House Democrats are calling on the Food and Drug Administration to empower an independent panel of experts to review and sign off before a coronavirus vaccine is distributed to the general public, a move aimed at quelling some health experts' fears the Trump administration might ram through a vaccine candidate ahead of the November election.
A new legislative proposal obtained by ABC News would require the FDA to seek input from the Vaccines and Related Biological Products Advisory Committee in a public hearing before giving an emergency authorization for the widespread use of any COVID-19 vaccine. The bill is expected to be publicly announced on Thursday and formally introduced on Friday by Rep. Raja Krishnamoorthi, D-Ill., the chairman of the House Oversight Committee Subcommittee on Economic and Consumer Policy.
“While it is essential that a COVID-19 vaccine become available to the public as quickly as possible, it is even more important that quality is not sacrificed for speed in testing and evaluating any such vaccine,” Krishnamoorthi said in a statement, noting that some experts have raised concerns that the Trump administration could seek to politicize the crash effort to find a vaccine under a plan known as Operation Warp Speed.
As recently as Thursday, President Trump suggested that the vaccine could be available around the time of the presidential election in November.
"I think in some cases, it's possible before, but right around that time,” Trump said in a radio interview with Geraldo Rivera.
Rep. James Comer, R-Ky. and the ranking member of the consumer policy subcommittee, said the new proposal was evidence of Congressional Democrats "play[ing] politics" during the pandemic and noted that the nation's leading health officials have said safety was not being compromised in the "pursuit of a COVID-19 vaccine."
"This Democrat messaging bill is nothing more than election-year political theater that would delay a safe and effective vaccine with needless bureaucratic roadblocks," he said.
In an interview on “Good Morning America” on Tuesday, Dr. Stephen Hahn, the FDA commissioner, told ABC Chief Anchor George Stephanopoulos that the agency will “make that decision based upon the science and the data from the clinical trials that are going,” and will consult with the group of outside advisors, which provides recommendations to the FDA on the safety and efficacy of vaccines and how to use them.
“We have a vaccine advisory committee. It's a standard approach we have, we will be using that to help us make this decision. These are outside experts from around the country,” he said.
Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia and a member of the FDA's advisory panel, was encouraged by Hahn's comments, and told ABC News that the group's "recommendations are generally taken up."
“It’s the rare time when they’re not," said Offit, who has raised concerns about the potential push for use of a vaccine in the fall ahead of the election.
Democrats and public health experts say they want to hold the FDA to that commitment, after the FDA granted emergency authorization for the use of antimalarial drug hydroxychloroquine in February. The authorization for the drug, which President Trump continues to tout as a treatment for COVID-19, was revoked after data from large clinical trials indicated that it was not effective against the virus, and also carries potentially serious side effects.
Democrats also accused the FDA of authorizing coronavirus antibody tests without properly vetting their accuracy, which led the agency to eventually pull some tests from the market.
“We understand and support expediency for a vaccine against COVID-19, but we must support the scientific process over expediency,” Democratic Sen. Bob Menendez and Rep. Bill Pascrell of New Jersey wrote in a letter to Hahn last month.
Several pharmaceutical companies are in the midst of a race to find a vaccine and have manufacturing capacity ready to distribute it broadly across the U.S. In recent weeks, three companies announced they had completed early trials and were moving into large-scale trials involving tens of thousands of volunteers. If those trials show the inoculations are both safe and effective, the federal government has plans to move them rapidly into circulation.
An ABC News/Washington Post survey in June found that 71% of Americans would get vaccinated against the coronavirus, while 27% of respondents said they definitely or probably wouldn’t get the vaccine. Of those who oppose getting vaccinated, half of the respondents said they do not trust vaccines in general.
There also can be risk associated with quickly bringing a vaccine to market, highlighted by the 1955 Cutter Incident, when 250 cases of polio were traced to vaccines that contained live virus, though experts have told ABC News that developments in science and oversight have made vaccine production safer than ever.
Dr. Anthony Fauci, the government’s top infectious disease expert, told lawmakers last week that he was “cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021.”
"I noticed some people of this seems like it is so fast, that they might be compromising safety and scientific integrity, and I can tell you that is absolutely not the case," he said last Friday.
Offit, the panel member, said he remained skeptical of the timeline put forward by the president.
“I don’t see how, even if we did meet at the end of October, how we would have the kind of data that would allow us to, with statistical rigor and robustness say, yes, this vaccine is effective, because that's what we need to know,” he said.
Under the Democratic proposal, no vaccine would go out to the public until the experts signed off that they considered it to be safe and effective. Members would be asked to signal if any additional study was needed, and present their guidance in a public meeting. All information provided to or from the advisory committee would also be made public.
A Democratic official told ABC News that the House Oversight Committee is working with Democratic leadership in the House and Senate to insert the proposed requirement into any future coronavirus stimulus package.
Other lawmakers who have signed on to the legislation include Reps. Mark DeSaulnier, D-Calif., Ro Khanna, D-Calif., Ayanna Pressley, D-Mass., Rashida Tlaib, D-Mich., Katie Porter, D-Calif., and Gerry Connolly, D-Va.
What to know about coronavirus:
- How it started and how to protect yourself: Coronavirus explained
- What to do if you have symptoms: Coronavirus symptoms
- Tracking the spread in the U.S. and worldwide: Coronavirus map