Imagine this scenario, perhaps a year or two in the future: An effective COVID-19 vaccine is routinely available and the world is moving forward. Life, however, will likely never be the same — particularly for people over 60.
That is the conclusion of geriatric medical doctors, aging experts, futurists and industry specialists. Experts say that in the aftermath of the pandemic, everything will change, from the way older folks receive healthcare to how they travel and shop. Also overturned: their work life and relationships with one another.
"In the past few months, the entire world has had a near-death experience," said Ken Dychtwald, CEO of Age Wave, a think tank on aging around the world. "We've been forced to stop and think: I could die or someone I love could die. When those events happen, people think about what matters and what they will do differently."
Older adults are uniquely vulnerable because their immune systems tend to deteriorate with age, making it so much harder for them to battle not just COVID-19 but all infectious diseases. They are also more likely to suffer other health conditions, like heart and respiratory diseases, that make it tougher to fight or recover from illness. So it's no surprise that even in the future, when a COVID-19 vaccine is widely available — and widely used — most seniors will be taking additional precautions.
"Before COVID-19, baby boomers" — those born after 1945 but before 1965 — "felt reassured that with all the benefits of modern medicine, they could live for years and years," said Dr. Mehrdad Ayati, who teaches geriatric medicine at Stanford University School of Medicine and advises the U.S. Senate Special Committee on Aging. "What we never calculated was that a pandemic could totally change the dialogue."
It has. Here's a preview of post-vaccine life for older Americans:
Medical Care
Time to learn telemed. Only 62% of people over 75 use the internet — and fewer than 28% are comfortable with social media, according to data from the Pew Research Center. "That's lethal in the modern age of healthcare," Dychtwald said, so there will be a drumbeat to make them fluent users of online healthcare.
1 in 3 visits will be telemed. Dr. Ronan Factora, a geriatrician at Cleveland Clinic, said he saw no patients age 60 and up via telemedicine before the pandemic. He predicted that by the time a COVID-19 vaccine is available, at least a third of those visits will be virtual. "It will become a significant part of my practice," he said. Older patients likely will see their doctors more often than once a year for a checkup and benefit from improved overall healthcare, he said.
Many doctors instead of just one. More regular remote care will be bolstered by a team of doctors, said Greg Poland, professor of medicine and infectious diseases at the Mayo Clinic. The team model "allows me to see more patients more efficiently," he said. "If everyone has to come to the office and wait for the nurse to bring them in from the waiting room, well, that's an inherent drag on my productivity."
Drugstores will do more vaccinations. To avoid the germs in doctors' offices, older patients will prefer to go to drugstores for regular vaccinations such as flu shots, Factora said.
Your plumbing will be your doctor. In the not-too-distant future — perhaps just a few years from now — older Americans will have special devices at home to regularly analyze urine and fecal samples, Dychtwald said, letting them avoid the doctor's office.
Travel
Punch up the Google Maps. Many trips of 800 miles or less will likely become road trips instead of flights, said Ed Perkins, a syndicated travel columnist for the Chicago Tribune. Perkins, who is 90, said that's certainly what he plans to do — even after there's a vaccine.
Regional and local travel will replace foreign travel. Dychtwald, who is 70, said he will be much less inclined to travel abroad. For example, he said, onetime plans with his wife to visit India are now unlikely, even if a good vaccine is available, because they want to avoid large concentrations of people. That said, each year only 25% of people 65 and up travel outside the U.S. annually, vs. 45% of the general population, according to a survey by Visa. The most popular trip for seniors: visiting grandchildren.
Demand for business class will grow. When older travelers (who are financially able) choose to fly, they will more frequently book roomy business-class seats because they won't want to sit too close to other passengers, Factora said.
Buying three seats for two. Older couples who fly together — and have the money — will pay for all three seats so no one is between them, Perkins said.
Hotels will market medical care. Medical capability will be built into more travel options, Dychtwald said. For example, some hotels will advertise a doctor on-site — or one close by. "The era is over of being removed from healthcare and feeling comfortable," he said.
Disinfecting will be a sales pitch. Expect a rich combination of health and safety "theater" — particularly on cruises that host many older travelers, Perkins said: "Employees will be wandering around with disinfecting fogs and wiping everything 10 times."
