Law360 (September 23, 2020, 10:11 PM EDT) -- Government health officials leading the Trump administration's response to the coronavirus pandemic on Wednesday answered senators' questions on Capitol Hill, defending the scientific basis of key decision-making related to vaccine development and distribution as well as agency guidance that has faced scrutiny.
Anthony Fauci of the National Institutes of Health told lawmakers on the Senate Health, Education, Labor, and Pensions Committee that the administration is not taking shortcuts on safety and efficacy in vaccine development and that the progress with the vaccine is a "reflection of the technological advances in vaccine platform technology as well as the risks that were taken financially."
"There's no cutting corners," Fauci said, noting that they will know by December whether the vaccine is effective.
"We feel strongly that if we have a combination of adherence to the public health measures together with a vaccine that will be distributed to people in this country and worldwide, we may be able to turn around this terrible pandemic," he said.
Fauci and the three other witnesses pledged that they would take the vaccine themselves in response to senators asking them to commit to publicly taking the vaccine to ensure public confidence. Democratic lawmakers have suggested that vaccine development is being rushed during an election year for political reasons.
As decisions are made about the efficacy of some vaccine candidates coming out of Phase 3 trials and the treatment awaits the U.S. Food and Drug Administration's stamp of approval, FDA Commissioner Stephen Hahn told lawmakers that politics will not guide the agency's actions.
"Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics," Hahn said, noting that companies applying for emergency use authorization will be guided by the agency's career staff.
Before the agency issues the emergency authorization, it would determine whether the statutory standard is met.
"This would be demonstrated based on adequate manufacturing data to ensure a vaccine's quality and consistency, and data from at least one, well-designed Phase 3 clinical trial that demonstrates its safety and efficacy in a clear and compelling manner," Hahn said.
Lawmakers, including Sen. Patty Murray, D-Wash., raised concerns Wednesday that the FDA, the Centers for Disease Control and Prevention, and the Department of Health and Human Services are being swayed by politics instead of science in their development of guidance and vaccine development.
On Monday, the CDC backtracked on an update to guidance it announced last week that the virus mainly spreads through the air, just days after the agency said it needed to reverse its earlier recommendations that asymptomatic individuals "do not need a test."
But Robert Redfield of the CDC said Wednesday that the guidance and subsequent changes were based on input from career scientists, not political appointees of President Trump, and those changes were misconstrued by the public health community.
"The intent of that document ... was never to limit testing, never to limit the testing of asymptomatic individuals," he said. "The attempt was to re-engage the medical and public health community as part of testing so that there was a public health action as a consequence of every test."
Once it became apparent that the guidance was being taken the wrong way, he said the CDC decided to make the clarification. That doesn't change the fact that the agency has been stressing that asymptomatic transmission is a key part of the transmission cycle, he added.
Brett Giroir, the Trump administration's COVID-19 testing czar and member of the White House coronavirus task force, rejected Sen. Murray's assertions that editing of the guidance was politically motivated.
"Senior scientists did not — unequivocally — did not recommend against testing asymptomatic individuals. In fact, there were multiple sentences that said that it's important to test asymptomatic individuals," Giroir said. "It was widely misinterpreted."
Instead, Giroir said the number of asymptomatic individuals getting tested has been a top priority for the government through surge testing in 20 cities. Over 106 million tests have been performed across the country, and states and tribes have been supported on rural testing and outbreak control, he added.
"We are at an inflection point in testing," Giroir said, noting that on average there will be 3 million tests available per day.
Giroir added that protecting the elderly is the top priority for the agency and that thousands of nursing homes across the country will receive 13,985 instruments and 9.9 million rapid point-of-care tests.
The officials also addressed the government's playbook on vaccine distribution released last week, shutting down concerns that states being informed about the rollout as early as October was a political move.
Fauci rejected claims that he thinks the country needs to undertake more lockdowns to slow the spread of the virus.
"We do not need to shut down," he said. "If we follow carefully and prudently the recommendations and guidelines for opening America again, I believe we can do that safely and still accomplish the goal of opening the economy again."
--Editing by Steven Edelstone.
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