Public Health Experts Fear a Hasty FDA Signoff on Vaccine

Yves here. This post confirms that readers who are worried about the too-obvoius signs of corners-cutting in the rush to develop a Covid-19 vaccine have esteemed company. There are at least two bad motivations in play.

First, the Trump administration is desperate for a pre-election boost. News in October that a vaccine was approved for rollout would make Mr. Market orgasmic. Many Trump voters are sensitive to the state of their portfolios and would look past his many other sins if their portfolios got a big pre-Christmas surprise.

Second, the drug companies likely believe that there is a big first mover advantage, that whoever gets a “good enough” vaccine out quickly wins. Given the considerable reservations of experts and the public, that may not prove to be true, but the MBA beancounters won’t hear that.

By Arthur Allen. Originally published at California Healthline, a service of the California Health Care Foundation

The vaccine trial that Vice President Mike Pence kicked off in Miami on Monday gives the United States the tiniest chance of being ready to vaccinate millions of Americans just before Election Day.

It’s a possibility that fills many public health experts with dread.

Among their concerns: Early evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the Food and Drug Administration. That conflict between science and politics might cause some people to not trust the vaccine and refuse to take it, which would undermine the global campaign to stop the pandemic. Or it could lead to a product that is not fully protective. Confidence in routine childhood vaccinations, already shaken, could decline further.

“The fear is that you wind up doing to a vaccine what [Trump has] already done with [opening] school,” said Dr. Joshua Sharfstein, a former FDA deputy commissioner and a professor at Johns Hopkins University in Baltimore. “Take an important, difficult question and politicize it. That’s what you want to avoid.”

On Monday at 6:45 a.m., the first volunteer in the landmark phase 3 trial for the Moderna Therapeutics vaccine received a shot at a clinic in Savannah, Georgia. Clinicians at 88 other sites, stretching from Miami to Seattle, were also preparing to deliver the experimental shot in a trial that aims to enroll 30,000 people. 

Dr. Anthony Fauci, the country’s leading infectious disease expert, told reporters he hoped 15,000 could be vaccinated by the end of the week, although he provided no information about progress toward that goal. All volunteers would receive a second shot 29 days after their first inoculation. (Half will receive a placebo containing saline solution.)

Another vaccine, produced by Pfizer with the German company BioNTech, also entered a large phase 3 U.S. trial this week. It’s being tested independently of the National Institutes of Health, which is partially funding the Moderna trial as well as tests for an Oxford University/AstraZeneca vaccine trial, and others in the future. AstraZeneca has said some doses of its vaccine might be ready as early as September.

Fauci said he expects the Moderna trial to provide an answer about whether that vaccine works by the end of the year — and it’s “conceivable” an answer could come in October. “I doubt that, but we are leaving an open mind that it is a possibility.”

Such a fast pace worries some experts.

“I don’t see how that’s remotely possible unless the thing I most fear happens, a truncated phase 3 trial with just an idea of efficacy, an idea of common side effects, and then it rolls out,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Pence downplayed such fears Monday, telling reporters: “There will be no shortcuts. There will be no cutting corners.”

Officials are pressing for an open and transparent process.

Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, is preparing to release a bill requiring the FDA to have an expert panel review any COVID vaccine and issue a recommendation before FDA Commissioner Stephen Hahn makes a decision.

With past vaccines, the FDA has generally relied on such a committee, made up mostly of vaccine experts and appointed by the FDA commissioner. They typically conduct a painstaking examination of all evidence before voting on whether the FDA should approve a vaccine. The commissioner has rarely, if ever, gone against the committee’s decisions.

Hahn undercut confidence in the FDA’s independence earlier in the year, many observers felt, when he issued an Emergency Authorization Use declaration for hydroxychloroquine, a drug used to treat malaria that President Donald Trump and members of his administration have continued to tout, erroneously, as a cure for COVID-19. The FDA later revoked the authorization, which was made without consulting an independent committee.

“FDA’s independence has been threatened, no question, by the hydroxychloroquine issue,” said Dr. Jesse Goodman, a Georgetown University professor who led the FDA’s biologics division and later was chief scientific officer.

The agency must give outside scientists and the public the opportunity to see the data and the FDA’s reasoning before coming to such a decision, he said.

