Ryan Gabrielson

Counties at highest risk for COVID harm often have lowest vaccination rates

As the U.S. rushes to vaccinate its population against the coronavirus, most counties with the sickest residents are lagging behind and making only incremental progress reaching their most vulnerable populations.

A ProPublica analysis of county data maintained by the U.S. Centers for Disease Control and Prevention shows that early attempts to prioritize people with chronic illnesses like heart disease, diabetes and obesity have faltered. At the same time, healthier — and often wealthier — counties moved faster in vaccinating residents, especially those 65 and older. (Seniors are a more reliable measure of vaccination progress than younger adults, who are less likely to have been eligible long enough to receive their second shots.) Counties with high levels of chronic illnesses or "comorbidities" had, on average, immunized 57% of their seniors by April 25, compared to 65% of seniors in counties with the lowest comorbidity risk.

A similar gap has also opened for all other adults. The one-third of counties with the highest chronic illness risk have on average finished shots for 15% of their 64-and-under residents, four percentage points below the average for the healthiest one-third of counties.

In counties with high rates of chronic disease, residents are more likely to die prematurely from heart or pulmonary diseases, diabetes or illnesses related to smoking or obesity. Those conditions also increase a person's risk of developing severe COVID-19.

People with chronic illnesses are especially important to vaccinate because their coronavirus infections are more likely to end in hospitalization and death, said Janet Baseman, an epidemiology professor at the University of Washington. If counties with high comorbidities remain behind, she said, "then we are not accomplishing our objective, as communities or as a nation, of saving lives."

In the four months since public vaccinations began, clear disparities have emerged in how quickly the richest and poorest counties have delivered shots to their residents. Multiple health experts and officials say the numbers underscore a key strategic misstep under the Trump administration, which asked state and local governments to prioritize people with illnesses that would increase their chances of hospitalization or death, but provided no additional funding to support the efforts.

Many states chose a simpler approach, opening vaccine appointments to everyone 65 and older with minimal on-the-ground outreach to people with chronic illnesses. "It made some states go a little bit faster," said Dr. Grace Lee, a member of the CDC's Advisory Committee on Immunization Practices and an infectious diseases physician at Stanford Children's Health. "But I think it really increased the inequities early on."

When vaccinations started in December and January for the general population, the federal Department of Health and Human Services distributed free doses and supplies, but almost no money or staffing to administer the shots. State and local health officials had to decide who would first be eligible for the small amounts of vaccine then available and how to get doses into arms. They also had to watch for interlopers — many of them young, white and from other locations — who booked appointments they didn't qualify for.

In counties with more chronic illness, identifying the neighborhoods and housing complexes where residents or critical workers most need the shots — and then actually getting them to accept vaccinations — can be complicated, time-consuming work. Health officials in several counties with high rates of chronic illness said they are making slow progress by focusing resources on small events and mobile teams instead of on sprawling mass vaccination sites.

ProPublica focused on comorbidities because they are directly related to increased risk of developing severe COVID-19. People with lower incomes are more likely to have comorbidities; urban counties with high average incomes tend to have fully immunized a larger share of their older residents than other counties. In addition to income, the analysis looked at the urban and rural divide, age demographics and differences between states' overall vaccination rates.

While communities of color have disproportionately high rates of chronic illness nationally, the analysis found no relationship between counties' racial demographics and coronavirus vaccination rates.

The rollout has largely relied less on government outreach than on individual initiative. People with flexible schedules, transportation and regular access to the health care system have been better able to get appointments on their own or with help from family and friends. Those with less support have fallen behind.

Separately, surveys by the CDC last year indicated that adults with underlying medical conditions were less interested in getting the vaccine than healthier adults. People surveyed who said they were unlikely to get vaccinated most often cited concerns about side effects and safety.

To date, more than 98 million people in the U.S. — including 37 million seniors — are fully vaccinated against the coronavirus, while another 150 million adults have yet to receive a shot. During an address to a joint session of Congress on Wednesday, President Joe Biden heralded the vaccination effort as "one of the greatest logistical achievements" in the country's history.

