Editor’s Note: Jonathan Sackner-Bernstein is a physician, author and clinical researcher. He served as Associate Center Director for Technology and Innovation in the Center for Devices at the Food and Drug Administration and as a consultant to DARPA. He currently consults for pharma and medical device companies. The views expressed here are his own. View more opinion on CNN.
On Monday, the US Food and Drug Administration took the much anticipated step of approving Pfizer/BioNTech’s Covid-19 vaccine.
While the vaccine was being administered under the FDA’s emergency use authorization (EUA), there was a tremendous amount of confidence from agency officials, public health specialists and clinicians in its safety and efficacy.
Now that the vaccine has full FDA approval, those who were skeptical of receiving the shots can rest assured knowing that the vaccine has gone through the vetting process that is standard for our most trusted pharmaceuticals and vaccines. Those previously hesitant to vaccination should celebrate this milestone by getting themselves fully vaccinated and helping others do the same.
In a data-driven, decision-making process, not getting the Covid-19 vaccine would be akin to refusing a new breakthrough medicine proven to keep you healthy after a heart attack or to prevent serious complications while being treated for cancer.
But what if vaccine hesitancy is not overcome by the Pfizer/BioNTech vaccine’s FDA approval?
If Americans who have not yet been vaccinated do not get their shots, we could be doomed to live in this pandemic reality for far longer than necessary. Many health officials have urged the public to get vaccinated for this very reason. The more people who remain unvaccinated, the more opportunities the virus has to infect and mutate, creating the risk of new variants that could circumvent our vaccine immunity.
As we’ve learned since we first started administering Covid-19 vaccines, some individuals are hard to convince that vaccination is the best way to protect themselves and their communities.
The result is the launch of several high-profile vaccine mandates. In July, the Biden administration began requiring that all federal workers be vaccinated or adhere to strict precautionary protocols (thought officials say it’s not a mandate). Meanwhile, some business, both large and small, health care facilities and universities have implemented mandates. Indiana University’s requirement was upheld in federal court when it was challenged. and The University of Virginia disenrolled 238 students who refused to abide by the policy.
Now with the vaccine’s approval, some mandates have been announced by public school systems and for the US military. These mandates are important because each institution has the legal authority – and I’d argue the ethical responsibility – to keep its consumers, students or personnel safe. And in this time of pandemic, that means requiring vaccinations.
The FDA publishes its requirements for vaccines to be approved, and it did so explicitly for the Covid-19 vaccine as the clinical trials were being launched. The data from the trials and the analyses by the FDA are part of the public record.
The clinical trials with the Pfizer/BioNTech vaccine studied its effects on about seven times more people than the FDA requires. Adverse reactions to new drugs or vaccines are generally apparent within six months of their widespread use. And this vaccine has been administered to over 92 million Americans. The benefit-risk ratio is undeniably favorable for this vaccine – there is no credible controversy about that in the scientific, medical or public health fields.
With the FDA approval of the Pfizer/BioNTech Covid-19 vaccine, it can no longer be called an experiment. State governments, schools and businesses must mandate vaccinations to protect constituents, students and employees, as well as the public at large – that is, if we want to base public health actions on rigorously scrutinized scientific data.