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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.

  • Hello Michael,

    Two comments, first you are pushing ” “better is the enemy of good enough” with your “And there is some evidence that natural immune responses to SARS-CoV-2 infection could be transient”, well that is certainly true for FLU vaccines, which is why its important to get a new FLU vaccination every year. And if it is “transient”, if most people get immunized it will cause COVID19 to fade for lack of susceptible people. And that will buy time for better testing among the myriad of other vaccines that are in development.

    Secondly, you succumb to “Ceteris paribus” in pushing to wait 1-2-3… years for a better, fully tested, fully vetted vaccine to minimize deaths due to a less-than-erfect vaccine now. That ignores all the deaths that will accrue to other side effects of the COVID19 pandemic. Deaths due to economic collapse and job loss, governments printing trillions of “paper” money eroding peoples savings, the associated increases in drug, alcohol related deaths, depression and suicide, undiagnosed cancers and heart disease, untreated cancers and heart disease, untreated dental problems, economic and civil unrest, war and other pestilences and all the other natural shocks flesh is heir to.

    So it’s good to be cautious (first due no harm) but you do need to step outside your medical expertise and recognize that your concern is only one of a myriad of concerns across a broad spectrum of human activities that need be taken into account. Remember there is more than 1 horseman of the apocalypse.

    • @Igp A very balanced comment. Too often people consider only only side of the ledger and only visible benefits or costs. Both sides must be considered and secondary and tertiary effects as well.

  • And how do you know it works? Because Trump says so? You are very very foolish and irresponsible.

  • I am a firm believer in vaccines, but I can tell you I will not touch a vaccine fast tracked by the Trump administration. Who in their right mind would put their health in the hands of that monster?

  • These are valid points to consider. Anyone blindly waiting in faith for this rushed vaccine is just following dogma, not science. Even some of the most pro vaccine leaders are concerned about this rush to the savior vaccine.

  • It seems that when noted rotavirus vaccine inventor,Dr Paul Offit, who has frequently spoke against vaccine exemptions such as religious exemptions, worries about the safety of the COVID vaccine, then perhaps everyone should be concerned.
    The vaccine manufacturers also seem to be worried. Astrozenca is pleased that they have now been given full immunity from liability in most countries, because , as they point out, they don’t want to be sued for side effects that are identified in two to four years time.
    Bill Gates also explained that the COVID vaccine needed to be indemnified, because of the risks.
    In what I am sure some would consider good news, no matter how bad or dangerous the vaccine, the companies are now completely safe from being sued.
    We all know that no one is going to sue about redness and swelling at the injection site.So , what kinds of risks are they talking about?
    Guilliame Barre ( paralysis, which sometimes requires a ventilator, and sometimes eventually reverses itself, but can also end in death) Encephalitis, ( inflammation of the brain, which can lead to brain damage) seizures, and epilepsy are all known side effects per the CDC table of vaccine injuries of vaccines that have already passed all the safety studies.
    Of course, the COVID safety studies have specifically excluded pregnant women, and study participants agreed not to get pregnant for 18 months. So, miscarriages? Life long birth defects? We don’t know, and won’t for several years after the vaccine is released.The study participants are the healthiest of the healthiest. They can’t have even smoked, let alone have autoimmune issues in their family. And yet, even so, some of them have suffered short term side effects such as fever, migraines,and fatigue. If they have other long term issues, such as autoimmune issues which take an average of 4.5 years after onset to diagnose, then we certainly won’t know about them yet either.
    And the question remains, what will happen when regular Joes with health conditions like obesity, smoking, autoimmune conditions, or diabetes, take the vaccine?
    We also don’t know how the COVID vaccine will interact with the flu vaccine, which will likely be given around the same time.
    And even if we do get a “safe” vaccine, some manufactures are already talking about an imperfect vaccine that just relieves symptoms. That means vaccinated people will be asymptomatic carriers( capable of spreading the disease, and the ones we want to quarantine, right now) but we can see with the chicken vaccine Mareks, what happens with an imperfect vaccine that only reduces symptoms. PBS and national public radio have both got easily searched articles, on how, normally a virus dies out if it kills its host too fast.In the case of Mareks, vaccinated chickens can still carry the virus, and the hottest strain which has developed in these vaccinated chickens, now has a 100% kill rate for unvaccinated chickens, in ten days, worse, apparently than even ebola. If we do this, and make the virus much more deadly, it will be too late then to wish we could reverse course.

  • I am not a scientist, just another stuck-at-home trying to do a cram course in virology and epidemiology, and avoid the crib notes put out by the “D” students while doing it. Turns out you have to open the textbooks and start reading at Page 1 to know what you are talking about- which I did not do – turns out virology and epidemiolgy are HARD – and it takes years to learn them.
    So, I cheated a lot but here is what I think I learned, people who actually know things please set me right, still trying to learn without doing all the homework:
    1. They should have done human challenge testing (HCT) for some obvious vaccine candidate in April- and it was entirely possible to have done so. It seems like the main objection was ADE. – ADE is Antibody Dependent Enhancement – you can sicker the second time you get some viruses, or, if you get infected after having a vaccine, because your antibodies enhance the virus. Human challenge testing was not worth not doing because of HCT – the very worst ADE can do is kill the person who got the shot when they subsequently got infected. If it does to your first ten volunteers – or ten out of the first hundred, or even first thousand – you STOP- you will know if it is happening in two weeks tops.
    2. I can not see the logic in the system they set up- instead of promoting one vaccine – with a somewhat new technology – why are we not going 10 or 20, and testing them while making millions of doses ? Considering the cost of the epidemic, it’s a few billion spent on insurance and trivial.
    3. As best I can tell, the chance of fatality for everyone from 21 to 50 with no clear risk factors is well under 1 in 1,000. Maybe more like 1 in 5,000. Chance of long term damage to health is probably a couple times that – not trivial but not high. And for women it may be even lower – I wish them well, but they do not need to get the vaccines first. Give the vaccines to over 50 year old people – if we die from the vaccine, bad luck, but the chances of dying from the virus were already high, making it well worthwhile to take the risk.
    3. My personal point of view – Phase 3 testing on 30,000 people is probably plenty for data collection – but if they are making 100 million does up anyway, and I want to take it, I am going to take the risk, why not give it to me on demand? Particularly if a person is not working, not providing any essential service to anyone- and the worst that might happen is they die- but, chances are it will protect them- why not just give the vaccine out to everyone who we can afford to lose? They are the same people who are going to get the worst of the epidemic, and outside all the essentials who will not get severely sick anyway.