Cruises will require proof of vaccination. Passengers — as well as cruise employees — will likely have to prove they've been vaccinated before traveling, Factora said.
Eating/Shopping
Local eateries will gain trust. Neighborhood and small-market restaurants will draw loyal customers — mainly because they know and trust the owners, said Christopher Muller, a hospitality professor at Boston University.
Safety will be a bragging point. To appeal to older diners in particular, restaurants will prominently display safety-inspection signage and visibly signal their cleanliness standards, Muller said. They will even hire employees exclusively to wipe down tables, chairs and all high-touch points — and these employees will be easy to identify and very visible.
Home Life
The homecoming. Because of so many COVID-19 deaths in nursing homes, more seniors will leave assisted living facilities and nursing homes to move in with their families, Factora said. "Families will generally move closer together," he said.
The fortress. Home delivery of almost everything will become the norm for older Americans, and in-person shopping will become much less common, Factora said.
Older workers will stay home. The 60-and-up workforce increasingly will be reluctant to work anywhere but from home and will be very slow to re-embrace grocery shopping. "Instacart delivery will become the new normal for them," Dychtwald said.
Gatherings
Forced social distancing. Whenever or wherever large families gather, people exhibiting COVID-like symptoms may not be welcomed under any circumstances, Ayati said.
Older folks will disengage, at a cost. Depression will skyrocket among older people who isolate from family get-togethers and large gatherings, Ayati said. "As the older population pulls back from engaging in society, this is a very bad thing."
Public restrooms will be revamped. For germ avoidance, they'll increasingly get no-touch toilets, urinals, sinks and entrances/exits. "One of the most disastrous places you can go into is a public restroom," Poland said. "That's about the riskiest place."
With millions of lives on the line, researchers have been working at an unprecedented pace to develop a COVID-19 vaccine.
But that speed — and some widely touted breakthroughs — belie the enormous complexity and potential risks involved. Researchers have an incomplete understanding of the coronavirus and are using technology that's largely unproven.
Among many worries: A handful of studies on COVID-19 survivors suggest that antibodies — key immune system proteins that fight infection — begin to disappear within months. That's led scientists to worry that the protection provided by vaccines could fade quickly as well. Some even question whether vaccines will really end the pandemic. If vaccines produce limited protection against infection, experts note, people will need to continue wearing masks and social distancing even after vaccines roll out.
Yet in an interview with KHN, the country's top infectious disease expert, Dr. Anthony Fauci, said he's "cautiously optimistic" that researchers will overcome such obstacles.
"We know the body can make an adequate response against this virus" after two shots of a vaccine being tested, Fauci said. "There's no reason to believe that we won't be able to develop a vaccine against it."
Scientists will get answers to some of their questions from the country's first large-scale COVID-19 vaccine trial, launched last week by the National Institutes of Health and Moderna at 89 locations around the country.
"Once we get a protective response, we will see how long it lasts," Fauci said.
"If we don't get as long a response as we want, we can always give a booster shot."
"Even more so than usual, as we create vaccines, we're sailing in uncharted water," said Dr. William Schaffner, a professor at the Vanderbilt University School of Medicine.
If approved, a COVID vaccine created by researchers at Oxford University and drugmaker AstraZeneca would be the first licensed vaccine to use a virus that causes colds in chimpanzees but doesn't sicken people. Scientists use the cold virus to deliver key elements of the vaccine into a patient's body. In this case, the virus delivers the gene that instructs the cell to make the spike protein, which helps the novel coronavirus enter cells.
Early studies show that the Oxford vaccine stimulates the immune system as intended. If the vaccine is successful, these antibodies and other immune cells will recognize and neutralize the spike protein if they encounter it again, protecting people from disease.
Two other candidates — a vaccine from Modernaand another from Pfizer and BioNTech, a German company — were also developed with novel methods. They use genetic material from the coronavirus called messenger RNA, or mRNA.
Unlike traditional vaccines, which expose the body to a viral protein to stimulate the immune system,mRNA acts as an instruction kit, telling the body how to construct the proteins itself. The immune system then responds to the viral protein by making antibodies.
