There's something vitally important missing from the Pfizer vax approval

Late last week, the Biden White House ordered approximately 100 million Americans to be vaccinated for COVID-19.  He required federal workers and contractors who work for the federal government to be fully vaccinated and, through OSHA, mandated that employees of businesses with more than 100 workers 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 lifesaving 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, the Judicial Branch of the federal government, or illegal aliens and refugees who come under government control.  This raises questions about why certain Washington political elites and people entering America illegally or as refugees have a choice, but so many other Americans do not.  It is reminiscent of the frustration that Americans experienced when their health care insurance was forcibly canceled 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 health care providers — and everything in between.  While it's not necessary to start crowdsourcing reviews of pharmaceuticals for 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.  They should not act simply because the White House instructs them to do so.

And here lies the problem: Americans can't obtain a full disclosure about the efficacy findings of the Pfizer and Moderna vaccines because the FDA hasn't released its Pfizer vaccine clinical efficacy and safety reviews yet.  (The myriad materials at the link do not include the clinical efficacy and safety reviews.)  This is true even though we know that these reviews are complete because they are required for the full approval that Comirnaty (the Pfizer vaccine) has been given.

Historically, both the safety and efficacy medical officer reviews are posted 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 data regarding their vaccines' safety and efficacy. 

This is especially important right now because there is a wide discrepancy between the safety findings of the vaccine on the confusing-to-use FDA Vaccine Adverse Event Reporting System (VAERS) website and the CDC's oddly titled "wonder" website.  The discrepancies include the number of deaths reported after the administration of Comirnaty and other COVID-19 vaccines.

Again, Americans and their health care providers are thoughtful people who want to be scientifically informed and do what's right and safe.  People understandably hesitate to accept mandates to do things when they lack information, and they become downright suspicious when the information they seek is being withheld or obfuscated by their government — while parts of the government itself are exempt from those same mandates, not to mention all the illegal aliens and refugees streaming into America.

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 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 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 adviser to the FDA commissioner for drug safety, drug epidemiology, FDA science policy, and FDA regulatory affairs.

Image by Doc Cassidy.

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