A six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of a vaccine to fight it. Modern and the National Institutes of Health have recently announced the start of a Phase 3 clinical trial, joining others in a constructive rivalry that could save millions of lives.
It is truly impressive a feat and a testament to the power of the basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once passed months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could be used alongside Apollo missions as one of the greatest scientific achievements in history.
I am optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps with a bit of anguish. Behind the proud statements, many science and medicine professionals have been whispering concerns. These whispers have escalated to a whisper. It̵7;s time to mourn them out loud:
Hey, Food and Drug Administration: Don’t feel rash. Early approval of a substandard Covid-19 vaccine could have serious implications, and not just in this pandemic. It could harm public health for years, if not generations.
Unfortunately, now the current elements make not only such a disastrous outcome possible, but it is really very likely. Specifically, the FDA and its staff of chronic regulators with too much work and underestimation will face enormous public and political pressure to approve a vaccine. Whether or not he worries about an “October surprise” aimed at the next election, regulators will be pressured. Some will stand firm. Some may resign in protest. But others could break down and allow the release of a bad vaccine.
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 proves ineffective, this could inadvertently promote a wider spread of the disease by people who presume they were protected. Also, a negative experience with a vaccine can discourage the use of other much safer and more effective vaccines, whether for Covid-19 or other vaccine-preventable diseases.
Some things need time. Under normal circumstances, making sure the effects of the vaccine are safe and lasting requires years of study and control. And there is some evidence that natural immune responses to SARS-CoV-2 infection could be transient, making sustained research more necessary. A merely short-term effect could encourage vaccinated individuals to resume risky behaviors, which would ensure that the epidemic suffers. And if unwanted side effects turn out to include, for example, chronic or autoimmune inflammatory diseases, a bad vaccine could cause lifelong damage.
But wait, there is no worse! A bad vaccine against Covid-19 could further undermine confidence in the many safe and reliable vaccines that already exist 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 the disappointing results of Covid-19, these malignant forces could facilitate the re-emergence of missing enemies: poliomyelitis, measles, rubella, rubella, diphtheria, coughing and tetanus, which once killed many children each year. .
These are huge risks. Putting all our bets on a small set of untreated vaccine technologies would be cheeky. This is exactly what we do now. Most high-profile names that capture headlines pursue relatively small variations on a topic of genetic vaccines (those delivered by DNA or RNA). If one approach works, the odds are higher, the others work too. Disappearing a candidate’s results, however, can be a failure on the entire board.
Instead of investing in a balanced portfolio of vaccines with different approaches, not to mention different therapies, devices, and diagnoses to treat Covid-19, there are too many observers, too many companies, and too many government officials focused on the hopes of a vaccine. “Savior.” If that savior failed, our national morale, already low, could fall even further.
Do not hurt me. I, along with millions of Americans, want a vaccine against Covid-19. But we deserve to be shown to be safe and effective.
It is not too late to take a deep breath and devise a strategy to balance short- and long-term goals, including vaccination, improved diagnosis, and existing and new treatments. We must support the FDA and expect its scientists and doctors to retain the strength and conviction to resist the approval of a lower vaccine.
To cheer ourselves up, we should look at Frances Oldham Kelsey, a true FDA patron. In 1960, during the first month she worked 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 detected a toxicity risk and dug into his heels. She refused to seal the permit. His actions saved the lives of countless babies. Kevadon, better known as thalidomide, turned out to be one of the most dangerous and disfiguring drugs in history.
Kelsey died in 2015 at the age of 101. We must pray that his spirit will inspire 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 Biotechnology Research and Drug Discovery at the University of Washington in St. Louis. Louis. He is the author of “Between Hope and Fear: A History of Vaccines and Human Immunity” (Pegasus Books, 2018) and two other books.