Signs of an ‘October Vaccine Surprise’ Alarm Career Scientists

Jerri-Lynn here. Some electoral phrases have become cliches. One is “October surprise.” Never thought I’d hear those words applied to a vaccine before, however. But as you can see, one of the many functions your very stable genius in chief may appropriate is just that.

Yikes?

A real far?

Or more Trump Derangement Syndrome run amuck.

Don’t know, but it’s a question about which the commentariat will have lots to say.

By Liz Szabo and JoNel Aleccia. Originally published at Kaiser Health News

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Azar — who reports directly to Trump — can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Dr. Preeti Malani, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

  • Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year,although the final analysis could take place next spring.
  • Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
  • AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in The Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Dr. Peter Marks, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare — my worst nightmare — because we will so confuse the public,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Avorn and co-author Dr. Aaron Kesselheim wondered whether Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

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38 comments

  1. The Rev Kev

    It might not be just Trump that would want to push for an early vaccine. I see that Putin has just offered UN staff a dose of Russia’s Sputnik V formula for free, Yes, he also pushed for a top-level meeting on joint global development of a Covid-19 vaccine but I bet that a lot of people in government would see these developments as the US falling behind Russia in the development of a working vaccine. This, to some in power, would call for a dramatic response on the part on the US so bringing out a vaccine for general use as an ‘October surprise’ would not be out of character.

    Reply
    1. Polar Socialist

      About two weeks ago UN approved a resolution for Comprehensive and coordinated response to the coronavirus disease (COVID-19) pandemic.

      Only USA and Israel voted against it, mainly because it calls “for the urgent removal of unjustified obstacles, in order to ensure the universal, timely and equitable access to, and fair distribution of, all quality, safe, efficacious and affordable essential health technologies and products” (read: sanctions) and “upon States to take all measures necessary to ensure the right of women and girls to the enjoyment of the highest attainable standard of health, including sexual and reproductive health, and reproductive right” (read: birth control and abortion).

      To the world it may appear US is not falling behind just Russia, but most of the civilized world.

      Reply
      1. L

        I believe China was also opposed or at least opposed to joining in on sharing their vaccine. This is in part due to the fact that they have been giving away loans to purchase the vaccine to members of the OBOR.

        Reply
  2. Maritimer

    “…vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.”

    Safe and effective. This would seem to be for English Professors to decide not scientists. What is safe? We already know that vaccines can harm people. What is effective? We already know that the effectiveness for similar vaccines are in a wide range, 20% to 60%.

    So, this “safe and effective” is simply setting the definitions. You cannot put the English language under a microscope. This process is horse-trading, bargaining, consensus, toss-a-coin, split-the-difference. It is not Science. It is not even Shortcut Science.

    Reply
    1. rusti

      What is effective? We already know that the effectiveness for similar vaccines are in a wide range, 20% to 60%.

      There was a discussion about this on This Week In Virology recently. According to a webinar with a bunch of the chief scientists of vaccine developers the consensus figure for “effectiveness” is 80% at mitigating or preventing disease. I’m terribly ignorant of how it’s all boiled down to one number, maybe Ignacio can elaborate.

      Reply
      1. BlakeFelix

        I think that there are levels of effectiveness, and safety. Even a 50% effective vaccine would help a lot if it was safe enough, it would probably help mitagate symptom severity and spread, and COVID isn’t terribly infective so that knocking Rt in half would probably kick its ass. There is a world of difference between multiplying by 1.5 and .75 every week.

        Reply
  3. Kasia

    Let’s just say that Covid-19 is not an issue that shines the best light on Trump. In other words it would be a strategic mistake for Trump to be putting Covid back into the conversation right before the election by releasing a vaccine. He is far better off provoking more BLM/Antfa riots, getting more Blue Cities to defund the police, pushing through a new Supreme Court justice, and mocking Joe Biden for his cognitive deficiencies. As tempting as it may be to turn the Democrats into anti-vaxxers, Trump’s smarter move is pretending the pandemic never happened.

    Reply
    1. L

      Well he can’t really do that. That is why he is still downplaying it “Affects virtually nobody” and why he keeps calling it the “China Virus” as if our bungled response can be totally blamed on them. It is the same logic DNC types keep using when they say that Clinton and Biden’s support for the Iraq war means nothing because Bush lied.