The push continues even as demand for shots appears to be declining, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Providers injected more than 21.7 million doses during the second week of April, according to CDC data, as the supply of vaccines from Pfizer, Moderna and Johnson & Johnson increased significantly. That number declined to 19.2 million shots the next week, and preliminary figures indicate immunizations dropped even more sharply last week. (Federal authorities temporarily paused use of the Johnson & Johnson vaccine for 10 days to study a small number of blood clot cases potentially related to the shot. It has since been cleared for use.)

There probably aren't yet enough fully vaccinated people in the U.S. to protect against another surge, Osterholm said, especially with the more transmissible coronavirus variants now prevalent. In Michigan, new cases again soared in April, setting records for daily COVID-19 hospitalizations.

"We're not out of the woods yet in this country," Osterholm said. "What happened in Michigan could still happen in a number of other states out there. Even with the level of vaccination they've had and the previous infections, look what still happened."

Reaching the most vulnerable has been a top concern for many of the poorest cities and counties since vaccinations began.

In Baltimore, COVID-19 caused far more severe illness and death in the majority-Black city's communities of color, where people with chronic illnesses are more common, according to Dr. Letitia Dzirasa, the city health commissioner. During the first month of the vaccine rollout, the Baltimore health department realized it needed different tactics for immunizing its seniors.

The city of Baltimore has the highest rates of diabetes, smoking and obesity of the seven counties in its metro area, and its premature death rate is nearly double that of its neighboring counties, data from the National Institute of Environmental Health Sciences shows. It ranks among the nation's most at-risk jurisdictions from chronic illness. Other parts of the region, like the more affluent nearby Howard County, are among the healthiest.

CDC data shows just 55% of Baltimore City's seniors were fully vaccinated as of April 25, 15 percentage points lower than the rate for residents 65 and older in larger Baltimore County, which surrounds the city.

Within Baltimore, Dzirasa said, the pandemic hit hardest in Black neighborhoods on the city's east and west sides, where residents have long struggled against discrimination, poverty and chronic illnesses. "Unfortunately, we've seen the same thing again with vaccination rates," she said.

The city health department knew that many of its most vulnerable seniors would have no transportation to vaccination sites, and that their senior living centers were less likely than facilities in wealthier communities to have relationships with pharmacies to secure doses.

In January, Dzirasa said, her staff partnered with hospitals and pharmacies to create mobile vaccine teams that could deliver shots directly to those most at risk of severe COVID-19.

The first step was to win residents' trust with visits to centers from community health workers, who explained the vaccines, provided reassurance and scheduled appointments. The teams identified 117 senior living centers and have immunized residents one by one at almost every facility over the past three months.

"It's definitely a slower approach," Dzirasa said. "At these events, we're doing anywhere from 75 to 150 people, tops."

Baltimore has multiple mass vaccination sites that can each provide from hundreds to thousands of shots a day. A couple of months ago, all site appointments were booked, and ineligible people had to be weeded out, Dzirasa said. Now, those spots are increasingly unfilled, and Dzirasa expects gradual progress going forward.

The disparity in vaccination rates between counties with high rates of chronic illness and the rest of the country is partly the result of the Trump administration's decision not to invest federal dollars in vaccine sites at the beginning, argues Lee.

"They launched this massive campaign and were like, 'Good luck, you're on your own,'" Lee said. "And not only do you have to deliver a very complicated series of vaccines, but on top of that we expect you to address inequities, all without any additional support."

The Biden administration set up several mass vaccination sites in high-risk communities in February and has now sent federal workers, equipment or funds to operate more than 400 vaccination sites nationwide. But many counties with high rates of comorbidity are still working to make up for a slow start.

The winter COVID-19 surge was peaking when vaccine doses started to arrive in Wyandotte County, part of Kansas City's urban core. Small deliveries containing about 2,000 doses arrived each week from the federal government, said Dr. Erin Corriveau, the county's deputy medical officer.

At first, only health care workers and nursing home residents qualified to be vaccinated. Then, on Jan. 21, Kansas Gov. Laura Kelly opened eligibility to everyone 65 and older, including more than 20,000 seniors in Wyandotte County.

"We're going, 'Oh my God, that's a huge number of people,'" Corriveau recalled. The county decided to set its own eligibility rules, since it was still receiving just 2,000 doses a week.

