Sen. Ron Johnson, R-Wisc., told federal health bureaucrats in a letter that their decision to hasten the approval process for Pfizer’s COVID-19 shot appears to “serve the political purpose of imposing and enforcing vaccine mandates.”
Johnson wrote the letter because the Food and Drug Administration announced on Friday that it would not hold “a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.”
“I see no need to rush the FDA approval process for any of the three Covid-19 vaccines,” he wrote. “The observational phases of FDA approval take time, because there is no substitute for time in detecting and determining possible long-term harm.”
Johnson warned that vaccine mandates could destabilize America’s health care facilities.
“We are already experiencing a severe health care worker shortage,” he wrote. “Frontline doctors and nurses that are contacting me are expressing grave concerns about vaccine mandates which will only exacerbate the shortage.”
The FDA told The BMJ in a statement that it did not need a formal advisory committee meeting because it held two Vaccines and Related Biological Products Advisory Committee meetings last year.
The VRBPAC hosted “a 22 October 2020 meeting to discuss, in general, the development, authorization, and licensure of covid-19 vaccines” and another Pfizer-specific meeting on 10 December 2020.
Johnson said he does not believe that these outdated meetings have sufficiently explored the Pfizer shot’s safety because he has not had his own questions answered.
He wrote four letters about the Vaccine Adverse Event Reporting System and its coronavirus-related findings but heard “little to no substantive response.”
Johnson told the federal health bureaucrats that they cannot proceed with the FDA’s Pfizer vaccine approval, which threatens to split the United States into vaccinated and unvaccinated camps, without a public meeting.
“The human toll of the social restrictions and economic devastation is incalculable,” he wrote. “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.”
Johnson addressed the letter to National Institutes of Health Director Dr. Francis Collins, CDC Director Dr. Rochelle P. Walensky, and Acting FDA Commissioner Dr. Janet Woodcock.