No matter how well-prepared we are, there won’t immediately be enough coronavirus vaccine to immunize all Americans. Choices will have to be made about who goes to the front of the line.
“It’s inevitable that the vaccine will come out more slowly than we like. We’re not going to have 350 million doses delivered day one,” said Andrew Pavia, chief of pediatric infectious diseases at the University of Utah in Salt Lake City.
To be most protective, a list of the first to be immunized must be carefully crafted based on what type of vaccine may become available, who it works best for and whether the disease is still raging.
Since 1964, the United States has relied on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to make those decisions. As soon as the Food and Drug Administration licenses a new vaccine, ACIP offers guidelines on how it should be distributed, to whom and when.
The World Health Organization has a similar group, the Strategic Advisory Group of Experts on Immunization.
ACIP already has begun working on a plan for SARS-CoV-2, the virus that causes COVID-19. The WHO group began its process last week.
“We’re starting as early as we can to deal with the torrent of data that’s coming out," said Dr. Grace Lee, a professor of pediatrics at Stanford University School of Medicine and current ACIP member. "We don’t want to wait until the vaccine becomes available and begin our deliberations then.”
Typically, ACIP’s guidelines would be used without question. That became slightly less clear on Friday with the announcement of a White House initiative called Operation Warp Speed.
In a news conference in the Rose Garden, President Trump said the initiative would create a group of experts and bring together the CDC, National Institutes of Health, the Food and Drug Administration and the U.S. military to work at “record speed” to find, test, manufacture and distribute a vaccine.
Moncef Slaoui, a former pharmaceutical executive who Trump named to head Operation Warp Speed, said early clinical trial data from at least one vaccine candidate made him confident “we will be able to deliver a few hundred million doses of vaccine by the end of 2020. We will do the best we can to do that.”
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Vaccine experts have consistently urged caution in presuming a vaccine will be available soon. The White House Coronavirus Task Force's Dr. Anthony Fauci has said while a vaccine is likely within the next year or two, the process takes time. Securing a vaccine quickly would require everything falling exactly into place, the director of the National Institute for Allergy and Infectious Diseases has said.
"You can rush vaccine development but only when you understand – there’s no way around it – you are trading safety for speed, said Dr. Greg Poland, director of the Mayo Clinic's Vaccine Research Group.
Few details of how coordination within Operation Warp Speed would work were provided and it is unclear what role it will play in vaccine allocation. An unnamed government official involved with the initiative told CNN earlier this month one of the tasks of the new group is to determine who gets the first doses.
The CDC referred inquiries about how the two groups would work together to the White House. The White House did not respond to a request for clarification.
Vaccine experts have spent years considering the best and most effective way to dole out immunizations. ACIP has clear and transparent guidelines on how to conduct the process available on its website, and all its meetings in which it votes on vaccine recommendations are public and webcast. The next is on June 24.
Discussions center on balancing protection for the largest number of people with protecting the most vulnerable.
“If I’ve only got 30 million doses for the next year and I’ve got a population of 350 million, who do I assign propriety to?” said Dr. Arthur Reingold, division head of epidemiology and biostatistics at the University of California at Berkeley and an internationally recognized expert on infectious disease.
Health care providers, first responders, the military, political leaders, the elderly, pregnant women and children are generally put at the front of the line, depending on the disease and the vaccine, said Reingold, who served on ACIP for many years.
“All kinds of ethicists are brought to the table,” he said.
Another approach to control an epidemic is to focus on hot spots where a disease is spreading and there are high transmission rates.
"You would rush vaccine to the area, open your clinics and try to get a large proportion of the population vaccinated quickly," said Pavia.
For SARS-CoV-2, the devil is in the details because so much remains unknown about who it affects and how.
Vaccines differ. One may be best for healthy adults, another better for children, and a third most effective for the elderly or those with preexisting medical conditions. ACIP reviews all the data and recommends who should get which vaccines and, if there are shortages, who should go first.
In the case of the new coronavirus, data might show while the elderly are severely affected by COVID-19 immunizing their caregivers could better protect them, depending on how effective the vaccine is for different ages.
“We think about who’s at risk for being exposed, who suffers the worst complications and which population provides the highest benefit due to herd immunity,” said Lee.
Herd immunity is when enough people in the population have been infected and developed immunity to the virus it can no longer spread freely. Scientists' models estimate 65% of the population needs to be immune to establish such immunity and stop the spread of the disease.
So far, infection rates alone are nowhere near high enough to create such herd immunity. While a national infection in the United States has not yet been determined, in France, an estimated 4.4% of the population is believed to have been infected with the disease as of May 11, according to a paper in the journal Science.
Whoever determines who gets inoculated first, public health experts say past experience shows the best medical conclusion isn’t always the best solution.
During a shortage of flu vaccine in 2004 it was decided that the elderly, who were at high risk, should get vaccinated first. It turned out they didn’t want it.
“They said, ‘I’d rather my grandchildren receive the vaccine,’” said Dr. William Schaffner, a professor in the division of infectious disease at Vanderbilt University in Nashville, Tennessee.
After health care workers and first responders are immunized, Schaffner suggested simply making a vaccine available on a first-come, first-served basis.
“Vaccine left in the refrigerator never protected anyone from anything,” he said.
Some health care professionals say Americans need to be part of the conversation about how any coming coronavirus vaccine should be doled out.
“We need to engage with the public now. You’ve got to consider public values,” said Daniel Salmon, a professor of international health who directs the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health. “It’s not all about what the scientists think.”