Category: From California Healthline.org

Following nationwide protests against police brutality in which law enforcement officers wounded or blinded protesters, state and local lawmakers and an international police association are taking steps to restrict the use of “less-lethal” weapons that caused the injuries.

At least seven major U.S. cities and a few states have enacted or proposed tight limits on the use of rubber bullets and other projectiles, though some efforts for similar actions have stalled in the face of opposition from police agencies or other critics.

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Additionally, clashes between law enforcement officers and protesters in Portland, Oregon, and Washington, D.C., have triggered investigations by federal inspectors general.

After the George Floyd protests, “there was this new appetite from legislators at all levels of government to look at how to better protect protesters,” said Nick Robinson, legal adviser at the International Center for Not-for-Profit Law.

Amid calls for restrictions, the International Association of Chiefs of Police, based in Virginia with 31,000 members in dozens of countries, plans to review its recommended policies on pepper spray and less-lethal “impact projectiles” as well as other aspects of crowd control, said Terrence Cunningham, the organization’s deputy executive director.

“It became very clear to us that we need to revise those policies” in the wake of the Black Lives Matter protests, he said. Some law enforcement agencies “have done a great job managing the crowds and the protests,” he said. “Others could have done a better job.”

The legislation and studies come after USA TODAY and KHN documented dozens of injuries sustained after the killings of George Floyd in Minneapolis and Breonna Taylor in Louisville. Weapons used by local police or other law enforcement agencies included sponge and bean bag projectiles as well as “pepper balls” — essentially paintballs filled with chemical irritants.

At least 30 people suffered eye injuries, and approximately one-third of the cases resulted in complete loss of vision in one eye, during protests in late spring, according to a study by the American Academy of Ophthalmology and the University of California-San Francisco’s ophthalmology department.

That’s what happened to Shantania Love in California.

“Peaceful protests shouldn’t end in people being blinded or shot in the head,” said Love, who permanently lost sight in her left eye in May after being shot with a less-lethal projectile in Sacramento.

Doctors at Dell Seton Medical Center at the University of Texas were so shocked by “rubber bullet” wounds in Austin that they documented them in a letter to the New England Journal of Medicine.

“All the injuries were bad. They made a hole in somebody. They broke bones,” said Dr. Jayson Aydelotte, the hospital’s chief of trauma surgery. “We wrote this to raise awareness so communities can make their own decisions about what to do with this information.”

The Austin police chief said his department would no longer use bean bag rounds on crowds after the projectiles — encased birdshot fired from a shotgun — caused many of the injuries seen at the hospital.

But many other U.S. law enforcement departments have continued using less-lethal weapons during protests across the nation.

Police in Rochester, New York, have repeatedly used pepper balls on crowds this summer, as recently as Wednesday. Officers from the Metropolitan Police Department of the District of Columbia fired sting balls and tear gas after protesters threw bricks, glass and smoke grenades at them during clashes over the weekend, The Washington Post reported.

There are no national standards for police use of less-lethal projectiles and no comprehensive data on their use, said Brian Higgins, a former New Jersey police chief who’s now an adjunct professor at the John Jay College of Criminal Justice in New York City.

Police department rules vary widely. In some incidents this year, police appear to have violated their own rules, which allow projectiles to be fired only at dangerous individuals.

In July, the International Association of Chiefs of Police held a webinar on lessons for law enforcement from this year’s protests and other recent demonstrations. It drew 800 participants, Cunningham said.

“It raised more questions than we had answers to,” he said. “For some of these practices, the policies that we have are pretty old, to be honest with you, and this is a great opportunity to rethink it.”

The association’s guidelines for sponge and bean bag rounds and other impact projectiles haven’t been revised since 2002. Meanwhile, the technology and tactics of less-lethal weapons have substantially changed.

Its review could eventually lead to another congress of police executives and union leaders, who produced a consensus policy on the use of force three years ago, Cunningham said.

One message in particular needs to be repeated and made clearer, he said. Less-lethal projectiles should be used only to subdue dangerous individuals and not fired indiscriminately into crowds, as happened in several instances that USA Today and KHN documented.

Crowd-control policies should be updated not just because of the injuries but to adapt to new tactics used by peaceful protesters and troublemakers, law enforcement officials said. Social media has transformed mass demonstrations, enabling marchers to assemble more quickly and in greater numbers, they said, and police need to respond.

“Some crowds have gone from a peaceful protest of 30 or 40 people to 1,000 strong within an hour,” said Larry Cosme, national president of the Federal Law Enforcement Officers Association.

Few if any of the initiatives will generate instant change, independent experts cautioned. Law-enforcement agencies oppose some restrictions on less-lethal projectiles, saying the weapons are a critical tool to control uncooperative people that stops short of deadly force.

The IACP makes recommendations on police use of force but law enforcement agencies set their own policies. Even the best policies — including those set in law — are just slogans unless departments have the resources to carry them out, experts said.

“I’d be very curious to know what they’re basing any changes on, other than placating people,” Charlie Mesloh, a certified instructor on the use of police projectiles and a professor at Northern Michigan University, said about the association’s initiative.

“Unless someone’s willing to pay for training that would make things better, this is just another piece of paper,” he said. “There are no magic solutions.”

Reform advocates took a setback this week when the California legislature failed to pass a bill that would have allowed police to use tear gas and riot projectiles only against dangerous individuals and only after warning the crowd they’re part of. It would have required police agencies to report their use of less-lethal force annually to the U.S. Justice Department.

Police groups opposed the bill, especially its limits on tear gas, which the Los Angeles County Sheriff’s Department told legislators can “prevent the escalation of physical force” by dispersing a crowd without the use of projectiles.

Assembly member Lorena Gonzalez, who sponsored the bill, said she’ll reintroduce it next year. Robinson, of the International Center for Not-for-Profit Law, said he expects many new measures to be proposed across the country in January, when state legislatures convene.

Another stalled effort is in Minnesota, where lawmakers did not approve a proposal that would have prohibited law enforcement agencies and peace officers from using chemical weapons and kinetic energy munitions such as plastic wax, wood or rubber-coated projectiles on civilian populations.

At the federal government level, a preliminary version of a proposed amendment to the National Defense Authorization Act included restrictions on less-lethal munitions. But the restrictions were cut from the proposal before it was voted on and turned down.

Washington, D.C., officials in July enacted a sweeping police reform measure that bans the use of rubber bullets or tear gas against nonviolent protesters. Less-lethal munitions and chemical spray were used to disperse a crowd in June before President Donald Trump walked through Lafayette Square to display a Bible in front of a historic church.

Derrick Sanderlin with his wife, Cayla Sanderlin. Derrick, who had trained San Jose police recruits on avoiding racial bias, was hit by a projectile that ruptured a testicle. (The Sanderlin family)

San Jose’s City Council is considering new controls on such weapons. In June, the Seattle City Council banned the weapons outright, but a federal judge blocked the law after the Justice Department argued it would take away law enforcement’s options to “modulate” the use of force.

As part of a larger police reform measure, Colorado banned law enforcement officers from firing less-lethal projectiles indiscriminately into a crowd or aiming them at someone’s head or pelvis. Language in a Virginia bill would ban their use by all law enforcement.

In addition, inspectors general at the Justice Department and the Department of Homeland Security are investigating the actions of federal law enforcement officers in Portland after lawmakers raised concerns. DOJ is also investigating federal officials’ role during protests in Washington, D.C.

