Published September 15, 2021
Late last week, the Biden White House ordered approximately 100 million Americans to be vaccinated for Covid-19. This included federal workers and contractors who work for the federal government and employees of businesses with more than 100 workers who must be vaccinated or tested on a weekly basis.
Irrationally, these orders do not exempt people who already have adequate Covid-19 antibodies due to a previous infection or vaccination.
Businesses that do not comply are subject to fines of $14,000 per violation.
In announcing the mandate Biden warned, “If you break the rules, be prepared to pay . . . And by the way, show some respect.”
As if such scolding weren’t enough, Biden added, “Let me be blunt: My plan also takes on elected officials and states that are undermining you and these life saving actions. . . If these governors won’t help us beat the pandemic, I will use my power as president to get them out of the way.”
…Don Corleone could not have said it better himself.
Notably, the Biden vaccine mandate does not cover the House of Representatives and the Senate, or the judicial branch of the federal government. This raises questions about why certain Washington political elites have a choice, but so many other Americans do not. It is reminiscent of the frustration that Americans experienced when their healthcare insurance was forcibly cancelled and their compliance was mandated for Obamacare, while the White House, Senate, and House were exempted.
Americans are thoughtful people who value their rights and freedoms. Most of all, Americans want to make informed choices. Today, dozens of online “review” websites cover everything from light bulbs to fishing lures to bottled water to healthcare providers — and everything in between. While it’s not necessary to start crowdsourcing reviews of pharmaceuticals from the general public, we do need external reviews by independent non-FDA clinical scientists to inform consumers about the medicines they receive, including vaccines.
Physicians and pharmacists should not be expected to blindly recommend and administer Covid vaccines to their patients without first personally reviewing and being comfortable with available efficacy and safety information — not simply because the White House instructs them to do so.
And here lies the problem: Americans and their medical providers can’t obtain the full review on the Pfizer and Moderna vaccines because the FDA hasn’t released its Pfizer Vaccine clinical efficacy and safety reviews yet. We know these reviews are complete and exist because they are required for full approval, which Comirnaty (the Pfizer vaccine) was given three weeks ago, on Aug 23rd 2021.
Historically, both the safety and efficacy medical officer reviews post online simultaneously with the FDA approval letter, but for one reason or another, they weren’t with Comirnaty. A lot of Americans don’t know — but deserve to know — the specific FDA findings regarding the safety and efficacy of their vaccines. Right now, there is a wide discrepancy about the safety findings of the vaccine on the confusing-to-use FDA Vaccine Adverse Event Reporting System (VAERS) website versus the CDC’s oddly titled “wonder” website, including the numbers of deaths reported after administration of Comirnaty and other Covid-19 vaccines.
Americans and their healthcare providers are thoughtful people who want to be scientifically informed and do what’s right and safe. People understandably hesitate to accept mandates when they lack information, and they become downright suspicious when information they seek is being withheld or obfuscated by their government — while parts of the government itself are exempt.
Americans are entitled to make informed decisions, and the FDA should disclose its safety and efficacy reviews for all to see. Having the White House mandate the administration of any vaccine without full transparency while Members of Congress are exempt is un-American and insulting.
Being secretive and non-transparent about public health data could potentially serve to further harden the anti-vaccine, and vaccine-hesitant movements in America and abroad.
Dr. David Gortler is a pharmacologist and a pharmacist and an FDA and health care policy scholar at the Ethics and Public Policy Center in Washington, D.C. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine and an FDA Medical Officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner for drug safety, drug epidemiology, FDA science policy, and FDA regulatory affairs.
