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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.

  • You didn’t cover the historical context of how it could have even been possible to get something so promising so quickly. It’s no accident, but decades in the making. The real key to the progression has been the advancement in virology in the last 30 years, most likely due to the massive influx of grant money due to the HIV epidemic. Virology was a reasearch backwater pre-1980, but in the next 10 years, it really hit the ground running. Dozens of laboratories were tremendously funded, excellent scientists were trained, science progressed rapidly, and we thus became ready for 2020. People need to understand that this rapidity to the COVID-19 vaccine was never reckless, but a reasonable progression from trained technical, Ph. D., and post-doctoral scientific personnel, research, and infrastructure investment over three long decades. A new scientific generation was born and raised. This is an amazing success story to be lauded, not feared. If allowed, I’ll be first in line for the vaccine.

  • I am still trying to catch up. I think we had a vaccine in March, based on the Spike, and it was working in macaques. No one would (openly at least) move to human challenge testing and now the talk is of a different vaccine just now going into Phase 3, which we will buy before we test. ?????

  • Please Google 2009 h1n1 swine flu timeline. This was a coronavirus vaccine that was developed in record time of what 7 months. When you say things like ‘normally’ it’s not scientific. Also it’s 2020, with 2020 technology. That changes a lot.

    I agree with you though, if we don’t get it right it’ll backfire and people will say I told you so. That’s why we can’t mess it up. Especially since it’s a new type of vaccine.
    30,000 people are gonna find out.

    • H1n1 is not a coronavirus. It’s influenza. My understanding is that we’ve never had an effective vaccine for any coronavirus.

  • Plesse do not create confusion before the event to disrupt a critical process.
    FDA KNOWS ITS JOB WELL.
    PLEASE TRUST INSITITUTIONAL AND SCIENTIFIC INTEGRITY.
    Take care and stay safe and wait for a vaccine.
    Best luck

    • The FDA is corrupt. People like you terrify me. You are extremely trusting and still believe in all these institutions. You will be among the people screaming for mandatory vaccination.

    • Read “Bottle of Lies” by Katherine Eban and then decide whether you want to trust the FDA.

  • Whispering concerns? Really? Who? C’mon, give us some names. A completely evidence free article. Sounds like what Mr. Kinch is really worried about is the possibility that a successful vaccine would help the re-election of the President. It seems insane, but there are clearly a lot of people in politics and in the news media who are rooting for the virus.

  • There are many problems with the COVID-19 vaccine. The first is COVID-19. At least 80% and probably more like 90% of patients who are infected with COVID-19 are either asymptomatic or mildly symptomatic, with a cold or flu like illness. Heretodate most reports indicate that the side effects of the vaccine are common and in given the minimal nature of the disease, are worse than the disease. 80% of the population already has cross reactive T cells to the corona virus. In macaque monkeys, giving a vaccination to an animal already infected with coronavirus precipitates ARDS (acute respiratory distress syndrome).

    A clinically effective vaccine must be safe, induce a protective immune response and is generally accepted by the population.

    Given this, the demonstration that a vaccine is clinically effective is difficult. We have a great model with the flu. A flu vaccine has been widely available for years. In some years, it is highly effective. In some years, we miss the mark and the vaccine is either ineffective or minimally effective. Despite the wide spread availability of the vaccine, and extremely minimal side effects, 40% of the population does not take it.

    A much better strategy: Promote diligent protection of the vulnerable populations (we know how to define them). Encourage mingling by the non-high risk population to induce herd immunity (which will protect the vulnerable). Encourage outdoor activity (sunshine is essential to optimal immune system activity and activity helps to offset obesity (a risk factor)); encourage healthy eating with minimal ingestion of highly sugared products (high blood sugar interfere with the immune system through inactivation of IRF5); encourage vitamin D ingestion (as low vitamin D is associated with poor outcomes; mechanism appears to be an effect on immune system but still debated). stay home if sick.

    • Vaccination has side effects. The H1/N1 vaccination program increased the incidence of Guillian Barre to about 1/1,000,000. The article cited raises the question of post-COVID-19 issues in patients with pre-existing cardiovascular disease but notes that it is only a possibility at this point point. COVID-19 is not unique in this sense. There are also issues with Coxsackie and other viruses that result in cardiovascular damage and other permanent damage, such as acute flaccid myelitis in young children. Where is the outrage and moonshot program to develop vaccines against these viruses?

