The U.S. Centers for Disease Control and Prevention unveiled its initial outline for distributing COVID-19 vaccines once those products are cleared for marketing, but the agency lacks the funds to carry out the strategy, its director, Robert Redfield, said.

The CDC has already spent about $600 million of funds it had on hand but will need between $5.5 billion and $6 billion to fully implement its vaccines distribution plan, Redfield said during a Sept. 16 Senate hearing.

Sen. Roy Blunt, R-Mo., chairman of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, noted that his chamber has proposed approximately $6 billion for COVID-19 vaccine distribution as part of the next coronavirus relief package, though no agreement has been reached on Capitol Hill, and the timing of any deal with the House is uncertain.

The distribution funds are "as urgent as getting these manufacturing facilities up" for the vaccines, Redfield told the subcommittee.

"Now is the time the rubber is hitting the road," the CDC chief said. "This is going to be a very resource-intensive distribution. We've never tried to distribute a vaccine that has a cold-chain requirement like this one does — minus 80 degrees potentially for one of the vaccines."

The 64 U.S. jurisdictions outlined in the CDC's COVID-19 vaccines distribution strategy "are not going to be able to put plans in place without resources," he said.

Redfield acknowledged he had been ordered by the White House and the U.S. Department of Health and Human Services to transfer $300 million of the CDC's funds to HHS for a public relations campaign aimed at making people feel better about the COVID-19 pandemic.

"While I think all of us want to make sure that Americans know that there is going to be a better time ahead for us, the timing of this contract raises real concerns about a potential intersection with the president's reelection campaign and more importantly, Congress didn't direct HHS to conduct this campaign," said Sen. Jean Shaheen, D-N.H.

Those funds could be going to the U.S. COVID-19 response instead, she said.

Leaders of the House Oversight and Reform Committee on Sept. 10 asked HHS Secretary Alex Azar to put a hold on the $250 million contract the agency awarded to Fors Marsh Group to create public service announcements as part of the campaign.

Redfield told senators at the hearing the CDC was not involved in designing or implementing the campaign and had no details about it.

'Deeply saddened'

The person in charge of the $300 million public relations campaign, Michael Caputo, assistant secretary for public affairs at HHS, started a 60-day leave of absence on Sept. 16 after making disparaging remarks about the CDC. Caputo and one of his politically appointed advisers, Paul Alexander, had also sought to review and edit the CDC's weekly scientific reports.

Alexander left HHS on Sept. 16, the agency said in a statement.

Redfield told senators he was "deeply saddened" by Caputo's unsubstantiated claims that CDC scientists were involved in "sedition" and were part of a "deep state" conspiracy to undermine President Donald Trump's chances for reelection.

He said he believed the scientific integrity of the CDC's reports "has not been compromised" by Caputo or anyone else for political purposes.

Control is key

At the hearing, Redfield pushed back against suggestions he had asked states in an Aug. 27 letter to assist the government's COVID-19 vaccines distribution contractor, McKesson Corp., to secure the permits and licenses it needs to get new facilities fully operational by Nov. 1 to help Trump's reelection.

Trump has repeatedly said he wants a COVID-19 vaccine available before the election.

The CDC chief said he anticipates a COVID-19 vaccine to be cleared for U.S. marketing "sometime between November and December, but very limited supply, and it will have to be prioritized."

But COVID-19 vaccines will not be available for the broader American public until "late second quarter, third quarter 2021," Redfield testified.

The CDC's Sept. 16 interim distribution playbook confirms the plan was based on anticipating the U.S. Food and Drug Administration will use its emergency use authorization mechanism to put COVID-19 vaccines on the U.S. market — information Redfield had initially disclosed Sept. 2.

The goal is to be able to have vaccine doses moving to administration sites within 24 hours after the FDA clears the products for the market, Lt. General Paul Ostrowski, the deputy chief of supply, production and distribution for the White House's Operation Warp Speed, told reporters during a Sept. 16 media briefing.

The key to the distribution plan working properly "is control," Ostrowski said.

"We absolutely, positively have to have control over each of these vaccines as they are distributed," he said.

Since most of the COVID-19 vaccines being developed will require at least two doses, it will be important to ensure people get the same type of vaccine for their second dose, Ostrowski said.

"These vaccines are not interchangeable," and the number of days will vary between first and second doses for the vaccines, he told reporters.

States, pharmacies, hospitals and doctors' offices already are part of various existing immunization databases, Ostrowski said.

"The hard part is to get the databases to talk to one another," he said.

The government is working on a datalink mechanism to allow the current systems to communicate with each other, Ostrowski said, though he was unable to give a timeline for the project's completion.