Amnesty International USA recently released a wide-ranging report on the protests, chronicling what it said were 125 instances of police violence against protesters, journalists, medics and legal observers in 40 states and Washington, D.C., in May and June. The group accused police of mishandling a litany of less-lethal devices, including sting-ball grenades, rubber pellets and sponge rounds.

Amnesty called for the development of national guidelines for less-lethal projectiles. The group said they should be independently tested for accuracy and safety, and they should be used only in situations of “violent disorder” in which “no less extreme measures are sufficient” to stop the violence.

Cosme said he’s open to starting discussions about updating the national consensus policy to include more detailed standards for less-lethal munitions. He also supports requiring testing of devices to ensure accuracy and safety.

But he said less-lethal munitions are critical tools for crowd control because officers can target individuals from a distance.

Chuck Wexler, executive director of the Police Executive Research Forum, a think tank for police leadership, said the protests in recent months could offer lessons for how police handle demonstrations.

“We’ll be looking at this,” he said. But Wexler said he does not have a concrete plan or timetable for convening reviews of what happened, given the pandemic.

“The real key question is, What kind of strategies can we develop that are the most humane for cops and for the community alike?” he said.

“What did we learn? What are some of the cautionary tales?” Wexler said. “What strategies were effective? Where were injuries the least for demonstrators and cops alike?”

One New Year’s Day, Rob Purdie woke up with a headache that wouldn’t quit. Vision problems, body aches and a slight fever followed. At the emergency room, the Bakersfield, California, resident was given antibiotics, which didn’t touch his symptoms. His headache turned into cluster headaches and the fatigue became worse.

“I was not really functional,” he said in a recent interview, recalling the beginning of his eight-year struggle with the mystery illness.

After five weeks, he ended up at Bakersfield’s Kern Medical, home to the Valley Fever Institute. A resident physician quickly realized the cause of the symptoms. A spinal fluid sample confirmed Purdie was suffering from valley fever, a fungal infection that occurs in the deserts of the Southwest, primarily Arizona and California. The infection had spread from his lungs into his brain, causing inflammation and headaches.

He was in and out of the hospital for a year with debilitating symptoms. There is no cure for valley fever; doctors use existing antifungal medications that often don’t relieve the symptoms. He tried three oral antifungal drugs and finally ended up with injections of amphotericin B — “salvage therapy,” meaning it is a drug of last resort — which he is still on, eight years later.

Purdie, 39, now works for the Valley Fever Institute, teaching others about the poorly understood disease. He still has no clue how he inhaled the spore that causes it. “I was probably out doing yardwork,” he said, “and took the wrong breath.”

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Valley fever — coccidioidomycosis (“cocci” for short) is the scientific name — is an “orphan disease.” An orphan disease is defined in the U.S. as one affecting fewer than 200,000 people. Valley fever is diagnosed in the range of 10,000 to 15,000 cases a year in the U.S. with 160 fatalities, though both numbers are likely several times higher in reality because many cases are never identified. That’s why it’s often hard to attract attention to developing a vaccine.

In the 1980s, a promising vaccine candidate failed in clinical trials. There has been no other candidate for a vaccine until recently. Now, with mouse studies showing promise, there is a renewed push. Dr. John Galgiani, head of the University of Arizona’s Valley Fever Center for Excellence, is heading up vaccine research there and believes the vaccine shown to prevent valley fever in mice should be available for dogs, which also get infected in large numbers, as soon as next year. A veterinary vaccine company, Anivive, is developing it. “It’s very promising,” said Galgiani.

The same vaccine is in the early stage of development for humans, though it’s still years away.

In addition to Galgiani’s research, the National Institutes for Health’s National Institute for Allergy and Infectious Diseases is funding two other cocci vaccine research projects.

One drug, nikkomycin Z, has cured the disease in mice; experts believe it could do the same for humans. It’s being developed by the University of Arizona with funding from the National Institutes of Health, the Food and Drug Administration and other sources.

Valley fever is getting more attention for a few reasons. The number of cases has been increasing, and a study last year predicted it may spread north through the West as the climate warms. By 2095, five more states may be added to the list of 12 where the fungus now lives, growing its range in a swath across the West and into the Great Plains from Texas to Montana and North Dakota. The fungus is also found in Mexico and in Central and South America.

U.S. House Minority Leader Kevin McCarthy represents parts of California’s Central Valley, where cocci is prevalent. It’s a voting issue there and the Republican has made it a priority, bringing federal dollars to bear for research, surveillance and awareness.

The big problem with developing a vaccine is the relatively small market. The cost of studies to bring the drug to market, Galgiani estimated, is $50 million, while a federal study in 2000 pegged the cost of developing a vaccine at $360 million — though Galgiani believes it could be done for half that, still a hefty cost for a small group of patients.

“We don’t compete effectively against other investment opportunities,” he said.

Two types of the fungus Coccidioides cause valley fever. They dwell in desert soil between 2 inches and a foot deep and when disturbed become suspended in the air and are occasionally inhaled.

Cocci, sometimes called “desert rheumatism,” causes fever, cough, body aches, extreme exhaustion and difficulty breathing. There is no person-to-person spread.

Because the pneumonia-like symptoms are similar to those caused by the novel coronavirus, many cases of valley fever are likely being reported as COVID-19, Galgiani said, which means they are not getting treatment with antifungal medications that can temper symptoms if applied early on.

The infection can spur inflammation that “causes scarring and damage to parts of your nervous system,” Galgiani said. “Early diagnosis means less damage.”

Valley fever case numbers have grown substantially in the past five years, though they are down this year, perhaps because many doctors mistake the condition for COVID-19.

Most cases resolve on their own without treatment. Yet in 5% to 8% of diagnosed patients, the disease spreads to skin, bones and organs, and can be deadly. If it reaches the brain and spinal cord, as it did with Rob Purdie, it can cause meningitis, or swelling of the membranes. These patients, if they don’t die, may need antifungal treatments for life.

Rob Purdie was infected with valley fever in 2012, and sought treatment at Kern Medical’s Valley Fever Institute in Bakersfield, California. Today, Purdie works at the institute as the patient and program development coordinator. (Valley Fever Institute)

Blacks and Filipinos are four times more likely to have these serious effects than other demographic groups, according to Galgiani.

An epidemic devastated prisoners in the San Joaquin Valley, the southern section of California’s Central Valley, in the early and mid-2000s. Investigation showed the rate in two prisons — which had populations with higher numbers of minorities than the surrounding communities — was hundreds of times higher than in the surrounding area. Eventually, more than 30 prisoners died and many more had serious chronic infections.

The high season for infection is late summer and fall. Some 95% of the cases occur in the Central Valley and the Phoenix area. “They are in urban areas; you don’t have to be out on the desert to be infected,” Galgiani said.

Compounding the effects of valley fever is that it often goes undiagnosed. Even in Phoenix’s Maricopa County — where the fungus is endemic in the desert soil and 50% of the nation’s cases occur — it’s not on the radar screen of many doctors. Further complicating a diagnosis is that test results are often wrong and it may take two or three tests to identify the disease.

The lack of awareness of valley fever is one of the factors that led Purdie to take a job last year as outreach coordinator of the Valley Fever Institute. “There’s a lot of misinformation about it,” he said.

The vaccine that experts are banking on is called Delta CPS-1. It has proved very effective in mice in published studies and could be on the market as soon as next year for dogs. It’s estimated that 60,000 dogs contract valley fever every year in what’s known as the “Valley Fever Corridor” between Phoenix and Tucson, Arizona, and the numbers are probably similar for Bakersfield and other parts of the Central Valley. Symptoms in canines are similar to those in humans.

