Officials from at least three states have suggested that they would refuse to distribute a COVID-19 vaccine if they believe it has not received adequate vetting by the federal government, or that it had been approved for political reasons.
The statements come as the Trump administration’s behavior has stoked fears that it will greenlight a vaccine before the November election in a bid to juice the President’s re-election chances.
California would “need evidence that the vaccine candidates are safe and effective before distributing them,” a spokesperson for the state Department of Public health told TPM.
New York Gov. Andrew Cuomo (D) suggested at a Thursday briefing that the state may make any federally approved vaccine subject to additional approval from the New York state Department of Health.
“It’s going to be an Election Day miracle drug,” Cuomo told reporters on Thursday. “So, we will, before we recommend New Yorkers take any vaccine, we will have the state Department of Health review it.”
A Cuomo spokesman declined to clarify whether the state would distribute a vaccine that it did not recommend.
In Washington, state Secretary of Health John Wiesman slammed the politicization of the COVID-19 vaccine, saying that “we want to make sure that the federal government takes all the steps they need to ensure that any release of the vaccine is not driven by politics.”
States refusing to distribute a vaccine raises the prospect of an unprecedented clash between a federal government acting to aid Trump politically and states with public health concerns about the vaccine approval process. It’s not clear how such a situation would develop, or whether the federal government would have the power to move a vaccine beyond state roadblocks.
HHS Assistant Secretary for Public Affairs Michael Caputo told TPM after publication that “any suggestion that the FDA would prematurely authorize a COVID-19 vaccine is irresponsible and undermines confidence in our public health system.”
“Data is driving the development of all COVID-19 vaccines and countermeasures, and the Administration has made it abundantly clear that any vaccine distributed to the American people will be held to the FDA’s gold standard,” he added.
The statements of caution from state health officials come after Centers for Disease Control Director Robert Redfield sent a letter last week to governors demanding that they ensure vaccine distribution sites be “fully operational” by Nov. 1.
That followed weeks of evidence that the Trump administration is tailoring its COVID-19 response to the President’s re-election hopes. The CDC last week issued guidance that would diminish the number of positive COVID-19 tests in the country, while the Food and Drug Administration has issued provisional, emergency approvals for drugs and treatments like hydroxychloroquine and blood plasma in what experts later said was the absence of adequate underlying evidence.
FDA chief Stephen Hahn has said that he would support an emergency approval of a vaccine before phase III trials are complete. President Trump, for his part, has antagonized Hahn and his agency, accusing the “deep state” at the FDA of slowing down vaccine trials.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
All of that has suggested that politics will play some role in whichever of the three vaccines currently in phase III trials is approved first.
Moving a vaccine beyond phase III trials too quickly could cut short data collection on key aspects of the vaccine, including its efficacy, experts told TPM. Though potential side-effects will continue to be monitored, ending the trial early could result in a vaccine approved without longer-term safety data and without a full review of whether the product works, what level of protection it provides, and for how long.
“It is incumbent upon the federal government to make sure that we wait until phase III trials are done and an independent board has verified the safety of the vaccine,” Wiesman, Washington state’s secretary of health, said Wednesday. Lisa Stromme, a spokeswoman for the state Department of Health, did not reply to follow-up questions about Wiesman’s statement.
“In order for a vaccine to be safely distributed, it certainly is our belief that the vaccine needs to fully pass through the phase III trials — larger trials for larger numbers of folks — for a period of time to assure both the safety and effectiveness of the vaccine, and we expect those trials to be completed before a vaccine is distributed, unless an independent board of scientists says otherwise — that the data coming out of those trials say for whatever reason it should be stopped sooner,” Wiesman continued. “We need to ensure the quality, safety and effectiveness of these vaccines, and we want to distribute them when it’s safe to do so.”
The concern partly reflects a lack of clarity from within Operation Warp Speed itself. Though the CDC has sent out information suggesting that a vaccine could be distributed as early as late October and President Trump has expressed his desire for the same, Operation Warp Speed director Moncef Slaoui said on Thursday that he doubts a vaccine will be ready by that time.
Meanwhile, officials with Operation Warp Speed — a joint HHS-DOD effort to accelerate vaccine development — have promised to “overwhelm” the airwaves with vaccine-related messaging by early November.
The final measure of whether any COVID-19 vaccine can be trusted boils down to whether the FDA’s vaccine advisory committee is consulted on its approval at the federal level, experts in public health and vaccines have told TPM.
Dr. Paul Offit, a member of the committee and director of the Vaccine Education Center at Children’s Hospital Philadelphia, told TPM last month that he was concerned that the administration would pick a vaccine “out of the bucket,” bypassing both necessary trials and the FDA panel.
This story has been updated.