    • You stated “why not just give the vaccine out to everyone who we can afford to lose, they are the same people who are going to get the worst of the epidemic.”

      Are there people we can “afford” to lose?” No, should a child lose his or grandparent who might be raising him or her? Many kids these days are raised by grandparents and they are vital. Should a husband or wife be OK losing a disabled spouse or a spouse or partner with co-morbidities? Is it OK if many of our middle aged and senior diabetics die despite the fact they are not only someone’s relative but also could be a doctor, psychologist, teacher, or CEO of a company. Even if a person is not working they still aren’t expendable. Perhaps they have already worked 30 or 40 years and currently are unemployed – what does that have to do with anything? Every person has value and every life should be preserved. And we don’t know the immunity status of those who are home. They could be COVID positive and asymptomatic, immune, or were sick and recovered. Also they could be staying home as caregivers to their children (remember, all the kids are out of school meaning millions of moms are home too) and their spouse could be working and financially supporting them. We can’t judge who has value and who doesn’t based upon being an essential work or not, or age, and we can’t assume who will or will not succumb to the virus.

    • lonib87 – I am not the death committee, so relax – we do NOT have choices such as those you imply with your rhetorical questions. I mean, if everyone acted with one mind and everything was done right – all the time – then we DO have choices. In the real world, we do NOT HAVE CHOICES.
      I am not trying to be obnoxious with the all capitals letters – not trying to sceam, if the word processor would let me use italics or underlines i would but:
      WE DO NOT HAVE CHOICES. By which I mean, we do not have the choice that no one dies from this point forward, we do not even have the choice of protecting one segment of the population at the expense of another, no matter how great the expense – we do not have the choice of “no one is a guinea pig” –
      we CAN choose which segment of the population is treated more as guinea pigs than others, all I am saying is it should be people who have the most to gain and the least to lose.

    • Steve I feel your pain.
      In the UK our daily briefings had a lot about the infection rate and R0 for several days I felt I had to start to get a handle on Stats so i started to (very ) slowly get on board with stats, I realized that the medical side would be far too difficult at the start. hint Stats is as well
      I found the AstraZeneca site useful at a high level. then WHO and Reuters the last two are less product based but for who is getting involved the AstraZenica site leads to a lot more links.but of course I am biased 🙂
      I have looked at other pharmaceutical sites but it is a similar story
      The UK Government has already started to prioritize the order of administering a vaccine when one is approved. so one less item for me to worry about.:)
      their order was NHS front line staff, elderly in care homes, elderly at high risk, then elderly, then the rest of the population , seemed fair to me. but your points 3 and 4 are why I satrted in on the Statistics area 🙂

  • Your concerns are valid , and should be raised, in the recent past there have been attempts to subvert the impartiality of several US government departments and undue pressure put on the FDA. Luckily the rest of the world has lesser pressures voiced about their approval agencies, many trials are being conducted across the world with many countries collaborating to find a safe solution the the virus.
    One of the currently leading contender vaccines is running phase 3 trials in several countries and is cooperating with international agencies and using at least one WHO project to spread the trials globally while it is possible for one country to falsify its claims and infect the remainder of its population with a worse disease, it gets progressively harder when many countries are working together as each knows their people will be the beneficiaries if it is successful and the victims if they fail. Trials are still in progress so failures could still happen, most people realise that but hope for the best.
    One trial has several countries interested and booking pre approval doses already even Russia has Been granted a license to manufacture the product at its labs . The pressure to get things right on them is far greater than that on the FDA.
    There would have to be a global failing for all the vaccine candidates that may pass their trials and then have the same failure in the population, they use different procedures and ideas . Long term problems are indeed an issue an the early recipients of the vaccine should be monitored so that the rollout programme can be halted . But by the end of the year the early tester will have had 6 months or so to develop any long term symptoms before public vaccinations start.
    Against That risk there is the certainty of large number of deaths so far 700,000 in just about 7 months, a choice has to be made that I leave up to more expert people.

  • You belie your political machinations doctor ..
    We professionals are supposed to place such opinions on the sideline and keep it all about helping those in need.
    Your words demonstrate that you have clearly lost that perspective
    You must look inside yourself and regain your professional objectivity
    The lives of your patients and their well being depend on it
    Best of luck …

  • I don’t think they would release a vaccine that would be bad for the public. Pretty sure that’s why they are testing people before releasing it what in the flip is this article?

    • You certainly are very trusting of a vaccine that’s being thrown together and tested in a matter of months, rather than the years most vaccines and meds take (some of which *still* winding up being unsafe). Perhaps you also missed the section that discussed long-term effects that would not be known due to rushing a vaccine to market. Or how a hurried vaccine that winds up not being effective may boost public mistrust or increase transmission by lulling the public into a false sense of safety.

    • Wouldn’t release a bad vaccine? With Trump – of course they would. Anything to get himself re-elected. He has no bottom to his depravity.

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