The same vaccine could one day prove effective in humans, though trials are years and many millions of dollars away. “It’s a great candidate for human immunization,” said Dr. Tom Monath, managing partner and chief scientific officer of Crozet BioPharma, which is working on the vaccine. “It’s hard to offer any promises, but it could take less than 10 years.”

Old. Chronically ill. Black.

People who fit this description are more likely to die from COVID-19 than any other group in the country.

They are perishing quietly, out of sight, in homes and apartment buildings, senior housing complexes, nursing homes and hospitals, disproportionately poor, frail and ill, after enduring a lifetime of racism and its attendant adverse health effects.

Yet, older Black Americans have received little attention as protesters proclaim that Black Lives Matter and experts churn out studies about the coronavirus.

“People are talking about the race disparity in COVID deaths, they’re talking about the age disparity, but they’re not talking about how race and age disparities interact: They’re not talking about older Black adults,” said Robert Joseph Taylor, director of the Program for Research on Black Americans at the University of Michigan’s Institute for Social Research.

A KHN analysis of data from the Centers for Disease Control and Prevention underscores the extent of their vulnerability. It found that African Americans ages 65 to 74 died of COVID-19 five times as often as whites. In the 75-to-84 group, the death rate for Blacks was 3½ times greater. Among those 85 and older, Blacks died twice as often. In all three age groups, death rates for Hispanics were higher than for whites but lower than for Blacks.

(The gap between Blacks and whites narrows over time because advanced age, itself, becomes an increasingly important, shared risk. Altogether, 80% of COVID-19 deaths are among people 65 and older.)

The data comes from the week that ended Feb. 1 through Aug. 8. Although breakdowns by race and age were not consistently reported, it is the best information available.

Mistrustful of Outsiders

Social and economic disadvantage, reinforced by racism, plays a significant part in unequal outcomes. Throughout their lives, Blacks have poorer access to health care and receive services of lower quality than does the general population. Starting in middle age, the toll becomes evident: more chronic medical conditions, which worsen over time, and earlier deaths.

Several conditions — diabetes, chronic kidney disease, obesity, heart failure and pulmonary hypertension, among others — put older Blacks at heightened risk of becoming seriously ill and dying from COVID-19.

Yet many vulnerable Black seniors are deeply distrustful of government and health care institutions, complicating efforts to mitigate the pandemic’s impact.

The infamous Tuskegee syphilis study — in which African American participants in Alabama were not treated for their disease — remains a shocking, indelible example of racist medical experimentation. Just as important, the lifelong experience of racism in health care settings — symptoms discounted, needed treatments not given — leaves psychic scars.

In Seattle, Catholic Community Services sponsors the African American Elders Program, which serves nearly 400 frail homebound seniors each year.

“A lot of Black elders in this area migrated from the South a long time ago and were victims of a lot of racist practices growing up,” said Margaret Boddie, 77, who directs the program. “With the pandemic, they’re fearful of outsiders coming in and trying to tell them how to think and how to be. They think they’re being targeted. There’s a lot of paranoia.”

“They won’t open the door to people they don’t know, even to talk,” complicating efforts to send in social workers or nurses to provide assistance, Boddie said.

In Los Angeles, Karen Lincoln directs Advocates for African American Elders and is an associate professor of social work at the University of Southern California.

“Health literacy is a big issue in the older African American population because of how people were educated when they were young,” she said. “My maternal grandmother, she had a third-grade education. My grandfather, he made it to the fifth grade. For many people, understanding the information that’s put out, especially when it changes so often and people don’t really understand why, is a challenge.”

What this population needs, Lincoln suggested, is “help from people who they can relate to” — ideally, a cadre of African American community health workers.

With suspicion running high, older Blacks are keeping to themselves and avoiding health care providers.

“Testing? I know only of maybe two people who’ve been tested,” said Mardell Reed, 80, who lives in Pasadena, California, and volunteers with Lincoln’s program. “Taking a vaccine [for the coronavirus]? That is just not going to happen with most of the people I know. They don’t trust it and I don’t trust it.”

Reed has high blood pressure, anemia, arthritis and thyroid and kidney disease, all fairly well controlled. She rarely goes outside because of COVID-19. “I’m just afraid of being around people,” she admitted.

Other factors contribute to the heightened risk for older Blacks during the pandemic. They have fewer financial resources to draw upon and fewer community assets (such as grocery stores, pharmacies, transportation, community organizations that provide aging services) to rely on in times of adversity. And housing circumstances can contribute to the risk of infection.

In Chicago, Gilbert James, 78, lives in a 27-floor senior housing building, with 10 apartments on each floor. But only two of the building’s three elevators are operational at any time. Despite a “two-person-per-elevator policy,” people crowd onto the elevators, making it difficult to maintain social distance.

“The building doesn’t keep us updated on how they’re keeping things clean or whether people have gotten sick or died” of COVID-19, James said. Nationally, there are no efforts to track COVID-19 in low-income senior housing and little guidance about necessary infection control.

Large numbers of older Blacks also live in intergenerational households, where other adults, many of them essential workers, come and go for work, risking exposure to the coronavirus. As children return to school, they, too, are potential vectors of infection.

‘Striving Yet Never Arriving’

In recent years, the American Psychological Association has called attention to the impact of racism-related stress in older African Americans — yet another source of vulnerability.

This toxic stress, revived each time racism becomes manifest, has deleterious consequences to physical and mental health. Even racist acts committed against others can be a significant stressor.

“This older generation went through the civil rights movement. Desegregation. Their kids went through busing. They grew up with a knee on their neck, as it were,” said Keith Whitfield, provost at Wayne State University and an expert on aging in African Americans. “For them, it was an ongoing battle, striving yet never arriving. But there’s also a lot of resilience that we shouldn’t underestimate.”

This year, for some elders, violence against Blacks and COVID-19’s heavy toll on African American communities have been painful triggers. “The level of stress has definitely increased,” Lincoln said.

During ordinary times, families and churches are essential supports, providing practical assistance and emotional nurturing. But during the pandemic, many older Blacks have been isolated.

In her capacity as a volunteer, Reed has been phoning Los Angeles seniors. “For some of them, I’m the first person they’ve talked to in two to three days. They talk about how they don’t have anyone. I never knew there were so many African American elders who never married and don’t have children,” she said.

Meanwhile, social networks that keep elders feeling connected to other people are weakening.

“What is especially difficult for elders is the disruption of extended support networks, such as neighbors or the people they see at church,” said Taylor, of the University of Michigan. “Those are the ‘Hey, how are you doing? How are your kids? Anything you need?’ interactions. That type of caring is very comforting and it’s now missing.”

In Brooklyn, New York, Barbara Apparicio, 77, has been having Bible discussions with a group of church friends on the phone each weekend. Apparicio is a breast cancer survivor who had a stroke in 2012 and walks with a cane. Her son and his family live in an upstairs apartment, but she does not see him much.

“The hardest part for me [during this pandemic] has been not being able to go out to do the things I like to do and see people I normally see,” she said.

In Atlanta, Celestine Bray Bottoms, 83, who lives on her own in an affordable senior housing community, is relying on her faith to pull her through what has been a very difficult time. Bottoms was hospitalized with chest pains this month — a problem that persists. She receives dialysis three times a week and has survived leukemia.

“I don’t like the way the world is going. Right now, it’s awful,” she said. “But every morning when I wake up, the first thing I do is thank the Lord for another day. I have a strong faith and I feel blessed because I’m still alive. And I’m doing everything I can not to get this virus because I want to be here a while longer.”

