The first COVID-19 vaccine administered in America was to Sandra Lindsey, an ICU nurse, in New York City on December 14, 2020.
After months of vaccine development, two companies, Pfizer-BioNTech and Moderna applied to the FDA for Emergency Use Authorization (EUA). To receive approval, the companies’ data had to be reviewed by the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP), which determined that health care workers and long-term care residents should be the first groups to receive the vaccine. [1, 2, 3, 4]
In a press release on December 10, 2020 the FDA assured the public that they would proceed “without sacrificing our rigorous scientific standards for safety and effectiveness.” “The FDA recognizes that transparency and dialogue are critical to building public confidence in COVID-19 vaccines.” “The FDA is considered the “gold standard” regulator of medical products. The process that the FDA uses to review is respected worldwide…”
On December 10, 2020 The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), “made up of independent scientific and public health experts from around the country”, met in open session to discuss the request for EUA of a “COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH” (Pfizer-BioNTech) “for the prevention of COVID-19 in individuals 16 years of age and older.” Which they approved on December 11, 2020..
ACIP met December 11& 13, 2020 “to review the Pfizer-BioNTech vaccine and recommended moving forward with its distribution to anyone over age 16. The FDA issued an EUA on Saturday 12th following the meeting and notified the CDC and Operation Warp Speed to coordinate distribution plans.”
On December 17, 2020 VRBPAC met again to discuss the EUA of the Moderna COVID-19 Vaccine “for the prevention of COVID-19 in individuals 18 years and older.” The following day on December 18, 2020 the FDA grants EUA to Moderna. [5]
Americans were assured by Operation Warp Speed that “Vaccines will help prevent the spread of COVID-19 and bring this pandemic to an end”
The CDC state that “Clinical trials provide data and information about how well a vaccine prevents an infectious disease and about how safe it is. The FDA evaluates these data, as well as manufacturing information, to assess the safety and effectiveness of vaccines. FDA then decides whether to approve a vaccine or authorize it for emergency use in the United States.”