AND Six months after the SARS-CoV-2 virus identified the cause of Covid-19, scientists find themselves in the abyss of having a vaccine to fight it. Modern and the National Institutes of Health recently announced the launch of a phase 3 clinical trial, joining several others in a constructive competition that could save millions.
This is a truly impressive feat and a testament to the power of basic and applied medical sciences. Under normal conditions, vaccine clearance has been measured for decades. Milestones that once took months or years were reached in days or weeks. If these efforts are successful, the Covid-19 vaccine could go hand in hand with Apollo̵7;s missions as one of history’s greatest scientific achievements.
I am an optimist. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps a little bad. According to proud declarations, many proponents of science and medicine are whispering concerns. These whispers turned into a roar. It’s time to shout them out loud:
Hey, food and medicine management: Don’t be weak! Premature approval of the substandard vaccine Kovid-19 can have serious consequences, and not only for this pandemic. This can be detrimental to human health for many years, if not subsequent generations.
Unfortunately, the elements that exist now make such a catastrophic outcome not only possible, but in fact quite probable. In particular, the FDA and its staff with chronically overburdened and underestimated regulators will face enormous public and political pressure to approve the vaccine. Whether or not someone is worried about the “October surprise” aimed at the upcoming election, regulators will be pushing hard. 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 a combination of the two. If an approved Covid-19 vaccine proves ineffective, it may inadvertently contribute to the spread of the disease to those who believe they have been protected from it. Similarly, a negative experience with one vaccine may prevent the use of other vaccines that are much safer and more effective, regardless of whether it is covid-19 or other vaccine-preventing diseases.
Some things take time. Under normal circumstances, ensuring that the vaccine is safe and long-lasting requires years of research and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection may be transient, making the necessary ongoing research even more necessary. Only a short-term effect can motivate vaccinated individuals to resume risky behaviors, which would only guarantee that the epidemic continues. And if it is found that accidental side effects include, for example, chronic inflammatory or autoimmune diseases, a bad vaccine can cause lifelong damage.
But wait, it’s even worse there! Poor Covid-19 vaccine can further undermine confidence in many of the safe, reliable vaccines already in our healthcare arsenal. Vaccine skepticism and anti-scientific bias spread by B-list celebrities and Russian troll farms are gaining momentum throughout the year. Combined with the disappointing results of Covid-19, such malignant forces can contribute to the re-emergence of once-defeated enemies – polio, measles, mumps, rubella, diphtheria, pertussis and tetanus – which kill many children each year.
These are huge risks. It would be ridiculously foolish to place all our bets on a small set of untested vaccine technologies. But that is exactly what we are doing now. Most high-profile names that capture headlines pursue relatively minor variants of the topic of genetic vaccines (those delivered by DNA or RNA). If one approach happens at work, the chances are higher, others will also work. The disappointing results of one candidate, however, can predict failure in general.
Instead of investing in a balanced range of vaccines with different approaches – not to mention different treatments, tools and diagnostics for Covid-19 treatment – too many observers, too many companies and too many government officials seem narrowly focused on hopes for vaccine “savior”. If this savior failed, our national morale, already low, could decline even more.
Don’t get me wrong. I, along with millions of Americans, want the Covid-19 vaccine. But we deserve to be proven safe and effective.
It is not too late to take a deep breath and develop a strategy to balance short- and long-term goals, including vaccination, improved diagnosis, and existing and new treatments. We must support the FDA and hope that its scientists and doctors will maintain the strength and convictions to oppose the approval of a non-standard vaccine.
For encouragement, contact Francis Oldham Kelsey, the real patron of the FDA. In 1960, during his first month at the agency, Kelsey was asked to approve a sedative called Kevadon, which had the potential to generate a billion in revenue. Despite the tremendous pressure, Kelsey noticed a risk of toxicity and snorted in her heels. She refused to affix the stamp for approval. Her actions saved the lives of countless babies. Kevadon, better known as thalidomide, has proven to be one of the most dangerous and degrading drugs in history.
Kelsey died in 2015 at the age of 101. We must pray that her spirit will inspire a new generation of FDA leaders to boldly say no.
Michael C. Kinch is an associate vice chancellor, professor of biochemistry and molecular biophysics, and director of the Centers for Research Innovation in Biotechnology and Drug Discovery at the University of Washington in St. Louis. He is the author “Between Hope and Fear: The History of Vaccines and Human Immunity” (Books of Pegasus, 2018) and two other books.