The head of the Food and Drug Administration (FDA), Stephen Hahn, told a congressional committe Tuesday that only “data and science” will determine when a vaccine for the coronavirus is ready — distancing the agency from the White House’s push for treatment.
“Let me be clear that data and science will dictate when we will have safe and effective treatments and vaccines for COVID-19,” Hahn said Tuesday, during a House Committee on Energy and Commerce oversight hearing on the Trump administration's repsonse to the coronavirus.
Several agency heads, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID), have voiced concern over pushing out a treatment for COVID-19 too quickly.
Fauci said Tuesday he “flinched a little” when he heard the title of the federal vaccine development project, Operation Warp Speed. Fauci also said in an interview with McClatchy last week that “there is no chance in the world I’m going to be forced into agreeing to something that I don’t think is safe and scientifically sound.”
Operation Warp Speed aims to have 300 million vaccine doses available by January 2021.
The project is a joint effort by different agencies within the Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), along with several other health forward agencies.
During Tuesday’s testimony, Hahn emphasized that the FDA is not prioritizing the federal government’s Warp Speed timeline agenda, but rather is focusing on finding a safe treatment.
“We absolutely must maintain regulatory independence and make the right decision for the American people based on the science and the data,” Hahn said Tuesday.
Hahn told the committee he also could not give a timeline on if or when the FDA would approve an Emergency Use Authorization (EUA) – an authority that allows unapproved medical products to be used during an emergency, for the treatment of the coronavirus.
Rep. Anna Eshoo, D-Calif., asked Hahn about any political pressure or interference that the agencies have received in regard to the use of hydroxychloroquine, an anti-malaria drug that President Trump touted earlier this year.
“I have not felt political pressure nor has the FDA to make any decision in any specific direction,” Hahn said, noting he would report any political interference to the committee.
Chairman Frank Pallone, D-N.J., also referenced potential outside political influence by asking about Trump’s remarks from the campaign rally in Tulsa, Okla., Saturday, in which the president said he had asked for testing to be reduced.
“None of us have ever been told to slow down on testing — that just is a fact,” Fauci said Tuesday. “In fact, we will be doing more testing.”
Fauci and Hahn reiterated that only data and science will determine when a vaccine will be ready, but they remain hopeful it will happen by the end of the year.
Hahn noted that the FDA is working to accelerate the development of the vaccine by providing additional assistance on clinical trials.
He also said the risks associated with the push comes in the form of financial risk during the development process, and “not [in] cutting corners with respect to the assessment of safety and effectiveness."
The Associated Press contributed to this report.