KHN data editor Elizabeth Lucas contributed to this story.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID patients to treat the disease in favor of dedicating their resources to a gold-standard clinical trial that could help settle the science for good.

As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.

Officials at some hospitals said they are considering committing only to the clinical trial — and either avoiding or minimizing use of convalescent plasma through an emergency use authorization issued Aug. 23 by the federal Food and Drug Administration.

The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma, which already has been administered to more than 77,000 COVID patients in the U.S. President Donald Trump characterized the treatment as a “powerful therapy,” even as government scientists called for more evidence that COVID plasma is beneficial.

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A National Institutes of Health panel this week countered the FDA’s decision, saying that the therapy “should not be considered the standard of care for the treatment of patients with COVID-19” and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it’s not definitive.

“It’s an important scientific question that we don’t have the answer to yet,” said Rice, an associate professor of medicine and director of VUMC’s medical intensive care unit.

Convalescent plasma uses an antibody-rich blood product taken from people who have recovered from a viral infection and injects it into people still suffering in the hopes that the therapy will jump-start their immune systems, boosting their ability to fight the virus. The approach has been used on an experimental basis for more than a century to fight other virulent diseases, including the 1918 flu, measles, Ebola, SARS and H1N1 influenza.

Last month, NIH officials awarded $34 million to Rice’s study, the Passive Immunity Trial of the Nation for COVID-19, dubbed PassItOnII, which has also received funding from country music superstar Dolly Parton. The trial, which aims to enroll 1,000 adult hospitalized patients, could meet its goals by the end of October. If it shows evidence of likely benefit to COVID patients, it could immediately change clinical practice, Rice said.

Half of the participants will receive convalescent plasma with high levels of disease-fighting antibodies from a stockpile of more than 150 units of the product already collected, Rice said. The other half will receive a placebo solution.

Though the trial launched in April, enrollment has been slow. The funding allows enlistment at more than 50 sites nationwide. That has spurred new conversations about joining the trial — and about not employing the controversial authorization issued by the FDA, said Dr. Claudia Cohn, director of the Blood Bank Laboratory at the University of Minnesota Medical School. She expected her institution to decide this week.

“I’d rather frame it as not rejecting the FDA, but simply taking the longer view,” said Cohn, who is also medical director for the AABB, an international nonprofit focused on transfusion medicine and cellular therapies.

At the Ohio State University Wexner Medical Center, officials have opted to join the trial and are considering making it “the first option” for COVID patients who qualify, said Dr. Sonal Pannu, an assistant professor and pulmonologist.

“Many of the academic leaders believe we should do the trial, and we would be severely limiting” the emergency use authorization, or EUA, she said, noting that first patients could be enrolled soon. The plasma still could be used under the EUA to treat patients such as prisoners, who are unable to consent to join a clinical trial, she added.

That’s the same stance adopted by the University of Washington, said Dr. Nicholas Johnson, an assistant professor of emergency medicine who’s leading the trial at the Seattle site. “We’re really interested in enrolling patients as the first option,” he said.

The questions are similar to those raised with hydroxychloroquine, another treatment Trump touted for treating COVID-19. FDA officials issued an EUA for the drug in April, only to revoke it in June after data indicated the drug might be harmful.

“On a couple of occasions, we’ve allowed clinical practice to get ahead of the science,” Johnson said. “We’ve learned that lesson a couple of times now.”

FDA officials did not respond to requests for comment.

Top federal health leaders, including NIH Director Dr. Francis Collins and Dr. Anthony Fauci, the nation’s leading infectious disease doctor, initially resisted the move to issue the EUA for convalescent plasma last month, telling The New York Times that the evidence for it was too weak.

Trump has criticized the FDA for moving too slowly to speed approval of treatments and vaccines for COVID-19. He announced the EUA on the eve of the Republican National Convention, calling it a “truly historic announcement.”

Issuing the EUA puts the fate of clinical trials into “extreme jeopardy,” said Arthur Caplan, a professor of bioethics at the New York University School of Medicine. With convalescent plasma in very short supply, it sets the stage for fights over access and makes sick patients less inclined to join a trial, where they might receive a placebo.

“If you have the EUA, it starts to damage the trials,” Caplan said.

Still, given that the FDA has authorized convalescent plasma for patients ill with COVID-19, hospitals that hesitate or refuse to provide it outside a trial are sure to face questions from families.

That creates “a very interesting and delicate ethics problem,” said Cohn.

“If you commit to the randomized controlled trial only, you’re committing to a long-term dedication to science,” she said. “The question is, is it ethically inappropriate not to provide a therapy that has been shown to be possibly beneficial?”

Johnson, at the University of Washington, said most patients have been willing — even eager — to participate in clinical trials once they understand the need for rigorous scientific results.

And Caplan, the bioethicist, applauded the decision of hospitals to minimize the EUA and focus on the trial, calling it “a pretty feisty action.”

“It’s sensible,” he said. “It’s likely to really generate an answer to the question of ‘Does COVID convalescent plasma do anything?’”

KHN Midwest editor and correspondent Laura Ungar appeared on Spectrum News Bay News 9 to discuss her recent investigation with The Associated Press on how Florida slashed its local health departments — downsizing staffing from 12,422 full-time equivalent workers in 2010 to 9,125 in 2019 and cutting spending from $57 to $34 per resident over that period. The staffing and funding fell faster and further in the Sunshine State than the nation, leaving Florida especially unprepared for the worst health crisis in a century.

Ungar also spoke on Fox 35 Orlando about the story, explaining how the cuts hampered the state’s ability to respond to the pandemic. Watch here:

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Millions of Americans are counting on a COVID-19 vaccine to curb the global pandemic and return life to normal.

While one or more options could be available toward the end of this year or early next, the path to delivering vaccines to 330 million people remains unclear for the local health officials expected to carry out the work.

“We haven’t gotten a lot of information about how this is going to roll out,” said Dr. Umair Shah, executive director of Texas’ Harris County Public Health department, which includes Houston.

In a four-page memo this summer, the federal Centers for Disease Control and Prevention told health departments across the country to draft vaccination plans by Oct. 1 “to coincide with the earliest possible release of COVID-19 vaccine.”

But health departments that have been underfunded for decades say they currently lack the staff, money and tools to educate people about vaccines and then to distribute, administer and track hundreds of millions of doses. Nor do they know when, or if, they’ll get federal aid to do that.

Dozens of doctors, nurses and health officials interviewed by KHN and The Associated Press expressed concern about the country’s readiness to conduct mass vaccinations, as well as frustration with months of inconsistent information from the federal government.

The gaps include figuring out how officials will keep track of who has gotten which doses and how they’ll keep the workers who give the shots safe, with enough protective gear and syringes to do their jobs.

With only about half of Americans saying they would get vaccinated, according to a poll from AP-NORC Center for Public Affairs Research, it also will be crucial to educate people about the benefits of vaccination, said Molly Howell, who manages the North Dakota Department of Health’s immunization program.

The unprecedented pace of vaccine development has left many Americans skeptical about the safety of COVID-19 immunizations; others simply don’t trust the federal government.

“We’re in a very deep-red state,” said Ann Lewis, CEO of CareSouth Carolina, a group of community health centers that serve mostly low-income people in five rural counties in South Carolina. “The message that is coming out is not a message of trust and confidence in medical or scientific evidence.”

