When a coronavirus vaccine is approved, huge obstacles remain to distribution

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“This will let the public know that it’s transparent, it’s not political,” said Dr Victor Dzau, president of the academy who told Collins his organization was up to the task. “The American public will want to know how you make this decision? Why don’t I understand her first? ”

The administration is taking action experts applaud as tapping on top health officials and industry experts to lead vaccination plans rather than politicians, but they still fear the overall effort – dubbed Operation Warp Speed ​​- remain shrouded in secrecy. And the administration’s response to the rest of the pandemic has not inspired confidence.

“It’s sort of manipulated like a secret weapon, which is never good,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “Transparency is always good. “

First in line

Once a vaccine is approved, not every American will be able to get it immediately. This sets up the unenviable task of deciding, in the midst of a deadly pandemic, who is most vulnerable to disease and who is most essential for rapid vaccination.

“People are a little worried about the government pulling the blows here,” NIH’s Dr. Collins told the Senate earlier this month.

Experts will need to consider vulnerable populations like those in assisted living centers or prisons, people working nearby like meat packing plants, and how to assess Americans with pre-existing conditions.

The National Academy of Medicine hopes its recommendations will be made public in August or September.

A second group of vaccine advisers for the Centers for Disease Control and Prevention – the Advisory Committee on Immunization Practices (ACIP) – also offers a set of guidelines. It’s still unclear whether the administration will choose one set of recommendations over the other or take both into account when making final decisions.

Last month, ACIP met electronically in a little-noticed meeting to discuss who counts as a critical worker, where teachers should be on the priority list, vaccinations for pregnant women and whether race and ethnicity should be taken into account as priority considerations.

“If we fail to treat this issue of racial and ethnic groups as a high risk in the prioritization, anything that comes out of our group will be looked at very suspiciously and with a lot of reservations,” said Dr José Romero, president of the group. .

The meeting summarized the steps the government is already taking to prepare for a vaccine, as well as the secrecy that still hangs over the effort.

Dr Matt Hepburn of Operation Warp Speed ​​kicked off his presentation on the development of a coronavirus vaccine by asking the panel to support his “lack of ability to provide a lot of detail about what we are doing.”

A few minutes later, he insisted, “We are not this secret organization that works with strangers and no one really understands what we are doing. ”

A senior Department of Health and Human Services official told CNN “we know there is a problem” with the transparency around Operation Warp Speed.

“Transparency is the key to acceptance,” the official said. “People have to believe in the safety and effectiveness of these vaccines. “

‘A colossal task’

Vaccine experts are already hitting the Trump administration for peddling an unrealistic timetable to the American people.

“I think when people tell the public that there will be a vaccine by the end of 2020, for example, I think they are doing the public a huge disservice,” said Ken Frazier, CEO of the pharmaceutical giant Merck, in a recent interview with Harvard Business School. “We don’t have a great history of rapid vaccine introduction in the midst of a pandemic. We want to keep this in mind. ”

Spreading false hopes and not succeeding is just one of the things that could further damage public confidence.

“You can’t give an optimistic message that the vaccine is going to be developed in December and then in December you don’t have a vaccine. Then people wonder what happened, ”said Vijay Samant, a vaccine expert who oversaw production. of three successful vaccines while working at Merck. “In the meantime, you know, they’ve given up on social distancing on the assumption that the vaccine is going to be developed in six months, and people are surprised what’s going on, they’re losing confidence.

Once a vaccine is available, it can take another six months to a year to vaccinate enough people to slow the spread.

“That’s if you’re lucky,” Samant said.

The Trump administration is trying to streamline this process with Operation Warp Speed. He partnered with vaccine developers to begin manufacturing and storing their drugs before safety trials were completed or the Food and Drug Administration approved the vaccines.

“We are literally making the vaccine on a commercial scale now, as we go through clinical trials,” Health and Human Services Secretary Alex Azar told CNBC on Wednesday. “We are doing this at risk, using all the power of the US government and our financial resources to do it. No one has ever done this before. ”

Once a vaccine is cleared, the goal is to deploy it immediately. By next year, the administration hopes to have around 300 million doses of the coronavirus vaccine. Whatever vaccine is available, it will likely require an initial dose followed by a second booster vaccine, vaccine experts and suppliers have said.

