Caroline Chen

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."

Stanford front-line residents excluded from COVID vaccine after 'algorithm' prioritizes leadership, high-ranking doctors

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

Stanford Medicine residents who work in close contact with COVID-19 patients were left out of the first wave of staff members for the new Pfizer vaccine. In their place were higher-ranking doctors who carry a lower risk of patient transmission, according to interviews with six residents and two other staff members and e-mail communications obtained by ProPublica.

“Residents are patient-facing, we're the ones who have been asked to intubate, yet some attendings who have been face-timing us from home are being vaccinated before us," said Dr. Sarah Johnson, a third-year OB-GYN resident who has delivered babies from COVID-positive patients during the pandemic. “This is the final straw to say, 'We don't actually care about you.'"

Another resident, who asked not to be named, said a nurse who works in an operating room for elective surgeries has been notified she'll get the vaccine in the first wave. “We test people for COVID before elective surgeries, so by definition, we will know if those patients have COVID," he said, so to him, it didn't make sense that that nurse would be prioritized.

“We take complete responsibility for the errors in the execution of our vaccine distribution plan," said Lisa Kim, a Stanford Medicine spokesperson. “Our intent was to develop an ethical and equitable process for distribution of the vaccine. We apologize to our entire community, including our residents, fellows and other frontline care providers, who have performed heroically during our pandemic response. We are immediately revising our plan to better sequence the distribution of the vaccine."

An algorithm chose who would be the first 5,000 in line. The residents said they were told they were at a disadvantage because they did not have an assigned “location" to plug into the calculation and because they are young, according to an email sent by a chief resident to his peers. Residents are the lowest-ranking doctors in a hospital. Stanford Medicine has about 1,300 across all disciplines.

Only seven made the priority vaccination list, despite the fact that this week, residents were asked to volunteer for ICU coverage in anticipation of a surge in COVID-19 cases.

Stanford Medicine didn't respond to a request for comment on how the vaccines were allocated and whether there was a flaw in the algorithm. The tumult reflects the difficulties of ethically parceling out a limited supply of vaccine and weighing competing factors, such as age, risk of contracting the disease and comorbidities. Adding to the challenge is the angst that comes when such decisions are made without all stakeholders involved.

In a letter to Stanford leadership sent on Thursday, the chief resident council wrote, “While leadership is pointing to an error in an algorithm meant to ensure equity and justice, our understanding is this error was identified on Tuesday and a decision was made not to revise the vaccine allocation scheme before its release today." The council asked for a timeline for vaccination of the residents and transparency regarding the algorithm.

In response to the residents' protests, Dr. Niraj Sehgal, chief medical officer, sent an email saying, “Please know that the perceived lack of priority for residents and fellows was not the intent at all." He added that with the anticipated authorization of Moderna's vaccine, “we're increasingly confident in getting everyone vaccinated, including all of you." He signed off with “heartfelt apologies."

Some departments appear to be trying to fix the problem on their own. Dr. Mary Hawn, chair of the department of surgery, confessed to being “disturbed and puzzled" by the vaccination roster that “included many of the medical staff list that aren't our physicians on the front line." She emailed her department asking people slotted for the first wave to “bring a resident that is patient facing to get the vaccine in your place" and to ask the program director for their “buddy" assignment.

She added: “Let's get this right."

Filed under:

The enraging deja vu of the third coronavirus wave

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

There's a joke I've seen circulating online, over and over during this pandemic, that goes along the lines of, “Months this year: January, February, March, March, March, March, March…"

My lips pull into a smile, but my heart's not in it.

I was on the phone two weeks ago with a nurse who lives in Missouri, where cases have risen from 1,100 per day in August to about 3,400 daily in November. Her husband works in the ER of a rural hospital. Every time a patient suspected of having COVID-19 walks in, the sample is sent to be tested in St. Louis, an hour and a half away. Results take eight hours or more to process.

Medical workers don't get enough protective equipment. “They're given one N95 mask and have to keep it in a bag to reuse for days," the nurse said, fretting about her husband's safety. “He should at least get a new mask for every shift, right?"

I looked at the calendar: It was Oct. 30, but it might as well have been March.

I could still hear the voice of another nurse, Sarah, in Illinois, who poured out her fears to me on March 2, when the coronavirus was just starting to make its presence known in her city.

Sarah told me she had been instructed to write her name on a brown paper bag and put her mask in it to reuse for the week. “There's this feeling like, we're just going to get it," she told me, sounding more resigned than scared.

As a health reporter covering the pandemic, I've experienced too many moments of deja vu. This summer, as the virus swept through the South, news footage of overwhelmed hospitals in Houston turning away ambulances recalled similar scenes from March and April in New York City. Now, we're in the so-called third wave of the pandemic, with the virus slamming into Midwestern states, and this week, Dr. Gregory Schmidt, associate chief medical officer at the University of Iowa Hospitals and Clinics, said his colleagues are converting 16 hospital beds into new ICU beds in anticipation of an influx of COVID-19 patients. “People in leadership are starting to say things in meetings like, 'I have a sense of impending doom.'"

