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Federal officials launch vaccine pilot program

A patients blood samples are seen during a COVID-19 vaccination study at Research Centers of America on August 07, 2020 in Hollywood, Florida. Research Centers of America is currently conducting COVID-19 vaccine trials, implemented under the federal government's Operation Warp Speed program. The center is recruiting volunteers to participate in the clinical trials, working with the Federal Government and major Pharmaceutical Companies, that are racing to develop a vaccine to potentially prevent COVID-19. (Joe Raedle/Getty Images/TNS)
August 12, 2020

After months of remaining vague about its plans to distribute a COVID-19 vaccine, the Trump administration is quietly piloting distribution working groups, CQ Roll Call has learned.

The plan, which is not yet public, was confirmed by four state health departments.

Federal officials from the Centers for Disease Control and Prevention, the Pentagon and the administration’s Operation Warp Speed initiative plan to conduct site visits and develop “model approaches” for other states based on what they learn, according to a CDC description of the project shared exclusively with CQ Roll Call. The states involved include California, Florida, North Dakota and Minnesota.

The start of vaccine distribution plans come amid calls by public health experts for a national strategy. Distributing any authorized vaccines effectively will be crucial to stemming the coronavirus pandemic. Normal life can’t begin to resume in the United States until a large proportion of residents are immune.

Public health advocates say they’re worried that U.S. immunization could resemble the dysfunction of state-by-state testing standards or the chaotic distribution of personal protective equipment.

A plan is needed to make the vaccine widely available, including to people who lack insurance, and convince skeptics to trust vaccines tested with unprecedented speed that may not have full Food and Drug Administration approval. The logistics of shipping and providing vaccines under precise conditions, managing potential supply chain shortages, monitoring patients, and ensuring equity will be complicated.

Democrats in the House and Senate who oversee health issues have pressured the Trump administration for a plan.

“Alarmingly, in the absence of a comprehensive plan, the Administration appears to be making decisions without the critical input of public health partners or consideration for the existing infrastructure the nation has long relied upon for the allocation, distribution, and tracking of vaccines,” Democrats on the House Energy and Commerce Committee wrote in an Aug. 5 letter. The letter lamented that the public has “yet to be informed about how the Administration intends to ensure the equitable distribution of a vaccine.”

CDC National Center for Immunization and Respiratory Diseases Director Nancy Messonnier held the first call with state immunization programs last week and announced the CDC would begin a “micro-planning” stage, according to a source on the call and a Democratic congressional aide.

Molly Howell, immunization program manager with the North Dakota Department of Health, confirmed that the state is one of the sites.

“We’re talking through plans to distribute and administer a COVID-19 vaccine, where we may have gaps and where we’re doing well, in preparation for it,” Howell said.

Howell said the working group would discuss how to distribute an eventual vaccine to long-term care facilities, pharmacies, Indian Health Service facilities, and other locations.

California, Florida and Minnesota confirmed participation as well.

“We are not in a position to talk about this, since it’s essentially in very, very early stages. Thus far, we have been asked to THINK about how a vaccine distribution plan might look. Nothing else has been done at this point,” Julie Bartkey, a Minnesota Department of Health spokesperson, said in an email.

“California has been selected for a joint planning mission and will work with a multiagency federal team, including staff from the CDC and the Department of Defense, to plan and prepare for COVID-19 vaccination response in California,” the state health department said in a statement.

“Florida supports this initiative and is one of four states that will be working with the CDC on this project,” a spokesman said in a statement. “The Department of Health will meet with representatives from the CDC to establish the details, however, an agenda for that meeting has not been created at this time.”

The CDC description indicated that Philadelphia, Pa., would also be involved but the city’s public health department said it had no knowledge of those plans. The CDC did not respond to multiple requests for more details.

Unanswered questions

CDC and Operation Warp Speed officials have been circumspect about the details of distribution for months.

The Association of Immunization Managers, the group of public health workers that typically implements immunization plans with CDC, said the federal agency stopped communicating with them.

The association, along with organizations representing state and local public health officials, asked the Operation Warp Speed leaders for details on a national vaccination plan in June.

“We strongly believe … that the enterprise to deliver and administer this vaccine to every American who wants it will be the greatest public health effort of our generation,” their letter read. “We seek to enhance the close coordination and cooperation between federal, state, local, and tribal authorities that will be necessary to achieve success.”

The group did not receive a reply.

Claire Hannan, executive director of the association, said she was relieved and optimistic after being on last week’s call with CDC. Hannan described Messonnier as saying something to the effect of, “we need to get moving.”

“She got a lot of questions that remain unanswered. But this is a great step forward,” Hannan said. “I hope they will put something out in writing to really get this clarified on the record so we can keep going forward.”

But some experts remain worried that the CDC, the agency that typically leads both yearly childhood and adult vaccination efforts, could be sidelined. In general, former CDC officials say the agency’s role during the COVID-19 crisis has been diminished compared to previous outbreaks.

