Officials in at least 3 states have reported that they will refuse to distribute a COVID-19 vaccine if it has not been approved by the federal government or has been approved for political reasons.
Statements come when the Trump administration’s habit has stoked fears that it will give the green touch to a vaccine before the November election in an effort to re-select the president.
California “would need evidence that candidate vaccines are effective before they are distributed,” a state department of public health spokesman told TPM.
New York Gov. Andrew Cuomo (left) warned at a briefing Thursday that the state can send any federally approved vaccine for further approval by the New York State Department of Health.
“It will be a miracle drug on Election Day,” Cuomo said Thursday.”So before we recommend that New Yorkers get a vaccine, we’ll ask the State Department of Health to review it.”
A Cuomo spokesman refused to comment on whether the state would distribute a vaccine it recommended.
In Washington, Secretary of Health John Wiesman criticized the politicization of the COVID-19 vaccine and said that “we must ensure that the federal government takes all steps to ensure that any vaccine launches have no political motivation.”
States that refuse to distribute a vaccine raise the possibility of an unprecedented confrontation between a federal government acting politically before Trump and states with public aptitude considerations about the vaccine approval process.It is not known how such a scenario would evolve, or whether the federal government would.have the strength to move a vaccine beyond state obstacles.
An HHS spokesman did not respond to a request for comment.HHS Undersecretary of Public Affairs Michael Caputo told TPM last week that the firm planned to deliver three hundred million doses until January 2021 and that “doctors and knowledge are the basis for the progression of all COVID-19 countermeasures.”
Statements of caution from state fitness officials occur after the director of the Centers for Disease Control Robert Redfield sent a letter last week to governors so that vaccine distribution sites are “fully operational” until November 1.
This follows weeks of evidence that the Trump administration is adapting its reaction to COVID-19 to the president’s hopes of re-election.Last week, the CDC issued rules that would determine the number of positive COVID-19 tests in the country, while Food and the Drug Administration issued provisional and emergency approvals for drugs and remedies such as hydroxychloroquine and blood plasma in what experts later said were absences of adequate underlying evidence.
FDA chief Stephen Hahn said he would emergency approve a vaccine before phase III trials are completed.President Trump, for his part, opposed Hahn and his agency, accusing the FDA’s “deep state” of slowing down vaccine testing.
– Donald J. Trump (@realDonaldTrump) August 22, 2020
All this makes the policy play a role in which of the 3 vaccines lately in phase III will be approved first.
Moving a vaccine beyond Phase III trials too temporarily can shorten the gathering of knowledge about key aspects of the vaccine, adding to its effectiveness, experts told the TPM, although the effects of prospective aspects will continue to be monitored. , the early end of the trial may result in an approved vaccine without long-term defense knowledge and without a complete review of the efficacy of the product, the point of coverage it gives and for how long.
“It is the duty of the federal government to wait until the Phase III tests are completed and that an independent board has verified the protection of the vaccine,” Wiesman, Washington State Secretary of Fitness, said Wednesday.Lisa Stromme, spokesperson for the state Department of Health, did not respond to follow-up questions related to Wiesman’s statement.
“For a vaccine to be distributed safely, in fact, the vaccine will have to go through Phase III trials (larger trials for more people) over an era of time to ensure the protection and efficacy of the vaccine, and we expect those trials to finish before a vaccine is distributed.Array, unless an independent scientific board says otherwise, knowledge of those trials implies that, for some explanation, why it deserves to be stopped earlier,” Wiesman continued.We want to make sure of the quality, protection and effectiveness of these vaccines, and we want to distribute them when it is safe to do so.”
This fear partly reflects a lack of clarity within Operation Warp Speed.Although the CDC has submitted data suggesting that a vaccine could be distributed as soon as late October and that President Trump has expressed a preference for doing so.Operation Warp Speed director Moncef Slaoui said Thursday that he doubts there will be a vaccine in good condition at the time.
Meanwhile, in Operation Warp Speed, a joint HHS-DOD effort to drive vaccine progression, they promised to “overwhelm” radio waves with vaccine-related messages until early November.
The final resolution on a COVID-19 vaccine can be reliable is reduced to FDA vaccine advisory committee being consulted on its federal approval, public health experts and vaccines told the TPM.
Dr. Paul Offit, a committee member and director of the Philadelphia Children’s Hospital’s Center for Vaccine Education, told TPM last month that he was involved in management deciding on a “ready-to-use” vaccine, without going through mandatory testing and the FDA panel.