Paying for the Rollout 

The U.S. has committed more than $10 billion to develop new coronavirus vaccines but hasn’t allocated money specifically for distributing and administering vaccines.

And while states, territories and 154 large cities and counties received billions in congressional emergency funding, that money can be used for a variety of purposes, including testing and overtime pay.

An ongoing investigation by KHN and the AP has detailed how state and local public health departments across the U.S. have been starved for decades, leaving them underfunded and without adequate resources to confront the coronavirus pandemic. The investigation further found that federal coronavirus funds have been slow to reach public health departments, forcing some communities to cancel non-coronavirus vaccine clinics and other essential services.

States are allowed to use some of the federal money they’ve already received to prepare for immunizations. But KHN and the AP found that many health departments are so overwhelmed with the current costs of the pandemic — such as testing and contact tracing — that they can’t reserve money for the vaccine work to come. Health departments will need to hire people to administer the vaccines and systems to track them, and pay for supplies such as protective medical masks, gowns and gloves, as well as warehouses and refrigerator space.

CareSouth Carolina is collaborating with the state health department on testing and the pandemic response. They used federal funding to purchase $140,000 retrofitted vans for mobile testing that they plan to continue to use to keep vaccines cold and deliver them to residents when the time comes, said Lewis.

But most vaccine costs will be new.

Pima County, Arizona, for example, is already at least $30 million short of what health officials need to fight the pandemic, let alone plan for vaccines, said Dr. Francisco Garcia, deputy county administrator and chief medical officer.

Some federal funds will expire soon. The $150 billion that states and local governments received from a fund in the CARES Act, for example, covers only expenses made through the end of the year, said Gretchen Musicant, health commissioner in Minneapolis. That’s a problem, given vaccine distribution may not have even begun.

Although public health officials say they need more money, Congress left Washington for its summer recess without passing a new pandemic relief bill that would include additional funding for vaccine distribution.

“States are anxious to receive those funds as soon as possible, so they can do what they need to be prepared,” said Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition, a national vaccine education and advocacy organization based in St. Paul, Minnesota. “We can’t assume they can take existing funding and attempt the largest vaccination campaign in history.”

What’s the Plan?

Then there’s the basic question of scale. The federally funded Vaccines for Children program immunizes 40 million children each year. In 2009 and 2010, the CDC scaled up to vaccinate 81 million people against pandemic H1N1 influenza. And last winter, the country distributed 175 million vaccines for seasonal influenza vaccine, according to the CDC.

But for the U.S. to reach herd immunity against the coronavirus, most experts say, the nation would likely need to vaccinate roughly 70% of Americans, which translates to 200 million people and — because the first vaccines will require two doses to be effective — 400 million shots.

Although the CDC has overseen immunization campaigns in the past, the Trump administration created a new program, Operation Warp Speed, to facilitate vaccine development and distribution. In August, the administration announced that McKesson Corp., which distributed H1N1 vaccines during that pandemic, will also distribute COVID-19 vaccines to doctors’ offices and clinics.

“With few exceptions, our commercial distribution partners will be responsible for handling all the vaccines,” Operation Warp Speed’s Paul Mango said in an email.

“We’re not going to have 300 million doses all at once,” said Mango, deputy chief of staff for policy at the Health and Human Services Department, despite earlier government pledges to have that many doses ready by the new year. “We believe we are maximizing our probability of success of having tens of millions of doses of vaccines by January 2021, which is our goal.”

Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said it will take time for the vaccines to be widespread enough for life to return to what’s considered normal. “We have to be prepared to deal with this virus in the absence of significant vaccine-induced immunity for a period of maybe a year or longer,” Adalja said in August.

In preliminary guidance for state vaccine managers, the CDC said doses will be distributed free of charge from a central location. Health departments’ local vaccination plans may be reviewed by both the CDC and Operation Warp Speed.

The CDC has vetted state and federal vaccination plans in five locations: North Dakota, Florida, California, Minnesota and Philadelphia. No actual vaccines were distributed during the “microplanning” sessions, which focused on how to get vaccines to people in places as different as urban Philadelphia, where pharmacies abound, and rural North Dakota, which has few chain drugstores but many clinics run by the federal Indian Health Service, said Kris Ehresmann, who directs infectious disease control at the Minnesota Department of Health.

Those planning sessions have made Ehresmann feel more confident about who’s in charge of distributing vaccines. “We are getting more specific guidance from CDC on planning now,” she said. “We feel better about the process, though there are still a lot of unknowns.”

Outdated Technology Could Hamper Response

Still, many public health departments will struggle to adequately track who has been vaccinated and when, because a lack of funding in recent decades has left them in the technological dark ages, said Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials.

In Mississippi, for example, health officials still rely on faxes, said the state’s health officer, Dr. Thomas Dobbs. “You can’t manually handle 1,200 faxes a day and expect anything efficient to happen,” he said.

When COVID-19 vaccines become available, health providers will need to track where and when patients receive their vaccines, said Moore, the medical director of Tennessee’s immunization plan during the H1N1 influenza pandemic in 2009 and 2010. And with many different shots in the works, they will need to know exactly which one each patient got, she said.

People will need to receive their second COVID-19 dose 21 or 28 days after the first, so health providers will need to remind patients to receive their second shot, Moore said, and ensure that the second dose is the same brand as the first.

The CDC will require vaccinators to provide “dose-level accounting and reporting” for immunizations, so that the agency knows where every dose of COVID-19 vaccine is “at any point in time,” Moore said. Although “the sophistication of these systems has improved dramatically” in the past decade, she said, “many states will still face major challenges meeting data tracking and reporting expectations.”

The CDC is developing an app called the Vaccine Administration Monitoring System for health departments whose data systems don’t meet standards for COVID-19 response, said Claire Hannan, executive director of the Association of Immunization Managers, a nonprofit based in Rockville, Maryland.

“Those standards haven’t been released,” Hannan said, “so health departments are waiting to invest in necessary IT enhancements.” The CDC needs to release standards and data expectations as quickly as possible, she added.

Meanwhile, health departments are dealing with what Minnesota’s Ehresmann described as “legacy” vaccine registries, sometimes dating to the late 1980s.

A Historic Task

Overwhelmed public health teams are already working long hours to test patients and trace their contacts, a time-consuming process that will need to continue even after vaccines become available.

When vaccines are ready, health departments will need more staffers to identify people at high risk for COVID-19, who should get the vaccine first, Moore said. Public health staff also will be needed to educate the public about the importance of vaccines and to administer shots, she said, as well as monitor patients and report serious side effects.

At an August meeting about vaccine distribution, Dr. Ngozi Ezike, director of Illinois’ health department, said her state will need to recruit additional health professionals to administer the shots, including nursing students, medical students, dentists, dental hygienists and even veterinarians. Such vaccinators will need medical-grade masks, gowns and gloves to keep those workers safe as they handle needles amid the contagious coronavirus.

Many health officials say they feel burned by the country’s struggle to provide hospitals with ventilators last spring, when states found themselves bidding against one another for a limited supply. Those concerns are amplified by the country’s continuing difficulties providing enough testing kits; supplying health workers with personal protective equipment; allocating drugs such as remdesivir; and recruiting contact tracers — who track down everyone with whom people diagnosed with COVID-19 have been in contact.

Although Ehresmann said she’s concerned Minnesota could run out of syringes, she said the CDC has assured her they will provide them.

Given that vaccines are far more complex than personal protective equipment and other medical supplies — one vaccine candidate must be stored at minus 94 degrees Fahrenheit — Plescia said people should be prepared for shortages, delays and mix-ups.