In its letter, the association pressed Operation Warp Speed not to reinvent the wheel, given CDC’s record of providing childhood vaccines across the country.

The CDC already distributes about 80 million doses of vaccines through 40,000 health care providers each year. CDC’s existing infrastructure is capable of expanding, as it did during the H1N1 pandemic when it distributed 138 million doses of vaccine, the public health workers pointed out.

“We strongly encourage you to build upon this existing system for COVID-19 vaccination and not reinvent vaccine distribution and information management systems,” they wrote, asking if federal officials are creating a new system.

Other public health experts have also said CDC should take the lead.

CDC’s Advisory Committee on Immunization Practices “is a greatly misunderstood and unappreciated organization that has managed to provide all the childhood vaccines to every school district in the United States quietly and efficiently for years and years,” said Barry Bloom, an immunologist and a Harvard T.H. Chan School of Public Health professor. “They would have to tool up and get resources if it were nursing homes and prisons (rather than schools) … but nonetheless, they’re the agency that could do it if they have the funding and personnel.”

The Defense Department could help get vaccines to distributors quickly, Bloom said.

“I would say there’s a complimentary role for the DOD to fly large numbers of vaccines fast to every distribution point,” said Bloom. “I don’t see the role of the military being to go into local school districts and actually handing it to the vaccinators or physician assistants in doctors’ offices or emergency rooms.”

But some worry that the DOD through Operation Warp Speed could encroach on CDC’s longstanding role.

“We cannot start from scratch during a massive public health crisis,” said Amy Pisani, executive director of Vaccinate Your Family, a pro-vaccine nonprofit. “I am concerned that there are so many various pieces of the puzzle that there may be groups that want to take over, but we have the CDC. … The CDC has an incredible track record of getting millions of vaccines into the arms of American citizens.”

Hannan and other vaccination experts worry how the involvement of the military might harm fragile public trust.

“I don’t think the public is used to the military giving vaccine. Our current system has really nurtured public trust and is built around trusted health care providers. It’s unknown how the public would accept the military’s role,” said Hannan.

Democratic senators leading the health and armed services committees wrote a letter Friday to Health and Human Services Secretary Alex Azar and Defense Secretary Mark Esper expressing alarm at the idea that the Pentagon may lead vaccination and asked for a briefing on the issue.

“It is essential the Trump Administration use existing expertise, systems, and infrastructure,” wrote Democratic Sens. Patty Murray of Washington and Jack Reed of Rhode Island.

Creating Operation Warp Speed as a separate entity from existing agencies like the CDC is typical of the Trump administration, Jason Schwartz, Yale University assistant professor of public health, said in a mid-July interview.

“It’s part of a pattern of direct control outside of what is traditionally the purview of nonpartisan career government officials,” Schwartz said. “The White House often views those officials as not in line with the mission.”

“I know (CDC) said they were anxious to be planning with us,” Hannan said. “I don’t know why there was a holdup.”

Significant obstacles are ahead in one of the greatest public health challenges in decades, experts said.

The first is funding. Congress is preparing to leave Washington without a deal so far on a new coronavirus relief bill, so it could be at least a month more before billions in funding needed for vaccine implementation and IT will reach public health departments.

“Congress needs to skip their vacation,” Pisani said.

Congress and the Trump administration have ploughed billions of public dollars into getting a vaccine, but money for vaccination has been slower to materialize.

Murray has called for $25 billion for a national immunization plan, including vaccine manufacturing and distribution. A Senate GOP leadership bill included $26 billion for that purpose, including $6 billion for vaccine distribution, signaling some bipartisan agreement.

Some experts advising Democrats estimate the cost of distribution alone will be closer to $10 billion, though, according to a memo shared with CDC Roll Call.

“State health departments are currently overwhelmed and will not by themselves be able to do everything needed with current staff and resources,” said Jesse Goodman, director of the Georgetown University Center on Medical Product Access, Safety and Stewardship and a former FDA official during the H1N1 pandemic.

Some vaccination experts say there’s still time to approve funding and devise a plan. Pharmaceutical companies are just beginning late-stage clinical trials for vaccines. Those will take months to attract thousands of patients and measure effectiveness.

“It’s not an absolute crisis yet,” said Walter Orenstein, associate director of the Emory Vaccine Center and an expert with the Infectious Diseases Society of America, who estimated that a vaccine won’t be authorized by the FDA until at least early 2021.

But Pisani said a plan is needed soon to get as many people as possible vaccinated for flu before winter hits, in order to prevent flu and COVID-19 from crushing hospitals.

The administration also has work to do to improve vaccination rates among Black and Latino populations, who often lack access to health care and have been hammered by the pandemic, Pisani said.

“If a vaccination plan is not created in the next several months, we’re going to have a lot to worry about,” she said.


© 2020 CQ-Roll Call, Inc.

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