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The U.S. Centers for Disease Control and Prevention has told states to prepare for the Covid-19 vaccine to be ready by November 1 and has asked them to remove roadblocks that would prevent the opening of distribution sites.
The date suggests that the federal government anticipates that a vaccine will be available just days before President Donald J. Trump stands for reelection on November 3, an aggressive goal that would hinge on the vaccines being tested and reviewed by then. Trump’s political future hinges on the response to the virus that has killed nearly 185,000 Americans.
The CDC in early August told states to assume that “limited doses” of a vaccine might be available in the fall. The new letter said that the Department of Health and Human Services and the CDC “are rapidly making preparations to implement large-scale distribution of Covid-19 vaccines in the fall of 2020,” according to a copy provided to Bloomberg.
The CDC declined to comment on the letter, the content of which was previously reported by the McClatchy news organization.
Trump has previously said he believes a vaccine will be ready by or shortly before Election Day. He also accused the Food and Drug Administration staff of slowing down vaccine work to harm it politically. The claims have raised questions about political interference in vaccine reviews; FDA Commissioner Stephen Hahn has repeatedly promised that science will guide any decision.
When asked about the CDC letter, Health and Human Services spokesman Michael Caputo said it was “increasingly likely” that many doses of vaccines will be available by January.
“Doctors and data are driving the development of all Covid-19 countermeasures,” Caputo said in an email. “FDA’s career scientists will make these calls: independent government experts solemnly dedicated to ensuring the safety and efficacy of all vaccines.”
States have been aggressively preparing for a Covid-19 vaccine, and the Nov.1 date has been consistent with previous preparations, said Michael Fraser, executive director of the Association of State and Territorial Health Officials.
Fraser said an emergency use authorization from the FDA would likely be needed to distribute a vaccine so soon. The designation allows the agency to use limited data to make a vaccine available to a smaller group of people. The association of health officials “would be extremely concerned about a vaccine that has not completed phase 3 trials,” Fraser said.
A federal official familiar with the plans said the Nov. 1 date is for planning purposes only and was not intended to influence the presidential election. The official said the government is proceeding on the assumption that there will be a vaccine ready.
Clearing the way
The CDC letter asks governors to expedite applications for permits for facilities from McKesson Corp., the distributor the government has contracted for the vaccine, and to waive rules that would prevent sites from being “fully operational” to November 1st.
State health officials have been separately told to submit distribution plans to the federal government by Oct. 1, Bloomberg reported this week.
The Association of State and Territorial Health Officials on Wednesday criticized the Trump administration for excluding members before announcing major decisions. He asked to isolate federal health agencies from political pressure.
“The CDC, FDA and other federal agencies must have the power to lead in order to maintain the scientific integrity of these decisions without fear of political retaliation,” the group said in a statement from its president, the Pennsylvania Secretary of Health, Rachel Levine.
First supplies of any vaccine are likely to be limited. In addition to making distribution plans, the government has been developing priorities for early access. An outside panel of advisers said Tuesday that the first doses should be given to front-line healthcare workers, followed by people at high medical risk. Much of the rest of the population will likely have to wait until 2021 for additional doses. Bloomberg News