Most new COVID-19 cases at the time were young adults. To help drive down case numbers, Corriveau said, the county temporarily narrowed eligibility to just residents 85 and older while adding critical workers whose jobs exposed them to greater infection risk.

Wyandotte County opened the shots to all seniors a few weeks later as case numbers dropped. But the demand for shots was modest, Corriveau said, especially compared to the clamor in other parts of the country, where older Americans struggled to find providers with available doses.

The county now runs three mass vaccination sites located on bus routes, with assistance from the Federal Emergency Management Agency. It keeps pharmacies stocked with vaccines, and dispatches "drop teams" to administer shots at small neighborhood operations. Doses are plentiful, but willing recipients are scarce. Corriveau said many of the county's seniors are wary about the vaccines' safety and have been unwilling to get the shots at large, impersonal sites.

"We've tried to make this vaccine as available as humanly possible," she said. "We're incentivizing vaccines with giveaways and food boxes and we're doing Saturday hours and expanding our evening hours."

Despite those efforts, only 56% of seniors in Wyandotte County were fully vaccinated as of April 25. A few miles south, in Johnson County, more than 83% were immunized.

The neighboring jurisdictions have little in common with each other. Wyandotte, meanwhile, stands out as being more diverse, with residents who suffer from far more chronic illness. Wyandotte's rate of premature death is double Johnson's rate, according to NIH data.

Tami Gurley, associate professor of population health at the University of Kansas Medical Center, said Johnson County has longstanding advantages that likely helped its residents get vaccinated so quickly.

"You have people with time, who can get on computers and sign up for multiple lists," Gurley said. "They all have their own transportation, nobody's relying on public transportation, it's all private cars out here."

The university medical center where Gurley works is located in Wyandotte and cares for its residents, she said. But many of its health workers live in other parts of Kansas City, including Johnson County. "That is where the doctors live, and the professors, and the people who tend to be more pro-vaccine to start with," she said.

Wyandotte's health officials are trying to reassure residents that the shots are safe and that communities of color can trust the county health department. "Frankly, there have been major, major issues of trust," Corriveau said of residents' view of local agencies, "which are warranted."

She and her colleagues are increasingly asking trusted community leaders to stand in for epidemiologists. Throughout the pandemic, Rev. Tony Carter, Jr., senior pastor of Salem Missionary Baptist Church, has encouraged his congregation to test for the virus, follow health protocols and, in recent months, get vaccinated.

Carter's church volunteered to host a Saturday neighborhood vaccine event on April 17, and nearly 50 people signed up for appointments to get the Johnson & Johnson shot. But several days before the event, federal authorities paused use of that vaccine as they investigated six cases of serious blood clots among the 6.8 million people who had received it. (The U.S. resumed use of the Johnson & Johnson vaccine without limitations on April 23.)

The county switched to another vaccine, but half of the recipients canceled their appointments. Carter reassured his congregants that the vaccine would offer a way of eventually reuniting with family. About two dozen people kept their appointments and received their first vaccine dose. "Most of those people stayed because of their connection to the church," he said.

How many vaccine shots go to waste? Several states aren't even counting

ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.

As reports emerge across the country of health facilities throwing out unused and spoiled COVID-19 vaccines, some state governments are failing to track the wastage as required by the Centers for Disease Control and Prevention, leaving officials coordinating immunization efforts blind to exactly how many of the precious, limited doses are going into the trash and why.

In Washington, a health facility allegedly threw out some COVID-19 vaccine doses at the end of workers' shifts because staff believed state guidelines blocked them from giving unused shots to people below the top priority tier. In Maryland, workers appear to have tossed thawed doses when they ran out of time to administer them safely. How many doses, exactly, have been wasted in those states is unknown because neither state is tracking unused or wasted vaccines.

In Indiana, where hospitals have told the media about discarding some shots, the state Health Department said it requires wastage to be reported but wasn't able to tell ProPublica how many doses have been tossed statewide. Nonetheless, it asserted that “wastage has been minimal."

