Wisconsin Senator Ron Johnson (R) has been questioning the safety of the COVID-19 vaccines since April. Johnson sponsored a June 28 video conference where 5 individuals spoke in Wisconsin about their injuries from the vaccines. Johnson then followed up with four letters. The first two identical letters request assistance from Moderna and Pfizer for individuals reporting serious adverse events from the vaccines. The third one was sent on Aug. 22, the day before the approval of the Pfizer vaccine known as Comirnaty. The fourth, sent on Aug. 26, addressed the Aug. 23 Pfizer FDA approval of Comirnaty.

Johnson, who is not an “anti-vaxxer,” wants transparency from the FDA and pharmaceutical companies. Introductory remarks indicated he is pro-vaccine. By his own admission, Johnson is a “huge supporter of Operation Warp Speed.” He is also a huge proponent of therapeutics and therapies. He is not vaccinated for COVID-19 because he already had COVID. However, he has stated:

“Over three hundred million doses have been giving in the U.S. and, for most people, the vast majority of people, the vaccine’s been administered with [little] or no side effects but just because the vaccine is generally safe, doesn’t mean that it’s one hundred percent safe.”

Johnson wants full transparency from drug companies, the FDA, and the ability for vaccine-injured people to be “seen and heard.”  Graphs from the June 28 conference are below:

 

VAERS Registered Deaths/Wisconsin Video Conference/June 28, 2021
VAERS Data/Johnson/June 28, 2021
Adverse Events Comparisons/Johnson/June 28, 2021

The August 22 letter, addressed to the heads of the NIH, the CDC, and the FDA, discussed the puzzling disregard for authorization procedures that other vaccines enjoy. Johnson refers to the fact that the FDA “decided ‘not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its COVID-19 vaccine.’”

He also discussed having written “four oversight letters” since April 27 on the “subject of vaccine safety,” to which he has received “little to no substantive response. This lack of transparency is unacceptable.” And why, he asks, is natural immunity “dismissed” by the FDA?

Johnson/Aug. 22/FDA

Johnson discusses the Vaccine Adverse Event Reporting System (VAERS) that has “reported 12,791 worldwide deaths associated with the three COVID-19 vaccines” as compared to “8,966 deaths related to all other vaccines reported on VAERS since the inception of VAERS —a period of 31 years.” Johnson continues with the alarming statistics on the “16,044 permanent disabilities, 51,242 hospitalizations, and 571,831 total adverse events related to the COVID-19 vaccines.”

In light of these injuries and deaths, Johnson questions the rush to approve vaccines, calling the process one that “serve[s] the political process of imposing and enforcing vaccine mandates.”

Ron Johnson Letter/Aug. 22, 2021

Johnson’s Aug. 26 letter references some of the confusing aspects of the full FDA approval of Comirnaty, which is, according to his letter and the FDA, “legally distinct” from the currently available Pfizer-BioNTech COVID-19 vaccine. The Washington Post explains:

“The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “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.”

One confusing issue is the liability coverage for the two vaccines. The Pfizer-BioNTech vaccine continues to be under Emergency Use Authorization (EUA), yet according to the message on the Pfizer phone line, the formulations are identical and interchangeable. Notably, language was added to the FDA Q & A on the evening of Aug. 23 regarding the interchangeability of the two vaccines. The earlier version without the reference can be found here. If they are identical formulations, why is one under EUA and the other not? Does that mean that Comirnaty does not have the same liability protections? The answers about liability protection are buried in bureaucratic legalese.

According to the Washington Post, both the Pfizer-BioNTech and the fully approved Comirnaty vaccine enjoy the same liability protection. However, the mechanisms for liability protection are somewhat different:

Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act).

In early 2020, after the coronavirus emerged, Health and Human Services Secretary Alex Azar invoked the PREP Act to ‘provide liability immunity for activities related to medical countermeasures against COVID-19’. So that covers all vaccines that might be produced to combat the coronavirus, whether fully authorized or not.

The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits.

In other words, a person cannot sue a manufacturer for an injury caused by a vaccine or other product listed as a countermeasure, but they can seek compensation from CICP filing a claim. The intent of the law is to urge manufacturers to quickly gear up to combat a possible pandemic without fear of lawsuits. (There is an exception in the law if a person can prove ‘willful misconduct’ by a manufacturer.)

A second issue discussed is the confounding FDA footnote stating that “there is not sufficient approved vaccine [Comirnaty] available for distribution.” The implications, at least in the short-term, are that people will then continue to get the Pfizer-BioNTech still under EUA—many possibly thinking they are receiving the fully authorized Comirnaty due to confusing messaging.

Johnson asks 5 questions of the FDA in his Aug. 26 letter, some of which seem to have been answered in the Washington Post reporting referenced above:

Johnson 5/Aug. 26 Letter to FDA

Johnson gives a deadline of Aug. 30 for answers to his questions and mentions he has received an inadequate response to his Aug. 22 letter but will soon follow up with a detailed response.