Moderna officials have said they were able to produce the COVID-19 vaccine so rapidly because they had developed experimental vaccines against two other lethal coronaviruses — those that cause SARS and MERS — which are closely related to the COVID-19 virus.
When the pandemic emerged, Moderna tweaked those vaccines to target COVID-19, Fauci told KHN. Fauci's team contacted the company the day after China made the virus's genome public.
Two months later, Moderna's vaccine was ready for a trial because "98% of the scientific work had been done," Schaffner said. "They went back to these scientific methods and adapted them very quickly. That saves years of work."
But there is a potential risk in relying so heavily on unproven techniques: New technology can sometimes cause unforeseen problems or side effects, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
For all their differences, most of the vaccines in development target the spike protein, Adalja said. That is likely a winning strategy, considering successful veterinary coronavirus vaccines also target the spike protein.
But some scientists say this uniform approach could also leave us vulnerable.
Ideally, scientists should diversify the portfolio of vaccines, in case targeting the spike protein doesn't work as well as researchers hope, Adalja said. Developing a vaccine that targets other key proteins might help scientists to hedge their bets.
Researchers around the world are working on more than 165 vaccines; more than two dozen are already being tested in people. Early human studies focus on safety and finding the best dose. Later clinical trials are larger and measure a vaccine's effectiveness by comparing the outcomes of volunteers who receive the vaccine with those of people given a placebo.
Fauci said he's reassured by early studies that showed the Moderna vaccine to be safe. Although some volunteers developed fevers and headaches after vaccination, these side effects were no worse than those caused by other licensed vaccines.
"That's not a showstopper at all," he said.
A Perplexing Pathogen
Some of COVID-19's most important mysteries involve the immune system, said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
Offit said he's mystified by the fact that a small fraction of people with COVID-19 don't make any antibodies against the virus. He knows of no other virus that does this.
"We're only seven months into this and we've had a lot of surprises," said Offit, a member of a National Institutes of Health effort to develop vaccines and drugs to treat COVID-19. "This virus does things that no other virus does."
This is not like preventing measles. "It's easier to create a vaccine for diseases that confer long-term immunity," Offit said. People never catch measles more than once. The two-dose measles vaccine stimulates immunity, protecting 97% of people for life, Offit said.
It's also not like strep throat or gonorrhea, which people can catch multiple times because the bacteria that cause them don't ignite lasting immunity. "That's why we don't have a vaccine for them," he said.
Some coronaviruses cause more serious symptoms than others. Coronaviruses that cause the common cold don't stimulate lastingantibodies, which is one reason people can catch colds repeatedly, Schaffner said.
Studies show that antibodies against more lethal coronaviruses last a bit longer. Antibodies against the severe acute respiratory syndrome virus, which caused a pandemic in 2003, and the Middle East respiratory syndrome virus, which appeared in 2011, appear to last two to three years.
People with severe symptoms from COVID-19 tend to have higher antibody levels than those with milder cases.
Some people fail to generate antibodies because they have compromised immune systems, said Mark Sangster, a research professor at the University of Rochester Medical Center.
Even when people do generate antibodies against the novel coronavirus, studies suggest the antibodies may not last long.
Such reports have worried some scientists, who fear that antibodies will decline just as rapidly among people vaccinated against COVID-19.
"One wants a vaccine that lasts longer than two months," Schaffner said.
Other antibody research has been more encouraging.
A July paper found that COVID-19 infection "induces robust, neutralizing antibody responses that are stable for at least three months." Antibodies typically rise during an infection, then fall again as the immune system returns to normal, said Florian Krammer, co-author of the study, which was published online before undergoing peer review.
"What we found looks like a normal antibody response to a viral infection," said Krammer, a professor of microbiology at the Icahn School of Medicine at Mount Sinai in New York.
Early studies of the Moderna vaccine suggest people mount a strong immune response after two doses, Fauci said. But because the earliest trials began just a few months ago, doctors don't yet know how long antibodies in vaccinated people will last.
Conflicting evidence on antibodies "shouldn't interfere with efforts to develop a safe and effective vaccine," added Fauci, noting he's encouraged by the results of early clinical trials. "The durability of the vaccine may be quite good."
