A just six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the verge of having a vaccine to fight it. Modern and National Institutes of Health recently announced the start of a Phase 3 clinical trial, combining it with several others in a constructive competition that could save millions of lives.
It is a truly impressive feat and a testament to the health of the basic and applied medical sciences. Under normal circumstances, vaccination approvals are measured in decades. The important points that once took months or years were achieved in days or weeks. If these efforts succeed, the Covid-19 vaccine could take place alongside the Apollo missions as one of the greatest scientific achievements in history.
I’m optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and maybe a bit of angst. Following the proud statements, many science and medicine professionals were raising concerns. These whispers escalated in the sounds. It’s time to mourn them:
Hey, Food and Drug Administration: Don’t be a rash! Early approval of a sub-standard Covid-19 vaccine could have severe implications, 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 a disastrous outcome not only possible but in fact quite likely. Specifically, the FDA and its staff of regulators who have overly chronic and unappreciated work have to face enormous public and political pressure to approve a vaccine. Whether one worries about an “October surprise” aimed at the next election, regulators will be pressed. Some will hold firm. Some may resign in protest. But others can break down and allow a bad vaccine to be released.
What is a “bad vaccine”? Insufficient protection against the disease is intended for side effects, side effects, or a combination of both. If an approved Covid-19 vaccine is ineffective, it may intentionally promote a wider spread of the disease by individuals who are assumed to have been protected from it. Similarly, a negative experience with one vaccine may discourage the use of other vaccines that are much safer and more effective, whether they are for Covid-19 or other vaccine-preventable diseases.
Some things take time. Under normal circumstances, ensuring that the effects of the vaccine are safe and lasting requires years of study and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection may be temporary, making sustained investigation all the more necessary. A simply short-term effect may encourage vaccinated individuals to resume risky behaviors, all of which guarantee that the epidemic will endure. And if unintended side effects turn out to include, for example, chronic inflammatory or autoimmune diseases, a bad vaccine can be life-threatening.
But wait, there’s worse! A bad vaccine against Covid-19 could further undermine confidence in the many safe and reliable vaccines that are already in our public health arsenal. Vaccine skepticism and anti-science prejudices, propagated by B-list celebrities and Russian troll farms, have been gaining strength all year. Along with the disappointing outcomes of Covid-19, such malignant forces can facilitate the emergence of once-ending foes – polio, measles, mumps, rubella, diphtheria, whooping cough, and tetanus – which once kill a large number of children every year.
These are huge risks. Placing all our bets on a small set of untreated vaccine technologies would be unnecessary. However this is exactly what we are doing now. Most of the high-profile news-catching names are following comparatively small variations on a genetic vaccination theme (those given through DNA or RNA). If one approach works, the odds are higher the others will work as well. Results that are not affected by a single candidate, however, can presume failure across the board.
Rather than investing in a balanced portfolio of vaccines with different approaches – not to mention different therapies, devices and diagnoses for the treatment of Covid-19 – there are too many observers, too many companies, and too many government officials seem focused. firmly on the hopes for a “savior” vaccine. If that savior fails, our national morale, already low, could decline further.
Don’t do it wrong. I, along with millions of Americans, want a vaccine against Covid-19. But we deserve one that has been proven to be safe and effective.
It is not too late to take a deep breath and devise a strategy to balance long-term and long-term goals, including vaccinations, improved diagnoses, and existing and new treatments. We want to support the FDA and hope that its scientists and doctors maintain the strength and conviction to resist approving a non-substantial vaccine.
For encouragement, we should look at Frances Oldham Kelsey, a true FDA saint. 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 found a risk for toxicity and dug into her heels. She refused to stamp the approval rubber. Her actions saved the lives of a number of babies. Kevadon, better known as thalidomide, proved to be the most dangerous and disfiguring drug in history.
Kelsey died 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 an associate vice chancellor, professor of biochemistry and molecular biophysics, and director of the Centers for Innovation in Biotechnology and Drug Discovery Research at the University of Washington in San Francisco. Louis. He is the author of “Between Hope and Fear: A History of Vaccines and Human Immunity” (Pegasus Books, 2018) and two other books.