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A mere six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of a having a vaccine to fight it. Moderna and the National Institutes of Health recently announced the start of a Phase 3 clinical trial, joining several others in a constructive rivalry that could save millions of lives.

It’s a truly impressive a feat and a testament to the power of basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of history’s greatest scientific achievements.

I’m optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps a bit of angst. Behind the proud declarations, many science and medical professionals have been whispering concerns. These whispers have escalated into a murmur. It’s time to cry them loudly:

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Hey, Food and Drug Administration: Don’t be rash! Premature approval of a sub-standard Covid-19 vaccine could have dire implications, and not just for this pandemic. It could harm public health for years, if not generations, to come.

Unfortunately, elements now in place make such a disastrous outcome not only possible but in fact quite likely. Specifically, the FDA and its staff of chronically overworked and underappreciated regulators will face enormous public and political pressure to approve a vaccine. Whether or not one worries about an “October surprise” aimed at the upcoming election, regulators will be pressed hard. Some will stand firm. Some may resign in protest. But others could break and allow a bad vaccine to be released.

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What makes a “bad vaccine”? Insufficient protection against the disease it is designed for, unwanted side effects, or some combination of the two. If an approved Covid-19 vaccine turns out to be ineffective, this could unintentionally promote wider spread of the disease by individuals who presume they were protected from it. Likewise, a negative experience with one vaccine might discourage the use of other vaccines that are far more safe and effective, whether they are for Covid-19 or other vaccine-preventable diseases.

Some things take time. Under normal circumstances, ensuring that a vaccine’s effects are safe and durable requires years of study and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection could be transient, making sustained investigation all the more necessary. A merely short-term effect could encourage vaccinated individuals to resume risky behaviors, which would all but guarantee that the epidemic endures. And if unintended side effects turn out to include, for instance, chronic inflammatory or autoimmune disease, a bad vaccine could impart lifelong damage.

But wait, there’s worse! A bad Covid-19 vaccine could further undermine confidence in the many safe, reliable vaccines already in our public health arsenal. Vaccine skepticism and anti-science bias, propagated by B-list celebrities and Russian troll farms, have been gaining strength all year. Combined with disappointing Covid-19 outcomes, such malign forces could facilitate the reemergence of once-vanquished foes — polio, measles, mumps, rubella, diphtheria, whooping cough, and tetanus — that once killed multitudes of children each year.

These are enormous risks. Placing all of our bets on a small set of untried vaccine technologies would be gobsmackingly foolish. Yet this is exactly what we are now doing. Most of the high-profile names capturing headlines are pursuing comparatively minor variations on a theme of genetic vaccines (those delivered via DNA or RNA). If one approach happens to work, the odds are higher the others will work as well. Disappointing results from one candidate, though, might presage failure across the board.

Rather than investing in a balanced portfolio of vaccines with different approaches — not to mention different therapies, devices, and diagnostics for treating Covid-19 — too many observers, too many companies, and too many governmental officials seem to be narrowly focused on hopes for a “savior” vaccine. Were that savior to fail, our national morale, already low, could plummet even further.

Don’t get me wrong. I, along with millions of Americans, want a Covid-19 vaccine. But we deserve one that’s been proven to be safe and effective.

It’s not too late to take a deep breath and devise a strategy to balance short- and long-term goals, including vaccination, improved diagnostics, and existing and novel treatments. We must support the FDA and hope that its scientists and physicians retain the strength and conviction to resist approving a substandard vaccine.

For encouragement, we should look to Frances Oldham Kelsey, a veritable patron saint of the FDA. In 1960, during her first month working for the agency, Kelsey was asked to approve a sedative called Kevadon, which had the potential to generate billions in revenue. Despite enormous pressure, Kelsey spotted a risk for toxicity and dug in her heels. She refused to rubber stamp the approval. Her actions saved the lives of countless babies. Kevadon, better known as thalidomide, proved to be one of the most dangerous and disfiguring drugs in history.

