Even once a vaccine gets approved, big hurdles remain

First in line

Once a vaccine is approved, every American won't be able to get it at once. That sets up the unenviable task of deciding, amid a deadly pandemic, who is most vulnerable to the disease and who is most essential to inoculate quickly.

"People are a little uneasy about the government calling the shots here," NIH's Dr. Collins told a Senate panel earlier this month.

Experts will have to consider vulnerable populations like those in assisted-living facilities or prisons, people working in close quarters like meat packing plants and how to assess Americans with preexisting conditions.

The National Academy of Medicine hopes to have its recommendations publicly available in August or September.

A second panel of vaccine advisers for the Centers for Disease Control and Prevention -- the Advisory Committee on Immunization Practices (ACIP) -- is also coming up with a set of guidelines. It's still unclear whether the administration will select one set of recommendations over the other or take both into account when making its final decisions.

Last month, the ACIP convened electronically in a little-noticed meeting to discuss who counts as an essential worker, where teachers should fall in the priority list, vaccinations for pregnant women and whether race and ethnicity should factor into priority considerations.

"If we fail to address this issue of racial and ethnic groups as a high risk in prioritization, whatever comes out of our group will be looked at very suspiciously and with a lot of reservation," Dr. José Romero, the panel's chairman, said.

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

Dr. Matt Hepburn of Operation Warp Speed kicked off his presentation on coronavirus vaccine development by asking the panel to bear with his "lack of ability to provide a lot of specifics about what we're doing."

Minutes later, he insisted, "We're not this secretive organization that's working with unknown people and no one really understands what we're doing."

A senior official at the Department of Health and Human Services told CNN "we know there is a problem" when it comes to transparency around Operation Warp Speed.

"Transparency is the key to acceptance," the official said. "People need to believe in the safety and efficacy of these vaccines."

'A humongous task'

Vaccine experts are already knocking the Trump administration for peddling an unrealistic timeline to the American people.

"I think when people tell the public that there's going to be a vaccine by the end of 2020, for example, I think they do a grave disservice to the public," said Ken Frazier, the chief executive of pharmaceutical giant Merck, in a recent interview with Harvard Business School. "We don't have a great history of introducing vaccines quickly in the middle of a pandemic. We want to keep that in mind."

Spreading false hope and failing to come through is just one of the things that could further damage the public's trust.

"You can't give an optimistic message that the vaccine is going to be developed in December and then come December you don't have a vaccine. Then people are wondering what happened," said Vijay Samant, a vaccine expert who oversaw the production of three successful vaccines when he worked at Merck. "In the meantime, you know, they have given up social distancing in the assumption that the vaccine going to be developed in six months, and people are taken aback what's going on, they lose confidence."

Once a vaccine is available, it could still take six months to a year to vaccinate enough of the population to slow the spread.

"That's if you're lucky," Samant said.

The Trump administration is trying to streamline that process with Operation Warp Speed. It has partnered with vaccine developers to start manufacturing and stockpiling their drugs before safety trials are completed or the Food and Drug Administration has signed off on the vaccines.

"We are literally making the commercial scale vaccine now, as we're going through the clinical trials," Health and Human Services Secretary Alex Azar told CNBC Wednesday. "We're doing that at-risk, using the full power of the US government and our financial resources to do that. No one's ever done this before."

Once a vaccine is authorized, the goal is to roll it out immediately. By next year, the administration hopes to have roughly 300 million doses of the coronavirus vaccine available. Whichever vaccine becomes available will likely require an initial dose followed by a second booster shot, vaccine experts and suppliers said.

Once a vaccine is ready, it is still a tall order to get from the lab and into the arms of Americans. The US government is already shelling out hundreds of millions of dollars for supplies like glass vials and syringes.

"We -- right at the beginning of Operation Warp Speed -- worked to lock down fill-finish capacity, as well as syringes, needles and glassware, so we've secured that to be able to ensure that we'll be able to vaccinate the American people once we get vaccines that are demonstrated safe and effective to the FDA's gold standard of approval or authorization," Azar told CNBC.

While the Trump administration has awarded some contracts to suppliers with thin track records, others have gone to major manufacturers like Corning Inc.

"I think that the US has kind of set a bar and the rest of the world is following the model, quite closely actually," said Brendan Mosher, vice president and general manager for Corning Pharmaceutical Technologies.

"Glass won't be the critical bottleneck," Mosher said. "There will be plenty to go around at the point 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 manufacturer -- said the US is making progress in securing syringe supplies as well. But it may still fall short of the 700 to 800 million syringes it will need to provide vaccines.

"Our understanding is that this is a process, right? And the federal government is placing some initial orders with us and other manufacturers, but it is, I think, the beginning 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 it tells us is that we're taking the steps now in order to prepare for potentially a seasonal Covid vaccine much like we have for the flu," Woody said.

The CDC and Pentagon are working in tandem to deliver the vaccine across America, though they haven't offered many details about how they plan to do so.

"This is a big task, even if you have a vaccine, getting these people vaccinated is a humongous task, humongous task," vaccine expert Samant said. "Because you need to convince people."

'Are we the guinea pig?'

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

Administration officials have publicly hammered home assurances that the vaccine will be thoroughly tested to prove it's safe and effective. Still, a May CNN poll found fully 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 sorts of vaccines. Others are wary of the safety of the coronavirus vaccine in particular since it is being produced on an accelerated timeline. To others, the vaccine effort is colored by politics.

"You're seeing people who are commenting 'I can't trust anything Trump says.' You've got people on the opposite end of the spectrum saying, 'Unless he says it's OK, I'm not going to do it,'" said Emily Brunson, an associate professor at Texas State and co-author of a recent report on public trust issues around the coronavirus vaccine. "You're going to get people who are hesitant who are not normally vaccine hesitant."

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

"There's a lot of work that needs to be done in terms of making sure we that engage them earlier to gain their trust," Dzau of the National Academy of Medicine said. "There are two ways that people can look at it. One is, are we the guinea pig? Or, two, we should get it first because we are more at risk."

The Trump administration is already envisioning a communications campaign to try to win over Americans, a senior HHS official said. The effort is expected to include advertisements on TV, radio, digital and billboards.

Next month, the administration plans to begin filming one-minute spots that feature the administration's top scientists, including National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, Surgeon General Dr. Jerome Adams, CDC Director Dr. Robert Redfield and others. In the ads, the doctors will field socially distanced questions from celebrities, musicians and athletes about coronavirus concerns ranging from testing to therapeutics to a vaccine.

Experts say those efforts can't come soon enough.

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

"It is not a foregone conclusion it's going to go well," Schoch-Spana said. "And it's not a foregone conclusion it's going to go poorly."