SEPTEMBER 4, 2020
U.S. President Donald Trump disembarks from Air Force One.
America’s state health officials pushed back on the Trump administration’s suggestion that a Covid-19 vaccine could be cleared for use before clinical trials are complete.
Days after the federal government told states to prepare for distributing a vaccine as early as Nov. 1, the group representing state public-health leaders said any vaccine approval must be insulated from political motives and driven by science.
“We want the safety and efficacy to be demonstrated,” Rachel Levine, president of the Association of State and Territorial Health Officials, said in an interview Thursday. Levine is Pennsylvania’s Secretary of Health, and the group represents top health officials and departments around the country.
“State health officials strongly encourage the FDA to complete phase 3 trials or some other very rigorous evaluation prior to approving a vaccine,” Levine said.
The Trump administration has floated the idea of releasing a vaccine to some parts of the public based on limited data, before trials are done. While drugmakers are rushing to complete tests of the shots, early looks at the results will provide only a limited picture of how effective they are, how long any protection from the virus lasts, and how safe they are.
President Donald Trump’s reelection hinges in large part on his response to the Covid-19 pandemic, and he has strongly suggested a vaccine will be ready just before election day on Nov. 3. He’s also accused the Food and Drug Administration of slowing work to hurt him politically.
The state-level push-back is the latest sign of a widening split between public-health professionals on the ground trying to suppress the virus and political leaders in Washington who set the agenda for the national response. State and local leaders say they’ve been blindsided by big policy changes, such as the Centers for Disease Control and Prevention’s recent guidance that not everyone exposed to Covid-19 needs to be tested.
Since the early days of Covid-19’s arrival in the U.S., the Trump administration promoted a response it has called “locally executed, state managed, and federally supported.” But state and local health leaders say they’ve frequently been sidelined in the response, learning of new developments only when the general public does.
State leaders had no heads up when the U.S. Department of Health and Human Services announced last week that it would buy 150 million rapid tests from Abbott Laboratories. Levine said the action raised a number of questions for health departments, even though the tests are slated to be shipped to state health departments.
She said the extra testing capacity is welcome, but it raises logistical problems that states and local officials must sort out: How will the tests be allocated? Who will administer them? How will results be reported back to health authorities?
“We were involved in none of that,” Levine said. “It’s still not even clear exactly when they’re coming and how many we’re going to get.”
Levine said she learned about a call last Friday to discuss distributing the tests in schools only after the state’s education department reached out and suggested public-health leaders join the meeting.
In a statement, the Health and Human Services Department said it planned to work “seamlessly” with states to distribute the Abbott tests.
“HHS works closely with Governors and state leadership, including State Health Officers,” said HHS spokeswoman Mia Heck. “The CDC testing prioritization guidance defers to the expertise of state public-health officers to determine asymptomatic testing.”
Local Tension
The rift between Washington and local health officials has grown since the beginning of the pandemic. State and local leaders met with officials at the White House back on Feb. 25, when the public-health groups were in Washington for a conference.
“We have not had any significant engagement with the White House and the Task Force since Feb. 25,” said Michael Fraser, chief executive officer of the Association of State and Territorial Health Officials. While health officers join calls where federal officials brief large audiences on talking points, he said, they’re not consulted before decisions are made or policies are announced.
That’s caused headaches when the Trump administration has made abrupt shifts. Last week, the CDC changed its guidelines to suggest that not everyone who has been in contact with a Covid-19 positive patient should necessarily be tested for the virus.
“We read about it at the same time everybody else did,” Fraser said. “It creates a lot of needless chaos and confusion at a time when that’s what we do not need.”
Rex Archer, director of health for Kansas City, Missouri, cited the testing guideline change as an example of politics interfering with public health.
“It really looks like the White House is intentionally trying to destroy confidence in government’s ability to handle this outbreak and undermine that,” Archer said. “And that’s no way to handle an outbreak.”
The risk of political interference, or merely the perception of it, will complicate the effort to deliver any Covid-19 vaccine whenever it becomes available. “The worst thing we can do for the public’s confidence in a vaccine is rush a vaccine out” before it’s been fully evaluated, he said.
HHS Secretary Alex Azar said the administration is committed to adhering to scientific standards. “Any vaccine that comes out is going to meet FDA’s gold standards for authorization or licensure,” Azar said in an appearance Thursday on CBS This Morning. “The president has made that clear, I’ve made that clear, the FDA commissioner has made that clear.”
Courtesy/Source: Bloomberg
