Top Trump administration health officials are seeking to reassure the public that any potential coronavirus vaccine will only be approved if it is safe and that the fast-track process won’t be influenced by political pressure.
Democratic lawmakers and public health experts have expressed concern that President TrumpDonald John TrumpTop intelligence officials release statements criticizing leaking of Russian bounties information Russian bounty intel was included in Trump’s daily briefing: reports Senators will have access to intelligence on Russian bounties on US troops MORE‘s focus on developing a vaccine will pressure the Food and Drug Administration into approving one before it’s safe.
To assuage some of that concern, the agency on Tuesday released a guidance that outlines conditions for approving a COVID-19 vaccine. Those include requiring any vaccine to be at least 50 percent more effective than a placebo in preventing the disease.
For comparison, the annual flu vaccine ranges from 40 percent to 60 percent effective.
FDA also said that drug companies must enroll at least 30,000 people in a clinical trial, including racial and ethnic minorities.
Vaccine experts have expressed concern about what could happen if companies rush through safety and efficacy trials and test too small a group of people too quickly.
The guidance was released concurrently with testimony from FDA Commissioner Stephen Hahn; Anthony FauciAnthony FauciThe Hill’s Coronavirus Report: Cure Violence Global founder Gary Slutkin says violence and epidemics follow same patterns; Global death toll surpasses half a million Governors urge Pence to promote mask-wearing The Hill’s 12:30 Report: Supreme Court ruling marks big win for abortion rights groups MORE, the nation’s top infectious diseases expert; and other top administration officials during a Senate health committee hearing.
Committee Democrats pressed Hahn to make a commitment to transparency in any vaccine approval.
“We cannot take for granted this process will be free of political influence,” Sen. Patty MurrayPatricia (Patty) Lynn MurrayOvernight Health Care: Trump refuses to say if he slowed down coronavirus testing | US COVID-19 cases rise, marking ugly contrast with Europe | Trump health officials to testify on continued dangers of coronavirus pandemic The Hill’s Coronavirus Report: Rep. Mark Takano says Congress must extend worker benefits expiring in July; WHO reports record spike in global cases Democrats: Trump has yet to spend nearly B for COVID tests, contact tracing MORE (D-Wash.), the committee’s ranking member, said.
When pressed by Sen. Tina SmithTina Flint SmithThe Hill’s Campaign Report: Candidates, lawmakers mark Juneteenth Group of Democratic senators to propose making Juneteenth national holiday Gun control group rolls out first round of Senate endorsements MORE (D-Minn.) about the possibility that a vaccine could be announced in October as a way to boost President Trump’s re-election effort, Hahn said any approvals will be guided by science.
The administration’s “Operation Warp Speed” aims to develop a successful vaccine by early next year at the latest, which would be faster than anyone previously thought was scientifically possible.
“I want the American people to hear me when I say we will use the science and data from those trials, and will ensure that our high levels of standards for safety and efficacy are met,” Hahn said.
Hahn assured senators that despite the urgency and speed, safety will not be sacrificed
“We want to demonstrate to the world that we are following our rigorous standards with respect to safety and efficacy. We drew a very bright line between FDA and our regulatory independence, and all the sponsors who are putting forth vaccine applications to us,” Hahn said.
Federal public health agencies have been under scrutiny during the COVID-19 pandemic, amid concerns they have been overly politicized.
FDA in particular has been under fire for its decision to grant emergency authorization to hydroxychloroquine to treat COVID-19 patients.
The anti-malaria drug was hyped by President Trump despite scant evidence of its safety or effectiveness. That authorization was revoked earlier this month after clinical results showed it did not help, and could cause serious heart problems.
Fauci, the head of the National Institute of Allergy and Infectious Diseases, said at least 75 to 80 percent of the public will need to be vaccinated in order to stop the spread of the coronavirus.
By comparison, only about 45 percent of the country was vaccinated against the flu, according to the most recent data from the Centers for Disease Control and Prevention.
The administration officials during the hearing acknowledged the difficulty in making sure the public trusts a potential vaccine when it is released.
“Public confidence in vaccines is so important,” Hahn said. “We have an obligation to use all of our scientific knowledge, regulatory framework to ensure that any vaccine that comes before us, whether for authorization or approval, meets our stringent standards for safety and effectiveness.”
Fauci said he is “thoroughly aware” of the challenges, and the administration has a community engagement program that is embedded within the sites where the vaccine trials will be conducted.
“It is a reality. A lack of trust in authority, a lack of trust in government, and a concern about vaccines in general,” Fauci said. “We need to engage the community by boots on the ground, and particularly those populations that have not always been treated fairly by the government- minority populations, African Americans, Latinx and Native Americans.”
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