Concerns about political interference arose recently when Trump talked excitedly about a vaccine, and Treasury Secretary Steven Mnuchin confidently told reporters there would be a vaccine by the end of the year for emergency use.

To be sure, it’s unlikely the FDA would be tempted to issue an emergency release without data that showed a vaccine was working and not causing serious side effects.

The massive coronavirus outbreaks in Texas and other hard-hit areas where the Moderna vaccine is being tested should provide an answer, although exactly when is an open question.

In theory, scientists might get a handle on a vaccine’s efficacy before all 30,000 people are enrolled, vaccinated and studied.

In fact, an answer could become clear after only 150 to 160 cases of disease are reported among the trial participants, Fauci said. If roughly two-thirds of those cases occurred in non-vaccinated people, it would show statisticians that the vaccine had above-60% efficacy, he said.

If the vaccine is 80% to 90% effective and the annual rate of infection in the places where it’s being tested is above 4%, scientists could get a signal of efficacy in such a trial with just 50 cases, or in as little as three months, said Ira Longini, a University of Florida biostatistician who designs vaccine trials.

The Moderna vaccine trial would hit that three-month threshold on Oct. 27.

The trial’s fate is partly in the hands of its 30-member Data and Safety Monitoring Board, whose members can see unblinded data about the participants in real time — pinpointing who was vaccinated with the actual vaccine and got sick, for example. The board will alert the NIH and vaccine maker if it sees surprising data — either dangerous side effects or powerful efficacy. Some fear that if the vaccine seems to work in an early review, the FDA would be pressured to stop the trial.

Offit said NIH should not accept anything less than a completed trial of 30,000 people. Fifty cases “is a very small number” to use as evidence for releasing a vaccine that could be administered to tens of millions, he said.

The public might clamor for the release of any vaccine that seemed to work. Moderna said it has already begun producing millions of doses of vaccine “at risk,” banking on the vaccine’s success. The FDA could release those under powers provided when the country declared a public health emergency in March.

With more than half the country deeply mistrustful of Trump, according to recent polls, any federal decision could be resisted and lead to widespread rejection of even a promising vaccine. Sharfstein worries about a “knee-jerk” reaction against the vaccine by Democrats if Trump touts it before the election.

Experts also worry about releasing a vaccine that shows some positive effects but isn’t robustly protective. A slide presented by FDA deputy director Philip Krause at the World Health Organization earlier this month said a weak vaccine could fail to protect the public adequately, leading to a false sense of security in those who’ve received it, while making it harder to test future vaccines.

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  1. Lambert Strether

    I think every member of Congress should agree to be vaccinated, as a trust-building exercise. They are also an at-risk population, so that makes medical sense.

    1. apleb

      I’d be more interested in all the medical professionals, virologists, CDC employees, etc. getting vaccinated. Then getting the same vaccine as them, not a different one (happens sometimes with yearly influenza vaccine: different for patients and medics).

      The virologists know the actual risks and benefits, with beltway critters anywhere it would only be a PR show what their experts tell them.

      1. PlutoniumKun

        Not necessarily – a lot of scientists (especially male ones, there is research on this), have a much higher tolerance for risk exposure in their areas of expertise. There are numerous stories out there, official and unofficial, of scientists doing crazy risky things simply out of scientific curiosity. Its a complex topic, but there are plenty of those in the risk assessment studies field who will tell you that scientists are among the very worst when it comes to assessing risks in their own areas of expertise.

        1. Ignacio

          When I studied my career one of the most respected teachers i had was a Virologist. Years later he developed a rare eye disease and was becomng blind. Physicians couldn’t help so he did his own research and demonstrated It was caused by a fungus. Then, an antifungal therapy cured him. It was awesome.

        2. apleb

          So who would you trust to assess the risks? I’m certain a politician is the wrong person in any case.

          The only assessment he makes is “how will it look in the press and how many votes will it get me”.
          Not a way I want to make my own healthcare decisions.

