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 say whether the state would distribute a vaccine that he did recommend.
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 that acts politically for 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 company planned to supply three hundred million doses through January 2021 and that “doctors and knowledge are the basis for the progression of all COVID-19 countermeasures.”
Warnings from state fitness officials come after the director of the Centers for Disease Control Robert Redfield last week sent a letter to governors 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, that the policy will play a role in the 3 vaccines that are recently in Phase III, which will be approved first.
Moving a vaccine beyond Phase III trials too temporarily can shorten knowledge collection on key facets of the vaccine, adding its effectiveness, experts told the TPM.an approved vaccine with no long-term defense knowledge and no full review of product efficacy, 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.
“In order for a vaccine to be safely distributed, in fact, the vaccine will have to go completely through Phase III trials (larger trials for more people) over an era of time to ensure the protection and efficacy of the vaccine. vaccine. and we hope that those trials will end before a vaccine is distributed, unless an independent board of scientists says otherwise: knowledge of those trials implies that, for some explanation, why it deserves to be stopped sooner, “he continued Wiesman. “We want to ensure the quality, protection and effectiveness of these vaccines, and we want to distribute them when it is safe to do so.”
This fear in part reflects a lack of clarity within Operation Warp Speed. Although the CDC has sent data suggesting that a vaccine could be distributed as early as the end of October and that President Trump has expressed a preference for doing so. Operation Warp Speed director Moncef Slaoui said Thursday that he doubts there is a proper vaccine 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 Center for Vaccine Education at Philadelphia Children’s Hospital, told TPM last month that he participated that management would decide on a “ready-to-use” vaccine, without going through mandatory testing and the FDA panel.