Vaccination plan misses targets
Federal government strikes out on enormous goal thanks to poor planning and underfunded allies
After accomplishing the astonishing feat of funding, testing and approving highly effective vaccines against COVID-19 in less than a year, Operation Warp Speed has failed badly in its other main objective: vaccinating 20 million Americans by Jan. 1.
Two weeks into January, the federal government is a little more than halfway to the goal, a performance that has troubled health experts and jeopardized hopes of returning to some degree of normal life by summer, or even fall.
The benchmark of vaccinating 20 million by Jan. 1 “was critical to achieving herd immunity by the summer in the U.S,” said Rasmus Bech Hansen, founder and chief executive officer of London-based Airfinity, a company that gathers and analyzes global scientific data.
Numerous factors have put the U.S. behind schedule on vaccinations, including the unprecedented size of the task, the nation’s fragmented health care system, poor planning by federal and state officials and chronic underfunding of public health.
“In my view, we’re failing,” said James McDeavitt, senior vice president and dean of clinical affairs at the Baylor College of Medicine. “I don’t think that there is any community in the whole country that is vaccinating at a rate that will achieve herd immunity by the fall.
“At the current rate, we’re probably two and a half years from achieving herd immunity.”
Herd immunity occurs when so many people have become immune — whether through vaccination or prior illness — that the virus struggles to find new hosts to infect. In such a community, transmission from one person to another becomes unlikely.
There are many scientists, however, who believe the new coronavirus is already endemic, meaning that it has established itself forever in humans, as influenza has done. If true, nations may be compelled to accept a less stringent view of herd immunity.
“The way to think about this is that our vision of the end game is something close to influenza,” Hansen said. “You need a vaccine or a booster every year.”
Flu seasons vary widely in severity. Since 2010, flu deaths in the U.S. have ranged from 12,000 to 61,000 per year.
“Flu is a big killer,” said Matt Linley, a senior analyst at Airfinity, “but life still goes back to normal.”
That is a long way from where we stand with COVID-19.
In the year since the new coronavirus invaded the U.S., it has caused more than 385,000 deaths. And the numbers aren’t declining; they’re soaring.
Four months ago, roughly 1,000 Americans were dying each day from COVID-19. Twice this month, on Jan. 7 and Jan. 14, the daily death count has exceeded 4,000.
“We have a historic surge of the virus and we have a large vaccination campaign getting underway. The sad reality is that those are separate challenges,” said McDeavitt, stressing the need for continued maskwearing and social distancing.
“I don’t see any scenario in which vaccinations get us out of the current surge.”
Campaign requires wartime logistics
The disappointing start to the vaccination campaign may have begun with an unrealistic goal that masked the enormity of the task.
Vaccinating 20 million Americans by Jan. 1 was an “aspirational goal, and aspirational in a political setting,” explained Gregory Poland, director of Mayo Clinic’s Vaccine Research Group and a member of the national Working Group on Readying Populations for COVID-19 Vaccines.
Operation Warp Speed set its targets in the heat of a bitter presidential election.
Poland said organizing and carrying out a campaign of this scale is “like wartime logistics,” and depends on smooth coordination between the federal government, states and thousands of county and municipal health departments.
“So every snafu you can imagine has, is or will happen,” he said. “You’re trying to build an airplane as you’re flying and getting shot at in the midst of a war.”
At present, America’s vaccination rate of 3.6% exceeds that of most countries, but it lags far behind Israel (24%), a much smaller country with more centralized health care than the U.S. Other nations that also lead the U.S. in vaccinations are the United Arab Emirates (14%), Bahrain (7.4%) and the United Kingdom (5%).
Federal vaccination guidance changed this week when Alex Azar, U.S. secretary of Health and Human Services, urged states to proceed to vaccinating all adults 65 and older and anyone with serious underlying health conditions. Up to now, vaccinations have been limited in this phase of the campaign to health care workers and residents in assisted living facilities.
But it is unclear whether the change will speed up the process.
“Potentially. Having a less restrictive plan should help the rollout of doses, if clinics are ready to vaccinate people,” said Hansen, at Airfinity. “It is still not fully clear what is causing the lack of doses being administered.”
Jeff Duchin, the King County health officer in Washington state, is not optimistic about the impact of Azar’s announcement.