          1. PlutoniumKun

            If you are breaking established and proven protocols for assessing the safety of a given treatment (which would be essential if a vaccine is released for the general public within a matter of months of it being developed), then IMO the only reliable guide would be independent multidisciplinary groups of scientists, public health experts and statisticians with open source deliberations. You could also, if you were so inclined, throw in some philosophers, psychologists and sociologists into the mix. The final decision would ultimately be political, but it should be on the basis of a range of the best advice. If you really wanted to go all in on transparency and public buy-in, a citizens jury could make the final decision.

            Just no economists for obvious reasons.

      2. Paul Kleinman

        Remember that many medical scientists may well believe that a vaccine approved so quickly and with an abbreviated safety and efficacy testing protocol should not not not be released for distribution, but would face pressure to not refuse a vaccination.

  2. GettingTheBannedBack

    There was a segment on radio in my neck of the woods yesterday with some handwringing about the fact that some study somewhere said recently that 33% of people were not keen to have the first vaccine that comes out. The handwringing was about the possible increase in people with anti-vaxxer tendencies.
    I hope that the approved messaging around a new vaccine doesn’t come with a dose of stigmatisation of those, like myself, who will wait and see how the first lot of vaccinated people fare.
    So I am very pleased to see that some with medical research chops have reservations. Given that some vaccines have taken 15 years to be fully tested and accepted for public use.

    1. Susan the other

      About a year ago NC, I think it was Yves, suggested it could take 10 years to do a vaccine. At the time I thought that was overly cautious. But since then I’ve been thinking about a book (Lamarck’s Signature) which went into good detail on the ability of the human immune system to be directly translated from soma adaptations into gene cells. That is, to become easily heritable. So now watching the pols do their snake dance around and around I’m definitely skeptical. These are RNA vaccines we are dealing with. I’ve never been an anti-vax person. Until maybe now. And my particular misgiving is that efficacy is one thing but long term effects might be another, more difficult problem. How they can separate the two is over my pay grade, but I’d just submit that it needs to be seriously looked at, especially when it comes to vaccinating children.

  3. the suck of sorrow

    I live in a great country because corporations can be people and economies can be priority patients.
    Just for clarification: I am a citizen of The United States of America.
    And note that the ‘great country’ was a bit of sarcasm.

  4. John Anthony La Pietra

    One thing which concerns me about the rush to approval isn’t mentioned in this article: the simultaneous push to give corporations “stay-out-of-court-free” immunity from liability. (Cue the “smart-ALEC” lobbyists and their partners.)

    At the very least, they and their investors should have to pay medical and related expenses from any vaccine-testing side-effects, much less head-on complications, that hit the volunteers. (Without the usual deny/delay/defend response of insurance companies, please. And with co-payment by US the People limited to the government’s share of the profits from the vaccine, perhaps.)

    1. John Anthony La Pietra

      Here’s an article about the Vaccine Injury Compensation Program from May 14 of last year — when the big concern was the re-appearance of measles:

      I would appreciate comments from those with some medical knowledge in their background. I do note that the proposed new rule mentioned above targets coverage of two types of injury cited in this article (shoulder injury and syncope/fainting), and has the HHS Secretary overriding the advisory committee on those issues — and on letting the CDC add vaccines, or injuries associated with them, to the “Vaccine Injury Table” of those covered by the program without the Secretary’s prior approval. (Hmm.)

      My own careers have included attorney and government staff person, so my background suggests to me that VICP is somewhat similar in approach to the “grand bargain” of workers’ compensation: broadly, employers promising to help cover some workplace injuries on a theoretical no-fault basis in exchange for being protected from some kinds of lawsuits.

      Unfortunately, the balance in that bargain has swung in favor of employers (with help from insurers and those de-emphasizing the watchdog role and/or capability of state governments). The USDOL used to report annually on which states were covering which of 19 key recommendation from a national commission — but even that report hasn’t been produced since 2004, as I mentioned here about a month ago, citing this link:

  5. run75441

    Hi Yves:

    In 2016 the 21st Century Cures Act was passed in Congress with a bi-partisan hurrah from both sides of the aisle as driven then by Committee on Energy and Commerce Freddie Upton. During the years this Act was being prepared and sponsored by Fred Upton, he was handsomely rewarded by the healthcare industry in $millions of political contributions (Open Secrets). It would have been handy if he was not reelected in 2018; but, he was with the help of Biden who came to Kalamazoo in praise of Upton and his efforts to pass this bill.