Dr. Michael Watson, who is developing Moderna's COVID-19 vaccine, said he hopes vaccinated people will have a stronger immune response than those sickened by the coronavirus. He said it's possible the virus not only infects cells, but also dampens the immune system, suppressing antibody response.
A vaccine that contains only one part of the novel coronavirus — a protein that allows it to enter cells — might be able to stimulate antibody production without suppressing the immune response, Watson said. Only large clinical studies will show whether this is the case.
Memories That Don't Fade
Yet there's more to the immune system than antibodies.
The body is also protected by memory T-cells, which can recognize viral threats to stimulate the production of antibodies even after many years, said Dr. Jeffrey Klausner, professor of infectious diseases at UCLA. Memory T-cells can stimulate B-cells to make antibodies, while instructing other immune system players to fight the virus in different ways.
"The T-cells are like the conductors of a symphony," Klausner said. "These multiple, complex arms of the immune system work together like a symphony to control infection."
Even if antibodies dwindle over time, memory cells can often replenish the supply, preventing infected patients from developing dangerous symptoms, Sangster said.
Fauci said it's too early to know what sort of role T-cells will play in defending against the novel coronavirus.
Researchers will get more definitive answers about vaccine-induced immunity to COVID-19 in coming months, after they complete large, rigorous trials of tens of thousands of volunteers, Offit said. Vaccine makers have said they plan to study their products' safety and effectiveness even after approval, to measure long-term efficacy as well to detect rare side effects that don't appear in smaller, shorter studies.
In addition to Moderna's trial, AstraZeneca said results from an ongoing study of 50,000 volunteers should be available this fall.
With so many vaccines in development, Adalja said, it's difficult to know which one will prove the safest and most effective.
"The first vaccines may not be the ultimate vaccine that everybody uses," he said.
And some vaccines may work better in certain populations than others, Offit said. For example, studies may find that one shot works particularly well in children, while another better protects older adults. "There is definitely a lot to learn," he said.
Ideally, doctors would like all vaccines to be as successful as the measles shot, Offit said. But a COVID-19 vaccine could more closely resemble flu shots and rotavirus vaccines, which don't prevent all infections but dramatically reduce the risks of hospitalization and death. Although some people who receive a flu shot still get influenza, their infections tend to be much milder than those of people who aren't vaccinated.
"You'd like to have a vaccine that protects against severe disease, and it likely will," Offit said. "But people might still get mild infections and still shed the virus and still spread it" even after being vaccinated.
If that happens, Offit said, the vaccine may not slow the spread of the pandemic as much as people have hoped. "You'd still need masks and social distancing" to reduce the spread of the virus, Offit said. "It's going to take both — a vaccine and these hygienic measures — to defeat the virus."
KHN editor Arthur Allen contributed to this story.
It is unclear whether secular hospitals can continue to offer services forbidden by church doctrine, including abortion, birth control, gender confirmation surgery and physician aid in dying.
The proposed merger of a well-regarded secular hospital system and a larger Roman Catholic system in Washington state has triggered new alarms about religious restrictions on patients' access to care.
Virginia Mason Health System and CHI Franciscan announced plans in mid-July to form a joint operating company including 12 hospitals and more than 250 other treatment sites in the Puget Sound region and the Yakima area in central Washington. They touted the deal as a way to improve care.
But the plan was unclear on whether the secular hospitals could continue to offer services forbidden by church doctrine, including abortion, birth control, gender confirmation surgery and physician aid in dying, which is legal in Washington.
These questions keep arising across the country because Catholic conglomerates are some of the largest hospital systems in the U.S. — with four Catholic systems ranked in the top seven — and they frequently gobble up smaller, non-Catholic medical centers.
The issue is particularly urgent in Washington, where Swedish Medical Center — the largest nonprofit health care system in the Puget Sound area — merged with Providence Health & Services in 2012 and stopped providing emergency services to end pregnancies at the hospital. Bellingham and other Washington cities saw similar service cessations following Catholic takeovers of secular hospitals.