Experts say that waste reporting is essential during a vaccination campaign to encourage careful handling and the use of every viable dose and, more importantly, to identify potential problems in the shipping and cold storage operations. With inconsistent reporting requirements and no enforcement of a federal mandate to report wastage, vaccine providers have little incentive to acknowledge wasting vaccines, said Dr. Ashish Jha, dean of the School of Public Health at Brown University.

Jha said he thinks that the true number of wasted doses across the country is far higher than a handful. After he detailed one anecdote he heard about an ER physician forced to waste vaccine doses in a thread on Twitter, his phone quickly filled with more than a dozen messages from other medical workers, confirming what he suspected: At a time when the U.S. is desperately short on vaccines, a significant number of doses are ending up in the trash.

Clinics and hospitals have “gotten slammed" when the media has learned of them wasting even a few doses, he said. “And the signal to everybody else is, if you have waste, don't report it. Because if you do, you're gonna get into a lot of trouble. That combination means, at least in my assessment, there's a lot of waste and a lot of underreporting of that waste."

The CDC requires all organizations that administer the vaccine to report the number of vaccine doses “that were unused, spoiled, expired, or wasted as required by the relevant jurisdiction." The CDC also asked states to describe their wastage monitoring method during the distribution planning process.

Vaccine providers, such as pharmacies and hospitals, are supposed to provide data on wasted doses to their state health agencies, which then send the information to the CDC. Like many parts of the vaccine rollout, that has not gone according to plan. State by state, ProPublica found, reporting requirements vary and are not reliably communicated to vaccine providers. Even when the rules are clear, they are not regularly enforced, nor are numbers reported to the public.

Maryland's Hospital Association said wastage data “is not systematically collected," while the state's Health Department said that “unless they are reported to us, MDH does not track specific instances of accidental vaccine wastage at the local level."A Washington State Health Department spokesperson said that the state “does not systematically capture wasted dose information." The spokesperson added that providers are encouraged to use up all of the shots they receive and that “if a provider doesn't have enough qualifying employees under" the top priority group, “they can help vaccinate workers

who aren't receiving vaccine directly from their employers."

Michigan's Department of Health and Human Services said, “We have not asked that vaccine providers report this data," though it said that 10 wasted doses had been reported to it as of Jan. 13.In some cases, states said they were aware of specific instances of wastage. New Jersey said that it was “aware of 16 vials that had to be discarded because they arrived broken when the boxes were open."

While a spokesperson noted that providers are instructed to give vaccines to people on waitlists to minimize the chances of vaccine being discarded, the spokesperson didn't respond to questions about whether providers were mandated to report wasted doses.

Other states do have wastage reporting mandates. Pennsylvania, for example, said it requires providers to report any doses that are received and are not able to be used and was able to give a percentage — 0.1% of doses received for injections as of Jan. 11 — that had to be disposed of. “The majority of discarded vaccine is related to vials broken in handling and syringe issues, such as bent or broken needles or clients refusing after the vaccine dose was drawn," said Department of Health spokesman Barry Ciccocioppo.

Colorado also said that waste is being tracked. “The state is aware that Pueblo Local Public Health rendered 300 doses of the Pfizer vaccine unusable after a portable vaccine storage unit malfunction," a spokesperson from the state's Joint Information Center said. “The state's goal is to use every single available vaccine, acknowledging that emergencies may occur infrequently in the distribution process."

In every mass vaccination effort, some share of doses unavoidably goes into the trash rather than arms. However, data on wasted shots — especially in large quantities — is an essential tool for federal and state health agencies trying to spot problems in how the vaccine is being shipped, stored and given to the public.

State vaccine officials monitor wastage numbers to determine if providers are mishandling shipments or improperly maintaining the temperature of their vials, said Dr. Kelly Moore, deputy director of the Immunization Action Coalition and former head of Tennessee's immunization program. "Are they tracking things and responding appropriately, if you're seeing extremely low wastage rates and everything is always perfect?" Moore said. "When things look too good to be true, they usually are."

The two vaccines currently authorized, made by Moderna and Pfizer-BioNTech, both must be used within six hours of leaving cold storage, reaching room temperature and being opened. If there are no-shows for vaccination appointments, pharmacists have to quickly find replacements before the thawed vaccines expire.