    The 21st Century Cures Act was full of giveaways to many different segments of the healthcare industry who also graciously gave to the Upton political grab-bag. Public Citizen has solid information on the rewards and critiques the bill itself and its shortcomings.. Even if Upton lost in 2016, he would have walked away with a campaign chest of funds. Corker left with $6 million after retiring.

    To my point and I will answer in brevity, the 21st Century Cures Act does allow for a short circuiting of the clinical trials and Upton even boasts of it. Here is Upton taking a victory lap this month.

    “Why it is important now, because when we do get a vaccine for this, we’re on a fast track, we’re going to get it maybe a year or two faster than we otherwise would have because of this bill I shepherded through. It was my landmark piece of legislation three-and-a-half years ago. We’re poised, really, to see some real progress as (the vaccine) is made.”

    Upton: 21st Century Cures will aid COVID vaccine production

    What the bill has done is to allow Real World Evidence (RWE) to be a criteria in deciding the effectiveness and safety of drugs.

    Studies designed around RWE have the potential to provide useful information about the effectiveness of drugs and biologics, particularly if they can increase the demographic diversity of patients in these studies and more closely reflect typical medical practice. But real-world data (RWD) and sources of RWD have many limitations and complicating factors that raise concerns about the validity and credibility of the data for either safety or effectiveness. Because RWD and RWD sources are not necessarily designed to answer questions about the safety or effectiveness of specific treatments, there are frequently problems with measuring outcomes or controlling for confounding variables.

    NCHR comments on FDA’s Framework for Real-World Evidence Program

    We have already seen how this president can influence outcomes in agencies with personal attacks and the firing of personnel and the spreading of disinformation and outright lies. He has loaded up the agencies with industry influenced people and his own cronies who lack the knowledge in the particular fields needed to understand what a department does and making decisions based upon political impact. Azar and Kudlow come to mins as of this moment. The Cures Act just makes it easier to influence the outcomes under Trump where a different president may proceed with caution. There is much to be concerned with here as they race this drug forward to market.

    It always made me wonder how they moralize the unknown giving of a saline solution to a patient who may die as a result especially if they are aware of the test results.

  6. Jack

    What I would like is for some of those so called experts to explain to me how they have managed to develop a vaccine for COVID 19 in a few short months, when the average timeline for vaccine development is 15 years? The record for development is the mumps which took 4 years. And how about all the viruses that we do not yet have vaccines against? HIV, Lyme, West Nile, Zika, and Hep C to name a few. There isn’t even an effective vaccine against the flu (40% effectiveness) which they have been trying to develop since the 1930’s.

    1. William Hunter Duncan

      [Well], As the Market is the Holy Hand of God [the Daimon], the diseases you mention only effect immoral degenerates – people who have sex out of wedlock, who take drugs [other then Pharmaceuticals] and who spend time outdoors – thus they are like the weak and infirm winnowed from the Herd of Righteousness. This disease then, because it inhibits the Holy Hand of God [the Daimon] and the Righteous from Dominion, is clearly the work of the Fallen One [Ecology?], and thus any attempt by those most Observant and Chosen purveyors of Gods Will [the Daimon], Corporations, will be as OF the Holy Hand of God [the Daimon], and cannot but be True, Restoring All That Is Good [pathological], in America’s Just Rule Over This World.

      [paraphrased from the Writ of Souls of the Social Darwinian]

    2. Dwight

      They already skipped animal trials for Moderna, and possibly for the Pfizer vaccine. So they have already cut corners, risking the human subjects.

      The California Healthline article didn’t mention this, but should have IMO.

    3. Michaelmas

      Jack wrote: … explain to me how they have managed to develop a vaccine for COVID 19 in a few short months, when the average timeline for vaccine development is 15 years?

      It’s 2020 is the short answer. So, to start with, what modern medical biotechnology calls a vaccine may not mean what was classically meant by a vaccine, which was usually a dead or partially deactivated sample of the pathogen or one closely-related.