  • It’s called being prudent. Until you have success in human trials it’s impossible to know the outcome.

  • My God up in Heaven! Does nobody have faith in sophisticated computers to test vaccine safety? You all act like this is the year AD 1800!

    • Last I checked, the vaccine was meant for people, not computers. My experience with computer modeling (in a very different and less critical context) leads me to suspect that no computer simulation would be able to account for all the complex issues and interactions involved in introducing a vaccine into an actual living subject, and therefore cannot really tell you in advance whether a vaccine is entirely safe or even effective. This is not to say that modeling is not helpful, but to point out that there is still a pretty big gap between simulation and reality.

    • To Brian, last time I checked, computers in 2020 are world changingly different than 2019, and exponentially more so the earlier you go. And you’re both right and wrong in the same sentence. The AI computers used to model this account for MORE variables than man or even testing can account for. You can only test 7 Billion people, a computer can test far more scenarios that may even currently exist. The right part is that humans aren’t cars, the fix isn’t always the same, nor does it ever always work exactly the same.

      I have no doubt the simulations will give a good yeah, or neah, I have doubts that the vaccine will be a permanent fix. But the models will likely tell us that as well.

    • We lack sufficient computer modeling power and algorithms to predict the outcome of complex, adaptable systems. There is nothing more complex and adaptable then a living organism; and in a living organism, there is nothing more complex and adaptable then the immune system. This means the only means to test at this time is empirical trials.

  • Old-School Vaccinologists Are Not What We Need

    How can I be so rough on our valued scientists, you might wonder. Well, I do not claim to be an expert in this field. But I do recognize data and can respond to the data that I can see through my ignorant eyes.
    Historically, vaccines took years to develop. While compelling, that is not part of the new—world solution to pandemics. All the experts repeat this fact ad noseeum (Data Point 1). That is not comforting. That indicates to me that the experts aren’t up to a modernized approach. While they are the best we have, they do not meet my expectation for out-of-the-box thinking. What we need is new thinking. Out of the box thinkers in the field can take us where the modern world needs.
    We should not pat ourselves on the back at the speed of the development. The technologies were already here. We didn’t recently develop DNA sequencing and electron microscopes and the like. Vaccine development techniques were known before COVID-19 reared its ugly head (Data Point 2). We were, however, over-constrained by the historical box we were used to playing in. Because of the global expanse of the pandemic, we were stressed to speed things up and to proceed in parallel. This should already be in the playbook and not forced into the open by the disaster. The new-school experts should have this and other plans in their back pocket yesterday.
    Besides, this is not the first COVID virus to come along (Data Point 3). It, after all, did not come from an asteroid. While it is interesting to note the nuances and differences and challenges that the “Novel” COVID-19 presents, vaccinologists should not be surprised by its appearance. We should have anticipated and prepared for its arrival. But we were caught nearly flat-footed. No one could have predicted the details for the DNA, but this pandemic was surely going to come in one form or another.
    As I read this article, I appreciated the apparent experience of the author right up to the point where he started to interleave severe caution and old-school thinking into the dialog. I diverged at that point. All due respect, we can do better than to remind the readers of the perils of approval outside of the traditional norms. There are many perils, some of which are revealed with over-abundance of old-school caution. We need to move into a new way of thinking.
    We have no data that these will be “bad” or “sub-standard” vaccines (There is No Data Point 4). Let’s not sensationalize fear and failure. Yes, let’s talk about the risks. Let’s frame things up within the medical context. But let us be rational and not conjecture based on immunological history. This is easy for the author. He knows the field, but I reject the fear. We should proceed (or not) based on data and not a hypothetical calamity.
    As far as the position that, if successful, this rivals the Apollo moon landing, well, not so fast Einstein. Let’s first finish the vaccine-rocket ship and then and only then, take us to the future the next time a pandemic comes to call.

    Maynard Hurley

  • It seems to me this article is rather premature. If upon completion of phase 3 trials of one of the current leading candidates the data appears troubling, that is the time to sound the alarm. But this article is nothing but speculation that could deter people from taking a vaccine that is indeed both safe and effective. Additionally, if the vaccine is safe but of marginal effectiveness, have we really lost much? Relaxation of precautions should be coupled with elimination of disease spread, vaccine or no. That is the messaging that should be done now.

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