Complicating the count is the fact that the number of doses available in a vial sometimes exceeds the amount prescribed on the label — pharmacists have commonly found that they can squeeze a sixth dose out of Pfizer's vials, even though they are labeled as containing five. That means that a vaccine site could be allocated a certain number of doses on paper, have a few extra ones left that need to be tossed and still come out net positive. In that situation, it is unclear if the discarded doses should count as waste.

Data on wasted doses is routinely monitored in childhood immunizations in large part because it is required by the federal Vaccines For Children program, which provides innoculations to millions of children not covered by private health insurance, said Dr. Sean O'Leary, a professor of pediatric infectious diseases at University of Colorado Medicine. “Practices that are participating in that program, which are the vast majority of pediatric practices and a lot of family medicine practices, are used to keeping track very carefully of their vaccine inventory."

There isn't a federal program overseeing most adult vaccinations, so any wastage reporting for adult shots, like the flu shot, would be managed state by state.

While collecting wastage data is a good business practice, O'Leary said it is most useful as a deterrent against vaccine providers mishandling or discarding doses irresponsibly.

"It's being tracked as a disincentive to letting [wastage] happen," he said, “for accountability for people who are delivering the vaccines that they are doing their best to give the vaccines and store them properly."

However, there is also a danger in stigmatizing the waste of vaccine doses, said Moore, the immunization coalition deputy director. Accidents and normal human error are going to make some vials unfit to use on patients. Doses compromised by unsafe temperatures or contamination need to be thrown out, not injected into people. “You never, ever want to have clinics feel pressured not to waste vaccine that needs to be wasted," Moore said. “If you say, 'No one should ever damage vaccine,' you're really going to be in trouble."

The CDC says vaccine providers should avoid wastage and disclose when it happens.

“If there is excess vaccine, clinic staff should do everything possible to avoid wasting the dose. If vaccine wastage occurs, it should be reported into CDC's Vaccine Tracking System (VTrckS)," said CDC spokeswoman Kristen Nordlund. “We are working to figure out how to provide this data online in the future when the data is more complete."

In the meantime, federal officials have begun to urge that priority guidelines not get in the way of using vaccines. “It's more important to get people vaccinated than to perfectly march through each prioritized group," Alex Azar, secretary of health and human services under President Donald Trump, said at a briefing on Jan. 6.

This means that a pharmacist should use a dose that's about to expire on any available person — even someone who isn't in a priority group — rather than letting it go in the trash. “There's always someone in line. The whole nation is in line," said Lori Freeman, chief executive officer of the National Association of County and City Health Officials. “There's no reason for any vaccine to go to waste."

Dr. Mysheika Roberts, health commissioner of Columbus, Ohio, said in an interview last week that her local vaccination site hasn't had to waste a single dose of vaccine so far. Initially, if there were extra doses at the end of the day, they used them on their own staff, she said. After that, the mayor allowed them to put police officers on the waitlist — even though only health care providers were technically eligible at the time — so the vaccinators could call the station if they had extra doses. Managing a waitlist is complicated, Roberts said, because you need to have people who want the vaccine and have both the transportation and flexibility to get to the vaccine clinic within about 30 minutes, but so far it has worked out. The vaccine clinic has also managed to further reduce potential waste by getting appointment confirmations and defrosting vaccine vials close to appointment times, she said.

An Ohio Department of Health spokesperson said the state requires providers to report waste, and that 165 doses of the vaccine had been recorded as wastage as of Jan. 15.

“I hope to never be in a position where I have to waste a dose," Roberts added. “I'd go on a street corner and find someone to give the vaccine to before I have to throw it away."

Who decides when vaccine studies are done? These internal documents show Fauci plays a key role

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Dr. Anthony Fauci, the nation's top infectious disease official, will oversee most of the ongoing COVID-19 vaccine trials in the U.S., but not that of the current front-runner made by Pfizer, documents obtained by ProPublica show.

According to a draft charter spelling out how most of the advanced COVID-19 vaccine trials will be monitored, Fauci is the “designated senior representative" of the U.S. government who will be part of the first look at the results. That puts Fauci in the room with the companies — including Moderna, Johnson & Johnson and AstraZeneca — in deciding whether the vaccines are ready to seek approval from the Food and Drug Administration.

