Initial supplies of any successful coronavirus vaccines are now expected to fall short of what is needed even for high-priority groups like health-care workers, forcing drugmakers and U.S. officials to grapple with the thorny question of who should be first in line.
Public-health officials estimate more than 100 million Americans, including doctors and nurses, other essential workers and nursing-home residents, should get vaccinated before the general public because they are at greater risk of exposure to the virus or of contracting more severe Covid-19 disease. They were widely expected to get the first supplies after a vaccine is cleared.
Yet initial supplies now look like they will cover only a fraction of the high-priority groups, if a vaccine clears testing and is authorized in the fall.
There may be 10 million to 20 million doses available at first, according to a slide presentation prepared by the U.S. Centers for Disease Control and Prevention staff and shown to a committee of outside vaccine advisers last week. A Trump administration official gave a roughly similar estimate during a call with reporters last week, too.
“Given the initial anticipated supply, not all groups that are deemed a priority will be able to be vaccinated at once,” Dr. Sarah Mbaeyi, a CDC medical officer, said during the presentation to the vaccine advisers.
The limited initial reserve is forcing U.S. health officials and their advisers to make hard choices about who should get vaccinated first. It could mean prioritizing staff at hospital emergency departments and intensive-care units over health-care workers who have less interaction with the sickest patients, the officials and their advisers say.
They are also weighing how high to prioritize people who work outside of health care but in important jobs like those in the food supply chain.
“There have been heartfelt discussions about this,” said William Schaffner, professor of preventive medicine and infectious-disease at Vanderbilt University Medical Center. He serves on a liaison group advising the CDC vaccine committee about coronavirus vaccines.
The deliberations come amid uncertainty over who has the final say on prioritization and distribution of coronavirus vaccines, as a number of different agencies and committees pursue plans at the same time.
There isn’t an approved vaccine against the new coronavirus. Companies including AstraZeneca PLC, Pfizer Inc. and Moderna Inc. have started large clinical trials of their candidates. Positive data from the studies could lead to vaccines getting a green light for U.S. use as early as October, companies say.
The companies say they are ramping up manufacturing to eventually produce hundreds of millions of doses, but that bigger supply is unlikely to kick in until next year.
Moderna says it could have millions of doses later this year, and expand to as much as one billion doses next year. Likewise, Pfizer, which is collaborating with BioNTech SE on a vaccine, plans to make up to 100 million doses globally by the end of 2020, and more than 1.3 billion doses by the end of 2021.
AstraZeneca, which is partnering with the University of Oxford, has agreed to deliver at least 300 million doses of a vaccine to the U.S. under a $1.2 billion federal funding deal, with initial supplies as soon as October.
The U.S. hasn’t settled on a plan for distributing vaccines, according to industry officials and government advisers. Nor is it clear who has final say on the plan, including which people get vaccinated first.
Several drugmakers say they will likely defer prioritization decisions to government officials, particularly if the U.S. grants emergency-use authorizations to any vaccines, though drugmakers may make recommendations.
“What we advocate as a company is to focus on the highest-risk people first, which are first of all the health-care workers who need to work day in, day out with people coming in, at risk of their own health or sometimes life,” Johnson & Johnson Chief Scientific Officer Paul Stoffels said in an interview.
Older adults and people with heart conditions and other health risks should also be prioritized, he added.
Novavax Inc. Chief Executive Stanley Erck said he expects the most difficult allocation decisions will be in the first six to nine months of vaccine availability, but then supplies should begin to catch up to the broader population.
The CDC’s vaccine committee typically makes recommendations about who should get vaccinated, and is working on a plan for coronavirus vaccines. The CDC has conducted focus group sessions to gauge public support for various options, which have indicated overwhelming support for prioritizing health-care workers, essential workers and high-risk populations, Dr. Mbaeyi said.
Yet the heads of the CDC and the National Institutes of Health asked the National Academies of Sciences, Engineering and Medicine last month to form a separate committee that will draw up a plan for equitable allocation of vaccine doses.
Meanwhile, the Trump administration has formed an initiative called Operation Warp Speed to provide federal funding that accelerates the testing, manufacturing and delivery of vaccines. Officials involved in that effort also are deliberating over who should get priority, an administration official said.
In June, Beth Bell, a global-health professor at the University of Washington who is a member of the CDC’s vaccine committee, asked Operation Warp Speed’s Matt Hepburn during a virtual committee hearing last month to include the committee in any decisions about coronavirus vaccine prioritization and distribution.
Dr. Bell said the vaccine committee has been in existence for decades, while Operation Warp Speed is a new organization. The vaccine committee “has developed a very well-oiled and highly respected process” of making recommendations based on scientific evidence, she said. Dr. Hepburn, an infectious-disease doctor retired from the U.S. Army, responded that he wanted to continue the dialogue.
“The way that vaccines have been distributed in similar circumstances in the past has been through the CDC,” said Dr. Schaffner, the Vanderbilt infectious-disease specialist who advises the health agency. “That’s a mechanism everyone in public health understands. Is this going to be an entirely different mechanism?”
The Food and Drug Administration may specify which groups get priority if it grants an emergency use authorization for a vaccine. The FDA, for instance, granted an emergency use authorization for a Covid-19 treatment, Gilead Sciences Inc.’s remdesivir, but specified that it must be used for hospitalized patients, not those outside of hospitals.
Another factor that could influence who gets vaccinated first is whether studies show that a vaccine works particularly well in one group of patients, or not so well in another group. For instance, if a vaccine is shown to be protective in the elderly, they may get high priority because older people are at higher risk of severe disease.