MI Joins States Refusing An Inadequately Vetted But Trump-Approved COVID Vaccine

The State of Michigan said that it would not agree to distribute a COVID-19 vaccine absent adequate data from the federal government, joining a growing list of states that would refuse to dole out a vaccine if they believe it was approved on a political schedule.

The state’s health department told TPM on Friday that it would not agree to distribute a vaccine that received federal approval without completing safety and efficacy trials or without approval from an independent board of scientists.

Instead, a spokeswoman said, the state wants to review the data before agreeing to distribute the vaccine.

“Before making decisions on the distribution of a COVID-19 vaccine in Michigan, we would need to evaluate the efficacy and safety data regarding any approved vaccine,” Lynn Sutfin, spokeswoman for the health department, told TPM on Friday.

She added that the state “would hope there would be transparency at the federal level regarding that data so we can make an informed decision.”

On Thursday, officials in three states said that they would refuse to play ball with any attempt from the Trump administration to speed a vaccine past the typical trial and review process.

A spokesman for California’s department of public health told TPM that the state would not distribute a vaccine that had not completed phase III trials or which had not passed muster under an independent review board. Washington and New York officials have also said that they would hold back on distributing such a vaccine.

The statements threaten to throw a wrench in the Trump administration’s plan to begin distributing a vaccine before the November election. As recently as last week, CDC Director Dr. Robert Redfield told the states to have vaccine distribution sites “fully operational” by Nov. 1.

President Trump has pressured the Food and Drug Administration, responsible for vetting and licensing vaccine candidates, to move quickly on approving a vaccine, saying that the “deep state” was slowing down the process.

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

The FDA did not immediately return a request for comment on whether it plans on sharing vaccine data with the states.

HHS spokesman Michael Caputo told TPM 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.”

Officials at Operation Warp Speed — the Trump administration’s effort to accelerate vaccine development — have promised to “overwhelm” the airwaves with vaccine messaging by November.

But it remains very unlikely that any of the three vaccine candidates currently in phase III trials will have enough data to assess by that time. Dr. Moncef Slaoui, director of Operation Warp Speed, said on Thursday that it would be “extremely unlikely” that a vaccine would have gathered enough data from the trial for a late-October approval.