Why Can’t the FDA Answer These Simple Questions?

by Sharon Rondeau

(Oct. 2, 2021) — Questions The Post & Email posed more than a week ago to the FDA regarding COVID-19 vaccines remain unanswered despite person-to-person contact between this writer and an FDA representative.

On Wednesday, September 22, The Post & Email contacted the FDA’s Center for Biologics Evaluation and Research (CBER) by phone with a media inquiry. Our telephone call was returned the following day, with the representative providing the division’s media email address. We then sent a list of what we believed were four simple questions, anticipating a prompt reply.

On August 23, the FDA reportedly “approved” Comirnaty (“COVID-19 Vaccine, mRNA”) produced by BioNTech Manufacturing GmbH for individuals aged 16 and older. According to the FDA:

…the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. 

According to one Florida physician, on August 23 the FDA approved only a Biologics License Application (BLA) for Comirnaty and not the product itself. On December 10, the FDA issued its approval under Emergency Use Authorization (EUA) for the “Pfizer-BioNTech COVID-19 vaccine” and another on December 18 for the Moderna vaccine; Johnson & Johnson’s vaccine was approved under the same authorization on February 27.

On January 12, 2021, the National Institutes of Health (NIH) termed coronavirus vaccines “experimental.”

Under Emergency Authorization Use, U.S. law protects pharmaceutical companies from product liability in the event of reported adverse events. Physicians and other medical personnel are required to report adverse events to the VAERS database, although evidence has surfaced indicating at least some government medical providers are not following the mandate.

As the Centers for Disease Control and Prevention (CDC) has reported, COVID-19 infections among the “fully vaccinated” became prevalent as the “Delta variant” arose earlier this year.

In interviews with RedVoiceMedia’s Stew Peters, at least two hospital-employed nurses claimed that COVID/”Delta variant” hospitalizations are in reality vaccine “injuries” and that patients are not receiving effective care. “We’re not talking about fevers, chills, malaise,” an on-camera nurse with two decades’ experience told Peters last month. “We’re talking about strokes, heart attacks, blood clots, severe cognitive impairments, loss of balance and ability to walk, Guillain-Barre…”

The latter nurse left her job as a result of a vaccine “mandate,” she told Peters.

According to Dr. Peter A. McCullough, MD, MPH, who has published 46 peer-reviewed papers on COVID-19, survived the disease and developed a protocol for its several stages, has gone as far as to say that “crimes against humanity” are taking place in the form of physicians failing to treat patients through means other than vaccination.

Rep. Louis Gohmert (R-TX1) agrees.

Atty. Thomas Renz, who represents the organization America’s Frontline Doctors (AFLDS) in a lawsuit filed in July, recently stated he has a number of “whistleblowers” providing data from the Centers for Medicare & Medicaid Services (CMS) showing the CDC is not releasing the actual numbers of deaths reported to VAERS from COVID-19 vaccines.

A slide from Renz’s presentation reads:

On August 24, Dr. Meryl Nass and Robert F. Kennedy, Jr., writing for ChildrensHealthDefense.org, reported:

There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

…The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products. The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.

At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

On August 30, Dr. Nass wrote:

FDA made some clear but cagey statements about the differences between the Comirnaty vaccine and the Pfizer-BioNTech EUA vaccine.

For example:

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

What does that statement mean? What, specifically, are the “certain differences” that make the two vaccines “legally distinct?”

The FDA did not explain this in any of the documents provided last week to the public.

The same day, Nass and Kennedy were refuted by The Washington Post‘s Glenn Kessler, who quoted a Pfizer spokesman as having told him, “The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions. Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”

The Post & Email’s questions to the FDA are:

1. Is the “Comirnaty” vaccine available in the U.S. now? If not, when is it expected to be?

2. Is the Pfizer/BioNTech vaccine authorized under EUA still being administered in the U.S. given the FDA’s approval of Comirnaty?

3. How often does the FDA review reports in the “VAERS” system from COVID-19 vaccines?

4. To the FDA’s knowledge, do vaccine mandates from government or private organizations apply to vaccines or other drugs authorized under an EUA only?

Updated 10:42 a.m. EDT.

Update, Oct. 3, 2021, 8:55 a.m.:  In a September 23, 2021 interview with Brian Hooker, Ph.D., chief scientific officer of Children’s Health Defense, McCullough said at 36:46, “Recently, our FDA did not approve Pfizer, but gave it continuation of the EUA based on ‘legacy’ data.”