      In Moderna’s case, it received the genomic sequence of COVID19 from a lab in China and designed a vaccine in silico — that is, on computers, which is common practice these days. They then used automated DNA synthesizers to build real samples of COVID19 in vitro in a day and then built their vaccine model in a couple more days.

      What Modern has created is an mRNA ‘module’ that encodes for a prefusion stabilized form of the Spike (S) protein of COV19, which is how the pathogen penetrates a human cell. So the mRNA tells the vaccinated individual’s body to create a sample copy of one small component of the pathogen, but NOT the rest of it. The antibodies and immune system, having been shown this protein, then recognizes it and learns to fight it. That’s the Theory 101 of it, as I understand it.

      This vaccine will *likely* be effective to a greater or lesser degree and continue to sail through human trials.

      BUT there are a couple of questions to ask about it:

      [1] The obvious one: how long this engineered immunity will be effective for?

      [2] Moderna’s technology has been a ‘personalized medicine’ approach. So, forex, they also have a cancer vaccine under review by the FDA — and how can you have a cancer vaccine?

      By using the same approach. A sample is taken of an individual patient’s specific cancer, various tools are used to assay that specific cancer’s vulnerabilities, and then an RNA ‘module’ creates a copy of specific parts of that cancer’s structure to be ‘shown’ to the individual patient’s immune system.

      This is — or was — high-end, bleeding-edge biotech. I’ve spoken to someone who described visiting Moderna’s automated factory, which is equally high-end (and, yes, in the U.S. on the East Coast).

      Sure, once you’ve created one mRNA vaccine that attacks COV19’s Spike protein, that should be generally applicable. So this won’t be the completely personalized approach of Moderna’s other vaccines and therapeutics. Nevertheless, you’ve got to wonder how difficult it’ll be to scale up mass production for such a vaccine so that it’ll be effective for a world of going on 8 billion people or, for that matter, a country of 330 million. Obviously, they’ll have had a year to work it out, but still.

      In the case of the Oxford-Astro Zeneca vaccine, which is the other front-runner candidate, I believe they took a classical vaccine designed to deal with another pathogen and already cleared through human trials, and used that as a chassis. Ignacio will probably know more about that.

  7. antidlc

    “This post confirms that readers who are worried about the too-obvoius signs of corners-cutting in the rush to develop a Covid-19 vaccine have esteemed company.”

    Thanks, Yves. Good to know I am not alone.

  8. tegnost

    A cure worse than the disease could bring down the entire facade, but the likely response by the elites of “Russia hacked the vaccine!” could buy them some time while the vaccine (which everyone with an operating brain cell knows will be foisted on the working poor to test it’s morbidity rate while the wealthy sit in their castles attending zoom meetings and ordering organic food from instacart and junk pre garbage trinkets from BuyNow!, almost entirely without risk) decimates (hopefully those deplorable trumpies/s) the population. I don’t trust “them” and won’t test their vaccine for them, but I expect to be pestered incessantly to do so for the good of society. High society.

  9. diptherio

    It was a little before my time, but we’ve been down this road before, and it didn’t go well. There was a swine flu scare during the Johnson administration and they also rushed a vaccine out:

    …public health officials were terrified of the possibility of a viral pandemic, like the one that had killed 50 million people worldwide and 575,000 in the United States in 1918: the Spanish flu, which was also an H1N1 strain of influenza…

    Inside the federal health care bureaucracy, top officials immediately started formulating plans for a major vaccination campaign. Within just a few weeks, Ford announced to the nation that his administration would buy enough vaccine doses to inoculate about 200 million people and oversee a national vaccination program. Eventually, the Democrat-led Congress endorsed the program with two new laws.

    Nothing on that scale had ever been attempted, even for polio or smallpox. That well-intentioned response still stands as one of the worst public health failures in U.S. history…

    Less than one-quarter of the population received the swine flu inoculation, and the vaccine itself was associated with a paralyzing immune disorder called Guillain-Barré syndrome, which caused more deaths than the virus it was supposed to prevent.

  10. Synoia

    ” Emergency Authorization Use declaration for hydroxychloroquine”

    I do wish these writer would understand the difference between PREVENTION and CURE.

    Hydroxychloroquine and its predecessor Chloroquine (Avaclor is one trade name) are anti malarial PROPHYLACTICS.