“It’s not going to allow us to catch up,” said Duchin. “The problem was there wasn’t enough vaccine and the vaccine delivery systems weren’t mature enough. I think it will create an initial demand that can’t be met.”
On Friday, The Washington Post reported that although Azar had pledged that the federal government would release doses being held for second shots, there are no such doses at present.
Under the current system, the federal government informs each state how many doses are allocated for the following week. The states place their orders, based on the needs of vaccinators — those actually putting the vaccine into people’s arms. However, states are warned that their orders may not come all at once but in shipments over several days.
Distribution is further complicated by the different shipping and handling requirements; the Moderna vaccine is frozen at minus 20 Celsius, while the Pfizer vaccine must be kept at minus 70.
While the Moderna shipments go straight to providers, Pfizer ships its doses to 16 Wisconsin distribution hubs, where they are broken into smaller amounts and sent to “spoke” locations throughout the state.
Failure to learn lessons from swine flu
The largest vaccination campaign in American history should have started on sounder footing, given that the nation has had a decade to learn from its mistakes during the 2009 swine flu pandemic.
“We are failing the same test twice,” Duchin said. The U.S., which suffered 12,500 deaths from swine flu, launched a major vaccination campaign late in 2009. About 61 million Americans — a little under 20% of the population — were vaccinated in the first three months, according to a report by the Institute of Medicine, a nonprofit, nongovernmental organization.
“We did not adequately learn the lessons of the swine flu campaign,” said Duchin. “We knew local and state health departments are extremely challenged to run a new mass immunization program. We knew that racial and ethnic disparities would mean that some communities would experience a disproportionate impact from COVID-19.
“We knew there would be misperceptions about vaccine safety. We knew there were a lot of rumors about inadequate safety testing. We knew there were risks to inappropriately raising expectations.”
As they responded to swine flu, local public health leaders learned, too, that federal stimulus money “doesn’t appear spontaneously ... and it’s not proportional to the magnitude of the need,” Duchin said.
When local and state health departments went to carry out the swine flu vaccination campaign, they found that decades of underfunding had left them illequipped.
Duchin said mass vaccinations require workers to plan the campaign, track who has been vaccinated and who hasn’t, staff call centers to answer questions from the public and meet with groups that are hesitant to embrace vaccines.
Even the actual vaccinations require a sizable staff: people to administer the shots, register the vaccinated, monitor each one for side effects for 30 minutes after the shot, schedule second visits and perform numerous other tasks.
“The federal government abdicated its responsibility to provide states with the resources to run a large scale, complex vaccination campaign,” Duchin said, referring to both swine flu and COVID-19. With COVID, however, states have needed the federal help much more, due to the severity of the disease and the magnitude of the immunization program.
Throughout the COVID-19 crisis, health experts have criticized the federal government for failing to coordinate the response and leaving states to fend for themselves, even for basic medical supplies.
Rob Davidson, an emergency room doctor in Michigan and executive director of the nonprofit Committee to Protect Medicare, put it this way: “In our country, the federal government basically said, ‘We got the vaccine developed, now it’s up to the states. You figure it out.’ “
Constantly asking: ‘What’s going on?’
The COVID vaccination campaign has also been plagued by what health experts call the “last mile problem.”
“A lot of us who work in the field say that vaccines don’t save lives, vaccinations do,” explained Claire Hannan, executive director of the Association of Immunization Managers. “That last mile of getting the vaccine into people’s arms is key.”
From the beginning, Hannan said, federal health leaders failed to communicate a clear vision of how the process would work, how vaccine shipments from manufacturers would proceed to the people waiting to be immunized.
She cautioned, however, that vaccination numbers posted by the Centers for Disease Control and Prevention are days out of date and therefore paint an overly grim picture of the progress being made.
In Wisconsin, the lack of guidance from the federal government continued at the state level, according to former Milwaukee Commissioner of Health Jeanette Kowalik, who left in late September to direct policy development for the nonpartisan Trust for America’s Health in Washington, D.C.
“The CDC would issue things and they would be so vague,” she said. “Normally we would get a tool kit. We were left to fend for ourselves and that’s why there was so much confusion.”
State, county and local officials often spoke daily, sometimes several times a day, as part of a Unified Emergency Operation Center.