“It’s probably going to be even worse than the problems with testing and PPE,” Plescia said.

Associated Press writer Michelle R. Smith and KHN Midwest correspondent Lauren Weber contributed to this report.

This story is a collaboration between The Associated Press and KHN, an editorially independent program of the Kaiser Family Foundation.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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NEW YORK — Evaristo “Risto” Grant counted down from 10 as his clients held their plank positions and shook with the effort. Michael Jackson’s “Wanna Be Startin’ Somethin’” blared in the background. Grant paced around his clients on their yoga mats, shouting words of encouragement.

It looked and sounded like any normal gym session. Except it wasn’t. Grant’s gym consisted of a few yoga mats and equipment underneath a strip of scaffolding in Carl Schurz Park, which borders the East River in Manhattan. People on their evening quarantine walks strolled by, many glancing with amusement at the signs Grant had taped to the scaffolding: “Get your sexy back … no more cookies!” and “Come for the party, stay for the workout!”

Grant, 57, was despondent for the first few weeks of quarantine last spring. New York City was quickly becoming the epicenter of the coronavirus pandemic, and everyone hunkered down at home. As a personal trainer who works for himself, Grant watched his income crumble.

Then, a lightbulb went off. Grant used some savings to buy face shields, disinfectant, hand sanitizer and some additional equipment. He set up shop in the park, which is just a few blocks from his house, and started to attract new clients.

“This is an opportunity to meet people and get prospective clients for the future,” Grant said. “I just talk to people, connect, share and inspire, hopefully.”

One new client is Elizabeth Pompa, a 53-year-old real estate agent living on the Upper East Side. Pompa, who used to teach Lotte Berk Technique dance-based exercise classes, has always valued fitness and personal training. Her husband struck up a conversation with Grant while working out next to him and later suggested Pompa give Grant a try. Since then, she’s seen Grant once a week.

“He pushes me, but in a great way,” Pompa said. “I know I’m not going to get hurt with him. For that hour, I forget everything that’s going on around me.”

Casey Grillo, a 40-year-old nurse practitioner, comes to Grant’s sessions twice a week. At the start of the pandemic, she would not have considered working out with others in person. But she said now that she and others know how to take the appropriate measures to stay safe, she’s comfortable at Grant’s sessions.

Grant holds small classes Sunday through Thursday, charging his clients $25 per session. And he teaches private clients on Fridays for $85. At every session, he wears a face shield and reminds clients to stay 6 feet apart. He disinfects equipment after every use and offers hand sanitizer to those who want it.

Grillo said she’s noticed a larger community of fitness enthusiasts getting their exercise outside. She admires everyone’s creativity.

“I’ve seen people use canned goods and water bottles and gallon jugs for weights,” Grillo said. “It’s really encouraging to see people still staying active.”

Grant is not the only personal trainer using Carl Schurz as gym space. Patrick Narain, a 36-year-old trainer and martial arts instructor, has been teaching classes in Carl Schurz, Astoria Park and Central Park. At the beginning of the pandemic, he mostly did virtual classes from home without charging people. It was tough, he said, staying financially afloat on solely the tips he got from online clients. Now he’s getting $15 from each class participant.

As for many people, Narain said the pandemic and subsequent quarantine have caused him anxiety.

“I find myself worrying too much about others and not really paying attention to taking care of myself,” Narain said. “It really caused me a lot of stress, to the point where I couldn’t really feel my right side.”

His stress slowly improved as he worked with another instructor to teach small classes in the park. He’s enjoying the fresh air and open space, though he’s careful not to push clients too hard in the heat.

Devin Paul, another trainer, also transitioned his business smoothly to the outdoors. He’d worked with a gym until the quarantine started, and now he’s training his own clients in Carl Schurz and in Jackie Robinson Park in Harlem.

Paul, 46, has found that since he’s working for himself, he’s making more money and working fewer hours. He said his minimum fee for a private lesson is $100.

“I’m at a point in my life where I don’t think I’m going to go back when the gyms open,” Paul said. “I can have a better peace of mind just doing everything on my own.”

Paul plans to rent a training studio when the weather turns too cold to work outside.

Grant said the personal trainer community has had one another’s backs through it all. He’s been a part of the industry for 17 years, ever since a fellow fitness enthusiast told him he’d be a “natural.” He’s seeing trainers he’s known for a long time using parks to their advantage, being creative and making things work.

“We just try to help each other out and stand for each other,” Grant said.

Pre-pandemic, Grant had been doing well financially with his model of meeting up with clients at gyms and getting new ones through referrals. Still, he’s taking the pandemic as an opportunity to reevaluate his operation.

“We have to really think about how to create something for the future and see the glass as half full and be optimistic because you’ll never know what you create when you put your mind to it,” he said.

For the foreseeable future, he’s sticking around at his makeshift gym throughout the week, hoping to entice people to “get your sexy back.”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

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Millones de estadounidenses esperan una vacuna contra COVID-19 para frenar la pandemia y volver a la normalidad.

Pero el camino para entregar vacunas a 330 millones de personas sigue sin estar claro para los funcionarios de salud locales que, se espera, sean los que realicen el trabajo.

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“No hemos recibido mucha información sobre cómo se implementará”, dijo el doctor Umair Shah, director ejecutivo del Departamento de Salud Pública del condado de Harris, en Texas, que incluye a Houston.

Los Centros para el Control y Prevención de Enfermedades (CDC) han dicho a los departamentos de salud locales a lo largo del país que diseñen planes de vacunación antes del primero de octubre, para una posible distribución de una vacuna contra COVID-19 tan pronto como el primero de noviembre.

Pero los departamentos de salud, que han carecido de fondos suficientes durante décadas, dicen que no tienen personal, dinero ni herramientas para educar a las personas sobre las vacunas; y luego para distribuir, administrar y rastrear cientos de millones de dosis. Tampoco saben cuándo, o si obtendrán ayuda federal para lograrlo.

Docenas de médicos, enfermeras y funcionarios de salud entrevistados por KHN y The Associated Press expresaron preocupación por la disposición del país para realizar vacunaciones masivas, y frustración por meses de información inconsistente por parte del gobierno federal.

Las brechas incluyen cómo se hará el seguimiento de los vacunados, y cómo mantendrán a los trabajadores que administran las vacunas seguros, con suficiente equipo de protección y jeringas.

Con solo la mitad de los estadounidenses diciendo que se vacunarán, según una encuesta del Centro de Investigación de Asuntos Públicos de AP-NORC, también será crucial educar a las personas sobre los beneficios de la vacunación, dijo Molly Howell, quien administra el programa de inmunizaciones del Departamento de Salud de Dakota del Norte.

Estados Unidos ha comprometido más de $10 mil millones para desarrollar nuevas vacunas contra el coronavirus, pero no ha asignado dinero específico para distribuirlas y administrarlas.

Y aunque los gobiernos locales recibieron miles de millones en fondos de emergencia del Congreso, ese dinero no está destinado a distribuir una vacuna.

Una investigación en curso de KHN y AP ha detallado cómo los departamentos de salud pública estatales y locales han sufrido décadas de desmantelamiento, lo que los ha dejado sin fondos suficientes para realizar servicios básicos, y enfrentar al coronavirus

Los estados pueden usar parte del dinero federal que ya han recibido para prepararse para las vacunas. Pero AP y KHN descubrieron que muchos departamentos de salud están tan abrumados con los costos actuales de la pandemia, como las pruebas y el rastreo de contactos, que no pueden reservar dinero para el proceso con las vacunas.