I'm exhausted and infuriated to be doing the same interviews and hearing the same stories for a third time. Why haven't we learned? What have we been doing between March and November?

Why is Dr. Peter Wentzel, in Grafton, West Virginia, only now able to order a point-of-care test system for his community clinic, just to be told that the cartridges for it will arrive in December at the earliest? Why are clinicians at Mountain Family Health Centers in Glenwood Springs, Colorado, once again facing seven- to 10-day wait times for their patients' test results?

I remind myself that many things have improved since March. An incredible amount of scientific knowledge has been amassed about the virus itself. Thanks to detailed contact tracingstudies around the world, we've learned that the virus can be spread beyond 6 feet via small particles suspended in the air, teaching us the importance of good ventilation to decrease transmission risk. Thanks to antibody studies, we're learning that reinfection, while possible, is likely rare.

We now use ventilators less aggressively and know the benefits of steroids like dexamethasone, while other treatments like hydroxychloroquine have lost favor thanks to rigorous studies that have debunked anecdotal hype. This week, an antibody therapy developed by Eli Lilly was granted emergency use authorization by the Food and Drug Administration. Trials have shown that it can help mild to moderate COVID-19 patients reduce hospitalizations. And Pfizer shared encouraging, early news from its ongoing trial, saying its vaccine was more than 90% effective in preventing people from getting sick. It is thanks to the work of so many career scientists and medical personnel that if one gets infected with the coronavirus today, the chance of survival is higher than in March.

Yet while some material supplies have increased since March (we thankfully have more COVID-19 tests, though still not enough), humans are a fixed resource, and the skilled labor of a veteran respiratory therapist or an ICU nurse is hard to come by. Before the pandemic, America already had a nursing shortage. Now, this dearth is becoming acutely felt.

A ER nurse who lives in Wisconsin told me that her hospital is starting to run out of beds, but more urgently, it is running out of staff, in part because some workers have gotten sick and others are in quarantine. “The state keeps talking about how many beds there are, but that doesn't mean there's staff for them," she said.

When no hospital beds are available, the emergency department gets full, she explained to me; she's had to board patients there for 20 hours. Meanwhile, she wields a faulty forehead thermometer at the door. Her own temperature recently read 84.9 F — hypothermic, if true. Staff members were given plastic water bottles emblazoned with the hospital's logo as a thank you.

“It's so demoralizing," she told me. “I would take getting punched on a daily basis rather than what we're going through now."

Tim Size, executive director of the Rural Wisconsin Health Cooperative, said some of his 43 member hospitals are seeing “significant staff shortages." Initially, he said, they were able to hire from staffing agencies, which recruit traveling nurses to work short-term contracts, but now that the virus is surging in multiple states, hospitals all over are competing for the same personnel. “So people are working more overtime, which is causing more fatigue, which will lead to more burnout," Size said. “If we don't stop the growth…" He shook his head.

Schmidt, at the University of Iowa, tells me he's concerned not just about overwork, but also about the psychological toll on medical staff. “You watch patients who are young and who should have had good lives die without their families by them, and their families being distraught, and then you go out through your community and you see people partying and going to bars."

He paused, then added. “We can do anything for two months," he said. “But surge after surge, it's hard for everybody."

One thing that's burned into my head is what Chrissie Juliano, executive director of the Big Cities Health Coalition, told me when I asked her whether the constant struggles to get on top of the coronavirus have simply been because this pandemic is so unprecedented that nobody could have prepared for it.

“We would be overwhelmed to some extent," she told me. “But it didn't have to be this bad."

So much has fed into our quagmire: a lack of national leadership, the perpetuation of misinformation. The nurse in Missouri told me about a man with preexisting conditions who ended up in the ICU because he believed that the virus would go away by Nov. 4 and went out to eat at restaurants. Of course, it didn't go away that day. Instead, we hit a record high of 103,067 cases, the first time we broke six digits; 1,116 people died. It didn't have to be this bad.

I don't want to hear the same stories in a fourth wave, a fifth wave, to feel like we are trapped in an endless spiral, unnecessarily repeating our own mistakes. New leadership is coming to the White House; Joe Biden's first move as president-elect was to announce a COVID-19 advisory board. I hope it will amplify the voices of our public health leaders, depoliticize the pandemic and deliver for all of the weary front-line workers.

But we don't have to wait until then. The best way to help our medical workers isn't to stand at our windows at 7 p.m. cheering or to give them thank-you water bottles. It's to stay out of their ERs and ICUs by keeping ourselves and our neighbors safe.

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

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

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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