The head of the U.S. Centers for Disease Control and Prevention pleaded with state governors to help McKesson Corp. secure the permits and licenses it needs to get new facilities fully operational by Nov. 1 to distribute the COVID-19 vaccine.
"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 Nov. 1," the agency's director, Robert Redfield, said in an Aug. 27 letter to the governors.
News about the letter was first reported by McClatchy. The CDC on Aug. 14 triggered an option under an existing 2016 contract signed by the Obama administration for McKesson to act as the centralized distributor for the COVID-19 vaccines. The company will be paid $178 million.
The timeline for any COVID-19 vaccines to be ready for marketing in the U.S. is uncertain, but President Donald Trump has said he wants those products available before the Nov. 3 election.
Trump's chief of staff, Mark Meadows, openly said the White House is putting pressure on the U.S. Food and Drug Administration and other scientific agencies to speed up the development and regulatory processes.
"If they don't see the light, they need to feel the heat," Meadows said Aug. 23 on ABC's "This Week."
FDA Commissioner Stephen Hahn told the Financial Times Aug. 30 he was willing to grant an emergency use authorization, or EUA, to COVID-19 vaccines before late-stage human trials are completed. He told CBS News the next day a decision for that EUA could come by election day — a highly unusual public prediction for a U.S. regulator to make about any experimental product under his jurisdiction.
Hahn and Redfield are slated to testify at a Sept. 23 Senate hearing, where they are expected to be asked about the political pressure on their agencies during the pandemic.
It is unclear whether the FDA will have its outside advisers review any COVID-19 vaccine applications before the agency permits a product on the market.
The FDA has scheduled an Oct. 22 advisory committee meeting but only to discuss general terms of COVID-19 vaccines and not any companies' specific applications — a decision that alarmed many in the scientific and public health communities.
After much criticism, Hahn said in a late-evening Aug. 28 statement that he was "also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate," but he did not make any firm commitments to do so.
In a series of Sept. 2 tweets, Hahn again suggested there may be more than the Oct. 22 session, but the FDA declined to state if any COVID-19 vaccine-specific advisory committee meetings would be held before an EUA or license is granted.
Distribution
Redfield told Yahoo Finance Sept. 2 that the CDC was "preparing earnestly" for having at least one COVID-19 vaccine, if not more, cleared by the FDA as early as November.
He had confirmed to reporters Aug. 28 the CDC was basing its distribution plan for the initial COVID-19 vaccine doses on the FDA granting an EUA rather than waiting for a full license.
On the same media call, officials emphasized the White House had no insight into any phase 3 data, despite Trump's repeated claims of an approval happening soon. They noted the decision on whether to end any of the clinical trials early was in the hands of the studies' independent data and safety monitoring boards to judge and no one else.
But Redfield wants states to be ready for distributing the vaccines by Nov. 1, despite having no clear idea if those products will be ready for marketing by that date.
"We have to figure out how to make sure they're distributed in a fair and equitable way," Redfield told Yahoo in the Sept. 2 video interview.
His remarks came the same day a panel of independent scientists and medical experts heard input from the public about the committee's draft report on equitably allocating the COVID-19 vaccines once they are granted a license or EUA by the FDA.
The special committee convened by the U.S. National Academies of Sciences, Engineering and Medicine laid out a four-phase strategy in its draft framework for who should get the vaccine and when. The panel's recommendations are expected to be finalized later this year.
Initially, there will be limited doses of COVID-19 vaccine available, so those scarce supplies must be allocated in ways that are thoughtful, strategic and fair, said Victor Dzau, president of the National Academy of Medicine.
"So it is important we have a solid, well-thought-out framework" that is "objective, transparent, trusted and independent" and is based on "science, public health, social factors and equity," Dzau said during the Sept. 2 online listening session.
Transparency
About 50 people provided input during the National Academies' more than five-hour online session, many of them pleading for the framework to be adjusted to prioritize certain groups for the vaccine.
But most of the speakers called for transparency, declaring the only way the U.S. government and vaccine makers would gain a skeptical public's trust was to be forthcoming in the development, regulatory and distribution processes.
"If there's a belief an expedited process means that shortcuts were taken, many communities will be wary of the vaccine, which could adversely impact the rate at which these communities get vaccinated," said Oluwaferanmi Okanlami, assistant professor of family and physical medicine, rehabilitation and urology at the University of Michigan.
The worst possible thing states and the federal government could do in the middle of the COVID-19 pandemic is try to create a new type of distribution process, said Christian Ramers, assistant medical director for research and special populations and director of graduate medical education at Family Health Centers of San Diego.
There are already trusted institutions, like community health centers, in place to handle vaccination, Ramers noted.
"Please use us, those of us who know what we're doing, since we've been doing it already," he said.