Los departamentos de salud deberán contratar personas para administrarlas y sistemas para rastrearlas, y pagar por suministros como máscaras médicas protectoras, batas y guantes, espacios para almacenarlas, y refrigeradores.

Por ejemplo, el presupuesto del condado de Pima, en Arizona, ya está unos $30 millones por debajo de lo que los funcionarios de salud necesitan para combatir la pandemia, y mucho menos planificar la vacunación, expresó el doctor Francisco García, administrador adjunto y director médico del condado.

Algunos fondos federales vencerán pronto. Por ejemplo, los $150 mil millones que los gobiernos estatales y locales recibieron de un fondo en la Ley CARES, cubren solo los gastos que se realicen hasta fin de año, dijo Gretchen Musicant, comisionada de salud en Minneapolis. Un problema, dado que la distribución de la vacuna puede que ni siquiera haya comenzado para ese momento.

Aunque funcionarios de salud pública dicen que necesitan ayuda, el Congreso dejó Washington para su receso de verano sin aprobar un nuevo proyecto de ley de ayuda para COVID, que hubiera incluido fondos adicionales para la distribución de vacunas.

Los estados no pueden simplemente tomar las fuentes de financiamiento existentes y utilizarlas para intentar la campaña de vacunación más grande de la historia, dijo la doctora Kelly Moore, de la Coalición de Acción de Inmunización, una organización nacional de educación y defensa de las vacunas.

Luego está la cuestión básica de la escala. El invierno pasado, el país distribuyó 175 millones de vacunas contra la influenza estacional, según los CDC.

Pero expertos dicen que, para que los Estados Unidos alcancen la inmunidad colectiva contra el coronavirus, es probable que se deba vacunar a aproximadamente el 70% de los estadounidenses, o 200 millones de personas. Las primeras vacunas requerirán dos dosis para ser efectivas: 400 millones de inyecciones.

Los mismos expertos auguran que muchos departamentos de salud pública tendrán dificultades para realizar un seguimiento adecuado de quién se ha vacunado y cuándo, porque la falta de fondos en las últimas décadas los ha dejado con tecnología obsoleta.

Moore, quien fue directora médica del plan de inmunización de Tennessee durante la pandemia de influenza H1N1, dijo que las personas necesitarán recibir su segunda dosis de COVID-19 21 o 28 días después de la primera, por lo que los proveedores de salud deberán recordarles a los pacientes que deben recibir su segunda vacuna.

También deben asegurarse que la segunda dosis sea de la misma marca que la primera.

Los CDC están desarrollando una aplicación llamada Sistema de Monitoreo de la Administración de Vacunas para los departamentos de salud cuyos sistemas de datos están rezagados, dijo Claire Hannan, directora ejecutiva de la Asociación de Administradores de Inmunización. Los departamentos están esperando saber más sobre esta tecnología.

Mientras tanto, se ocupan de los registros de vacunas que a veces datan de finales de la década de 1980.

Los abrumados equipos de salud pública ya están trabajando largas horas para hacer pruebas a los pacientes y rastrear sus contactos, un proceso que requiere mucho tiempo y que deberá continuar incluso después que las vacunas estén disponibles.

Cuando eso suceda, los departamentos necesitarán más personal para una variedad de trabajos, incluida la educación del público, el seguimiento de los pacientes y la notificación de efectos secundarios graves.

En una reunión de agosto sobre la distribución de vacunas, la doctora Ngozi Ezike, directora del departamento de salud de Illinois, dijo que su estado necesitará contratar profesionales de salud adicionales para administrar las vacunas, incluidos estudiantes de enfermería, estudiantes de medicina, dentistas, higienistas dentales e incluso veterinarios.

Todos necesitarán máscaras, batas y guantes de grado médico para seguridad mientras manipulan agujas en medio del contagioso coronavirus.

Dado que las vacunas son mucho más complejas que el equipo de protección personal y otros suministros médicos (una vacuna candidata debe almacenarse a menos de 94 grados Fahrenheit), el doctor Marcus Plescia, director médico de la Asociación de Funcionarios de Salud Estatales y Territoriales, dijo que las personas deben estar preparadas para escasez, retrasos y confusión.

“Probablemente será incluso peor que los problemas con las pruebas y los equipos de protección personal”, dijo Plescia.

La escritora de Associated Press Michelle R. Smith y la corresponsal de KHN en el Medio Oeste Lauren Weber colaboraron con este informe.

Esta historia es una colaboración entre The Associated Press y KHN.

A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci, the nation’s top infectious disease official, in an interview Tuesday with KHN.

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,’” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

Fauci’s comments come at a time of growing concern about whether political pressure from the Trump administration could influence federal regulators and scientists overseeing the nation’s response to the novel coronavirus pandemic, and erode shaky public confidence in vaccines. Prominent vaccine experts have said they fear Trump is pushing for an early vaccine approval to help win reelection.

Fauci, director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.

“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. “I’m not concerned about political pressure.”

The safety board periodically looks at data from a clinical trial to determine if it’s ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they’re receiving.

Manufacturers are now testing three COVID vaccines in large-scale U.S. trials. The first two studies — one led by Moderna and the National Institutes of Health and the other led by Pfizer and BioNTech — began in late July. Each study was designed to enroll 30,000 participants. Company officials have said both trials have enrolled about half that total. AstraZeneca , which has been running large-scale clinical trials in Great Britain, Brazil and South Africa, launched another large-scale vaccine study this week in the U.S., involving 30,000 volunteers. Additional vaccine trials are expected to begin this month.

In trials of this size, researchers will know if a vaccine is effective after as few as 150 to 175 infections, said Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, in a call with reporters Friday.

“It may be surprising, but the number of events that need to occur is relatively small,” Redfield said.

Right now, only the safety board has access to the trial data, said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services. As for when trial results will be available, “we cannot determine if it will be the middle of October or December.”

Safety boards set “stopping rules” at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol, executive vice president for research at Scripps Research in San Diego and an expert on the use of data in medical research.

Although the safety board can recommend stopping a trial, the ultimate decision to halt a study is made by the scientists running the trial, Topol said.

A vaccine manufacturer could then apply to the Food and Drug Administration for an emergency use authorization, which can be granted quickly, or continue through the regular drug approval process, which requires more time and evidence.

Safety monitors also can stop a trial because of safety concerns, “if it looks like it’s actually harming people in the vaccine arm, due to a lot of adverse events,” Fauci said.

Fauci said people can trust the process, because all the data that outside monitors used to make their decisions would be made public.

“All of that has to be transparent,” Fauci said. “The only time you get concerned is if there is any pressure to terminate the trial before you have enough data on safety and efficacy.”

Topol and other scientists have sharply criticized the FDA in recent weeks, accusing Commissioner Stephen Hahn of bowing to political pressure from the Trump administration, which has pushed the agency to approve COVID treatments faster.

Stopping trials early poses a number of risks, such as making a vaccine look more effective than it really is, Topol said.

“If you stop something early, you can get an exaggerated benefit that isn’t real,” because less positive evidence only emerges later, Topol said.

Stopping the studies early also could prevent researchers from recruiting more minority volunteers. So far, only about 1 in 5 trial participants is Black or Hispanic. Given that Blacks and Hispanics have been hit harder than other groups by the pandemic, Topol said, it’s important that they make up a larger part of vaccine trials.

