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PROVIDENCE, Rhode Island – The federal government has told states to be ready to distribute a coronavirus disease (Covid-19) vaccine by Nov. 1.
The schedule sparked concern among public health experts about an “October surprise”: a vaccine approval driven by political considerations before a presidential election, rather than science.
In a letter to governors dated Aug. 27, Robert Redfield, director of the US Centers for Disease Control and Prevention, said states “in the near future” will receive permit applications from McKesson Corp ., which has contracted with the CDC to distribute vaccines to locations including hospitals and state and local health departments.
“CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving the requirements that would prevent these facilities from being fully operational by November 1, 2020.” Redfield wrote.
He wrote that any exemption will not compromise the safety or efficacy of the vaccine. The Associated Press obtained the letter, which was first reported by McClatchy.
The CDC also sent three planning documents to some health departments that included possible deadlines for when vaccines would be available. The documents will be used to develop early vaccination plans when supply may be limited, according to one of the documents, which outlined a scenario where a vaccine could be available as early as the end of October.
“The Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information becomes available,” the document reads.
Another of the documents says that limited doses of the Covid-19 vaccine may be available in early November and that the supply will increase substantially in 2021.
It also states that the vaccines available initially will be approved by the Food and Drug Administration or authorized by the agency under its emergency powers.
The documents encourage health officials to now determine which groups to prioritize for a vaccine, identify the providers who will administer the vaccine, and take other steps to prepare. The planning documents were first published by The New York Times.
Redfield told Yahoo Finance that officials were preparing “for what I anticipate will be reality, is that there will be one or more vaccines available to us in November, December.”
James S. Blumenstock, senior vice president of the Association of State and Territorial Health Officials, said the CDC was offering “an aggressive but necessary schedule” and that public health agencies were mobilizing to prepare detailed plans.
Several public health experts noted that end-stage trials of experimental vaccines are still recruiting, and are in the middle of that process, at best. The vaccines are two doses and each one is given one month apart. Experts told the AP they did not understand how there could be adequate data on whether the vaccines work and are safe before Nov. 1.
“Being ready is reasonable. Cutting out the phase 3 trials before you get the information you need is not, ”said Dr. Paul Offit, an immunization expert at Children’s Hospital of Philadelphia who sits on the FDA’s vaccine advisory committee.
Peter Hotez, dean of the Baylor University School of Tropical Medicine, said he was “very concerned” about whether the FDA would use an emergency use authorization to approve a vaccine before knowing if it works and is safe.
“It gives the appearance of a gimmick rather than an expression of public health concern,” Hotez said.
FDA Commissioner Stephen Hahn previously said the agency would not take shortcuts in evaluating vaccines, although its goal would be to speed up its work. He told the Financial Times this week that it might be “appropriate” to approve a vaccine before clinical trials are completed if the benefits outweigh the risks.
Unlike a treatment given to sick people who may have no alternative, a vaccine is given to healthy people, “so it has a much higher burden of proof,” said Ashish Jha, dean of the School of Public Health of Brown University.
“I think it’s reasonable to contact the hospitals and say: sometime in late fall or winter,” Jha said. “November feels awfully early.”
Michael Osterholm, an infectious disease expert at the University of Minnesota, said he was concerned about an “October surprise” with a vaccine that he was quick to pass before the election.
“The public health community wants a safe and effective vaccine as much as anyone could want it,” Osterholm said. “But the data must be clear and convincing.”
He said there was a “credibility gap” between doctors and the FDA about how rigorously products are evaluated during the pandemic.
Some state officials said Wednesday they were working on next steps while waiting for details from the CDC, with some giving a note of caution.
Kris Ehresmann, Minnesota’s director of infectious diseases, told the AP that the state would only move forward “once we know it’s safe.” She said they would take the lead from the CDC’s Advisory Committee on Immunization Practices, which said it will “only recommend a vaccine that meets safety criteria.”
The Oregon Board of Pharmacy said it would expedite McKesson’s applications, but would not eliminate the requirements necessary to maintain public health and safety. Its chief executive, Joe Schnabel, said in a statement that the board did not have enough information about how the distribution would work “to speculate whether it will be fully operational by November 1.”
Pennsylvania Governor Tom Wolf, a Democrat, said state officials don’t yet know what is being asked of them and will first need to do “a comprehensive review of the potential benefits or dangers of such exemptions.”
New Mexico Human Services Secretary David Scrase said the state was preparing to administer coronavirus vaccines on a limited basis beginning in November to healthcare workers and residents of long-term care facilities. The wide public rollout of vaccines is scheduled for January. He said the current vaccine provider networks are strong and suitable for the Covid-19 effort.
Regarding the timing of the CDC’s request to speed up or waive permits for distribution centers to open on November 1, Scrase said, “I can’t tell you about the political motivations in this regard.”
A spokesman for Tennessee’s Republican Governor Bill Lee said the state was reviewing its next steps.
“The news of a vaccine is encouraging and a testament to the power of American innovation,” said spokesperson Gillum Ferguson.
And in Florida, Republican Gov. Ron DeSantis said he was not aware of the CDC news, but said people shouldn’t think the virus will be gone in two months once a vaccine is released.
“I hope the federal government will take the lead on that,” said DeSantis, a Trump ally. “Hopefully they have a plan to do it and they will really target the vulnerable among us.” (AP)
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