Fauci's role, which has not been previously reported and was confirmed for ProPublica by the National Institutes of Health, could offer some reassurance in the face of widespread concerns that President Donald Trump wants to rush through an unproven vaccine. As Sen. Kamala Harris, the Democratic nominee for vice president, put it at last week's debate, “If the public health professionals, if Dr. Fauci, if the doctors tell us that we should take it, I'll be the first in line to take it."

But there's a big caveat. Fauci doesn't have the same hands-on role for the vaccine that seems poised to show results soonest: Pfizer's. That's because Pfizer opted not to accept government funding and participate in the federal program to develop a coronavirus vaccine, known as Operation Warp Speed. (The government did make an almost $2 billion deal with Pfizer to preorder up to 600 million doses of the company's vaccine, but it isn't contributing money to the vaccine's development like it is for other companies.)

“(We) offered opportunities for collaboration with Pfizer," said a spokesperson for the National Institutes of Allergy and Infectious Diseases, a branch of the NIH. “Pfizer chose to conduct their Phase 3 study without Operation Warp Speed or NIH support."

Pfizer's CEO, Albert Bourla, said Friday that the earliest his company would be ready to apply for authorization would be the third week of November. While Pfizer might know by the end of October if its vaccine is effective, it would need additional time to gather sufficient safety data to present to the FDA, Bourla said in an open letter on the company's website.

Fauci's role in overseeing the companies that are participating in Operation Warp Speed arises from a unique arrangement that the government set up to monitor the trials. Typically, clinical trials set up their own independent panels of scientists, known as a data safety monitoring board or DSMB, to watch out for safety concerns or early signs of success. But all of the vaccine trials in Operation Warp Speed are sharing a common DSMB whose members were selected by Fauci's agency, the NIAID. They're also sharing a network of clinical trial sites where some volunteers are recruited for the studies.

A DSMB is responsible for making recommendations such as halting the trial if there is a safety concern or letting the manufacturer know that there's enough evidence to submit an application to the FDA. Ordinarily, a DSMB's recommendation goes to the company running the trial. In this case, the U.S. government — which gets two representatives, one from the NIAID and one from the Biomedical Advanced Research and Development Authority — will also have a seat at the table in deciding what to do next.

“Once the DSMB makes a decision, the DSMB provides the recommendation to not only the study sponsor but also to the" U.S. government, whose “designated senior representative" is Fauci, the NIAID confirmed in an email. Fauci declined to be interviewed.

That's not the same as saying Fauci has the last word. The company and the government are supposed to reach a consensus, the agency said. But if they can't all agree, the ultimate decision belongs with the company.

Still, it would be an improbably brazen move for a company to move ahead over Fauci's objection, given his public stature, experts said. “These are the most important trials in medical history, this is the ultimate fishbowl," said Dr. Eric Topol, director of the Scripps Research Translational Institute. “I don't think any sponsor would dare defy the DSMB's recommendation."

While the mechanics of a DSMB may be unfamiliar to most members of the public, people probably know and trust Fauci, according to Amy Pisani, executive director of the national nonprofit organization Vaccinate Your Family. “(He's) the sweetheart of the nation right now," Pisani said. “I do think people have faith in Anthony Fauci."

“Having Fauci with oversight is terrific," Topol added. “The more people who are experts looking at it, the better. You can't be careful enough."

Other members of the DSMB for the COVID-19 vaccines, though not as well known as Fauci, are also widely respected in their fields. DSMB members are typically kept confidential to shield them from outside influence, but ProPublica has been able to identify a few members. The charter obtained by ProPublica described the group, which has about a dozen members, as having expertise in “biostatistics, clinical trials, infectious diseases, vaccine development and ethics."

The panel's chair is Dr. Richard Whitley, a professor of pediatrics, microbiology, medicine and neurosurgery at the University of Alabama at Birmingham. His role became public when the university announced it, though the webpage was later taken down.

His leadership provides another level of comfort in the trustworthiness of the trials to those who know him. “He is not only famously bright but he is famously independent and outspoken," said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt Medicine. “He'll look at the data and tell you exactly what he thinks."