Already, 1 in 6 U.S. hospital beds are in Catholic facilities. The figure is 41% in Washington, according to a new report on religious-based hospital systems to be released in September by MergerWatch. If the Virginia Mason merger goes through, four cities in the state — Bellingham, Centralia, Walla Walla and Yakima — will have only a Catholic hospital.
Seattle-based Virginia Mason said that, as part of the deal, it would work with CHI Franciscan to comply with the directives governing Catholic health care institutions.
But it declined to offer specifics on what services the system would stop offering or make an executive available for an interview. Tacoma-based CHI Franciscan is part of the 137-hospital Catholic giant CommonSpirit Health, the second-largest hospital system in the U.S.
The U.S. Conference of Catholic Bishops' Ethical and Religious Directives forbid services such as abortion, contraception, tubal ligation and physician aid in dying for terminally ill patients. Catholic providers differ over whether gender transition care is permitted, but Virginia Mason said its service offerings for LGBTQ patients would not change.
In a July 21 letter, 12 organizations — including the ACLU of Washington, NARAL Pro-Choice Washington, End of Life Washington and the state chapter of the American Academy of Obstetricians and Gynecologists — warned the proposed merger would jeopardize access to needed services. The ACLU and Planned Parenthood have set up meetings for early this month with Virginia Mason's CEO, Dr. Gary Kaplan, to discuss ways to maintain those services.
"We're actively working with community groups to address their questions," Virginia Mason and CHI Franciscan said in a joint written statement.
It's the latest conflict to arise as more Catholic and non-Catholic hospital systems around the country consider merging, driven by the long-running consolidation in the health care industry and now by the economic collapse caused by the COVID-19 pandemic. Some of these efforts have been derailed by objections from regulators and advocacy groups to Catholic care restrictions.
The Washington attorney general's office said it will review the proposed merger to ensure it doesn't lessen competition or harm state residents. But advocacy groups don't expect the state to block the deal.
Research shows that most Catholic facilities do not explicitly inform patients about their religious care restrictions and that physicians, particularly OB-GYNs, often struggle to arrange workarounds to get patients care they need, such as birth control devices. Doctors say they are discouraged from even informing patients about medical options forbidden by Catholic rules.
Washington advocacy groups are particularly worried the merger will reduce access to services in Yakima, a geographically isolated city of 94,000 east of the Cascade Mountains, where Virginia Mason Memorial is the only hospital.
"The people of Washington have voted many times for access to abortion and Death with Dignity, and it's really frustrating that hospitals won't be delivering those services," said state Rep. Eileen Cody (D-Seattle), who chairs the House health committee.
Women's health groups are particularly worried that Virginia Mason's facilities in Seattle and Yakima will stop providing services to terminate a pregnancy or remove fetal tissue in emergencies such as ectopic pregnancies and miscarriages or allow tubal ligations. Many Catholic-controlled hospitals don't offer those procedures.
"In secular hospitals, when a woman is miscarrying, she'll be given the option to wait and see if the bleeding passes, or to immediately terminate the nonviable pregnancy," said Linda McCarthy, CEO of Mt. Baker Planned Parenthood in Bellingham. "In Catholic hospitals they don't get that option."
Planned Parenthood may ask Virginia Mason to set up a model similar to one it established with Swedish Health Services in Seattle after that system affiliated with Providence, said Christine Charbonneau, CEO of Planned Parenthood of the Great Northwest and the Hawaiian Islands. Swedish funded a new Planned Parenthood clinic near its campus for procedures that violate Catholic doctrine.
Similarly, End of Life Washington wants Virginia Mason to agree to let its physicians individually choose whether to provide patients with aid in dying, as Swedish did after its merger, said Dr. Robert Wood, the group's medical adviser.
"But we've heard CHI Franciscan is a more conservative group than Providence, and we're not optimistic that VM can negotiate that deal," Wood said.
Virginia Mason has said its physicians would inform patients about all their treatment options and would provide information about other providers if patients seek services it doesn't offer.
Another barrier is that the Catholic bishops revised their religious care rules in 2018 to toughen church scrutiny of workaround deals in which non-Catholic merger partners seek to preserve access to Catholic-prohibited services.
