I write to you today to urge that you and your fellow legislators launch an immediate investigation into the U.S. Food and Drug Administration (FDA) for failing its duty to ensure the safety of the products it approves for use by the public. Documented safety concerns were sent to the agency on September 20, 2020, by a former employee of Ventavia, a contract research company that conducted COVID-19 vaccine trials for Pfizer. These concerns included falsified clinical trial data, inadequately trained vaccinators, and slow follow-up on adverse events reported in Pfizer’s phase III trial. The whistleblower also reported that staff who conducted quality control checks were overwhelmed by the volume of problems they were finding: https://www.bmj.com/content/375/bmj.n2635

Despite these serious concerns, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) rushed through an approval process for granting Emergency Use Authorization for Pfizer’s COVID-19 vaccine for children ages five through eleven on October 26, 2021--nearly a year after the FDA was notified of the problems occurring in the Pfizer trials. Additionally, VRBPAC--as well as the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices--have extensive conflicts of interest with the pharmaceutical industry that have no doubt influenced the outcome of their deliberations regarding COVID vaccines. The inaction of the FDA regarding these claims plus its eagerness to place the children of this nation in harm’s way by subjecting them to shoddily tested, risky, and potentially fatal injections demand your immediate attention.

Children have virtually no risk from severe symptoms of COVID-19 and enjoy the highest survival rate (almost 100%) of any population. Yet, our agencies are recommending they take a vaccine that has the highest injury profile of any other vaccine in history according to the governments’ own Vaccine Adverse Event Reporting System. Between mid-December, 2020 and October 29, 2021, there have been over 850,000 reports of injury (https://bit.ly/3qk9Gcy) following COVID vaccines including over 18,000 deaths (https://bit.ly/31OpYQJ).

The public--especially your constituents--will be watching your actions very closely in the coming days. Please do all in your power to get an investigation of the FDA’s mishandling of these safety concerns and its conflicts of interest with vaccine makers underway today. The health of children in the US and the world is at stake.