WASHINGTON — Food and Drug Administration Commissioner Stephen Hahn and infectious disease expert Dr. Anthony Fauci on Wednesday said the public should trust the COVID-19 vaccine approval process.
Hahn, whose agency would approve a vaccine, and Fauci told a Senate committee they would take a vaccine themselves — after Democratic presidential candidate Joe Biden and running mate Sen. Kamala Harris (D-Calif.) said President Trump may corrupt the science.
Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases and a White House coronavirus task force member, vouched for vaccine production.
“The rapidity of where we are right now is a reflection of the technological advances in vaccine platform technology, as well as the risks that were taken financially so that we will have doses available when the decision is made by the FDA as to the safety and efficacy,” said Fauci.
“There’s no cutting corners,” he emphasized.
Hahn told senators he believes it’s “essential that the criticism we get never shapes the underlying faith the public has and should have an FDA and our commitment to protecting the public health.”
Hahn said the FDA will consider vaccine approval or emergency-use authorization after a drug company determines it has enough date from phase three clinical trials.
“When a vaccine sponsor reaches the conclusion that the data from its phase three clinical trials are adequate to submit to FDA, they will decide whether to apply for approval or emergency use authorization,” Hahn said.
“This will be based upon the trial meeting pre-specified success criteria that were established by that sponsor. Now this is really important: They should also be consistent with FDA recommendations regarding those criteria. FDA will receive that application or submission, and our career scientists will review its safety and efficacy data, as well as manufacturing quality and consistency data.”
Last week, Trump promoted the possibility of a vaccine breakthrough in October, with enough doses for every American by April. Fauci said Wednesday results of clinical trials for vaccines might not be known until November or December.
Hahn said that the FDA plans to seek advice from an advisory committee of outside independent experts.
“FDA also expects that an [emergency use] request would include a plan for active followup to monitor safety among individuals who receive the vaccine. In the end, FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families,” he said.
Hahn said “FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes and science will guide our decisions. FDA will not permit any pressure from anyone to change that.”
Fauci said that if a vaccine is “authorized by the FDA to be safe and effective, I certainly would take that vaccine and I would recommend to my family that they take that vaccine.”