Kelsey passed away in 2015 at the age of 101. We must pray that her spirit inspires a new generation of FDA leaders with the courage to say, “No.”

Michael S. Kinch is associate vice chancellor, professor of biochemistry and molecular biophysics, and director of the Centers for Research Innovation in Biotechnology and Drug Discovery at Washington University in St. Louis. He is the author of “Between Hope and Fear: A History of Vaccines and Human Immunity” (Pegasus Books, 2018) and two other books.

  • Is the science community looking at natural substances such as supplements or herbs etc.. that can alleviate the course of Covid 19?

  • This article seems to be written to confuse the subject and cause fear.

    The FDA has tough job, many people can die if they say “yes” or “no” incorrectly. If you delay a good vaccine a year you kill >100,000 Americans. It is not a simple matter of the more “no” the better.

    What is your proposal for approval? Wait 3-4 years?

    In 1958 a serious flu hit the US. Maurice Hilleman pushed out a vaccine in about 8 months, and that was when technology was much more primitive. This saved 100,000 to 800,000 lives in the US.

  • I think the author misjudges the public. The view is already that vaccines maybe sub-optimal to start with. They recognize for starters that the treatments being looked at may only offer small incremental improvements in recovery and mortality rate. Of the two existing drugs identified one improves recovery but not mortality and the other improves the mortality rate of ICU patients. There will be no silver bullet from treatments but likely an array of drugs that have an impact. The reframe project seems to have some interesting potential. On vaccines there is full awareness that they may not be gold standards vaccines. They may have time limited effect and not work on some groups. Anti body levels do seem to wear off after a period although we do not know if this is only mechanism to fight the virus. We could of course get some very pleasant surprises.

    I believe it is possible COVID 19 is medically resolved in steps of improving treatments and vaccines. The aim is to reduce the mortality rate and the strain on healthcare. I recognize this can be done in steps.

  • As someone in a high risk group who may be assumed to be pressuring the gov’t for a vaccine asap, I heartily, totally second the author’s opinion.
    Perhaps the author, or readers with gov’t connections, can see to it that the “warp speed” part is the announcement, and availability is rolled out SLOWLY.
    Layman’s suggestion: Start with a small group who is presumably at high risk of catching it but at low risk from any new vaccine complications: Nursing home staff. Next, move to high risk to contract and also to die from the virus; nursing home patients. They will of course have higher risk of complications, but the risk/reward is still high.
    Finally, move to SOME, not all public contact people, such as grocery store clerks and waiters.
    By doing this one can have the (sadly necessary) political aspect of “hey look, we have a vaccine, you can stop panicking now), but also conduct what amounts to a Phase 3.5 test.
    In the event someone (fearful aunt Flossie, rambling fed Representative, etc) complain they want it for “my special group, NOW, have it explained that the rollout is designed reach high contact and high risk people, which will have a higher impact on lowering virus prevalence. This happens to be true, although mass public vaccination before safety has been really proven would work faster. That option sure AF is not better.

    Me? Despite being high risk and living in a large, filthy city, I’ll wait towards the end of the line. Vaccines are the true miracle** drugs, but they got that way by immense testing and many rejections, not by haste.

    **Miracles built by 250 years of knowledge construction.

  • Too many commenters here bring up the point about the “headstart” of the vaccine candidates here being tested for SARS or MERS, for example. This is irrelevant and totally misses the point. Many vaccines previously have had a “headstart” in one form of another, and if anything the old technology of killed virus particles was a whole lot faster to develop than the more newfangled, nucleic acid-based vaccines favoured today. The reason vaccines have always taken a decade or more, is that they’re being given to healthy people, not those with disease, and they must be tested with great rigour when given to such a large population, over many years, to account for the “unknown unknowns” that could kill kids and healthy people.

