A Just six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of having a vaccine to combat 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 is a truly impressive feat and a testament to the power of basic and applied medical science. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been accomplished in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of the greatest scientific achievements in history.
I am optimistic. And yet, as someone studying drug development, I want to moderate expectations with a dose of realism and perhaps a little heartbreak. Behind the proud statements, many science and medicine professionals have been whispering concerns. These whispers have become a whisper. It’s time to cry them out loud:
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Hello, Food and Drug Administration: Don’t be reckless! Premature approval of a below-standard Covid-19 vaccine could have serious consequences, and not just for this pandemic. It could harm public health for years, if not generations, to come.
Unfortunately, the elements now in place make such a disastrous outcome not only possible, but actually quite likely. Specifically, the FDA and its underworked and chronic overworked regulatory staff will face enormous public and political pressure to approve a vaccine. Whether or not you worry about an “October surprise” aimed at the upcoming elections, regulators will be hard pressed. Some will stand firm. Some may resign in protest. But others could break down and allow a bad vaccine to be released.
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What Makes A “Bad Vaccine”? Insufficient protection against the disease for which it is designed, unwanted side effects or some combination of both. If an approved Covid-19 vaccine turns out to be ineffective, this could unintentionally promote further spread of the disease by people who presume they were protected from it. Likewise, a negative experience with a vaccine could discourage the use of other vaccines that are much safer and more effective, whether for Covid-19 or other vaccine-preventable diseases.
Some things take time. Under normal circumstances, ensuring that the effects of a vaccine are safe and long-lasting requires years of study and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection may be transient, making sustained research even more necessary. A purely short-term effect could encourage vaccinated people to resume risky behaviors, ensuring that the epidemic would endure. And if unwanted side effects include, for example, chronic inflammatory or autoimmune disease, a bad vaccine could carry life-long harm.
But wait, there is something worse! A bad Covid-19 vaccine could further undermine confidence in the many safe and reliable vaccines that are already in our public health arsenal. Vaccine skepticism and unscientific bias, propagated by Russian B-list celebrities and Russian trolley farms, have been building momentum all year. Combined with the disappointing results of Covid-19, such evil forces could facilitate the resurgence of enemies that were once vanquished: polio, measles, mumps, rubella, diphtheria, whooping cough, and tetanus, which once killed multitudes of children each year.
These are huge risks. Placing all of our bets on a small set of unproven vaccine technologies would be incredibly silly. However, this is exactly what we are doing now. Most of the high-profile names captured by headlines pursue relatively minor variations on a subject of genetic vaccines (those administered through DNA or RNA). If one approach works, the odds are higher than the others will also work. However, a candidate’s disappointing results could portend failure across the board.
Instead of investing in a balanced portfolio of vaccines with different approaches, not to mention different therapies, devices, and diagnostics to treat Covid-19, too many observers, too many companies, and too many government officials seem to focus closely on the hopes for a “life-saving” vaccine. . If that savior failed, our already low national morale could drop further.
Do not misunderstand. I, along with millions of Americans, want a Covid-19 vaccine. But we deserve one that has proven to be safe and effective.
It is not too late to take a deep breath and come up with a strategy to balance short and long term goals, including vaccination, improved diagnosis, and new and existing treatments. We must support the FDA and expect its scientists and doctors to retain the strength and conviction to resist approval of a poor vaccine.
To encourage us, we should look at Frances Oldham Kelsey, a true patron 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 the enormous pressure, Kelsey discovered a toxicity risk and nailed it to her heels. She refused to seal 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 Innovation in Research in Biotechnology and Drug Discovery at the University of Washington 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.