Ending vaccine trials early also carries safety risks, said Dr. Paul Offit, a vaccine developer who serves on an NIH advisory panel on COVID vaccines and treatments.

A smaller, shorter trial could fail to detect important vaccine side effects, which could become apparent only after millions of people have been immunized, said Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Researchers will continue to follow vaccinated volunteers for a full year to look for long-term side effects, Redfield said.

And Fauci acknowledged that cutting a trial short could undermine public confidence in COVID vaccines. One in three Americans is unwilling to get a COVID vaccine, according to a recent Gallup Poll.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Una vacuna contra COVID-19 podría estar disponible antes de lo esperado si los ensayos clínicos en curso producen resultados abrumadoramente positivos, dijo el doctor Anthony Fauci, funcionario de enfermedades infecciosas de más alto rango del país, en una entrevista con KHN.

Aunque se espera que dos ensayos clínicos en curso con 30,000 voluntarios terminen para fin de año, Fauci dijo que una junta independiente tiene la autoridad para finalizarlos semanas antes si los resultados provisionales son abrumadoramente positivos o, por el contrario, negativos.

La Junta de Monitoreo de Datos y Seguridad (DSMB) podría decir: “al momento, los datos son tan buenos que se puede decir que son seguros y efectivos”, explicó Fauci. En ese caso, los investigadores tendrían “la obligación moral” de finalizar el ensayo antes de tiempo y hacer que la vacuna esté disponible para todos en el estudio, incluidos los que recibieron placebos, y acelerar el proceso para administrarla a millones.

Los comentarios de Fauci, quien es director del Instituto Nacional de Alergias y Enfermedades Infecciosas, ocurren en un momento de creciente preocupación sobre si la presión política de la administración Trump podría influir en los reguladores federales y los científicos que supervisan la respuesta de la nación a la pandemia del nuevo coronavirus. Y erosionar la débil confianza del público en las vacunas.

Destacados expertos en vacunas han dicho que temen que Trump esté presionando por una aprobación temprana de una vacuna para ayudar a ganar la reelección.

Fauci dijo que confía en los miembros independientes del DSMB, que no son empleados del gobierno, para mantener las vacunas a altos estándares sin influencias políticas. Los miembros de la junta suelen ser expertos en inmunización y bioestadística, y suelen dar cátedra en las principales escuelas de medicina.

“Si estás tomando una decisión sobre la vacuna, es mejor asegurarse de tener muy buena evidencia de que es segura y efectiva”, dijo Fauci. “No me preocupa la presión política”.

La junta de seguridad analiza periódicamente los datos de un ensayo clínico para determinar si es ético continuar inscribiendo voluntarios, que se asignan al azar para recibir una vacuna experimental o una inyección de placebo (que no contiene la dosis de la vacuna). Ni los voluntarios ni los trabajadores sanitarios que los inyectan saben qué vacuna están recibiendo.

Los fabricantes ahora están probando tres vacunas contra COVID en ensayos a gran escala en los Estados Unidos. Los dos primeros estudios, uno dirigido por Moderna y los Institutos Nacionales de Salud y el otro dirigido por Pfizer y BioNTech, comenzaron a fines de julio.

Cada estudio fue diseñado para inscribir a 30,000 participantes. Los funcionarios de la compañía han dicho que ambos ensayos han inscrito aproximadamente la mitad de ese total. AstraZeneca, que ha estado ejecutando ensayos clínicos a gran escala en Gran Bretaña, Brasil y Sudáfrica, lanzó otro gran estudio con una vacuna en los Estados Unidos la primera semana de septiembre, en el que participan 30,000 voluntarios. Se espera que comiencen ensayos adicionales de vacunas este mes.

En ensayos de este tamaño, los investigadores sabrán si una vacuna es efectiva después de tan solo 150 a 175 infecciones, dijo el doctor Robert Redfield, director de los Centros para el Control y Prevención de Enfermedades (CDC), en una llamada con periodistas el viernes 28 de agosto.

“Puede ser sorprendente, pero el número de eventos que deben ocurrir es relativamente pequeño”, dijo Redfield.

En este momento, la junta de seguridad sólo tiene acceso a los datos del ensayo, dijo Paul Mango, subdirector de personal para Normas del Departamento de Salud y Servicios Humanos (HHS). En cuanto a cuándo estarán disponibles los resultados de la prueba, “no podemos determinar si será a mediados de octubre o diciembre”.

Las juntas de seguridad establecen “reglas de detención” al comienzo de un estudio, lo que deja muy claro sus criterios para finalizar un ensayo, dijo el doctor Eric Topol, vicepresidente ejecutivo de investigación de Scripps Research en San Diego y experto en el uso de datos en investigación médica.

Aunque la junta de seguridad puede recomendar detener un ensayo, la decisión final la toman los científicos que lo está realizando, dijo Topol.

Luego, un fabricante de vacunas podría solicitar a la Administración de Alimentos y Medicamentos (FDA) una autorización de uso de emergencia, que se puede otorgar rápidamente, o continuar a través del proceso regular de aprobación de medicamentos, que requiere más tiempo y evidencia.

Los que monitorean la seguridad también pueden detener un ensayo debido a preocupaciones de seguridad, “si parece que realmente está dañando a las personas en el brazo, o por una una gran cantidad de efectos secundarios”, dijo Fauci.

Fauci dijo que la gente puede confiar en el proceso, porque todos los datos que los monitores externos usaron para tomar sus decisiones se hacen públicos.

“Todo eso tiene que ser transparente”, dijo Fauci. “El único momento preocupante es si existe alguna presión para terminar el ensayo antes de tener suficientes datos sobre seguridad y eficacia”.

En las últimas semanas, Topol y otros científicos han criticado duramente a la FDA, acusando al comisionado Stephen Hahn de ceder ante la presión política de la administración Trump, que ha empujado a la agencia a aprobar los tratamientos para COVID más rápido.

Frenar los ensayos antes de tiempo plantea una serie de riesgos, por ejemplo,  hacer que una vacuna parezca más eficaz de lo que realmente es, dijo Topol.

“Si detienes algo antes, puedes obtener un beneficio exagerado que no es real, porque la evidencia menos positiva solo surge más tarde”, dijo Topol.

Detener los estudios antes de tiempo también podría evitar que los investigadores recluten más voluntarios de minorías. Hasta ahora, solo 1 de cada 5 participantes del ensayo son personas de raza negra o hispanos (de todas las razas). Dado que esos grupos se han visto más afectados por la pandemia que otros, es importante que constituyan una parte más importante de los ensayos de vacunas, agrego Topol.

La finalización temprana de los ensayos de vacunas también conlleva riesgos de seguridad, expresó el doctor Paul Offit, desarrollador de vacunas que forma parte de un panel asesor de los NIH sobre vacunas y tratamientos para COVID.

Un ensayo más pequeño y más corto podría no detectar efectos secundarios importantes de la vacuna, que podrían hacerse evidentes solo después de que millones de personas hayan sido inmunizadas, dijo Offit, director del Centro de Educación sobre Vacunas del Hospital de Niños de Philadelphia.

Los investigadores continuarán siguiendo a los voluntarios vacunados durante un año completo para detectar efectos secundarios a largo plazo, dijo Redfield.

Y Fauci reconoció que acortar un ensayo podría socavar la confianza del público en las vacunas contra COVID. Uno de cada tres estadounidenses no está dispuesto a recibir una vacuna contra el nuevo coronavirus, según una encuesta reciente de Gallup.

Esta historia fue producida por Kaiser Health News, un programa editorial independiente de la Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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