Millions of people, including the president of the United States, have seen or shared a video in which a doctor falsely claims there is a cure for the coronavirus, and it's a medley starring hydroxychloroquine.
The video shows several doctors in white coats giving a press conference outside the Supreme Court in Washington, D.C. It persists on social media despite bans from Facebook, Twitter and YouTube, and it was published by Breitbart, a conservative news site.
The July 27 event was organized by Tea Party Patriots, a conservative group backed by Republican donors, and attended by U.S. Rep. Ralph Norman, R-S.C.
In the video, members of a new group called America's Frontline Doctors touch on several unproven conspiracy theories about the coronavirus pandemic. One of the most inaccurate claims comes from Dr. Stella Immanuel, a Houston primary care physician and minister with a track recordof making bizarre medical claims, such as that DNA from space aliens is being used in medical treatments.
"This virus has a cure. It is called hydroxychloroquine, zinc, and Zithromax," Immanuel said. "I know you people want to talk about a mask. Hello? You don't need [a] mask. There is a cure."
As of July 27, nearly 150,000 Americans had died because of the coronavirus. Could those deaths have been prevented by a drug that's used to treat lupus and arthritis?
No. Immanuel's statement is wrong on several points.
'This Virus Has a Cure'
There is no known cure for COVID-19.
According to the Centers for Disease Control and Prevention, there is no specific antiviral treatment for the virus. Supportive care, such as rest, fluids and fever relievers, can assuage symptoms.
"There is currently no licensed medication to cure COVID-19," according to the World Health Organization.
The Cure Is 'Hydroxychloroquine, Zinc and Zithromax'
In spite of Immanuel's anecdotal evidence, hydroxychloroquine alone or in combination with other drugs is not a proven treatment (or cure) for COVID-19.
The Food and Drug Administration has not approved hydroxychloroquine for the prevention or treatment of COVID-19. In mid-June, the FDA revokedits emergency authorization for the use of hydroxychloroquine and the related drug chloroquine in treating hospitalized COVID-19 patients.
"It is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks," FDA Chief Scientist Denise M. Hinton wrote.
The WHO and the National Institutes of Health have also stopped their hydroxychloroquine studies. Among the safety issues associated with treating COVID-19 patients with hydroxychloroquine includeheart rhythm problems, kidney injuries and liver problems.
While some studies have found that the drug could help alleviate symptoms associated with COVID-19, the research is not conclusive. Few studies have been accepted into peer-reviewed journals. And large, randomized trials — the gold standard for clinical trials — are still needed to confirm the findings of studies conducted since the pandemic began.
In the video, Immanuel citeda 2005 study that found chloroquine — not hydroxychloroquine — was "effective in inhibiting the infection and spread of SARS CoV," the official name for severe acute respiratory syndrome. But the drug was not tested on humans, the authors wrote that more research was needed to make any conclusions, and SARS is different from COVID-19.
'You Don't Need a Mask'
Health officials advise everyone to wear a mask in public.
The reason has to do with how the coronavirus spreads. When an infected person coughs or sneezes, they expel respiratory droplets containing the virus. Those droplets can then land in the mouths or noses of people nearby.
Since some people infected with the coronavirus may exhibit no symptoms, public health officials say everyone should cover their face in public — even if they don't feel sick.
"The spread of COVID-19 can be reduced when cloth face coverings are used along with other preventive measures, including social distancing, frequent handwashing, and cleaning and disinfecting frequently touched surfaces," according to the CDC.
Our Ruling
In a viral video, Immanuel said there is a cure for COVID-19, hydroxychloroquine can treat it, and people don't need to wear masks to prevent the spread of the virus.
All of those claims are inaccurate. There is no known cure for COVID-19, hydroxychloroquine is not a proven treatment, and public health officials advise everyone to wear a face mask in public.
The coronavirus has so diminished trust in the U.S. medical system that even people with serious illnesses are staying out of the ED, with potentially mortal consequences.
These days, Los Angeles acting teacher Deryn Warren balances her pain with her fear. She's a bladder cancer patient who broke her wrist in November. She still needs physical therapy for her wrist, and she's months late for a cancer follow-up.
