume the authors have no questions about possible *safety* issues of the vaccines. Is this a settled issue? Not to my knowledge, and it is an important one if we are to make risk-benefit decisions for healthy young people. So has the evidence of flawed or skewed trials, serious adverse effects, etc., all been addressed and/or debunked now? I appreciate the (obvious) criticisms of profiteering and unequal access, but implying that those with safety concerns are just stupid irritates the hell out of me. This is especially the case if they are pushing these “vaccines” onto my young grandchildren.

      1. 1 Kings

        They are going to triple and quadruple down on their vaccine bs.
        And having the cost per going up by the same multiple means more ‘Mandate’ efforts.
        They will never admit they were or are wrong. Never.
        We have to deal with it.

  5. A G Kaiser

    A lot of legitimate mistrust will be cleared up when all of pharma and medicine are non profit owned and run of, by and for the people. Communitize medicine and pharma now!

  6. Telee

    The development of a nasal vaccine which would theoretically block the infection of all types of covid seems to be an alternative to pursue. India is supposed to be using it, however from what I gather from my reading is that their is little financial support for its development in the US.

  7. Alex Cox

    I hope this isn’t off-topic, but on the subject of vaccines, readers may already know, or be interested to learn, that Cuba has developed a vaccine against lung cancer.

    Unfortunately it isn’t available in Europe or the United States, and it’s illegal for Americans to visit Cuba for medical treatment.

  8. psmith

    I’ve followed Céline Gounder on Twitter through much of the pandemic and she’s had an interesting trajectory, sometimes being quite critical of the Biden administration and sometimes more supportive. Anyway, a very interesting essay!

  9. Mike1928

    Re: ” We’re both up-to-date with our covid vaccinations and don’t understand why anyone would choose not to be, playing Russian roulette with their health.”

    Seriously? I can’t understand how otherwise intelligent people can’t understand why there is a reluctance that others have to take the vaccine. There are so many reasons someone could probably write a book as to why some people object but I’ll mention just a few. The subject has been politicized and polarized people. The same people that were insisting the vaccine was dangerous during the Trump administration mandated the vaccine under Biden. The public has been continually lied to regarding just about everything to do with Covid, from it’s origins, masks/no masks, the spread is not airborne/is airborn, children should/should not take the vaccine (depending on the country you live in), mandates/no mandates, and the list goes on.

    1. Jeff

      Fear and anger are very effective tools for blaming woes on ‘the other’. We’ve seen a 2.5 year masterclass in this.

  10. Rodney

    I just got back from Kauai and used the nitrous oxide based Enovid from a pharmacy in Isreal. So far testing negative after starting testing the second day there. I was exposed quite a bit while eating, a concert, and typical Hawaiin tourist stuff but did wear a mask on the flight. We also still used hand sanitizers. My wife also is testing negative. We have had 3 shots but the last one was almost a year ago.
    Was I exposed? Who knows but chance says yes. But finally was able to take a vacation and all is well so far.

  11. david anthony

    Especially when these funds had to be pulled from other covid response efforts, like testing and treatment.

    Didn’t actually. Tons of covid funding could have been a part of the reconciliation bill.

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