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FILE PHOTO: General view of the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, September 30, 2014. REUTERS / Tami Chappell / File Photo
PROVIDENCE, RI – The federal government has told states to prepare for a coronavirus vaccine to be ready for distribution by November 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 requests from McKesson Corp ., which has contracted with the CDC to distribute vaccines to places 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.
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,” but public health agencies were mobilizing to prepare detailed plans.
Several vaccine and public health experts noted that end-stage trials of experimental vaccines are still being recruited and are in the middle of that process at best. The vaccines are two doses and each one is given one month apart. Several experts told the AP they didn’t 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 Food and Drug Administration 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.
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, that the vaccine is effective and safe.”
He said there was a “credibility gap” between doctors and the FDA over how rigorous products are evaluated during the pandemic.
Some states said Wednesday they were working on next steps while waiting for details from the CDC.
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 adequate 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 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.
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