    They are not cures. They are asserted to be anti Covid 19 prophylactics. As such it should be as easy as a Vaccine to test.

  11. Ignacio

    The worries expressed are very real. In fact i suspect we are running wild with too many Phase III trials withot having done properly comprehensive preclinical studies.

  12. Ping

    Scientific talking heads apparently do not have to disclose their financial interests in the vaccines/treatments they are hyping on TV. Is it true Fauci owns half the patent for Moderna’s new technology whose stock behaves like classic pump and dump?

    I find this entire “rushed vaccine theater” horrifying and insane and should be obvious with a minimum of independent research how life-altering autoimmune diseases are easily triggered. It’s well documented military has had a significant problem with mandatory vaccine for things like anthrax causing lupus and MS. I know of a NAVY husband and wife who got a “bad batch” of anthrax vaccine and both developed Multiple Sclerosis.

    Auto immune disease will be delayed onset which would then not get documented in the short time span of these rushed trials as Robert Kennedy Jr. illuminates and also how “rigged”, if you will, the phase 1 or 2 the tiny Moderna human trial was basically excluding anyone who wasn’t a perfect specimen in their prime and even those people had a high percentage of adverse reaction with 1 hospitalization.

    In all, I feel like I’m living in a “Twilight Zone” episode.

    1. antidlc

      “In all, I feel like I’m living in a “Twilight Zone” episode.”

      I have said the same thing.

      I had this dream (nightmare) that a vaccine was forced on the US population and within six months everyone died.

  13. antidlc

    We’re Paying a Drug Company Twice Over for Unguaranteed Coronavirus Vaccine

    Based in Cambridge, Mass., Moderna should certainly get an award for milking the government.

    It doesn’t matter if the vaccine works. Moderna already was paid twice over.

    The big winner in initial contracts, Moderna got $483 million in April to develop a vaccine. While that may have seemed adequate to jockey the vaccine through both the development and testing process, the company decided to go back to the trough for more. It is having the government pay $472 million for the Phase 3 testing.

    Together these payments virtually guarantee that the company will make a substantial profit. Yet, Moderna will still get a patent monopoly on the vaccine, which will allow it to charge people in the United States and elsewhere in the world as much as it wants.

  14. Marshall Auerback

    Skepticism and outright denialism about vaccine safety and efficacy existed way before Covid-19, resulting in poor coverage by vaccines for some diseases and among some communities. Uncertainty about the data or the specter of political manipulation of results will only undermine public confidence, just when we need it most.

    1. drumlin woodchuckles

      It would appear that this particular push for this particular cluster of vaccines to be ready ” immediateliest”
      will cut/ is cutting so many corners and inviting so many risks and hazards that any public underminement of trust in this particular vaccine cluster will be entirely appropriate and totally called for.

      I have said before that I may choose to not be part of the Beta Test population for any of these covid vaccines. And I think I may mean it.

  15. Jeff W

    …the drug companies likely believe that there is a big first mover advantage, that whoever gets a “good enough” vaccine out quickly wins…

    Aside from the dangers inherent in the rush to be first or, at least, earlier, there’s also the possibility that a later, more effective vaccine loses out, assuming there is a first mover advantage.

    Novavax’s NVX-CoV2373 vaccine, something of a dark horse among these Phase III candidates, produced neutralizing titers in the 10,000 range in nonhuman primates—“the highest reported levels of neutralizing titers in non-human primate studies”—and much higher than the other candidates (which produce neutralizing titers in the 40–200 range, according to this article), but is the last to be tested in these Phase III trials—in October. (The order is Moderna’s vaccine now, Oxford/AstraZeneca’s in August, Johnson & Johnson’s in September, and Novavax’s in October.) 

  16. Michaelmas

    there’s also the possibility that a later, more effective vaccine loses out

    Good point.

  17. Jack

    This is another sign that the FDA credibility and maybe the entire NIH system is at rock bottom. There should be no dispute, none, over what gets released and when. If there ever was a need for political, medical and social harmony this is it.

  18. Sound of the Suburbs

    I don’t think I’ll be rushing to get vaccinated ASAP.
    I’ll let some more guinea pigs, carry out some more extensive testing before I take the plunge.

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