    This includes things like antibody-dependent enhancement (ADE) which can actually make an infection MORE dangerous instead of protecting against it, which is what we saw with RSV and dengue fever vaccines that turned out to be disasters. Or that stimulate autoimmune reactions that kill thousands, as we saw for instance with the swine flu vaccine disaster in the 1970’s. Or that are manufactured wrong, as we saw with the Cutter polio vaccine that killed kids. Or, most frighteningly, that actually cause disease themselves, as we saw with the rushed HIV vaccine (nef deleted) in the 1990’s. This is the most terrifying cautionary tale about rushed vaccines, as there was enormous political and financial pressure in the early 1990’s to release the nef deleted HIV vaccine which showed promising early results, and over 7 years there was mounting pressure to push it out. But at the last second, some courageous researchers uncovered a fatal flaw that not one doctor or scientist in a million had even anticipated–the vaccine had the potential to recombine (including with endogenous retroviruses that at the time were hardly understood at all), and if given on a widespread basis, that vaccine would have actually caused HIV itself, and killed hundreds of millions of healthy people!

    The scariest thing about the historical vaccine disasters above is that, in general, they showed very good early results in early clinical trials (including in Phase 3) and had the blessing and support of industry, academia, the FDA, almost all scientists and doctors, and other expert and regulatory agencies, including Dr. Anthony Fauci’s own NIAID. But their dangers did not become apparent until much more widespread examination and testing, which often took at least 7-12 years to fully grasp. And there were hundreds more vaccine candidates that showed early promise, including in Phase III trials, but that were halted only toward the end of the trials (often 9-10 years later) when the data were examined in full. This includes vaccine candidates that looked far more promising than the “ChadOx” vaccine candidate from Oxford or Moderna’s system–which both are already showing concerning shortcomings, such as the debilitating short-term reactions from the Oxford vaccine (indicative of a likely autoimmune or or inflammatory process we know precious little about), the need for a booster after 3 weeks, and the very weak T-cell and humoral stimulation. Yet even those apparently “spotless” vaccine candidates later showed problems that became evident only after 5 or 10 years of thorough testing, including additional animal testing and wider population-based testing. Even more so for the vaccines (like the swine flu vaccine, dengue and RSV) that were released and turned out to be disasters.

    The difference back then, is that there was not a ridiculous media circus as there is now trying to push out a vaccine to boost corporate profits, or with more of an interest in quarterly earnings reports for the stock market than long term health. Had we had such an irresponsible media and press environment back then as we do now, then that catastrophic HIV candidate vaccine would have likely been released a couple years after its development, and killed hundreds of millions of healthy people! We’re already seeing some frightening early signs about COVID-19’s weird immunological behavior, including things like antibody-dependent enhancement becoming apparent in the patients who’ve been reinfected with the novel coronavirus, with their second infection in general being much more severe than the first–the opposite of what we would have expected. ADE must be thoroughly tested and it will take 3-5 years to know for sure. We also need much more information about the inflammatory process that was striking almost all the volunteers who received the Oxford vaccine in the Phase I and II clinical trials, and left them practically unable to function for 1-2 days. This is very alarming and we need to know exactly what is going on before putting something like this in our bodies. Same thing with the devastating adverse effects that struck about 10% of early recipients of the Moderna vaccine candidate (when they finally released their data to the public instead of press releases following their little “pump and dump” of their stock–itself a red flag). We also need a better understanding of MIS-C, the devastating Kawasaki-like disease that has been killing or badly harming many kids infected with COVID-19. This too indicates a subtle immunological process at work with COVID-19 and it must be better understood before any vaccine is given to millions of people, doing otherwise would risk disasters like what we saw with the dengue and RSV vaccines, and the swine flu vaccine calamity of the 1970’s. As scary as COVID-19 is, it can be controlled with disciplined public health measures to contain it, like what we’ve seen in Asian countries like South Korea, Taiwan and Vietnam, in Slovakia, Hungary, Czechia, Poland, Denmark and Austria in Europe, in New Zealand, or Argentina in South America, that have nearly eradicated it. Given this ability, there is no excuse to rush out a vaccine simply because a country’s public health and other institutions are simply to lazy or incompetent to get their act together.