      I agree with you that rushing a Vaccine would be bad messaging on one level because the conversation would shift. But on the other hand the hail mary pass there would be for him to claim that he wanted to cure it and the mean ol scientists tried to stop him. That is generally his MO for most things. He has always wanted to stoke crises and be looking for the miracle out. That, I think, is why he was so attached to HCQ because it would be a one time cure for a problem that, per Woodward, we know that he knew was serious.

      Reply
      1. Kasia

        Trump is an apex narcissist and while often this condition serves him well, during the pandemic it nearly destroyed him. I agree that he will be sorely tempted to launch one final Hail Mary pass but his advisors need to tell him to check his narcissism since the pandemic score is 35-0 and so he needs to just take a knee and get on with with emphasizing other games where he is doing much better, like the riots and the Supreme Court.

        Reply
    2. diptherio

      Nice right wing talking points you got there. Despite what the news would have you believe, only about 5% of protests have involved protesters engaging in any kind of violence. But “if it bleeds, it leads,” so you feel justified in referring to all of them as riots and lumping BLM and Antifa into one basket because they both show up at protests against police violence, smh.

      As for defunding the police, would that it were so. In reality, more cities have increased funding than decreased it, even in this environment of massively reduced income to local governments.

      Reply
      1. Kasia

        It’s actually 93% of protests were peaceful. But if we think about that…

        93% of my bank transactions were done properly.
        93% of flights safely landed today.
        Jeffery Dahmer didn’t eat 93% of the guys he met on the street.
        93% of all Russian Roulette games end peacefully. (Yeah, I know, it’s actually 83.3%)
        93% of unarmed BIPoC arrests don’t end in shootings.
        93% of Iraqis were not killed during the US invasion.
        93% of US taxes collected do not get sent to Israel.
        and
        99% of Covid patients recover just fine.

        Reply
        1. diptherio

          So, to be clear, unless 100% of all protests against the authorities murdering people are 100% peaceful (I mean, from the protester side, I don’t suppose cops using teargas and rubber bullets counts as violence, just maintaining order), they’re all illegitimate. Have I got that right?

          Reply
          1. Kasia

            No, the real question is how many riots is it going to take to get enough Biden voters to forget Covid and flip to Trump due to worries (perhaps irrational) about getting their homes or businesses burned down. I can assure you right now Trump Nation is salivating at the possibility that in a couple hours, Louisville will explode in violence, nudging Trump’s Covid failures closer towards the memory hole.

            Reply
            1. Kurtismayfield

              How many people died in these protests?

              How many people die to cops every year?

              How many people die to Covid?

              Two of these things are an actual threat to me. One is not. If my home or business burns down I have insurance. If I get paid 12 million by the police department after my death I can’t cash the cheque.

              Reply
  4. Ignacio

    A first read on the first paragraph:, OK, let’s assume that it is true that Trump could authorize a vaccine by himself for the simple benefit of having it announced before the election day. I indeed believe this will occur being this an extreme case of using public power, the power of the Presidency, for personal benefits.

    One thing is to give approval and a different matter is vaccine deployment. Let’s let aside the case for emergency use to make this simpler. Imagine Trumps approves in October the Moderna vaccine. Will Moderna rush to deploy it massively without having fulfilled the primary objectives of their vaccine. I think they will think twice and probably wait until they have enough data on safety issues before massive deployment. So, Trump might play with approval announcement but knowing that deployment would be another issue. Would he be able to force a compromise from Moderna to deploy the vaccine before they have enough data on vaccine safety? I doubt he would try that because the risks for him would be too high and quite probably he understands those risks. He is just playing with election day. Once election day passes, the pressure would relax and whether Trump wins or losses, the deployment would be delayed until enough data on vaccine safety and efficacy has been gathered. That’s my guess.

    We shouldn’t be carried away by Trump craziness.

    Reply
    1. PlutoniumKun

      Yes, I think there is an obvious ‘bait and switch’ strategy that Trump can use. He’ll pick the most successful looking vaccine and announce it as the winner, but the actual vaccination process will not be possible of course until after the election, by which time he won’t care, if he wins he’d be happy to just roll back and allow the normal process to resume.

      Reply
        1. Larry

          Completely agree. I’m not sure what voter is going to be convinced by this action. Are there undecided voters who will jump when he just picks a vaccine? If that’s the case then they should already love Trump his press conferences declaring how great he’s handled this whole ordeal.

