Ron Johnson Warns of FDA COVID-19 Vaccine Approval Shortcuts
Senator Ron Johnson called health agencies in the Biden administration on Sunday for shortening the usual safety reviews in a rush to give final approval to COVID-19 vaccines, including failing to account for the thousands of deaths and side effects among people around the world who have received vaccines.
In a letter to senior administration health officials, the Wisconsin Republican warned of 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 seemed more political than scientific as it ignored the usual formal advisory committee meeting and did not fully consider reports of deaths and disabilities suffered by people after being vaccinated.
“I don’t see the need to rush the FDA approval process for any of the three COVID-19 vaccines. Speeding up the process only appears to serve the political purpose of imposing and enforcing vaccination warrants, ”Johnson wrote in the letter, a copy of which was obtained by The Washington Times.
Indeed, the Biden administration seemed eager to use the approval to pursue mandates.
US Surgeon General Vivek Murthy told “Fox News Sunday” that moving Pfizer’s vaccine from “emergency” to “full approval” would make terms more attractive.
“There are universities and companies that have considered imposing vaccine requirements in order to create a safer working environment, a learning environment,” he said. “I think this FDA announcement would probably encourage them and put them more comfortable to put certain requirements in place.”
Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board of directors, also said full approval would result in more vaccine mandates.
“They think they will have a more solid legal basis to impose vaccination in this context. I also think there are some consumers who were waiting for this step, awaiting full approval and an indication that the FDA has finished evaluating the dataset to give them more confidence in the use of the vaccine ”, Mr. Gottlieb said on the CBS ‘Face the Nation’ Program.
Mr Johnson’s letter was addressed to Director of the National Institutes of Health Francis Collins, Director of the Centers for Disease Control and Prevention Rochelle P. Walensky and Acting FDA Commissioner Janet Woodcock.
The NIH, CDC and FDA did not immediately respond to a request for comment.
Mr Johnson stressed that he is not anti-vaccine but wants all the usual reviews of safety, efficacy and adverse events to be completed before the COVID-19 injections get the seal of approval. FDA approval.
The FDA recently told BMJ, a UK peer-reviewed medical journal, that it would not reconvene its Vaccines and Related Biologics Advisory Board (VRBPAC) for final approval of the Pfizer vaccine. The agency said the committee discussed the Pfizer vaccine in general at a meeting in December 2020.
Since April, Mr Johnson has sounded the alarm on shortcuts to approving 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 “had received little or no substantial response.”
In the letter, Mr Johnson described some of the VAERS data, which accounts for side effects in people who receive injections, although injections have not been shown to be the cause of side effects:
• As of August 20, 12,791 deaths worldwide 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 vaccination.
• A total of 571,831 adverse reactions 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 inception 31 years ago.
“I am receiving an increasing number of letters from doctors and nurses detailing the vaccine injuries they are witnessing and treating, as well as the suppression and censorship of this information of which they are victims,” the senator said in the statement. letter.
He said the lack of transparency in the approval process was a disservice to Americans who have already suffered from the pandemic.
“Over the past year and a half, decisions by federal health agencies have dramatically affected the lives of all Americans. The impact of these decisions has been felt on Americans’ treatment options, jobs, schools, housing and travel, and countless other ways, ”Mr. Johnson said. “The human toll of social restrictions and economic devastation is untold. “
He concluded, “Unfortunately, your federal health agencies have not been transparent with the American people about how these life-changing decisions were made or the science and data upon which they are based. I urge you to… reconsider your decision not to hold a public meeting of the VRBPAC before any final approval of the COVID-19 vaccine is granted. “