    • Another voice of sanity! But, don’t waste your effort yelling at the Internet. You sound to be someone who works in virology or a related field, so bring your technical concerns and, especially, the examples of why not to rush to your 3 Federal reps and any public figures you may know.

      Except celebutards, they’re incapable of understanding anything other than how to obtain more attention, cash and perhaps crazy sauce.

    • Thank you, Walter, for your clear headed assessment. Please continue to comment and confuse the prevailing mob narrative with the all facts, a call for transparency, bold yet judicious vision, and even braver hindsight. Boy, do we ever need a course correction. So happy to see critical thinkers are still in the game. May I share it?

    • “The difference back then, is that there was not a ridiculous media circus as there is now trying to push out a vaccine to boost corporate profits, or with more of an interest in quarterly earnings reports for the stock market than long term health.”

      The Oxford vaccine is not for profit. That should quell your outrage a little.

  • …and then again the Moderna vaccine (and the others in or close to Phase 3) may end up being safe and effective, and stop the pandemics in its tracks.

    This is going to be the most scrutinized clinical trial in the history of medicine. One death that could remotely be attributed to the vaccine, even if it’s one in a zillion, and Moderna is toast and NIAID/NIH has eggs all over their face. In a business where $billions and scientific egos reign supreme, this is a pretty powerful deterrent. Most everybody has already decided whether to vote for or against Trump, a vaccine related “October surprise” will change few minds if any.

  • We need to pray if this is a vaccine
    For us all trials and approval will be an answer from God, we need to ask God to bless this process, God have mercy on us ☹️

  • Oh splendid.you really have knowledge to write a gambit of things happenings very cohesively.

  • You warn, Don’t Be Rash!…. It is our reality that that exact warning will be ignored as the political pressure from trumpland fuels rashness. The nightmare of suffering will just be lengthened by the corruption of our health agencies as ANY vaccine to surface first will be foisted upon us all. Just include a generous amount of morphine in the shot so we can all tell our fellow citizens..”You’ve just got to get that vaccine shot, Bro!”

  • I appreciate the discussion in comments, going back and forth on the merits of “old school thinking” vs. “modern-world” … or being too cautious vs being too innovative and disregarding unforseen side effects… This is a difficult line to walk.

    To those being very critical in one way or the other between those 2 extremes: it is too soon to tell what the correct amount of caution is. Rather than ramble on for pages let me summarize it below:

    1. A couple months ago, we had “consensus” that post-recovery immune responses to Covid19 were “probably” durable.

    2. Now, we are slowly getting published evidence that a post-recovery immune response is “not durable” – meaning immunity could wear off and an already recovered person could get covid 19 again the following year, or w/e…

    3. The takeaway is that we simply don’t know if natural immune responses are durable or not. It is not confirmed. There has neither been enough time nor enough published, peer-reviewed research. We simply don’t know yet.

    And if that is the case… how can we possibly say the method of deliberately encouraging exposure among NOT at-risk persons for the sake of herd immunity is a good thing? Likewise, how can we possibly say that a near future vaccine, though FDA-approved, will be able to account for the (possible) waning of post-recovery immunity that illness-recovered people may be having.

    We can’t be certain of either direction….and that is the scary part. I think a lot of people on Facebook and the news don’t get that last part. It is a nuance.. It should scare us a little.

    My only last off-the-cuff comments are these. Best case scenario: an approved vaccine does confer long-term sterilizing immunity against covid19 virus. Next-best case scenario: it does not, but the new American way of life is to get a safe, effective covid19 vaccine dose every 6 or 12 months of their lives until further notice (possibly years), to account for how the immunity wears off every 6 or 12 months, etc.

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