The US Centers for Disease Control and Prevention (CDC) has told states to get ready to distribute a potential coronavirus vaccine by November 1 – two days before the country’s presidential election.
The timing of a vaccine has taken on political importance as President Donald Trump seeks re-election in the world’s hardest-hit country, with some public health experts expressing concern a vaccine might be rushed through before the highly anticipated vote.
In a letter to governors dated August 27, CDC Director Robert Redfield said states “in the near future” will receive permit applications from McKesson Corp, which has a contract with the agency to distribute vaccines to places including state and local health departments and hospitals.
“CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020,” Redfield wrote in the letter, which was first reported by McClatchy.
He wrote that any waivers will not compromise the safety or effectiveness of the vaccine.
To date, the United States has reported more than 6.1 million confirmed coronavirus cases including 863,445 deaths, according to Johns Hopkins University.
The CDC also sent three planning documents to some health departments that included possible timelines for when vaccines would be available. The documents, which were first reported by The New York Times, are to be used to develop plans for early vaccination when the supply might be constrained, according to one of the documents, which outlined a scenario in which a vaccine could be available as soon as the end of October.
“The COVID-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available,” the document reads.
Another of the documents says that limited COVID-19 vaccine doses may be available by early November and that supply will increase substantially in 2021.
It also states that initially available vaccines will either be approved by the Food and Drug Administration (FDA) or authorised by the agency under its emergency powers.
The documents encourage health officials to work out now which groups to prioritise for a vaccine, identify providers who will administer the vaccine and take other steps to prepare.
Redfield told Yahoo Finance that officials were preparing “for what I anticipate will be reality, is that there’ll be one or more vaccines available for us in November, December”.
James S Blumenstock, a senior vice president at the Association of State and Territorial Health Officials, said the CDC was offering “an aggressive but necessary timetable” and that public health agencies were mobilising to prepare detailed plans.
Several public health experts pointed out that final stage trials of experimental vaccines are still recruiting, and are at best halfway through that process. The vaccines are two doses, and each is given a month apart. The experts told The Associated Press news agency they did not understand how there could be adequate data on whether the vaccines work and are safe before November 1.
“Being ready is reasonable. Cutting short phase three trials before you get the information you need isn’t,” said Paul Offit, a Children’s Hospital of Philadelphia immunisation expert who sits on the FDA’s vaccine advisory committee.
Peter Hotez, dean of Baylor University’s tropical medicine school, said he was “very concerned” about whether the FDA would use an emergency use authorisation to approve a vaccine before knowing if it works and is safe.
“It gives the appearance of a stunt rather than an expression of public health concern,″ Hotez said. FDA Commissioner Stephen Hahn previously said the agency would not cut corners in evaluating vaccines, though it would aim to expedite its work.
He told the Financial Times this week that it might be “appropriate” to approve a vaccine before clinical trials were complete if the benefits outweighed the risks.
Unlike a therapeutic that is given to sick people who may have no alternative, a vaccine is given to healthy people, “so you have a much higher burden of proof,” said Ashish Jha, the dean of Brown University’s public health school.
“I think it’s reasonable to be communicating to hospitals and saying – at some point late in the fall or winter,” Jha said. “November feels awfully early.”
Michael Osterholm, a University of Minnesota infectious disease expert, said there was a “credibility gap” between doctors and the FDA about how rigorously products are being evaluated during the pandemic.
“The public health community wants a safe and effective vaccine as much as anybody could want it,” Osterholm said. “But the data have to be clear and compelling.”
Some state officials said on Wednesday that they were working on next steps while still awaiting details from the CDC, and some sounded a cautious note.