Once a vaccine is ready, it is still difficult to move from the laboratory to the arms of Americans. The US government is already spending hundreds of millions of dollars on supplies such as glass vials and syringes.

“We – from the start of Operation Warp Speed ​​- worked to lock in the fill-finish capacity, as well as the syringes, needles and glassware, so we secured that to be able to ensure that we will be able to immunize the American people once we receive vaccines that have been shown to be safe and effective according to the standard of FDA approval or clearance, ”Azar told CNBC.

While the Trump administration awarded some contracts to suppliers with minimal track records, others went to big manufacturers like Corning Inc.

“I think the United States has kind of set the bar and the rest of the world is following the pattern, very closely actually,” said Brendan Mosher, vice president and general manager of Corning Pharmaceutical Technologies.

“Glass won’t be the critical bottleneck,” Mosher said. “There will be a lot of things to do by the time a vaccine is, is ready, so I think we’re going to be in pretty good shape. ”

Beckton, Dickinson and Company – the world’s largest syringe maker – said the United States is also making progress in securing syringe supplies. But he may not yet have the 700 to 800 million syringes he will need to provide vaccines.

“We understand that this is a process, don’t we? And the federal government does some initial orders with us and other manufacturers, but that is, I think, the start of the process, ”said Elizabeth Woody, vice president of public affairs for the company.

The government has already ordered 190 million syringes from Beckton, Dickinson and Company as it partners with them to expand its manufacturing capacity.

“What he is telling us is that we are taking the steps now to prepare for a potentially seasonal Covid vaccine, just like we did for the flu,” said Woody.

The CDC and the Pentagon are working in tandem to deliver the vaccine across America, although they haven’t provided many details on how they plan to do so.

“It’s a huge task, even if you have a vaccine, getting these people vaccinated is a colossal task, a colossal task,” said vaccine expert Samant. “Because you have to convince people. “

“Are we the guinea pig?

Providing a vaccine is one thing. Convincing the Americans to take it over is another.

Administration officials have publicly hammered home assurances that the vaccine will be thoroughly tested to prove it is safe and effective. Still, a CNN poll in May found that a third of Americans said they would not get the coronavirus vaccine, even if it was affordable and widely available.

Some Americans are skeptical of all kinds of vaccines. Others are wary of the safety of the coronavirus vaccine in particular as it is produced on an accelerated basis. For others, the vaccination effort is tinged with politics.

“You see people commenting ‘I can’t trust anything Trump says’. You have people on the other end of the spectrum who say, “Unless he says it’s okay, I’m not going to do it,” said Emily Brunson, associate professor at Texas State and co-author of a recent report on public trust issues around the coronavirus vaccine. “You’re going to have people who are hesitant who are not normally hesitant to get vaccinated. ”

Convincing minority communities that have experienced higher rates of hospitalizations and deaths to get vaccinated is a major concern. Experts said this will need to involve community outreach through organizations people already trust, such as faith-based organizations.

“There is a lot of work to be done to make sure we engage them earlier to gain their trust,” said Dzau of the National Academy of Medicine. “There are two ways people can look at it. The first is, are we the guinea pig? Or, second, we should get it first because we are more at risk. ”

The Trump administration is already considering a communications campaign to try to convince Americans, a senior HHS official said. The effort should include television, radio, digital and billboard advertisements.

Next month, the administration plans to start filming one-minute spots featuring top scientists in the administration, including the director of the National Institute of Allergy and Infectious Diseases, Dr Anthony Fauci, the general surgeon, Dr. Jerome Adams, CDC director, Dr. Robert Redfield and others. In the ads, doctors will answer socially distanced questions from celebrities, musicians and athletes about coronavirus issues ranging from tests to therapeutics to a vaccine.

Experts say these efforts cannot come soon enough.

“We have this window of time,” said Monica Schoch-Spana, a senior researcher at the Johns Hopkins Center for Health Security, who also co-authored the report on public confidence and the coronavirus vaccine.

“It is not a given that it’s going to go well,” said Schoch-Spana. “And it is not a given, it will go badly. “

CNN’s Ellie Kaufman, Cat Gloria, Austen Bundy and Daniella Mora contributed to this report.

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