Whitley declined to comment.

Susan Ellenberg, professor of biostatistics at the University of Pennsylvania and a former director at the FDA, told ProPublica in an interview that many people, including herself, were worried the NIH might be “pushed by the political leadership at HHS to release data" from trials prematurely, which could undermine the integrity of a trial. HHS, the U.S. Department of Health and Human Services, is the NIH's parent agency. Her concern was that political leaders might not understand scientific arguments to not disrupt the trials when wanting to have data “to be able to move quickly in an urgent situation," she said.

At the time of the interview, Ellenberg had not identified herself as a member of the NIH's DSMB, but later acknowledged that she was a member.

Dr. Malegapuru William Makgoba, an immunologist based in South Africa, is one of a few international members of the DSMB. Makgoba is well known for his work on public health initiatives around HIV/AIDS, including the South African AIDS Vaccine Initiative. Makgoba confirmed his role on the DSMB but declined to comment further.

The common DSMB appears to be unprecedented, if only because there have not previously been multiple vaccines in development for the same disease at the same time. Experts said the arrangement offers benefits such as bolstering the evidence available to show that any one shot is safe and effective.

Standardizing trial measurements should make the vaccines easier to compare head to head, which may be useful for knowing whether one is better or worse than another in certain subgroups, such as the elderly or people with compromised immune systems, according to Vanderbilt's Schaffner.

“To me, it's better for public health to have a fairly common assessment," said Dr. Gregory Glenn, president of research and development at Novavax, which has received $1.6 billion from Operation Warp Speed and hopes to begin its Phase 3 trial in the U.S. this month as part of the NIH's clinical trial network.

There may also be some benefits from a safety perspective.

If a potential safety issue appears in one trial, having a common data safety monitoring board for multiple trials means that the board knows to look out for that same issue across all the trials, said Dr. Tal Zaks, chief medical officer of Moderna. “When AstraZeneca had an adverse side effect, we have a DSMB looking at our trial — the fact that it's the same DSMB means that there's not one DSMB that has to go educate another DSMB," Zaks said. (ProPublica's board chairman, Paul Sagan, is a member of Moderna's board and a company stockholder.)

AstraZeneca's trial has been put on hold in the U.S. while the company and the FDA investigates what happened with a participant who had a bad reaction. It's not yet clear whether the reaction was due to the vaccine or unrelated.

“AstraZeneca is committed to working with governments and key partners to ensure we develop and gain regulatory approval for an effective vaccine as quickly as possible," the company said in a statement.

AstraZeneca added that another benefit of joining the government's consortium was that its large network of trial sites can help reach minority communities that are historically less represented in clinical trials and also more vulnerable to COVID-19.

Pfizer's decision not to participate means that it and the other companies may miss out on some of these benefits of pooling resources. “It's at least unfortunate, and not very sporting, as the British would say," Schaffner said.

At the same time, there could be advantages to Pfizer's going solo. “One of the greatest risks to this process is the perception of political influence, and in that regard, having parallel efforts, especially efforts seen as independent of one another and/or independent of perceived sources of political influence, is a good thing," said Mani Foroohar, an analyst at the investment bank SVB Leerink.

Pfizer declined to comment on its decision not to join the government's shared DSMB and trial network.

Whether it's Pfizer or one of the companies participating in Operation Warp Speed, the final say on whether a vaccine is ready for public use belongs to the FDA.

The FDA has promised to present the data to an advisory committee of external experts in a public meeting. A preliminary meeting will be held on Oct. 22 to discuss, generally, the standards the FDA will seek to see before authorizing any vaccine. The agency has also committed to holding advisory committee meetings to review data from individual vaccine candidates.

Between the independent trial safety monitoring boards and the public advisory committee meetings, “any kind of hanky-panky there that people are worried about is going to (go through) multiple checkpoints," Fauci said in an interview with Dr. Howard Bachner on the JAMA Network podcast on Sept. 25. “The big elephant in the room is, is somebody going to try to make a political end run to interfere with the process? … If you look at the standard process of how these things work, I think you can feel comfortable that it is really unlikely that that is going to happen."

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