          Reply
          1. Samuel Conner

            It’s for his “base”, to reassure waverers that he is able to keep promises. Or maybe to reassure them that he actually gives a d@mn about them. I am stunned by the number of DJT supporters among my friends and family who affirm that they believe “the President really does care.”

            “See, I promised a vaccine in time, and I delivered. Of course, it’s up to you whether or not you want to take it.”

            Reply
            1. tegnost

              While that’s all well and good this particular article is making the same old “but trump” argument that miracuously shelters the dems peeking out of the pockets of the big pharm.
              See this article…
              https://www.statnews.com/feature/prescription-politics/prescription-politics/

              In the real world, which is rarely commented on in these hair on fire articles,
              who in their right mind would trust any vaccine rushed out…if biden stepped forward and said we have a vaccine I wouldn’t believe him either. For very good reasons listed in the linked article. I found it when looking for a quote I recall from I think pelosi who said something along the lines of “here’s a chance for big Pharm to prove it’s worth but couldn’t find that. I read the posted article and think it’s either my rich friends vs your rich friends (first mover and all) or a big silo for the TDS crowd. It’s a big silo and I ain’t in it (h/t george carlin). There’s not an ethical side to big pharm. Joe Biden does not represent the ethical side of big pharm because there isn’t one.They’re all in it for the money.

              Reply
            2. Adam1

              But it carries a huge risk. Once he announces a vaccine it comes with another entity he can’t control. They better lock up the executives of the named vaccine maker as one could easily see them deluged with press demands to know the distribution timeline. Trump would look like a ninny if they said 6 to 9 months or worse “we are not sure”.

              Reply
  5. SteveB

    Years ago when the Ebola was the virus dujour, I took a 4 ft long 1/2 inch dowel and wrote “you” on one end and “Them” on the other. I named it “The Ebola Stick” and the instructions were to hold out the dowel like a sword to keep anyone from getting any closer to you than arms length plus 4 ft.
    It got quite a few laughs…………………………

    Who knew….. I was on to something……..just ahead of my time !!!!!!

    Reply
  6. voteforno6

    He’ll probably try something, but if there’s too much opposition, he’ll pull back, as he’s done before. If he’s desperate enough, though, I wouldn’t be shocked it he tried some other October Surprise, such as starting a war with Iran.

    Reply
    1. L

      Honestly Ruth Bader Ginsburg’s passing has already given him his October Surprise. As awful as this may sound, Iran is probably safer because of it.

      Reply
  7. Krystyn Podgajski

    He is taking a page from Elon Musk. He can announce emergency approval in October and pump up his numbers. but the vaccine will not be available until June 2021.

    Reply
  8. TomDority

    Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

    How would any drug company be reluctant to manufacture their vaccines – safe or not – given the 1950 DPAct offers a perfect cover for whatever they churn out –
    We committed treason by not producing or we are in a war against an unseen enemy and did everything we could do in this emergency – what reluctance and what pressure.
    Seems everybody thinks the private sector will do what is correct because the ‘free market’
    Tell me where the stop button is because I have not seen it on the Democratic or Republican side.
    Sorry about the negativity but, the legislative branch no longer legislates — they seem to ask the other side to please don’t do this or that, be nice play nice please – pretty please ??? why do elected officials always avoid their jobs and never pass any laws for the common good – they are always looking for cover and finger point – Trump does this finger pointing and blaming others while maintaining a schoolboy bully posture better than most because he is a true coward and scared little spoiled punk – yellow narccisistic adult child President shin-splints.
    Of course these are my opinions

    Reply
  9. John Beech

    I suppose it’s inconceivable the scientists, themselves left-leaning, would be pleased to wait until after the election? After all, what are a few more deaths versus the desperate need to remove the horrible orange man, right?

    I honestly feel we need some way to reign in the media, which doesn’t interfere with the 1st amendment but also curtails their influence and power to deceive – witness the New York Times’ unceasing Russia, Russia, Russia, which turned out to be pure theater. For shame the only protected class in the US Constitution has given away their gravitas.

