Ron Johnson warns of FDA COVID-19 vaccine approval shortcuts

Sen. Ron Johnson called out the Biden administration’s health agencies Sunday for shortcutting the usual safety reviews in a rush to give final approval to COVID-19 vaccines, including failing to account for thousands of deaths and adverse reactions among people worldwide who got the shots.

In a letter to the administration’s top health officials, the Wisconsin Republican warned against the Food and Drug Administration’s pending approval of Pfizer-BioNTech’s COVID-19 vaccine, which is expected Monday.

He said the fast-track decision appeared more political than scientific since it skipped the usual formal advisory committee meeting and did not fully account for the reports of deaths and disabilities suffered by people after being vaccinated.

“I see no need to rush the FDA approval process for any of the three COVID-19 vaccines. Expediting the process appears to only serve the political purpose of imposing and enforcing vaccine mandates,” Mr. Johnson wrote in the letter, a copy of which was obtained by The Washington Times.

Indeed, the Biden administration appeared eager to use the approval to pursue mandates.

U.S. Surgeon General Vivek Murthy told “Fox News Sunday” that moving the Pfizer vaccine from “emergency” to “full approval” would make mandates more appealing.

“There are universities and businesses that have been considering putting in vaccine requirements in order to create a safer, a workplace, a learning environment,” he said. “I think this announcement from the FDA would likely encourage them and make them feel more comfortable in putting some requirements in place.”

Former FDA Commissioner Scott Gottlieb, who is on the Pfizer board of directors, also said the full approval will prompt more vaccine mandates.

“They feel they’ll be on stronger legal ground to mandate vaccination in that setting. I also think that there are certain consumers that have been waiting for this milestone, waiting for the full approval and an indication that the FDA is done evaluating the data set to give them more confidence about using the vaccine,” Mr. Gottlieb said on the CBS program “Face the Nation.”

Mr. Johnson’s letter was addressed to National Institutes of Health Director Francis Collins, Centers for Disease Control and Prevention Director Rochelle P. Walensky, and FDA Acting Commissioner Janet Woodcock.

The NIH, CDC and FDA did not immediately respond to a request for comment.

Mr. Johnson has stressed that he is not anti-vaccine but wants all the usual reviews of safety, effectiveness and adverse events completed before the COVID-19 shots get the FDA stamp of approval.

The FDA recently told the BMJ, a peer-reviewed British medical journal, that it would not reconvene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for the final approval of the Pfizer vaccine. The agency said the committee discussed the Pfizer vaccine in general at a December 2020 meeting.

Since April, Mr. Johnson has raised alarms about the shortcuts to approve the vaccine. He also demanded transparency in the scientific review of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS).

He said that so far he “received little to no substantive response.”

In the letter, Mr. Johnson outlined some of the data from VAERS, which tallies adverse effects in people who get shots, though the shots have not been shown as the cause of the adverse effects:

• As of Aug. 20, 12,791 worldwide deaths over an eight-month period have been associated with the three COVID-19 vaccines.

• Of the deaths, 4,632, or 36.2%, occurred within two days of the vaccination.

• A total of 571,831 adverse effects were reported, including 51,242 hospitalizations and 16,044 permanent disabilities.

Mr. Johnson noted that the 12,791 deaths eclipse the 8,966 deaths related to all other vaccines reported on VAERS since its creation 31 years ago.

“I am receiving a growing number of letters from doctors and nurses detailing the vaccine injuries they are witnessing and treating, together with the suppression and censoring of this information they are experiencing,” the senator said in the letter.

He said the lack of transparency in the approval process was a disservice to Americans who have already suffered through the pandemic.

“Over the last year and a half, the decisions of federal health agencies have dramatically affected the lives of all Americans. The impact of these decisions has been felt in Americans’ treatment options, employment, schools, housing and travel, and in countless other ways,” Mr. Johnson said. “The human toll of the social restrictions and economic devastation is incalculable.”

He concluded: “Unfortunately, your federal health agencies have not been transparent with the American people about how these life-altering decisions have been made or what science and data they are based upon. I urge you to … reconsider your decision not to assemble a VRBPAC public meeting prior to the granting of any final COVID-19 vaccine approval.”

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