“The state was on all of those calls. We would always say, ‘What’s going on?’ and they would say, ‘Well, we’re working on it,’ “Kowalik explained.
“At some point there needs to be some decisionmaking and leadership.”
She said the city sometimes could not wait for state guidance and had to “call audibles.”
The Wisconsin Department of Health Services said Friday it has provided daily email updates and held regular forums for local and tribal health departments, and is always available for questions.
Around the country, interviews with health officials show that sometimes vague messages sent from the highest levels of the federal government trickled down to the states, the communities and even the institutions administering the shots.
In Pennsylvania, the University of Pittsburgh Medical Center, a major vaccination center, has struggled with planning because organizers get little advance notice of how many doses they are receiving.
“As we’ve pivoted toward giving shots to non-UPMC employees, I’m not able to forecast how much vaccine doses we will have in the next week, two weeks, three weeks,” said Graham Snyder, who is co-leader of the vaccine rollout at UPMC, which has over 90,000 employees.
“What they give us is unknown until we get it.” McDeavitt has encountered similar uncertainty at Baylor College of Medicine in Houston. He has 63,000 patients waiting to be immunized in Phase 1b of the process but has only received 4,000 doses. On Monday he learned he would not be getting any doses the following week.
“We neglected to solve the problem of the last mile,” McDeavitt said. “It’s as if we had a fabulous set of power plants built that were clean and efficient and produce lots of electricity, and we built a great electrical grid.
“What we neglected to do is string up the wires to people’s homes.”
Some optimism going forward
The transition team for President-elect Joe Biden has been briefed on the early problems with the vaccination campaign, according to Julie Morita, one of 15 experts tasked with the job on the COVID-19 Advisory Board.
“This is the biggest health emergency we’ve experienced in a century,” she said, explaining that there was relatively little time to prepare plans tailored to the vaccines that were first to receive emergency use authorization from the federal government.
Another part of the problem, she said, is that some of the work on vaccinations was delegated to underfunded and understaffed local health departments that were already swamped with contact tracing and other pandemic duties.
However, Morita said there is reason for optimism, including the president-elect’s stated commitment to vaccinating 100 million Americans in his first 100 days in office.
“I think we are seeing a trend that the vaccine is being administered more rapidly,” she said. “Resources are beginning to flow.”
Vaccine acceptance, at least among health care workers, may be another cause for optimism.
So far the acceptance rate has been between 75% and 80% at UPMC, Snyder said, adding, “That’s better than I had expected.”
How many will be vaccinated?
From the start, the new coronavirus has posed a unique challenge to science and medicine, and the vaccination campaign is proceeding despite some key unknowns.
Although the CDC is tracking the number of people who receive the vaccine, no one knows how many Americans have attained immunity already through previous infection. Because the virus produces symptoms in some people but not in others, it is impossible to calculate the total number who have immunity. Nor is it clear how long a person is immune after contracting the virus and fighting it off.
Also, the vaccines that have been approved prevent severe illness caused by COVID-19. Scientists do not know if they actually prevent transmission of the virus.
That means a person who has been vaccinated may be able to get the virus without experiencing symptoms and transmit it to others.
Finally, serious questions remain about how many Americans outside the medical community and longterm care facilities will decide to get immunized.
A national survey published in December by the Pew Research Center found 60% of Americans “definitely or probably” planned to get vaccinated. The percentage had risen from 51% in September.
A Kaiser Family Foundation poll released later in December found 71% of Americans were planning to get vaccinated.
Vaccine acceptance appears to be much higher in other countries, according to a recent preprint that has yet to be peer-reviewed or published.
The preprint, written by a doctor at Jordan University Hospital in Amman, quoted acceptance rates for the COVID-19 vaccine of 97% in Ecuador, 94% in Malaysia, 93% in Indonesia and 91% in China.
Estimates about the vaccination rate necessary to achieve herd immunity vary.
Rasmus Bech Hansen, at Airfinity, said that when the infectivity of the virus and the effectiveness of the vaccines are taken into account, a 75% vaccination rate would probably be sufficient to reach herd immunity. Hansen added a caveat.
Discovery of the new, more transmissible version of the virus in the United Kingdom and elsewhere may raise the required vaccination level for herd immunity to about 80%.