    Reply
    1. Samuel Conner

      re: “we need some way to reign in the media, which doesn’t interfere with the 1st amendment but also curtails their influence and power to deceive”

      I think that the mainstream media is already on the case; it’s a self-limiting phenomenon. Already nearly half of the electorate regards the “merely somewhat right of center” media behind the Russia! narratives as purveying “fake news”. Plenty of us who are left of center regard all mainstream outlets with skepticism, and the MS(print)M business model is in trouble.

      Trustworthy alternative outlets may arise and become economically viable.

      Is the NC model scalable to large numbers of specialist ‘blogs with a niche reporting focus (NC’s being CALPERs and wider financial shenanigans, with the WC specialist focus on political analysis) combined with news aggregation? In such an “ecosystem”, the news aggregation could increasingly point to original reporting done from within the alternative reporting ecosystem. There is some of that already.

      I don’t see why it wouldn’t be possible. But it might take some sort of larger cooperative effort (like a jointly-own media company that had enough economic power to overcome obstacles such as bandwidth throttling if the ISPs decide to suppress unfavored views appearing in small outlets.

      Reply
    2. FluffytheObeseCat

      Scientists are not in general “left-leaning“. At least not until quite recently. The current science-bashing passion of the American ultra right has begun to change this in the younger cohort. No one embraces a political movement that demonizes him for cheap thrills and tribal purity exercises.

      Reply
      1. diptherio

        I dated a chemist for many years, while she was in grad school and after as she moved into the corporate hellscape, and from her experience I’d say that, if anything, most scientists in her fields (chem and physics) are right-leaning. She had one colleague who listened to Rush and his ilk all day, and about 80% of her grad school cohort were evangelical, fundamentalist Christians. Maybe John Beech is thinking of social scientists?

        Reply
  10. shinola

    Consider:

    Big Pharma’s main concern is… Profits!

    Trump’s main concern is… Trump!

    So, could/would Trump persuade (bribe) a pharma co. to announce a vaccine prematurely by having the gov’t pay for it & providing immunity from any liability for death or injury caused by a defective/ineffective product?

    Reply
  11. ultrapope

    Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

    This is a disturbing comment – if the vaccine is not properly tested, scientific authorities should urge people not to be vaccinated, full stop. The case scientists should be making is not vaccination for vaccination’s sake – its vaccination for public health’s sake. Do scientific authorities not see the possible benefits coming out against an untested vaccine might afford them? Is it not a common anti-vaxxer screed that scientific authorities should not be trusted because they refuse to acknowledge the supposed dangers of vaccines? By coming out against a rushed, untested vaccine, these authorities can deliver a one-two punch against this argument: not only will we refuse to push a vaccine that is dangerous, we will also not push a vaccine whose safety has not even been properly tested.

    God this comment pissed me off.

    Reply
    1. diptherio

      Yeah, this sounds to me like one more example of “the experts” assuming the rest of us are a bunch of drooling morons, unable to deal with even the slightest nuance. They really do seem to think that people can only manage to think either ‘all vaccines good’ or ‘all vaccines bad,’ rather than ‘these time-tested vaccines with known safety profiles are good, this new, untested vaccine of questionable safety is not so good.’

      Reply
    2. Tom Bradford

      coaxing hesitant parents to ignore baseless fears.”

      Baseless? Some hesitant parents haven’t forgotten Thalidomide.

      Reply
  12. diptherio

    Not gonna lie, part of me is hoping Trump does this, just so I can rub it in the faces of my neighbors who are all-in on QAnon and anti-vaxx. So far, they’ve been able to convince themselves that Trump isn’t really pushing for a vaccine, even though he keeps saying he is, rather he’s engaging in some elaborate 11 dimensional chess move to bring about their beloved “Storm”

    We now believe, for reasons outlined here, that the “military deployment” of vaccines is a cover story. Trump is using the vaccine issue to place military units in position all across the nation to prepare for a post-election invocation of the Insurrection Act which would activate the military to confront and arrest or eliminate domestic terrorists across the country.

    In other words, Trump isn’t really leaping in with the vaccine industry as much as we once feared. “Operation Warp Speed” isn’t really a vaccine operation but rather a national security operation that will put US troops on the streets of every American city in an effort to restore the rule of law, arrest treasonous actors (including mayors and governors) and put down left-wing terrorists.

    So part of me (just part, not all) is hoping he goes through with it just so I can say “I told you so.”

    Reply

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