But Warren won't go near a hospital, even though she says her wrist hurts every day.
"If I go back to the hospital, I'll get COVID. Hospitals are full of COVID people," says Warren, a former film director and author of the book "How to Make Your Audience Fall in Love With You."
"Doctors say, 'Come back for therapy,' and my answer is, 'No, thank you.'"Bottom of Form
Many, many patients like Warren are shunning hospitals and clinics. The coronavirus has so diminished trust in the U.S. medical system that even people with obstructed bowels, chest pain and stroke symptoms are ignoring danger signs and staying out of the emergency room, with potentially mortal consequences.
A study by the Centers for Disease Control and Prevention found that emergency room visits nationwide fell 42% in April, from a mean of 2.1 million a week to 1.2 million, compared with the same period in 2019.
A Harris poll on behalf of the American Heart Association found roughly 1 in 4 adults experiencing a heart attack or stroke would rather stay at home than risk getting infected with the coronavirus at the hospital. These concerns are higher in Black (33%) and Hispanic (41%) populations, said Dr. Mitchell Elkind, president of the American Heart Association and a professor of neurology and epidemiology at Columbia University.
Perhaps even more worrisome is the drastic falloff of routine screening, especially in regions hit hard by the virus. Models created by the medical research company IQVIA predict delayed diagnoses of an estimated 36,000 breast cancers and 19,000 colorectal cancers due to COVID-19's scrambling of medical care.
At Hoag Memorial Hospital Presbyterian in Newport Beach, California, mammograms have dropped as much as 90% during the pandemic. "When you see only 10% of possible patients, you're not going to spot that woman with early-stage breast cancer who needs a follow-up biopsy," said Dr. Burton Eisenberg, executive medical director of the Hoag Family Cancer Institute.
Before the epidemic, Eisenberg saw five melanoma patients a week. He hasn't seen any in the past month. "There's going to be a lag time before we see the results of all this missed care," he said. "In two or three years, we're going to see a spike in breast cancer in Orange County, and we'll know why," he said.
Dr. Farzad Mostashari, former national coordinator for health information technology at the U.S. Department of Health and Human Services, agreed. "There will be consequences for deferring chronic disease management," he said.
"Patients with untreated high blood pressure, heart and lung and kidney diseases are all likely to experience a slow deterioration. Missed mammograms, people keeping up with blood pressure control — there's no question this will all cause problems."
In addition to fear? Changes in the healthcare system have prevented some from getting needed care.
Many medical offices have remained closed during the pandemic, delaying timely patient testing and treatment. Other sick patients lost their company-sponsored health insurance during virus-related job layoffs and are reluctant to seek care, according to a study by the Urban Institute.
"Many screening facilities were shuttered, while people were afraid to go to the ones that were open for fear of contracting COVID," said Dr. William Cance, chief medical and scientific officer for the American Cancer Society.
And then there are patients who have fallen through the cracks because of the medical system's fixation on COVID-19.
Dimitri Timm, a 43-year-old loan officer from Watsonville, California, began feeling stomach pain in mid-June. He called his doctor, who suspected the coronavirus and directed Timm to an urgent care facility that handled suspected COVID patients.
But that office was closed for the day. When he was finally examined the following afternoon, Timm learned his appendix had burst. "If my burst appendix had become septic, I could have died," he said.
The degree to which non-COVID patients are falling through the cracks may vary by region. Doctors in Northern California, whose hospitals haven't yet seen an overwhelming surge of COVID-19 cases, have continued to see other patients, said Dr. Robert Harrington, chairman of the Stanford University Department of Medicine and outgoing president of the American Heart Association. Non-COVID issues were more likely to have been missed in, say, New York during the April wave, he said.
The American College of Cardiology and American Heart Association have launched campaigns to get patients to seek urgent care and continue routine appointments.
The impact of delayed care might be felt this winter if a renewed crush of COVID-19 cases collides with flu season, overwhelming the system in what CDC Director Robert Redfield has predicted will be "one of the most difficult times that we've experienced in American public health."
The healthcare system's ability to handle it all is "going to be tested," said Anthony Wright, executive director of Health Access California, an advocacy group.
But some patients who stay at home may actually be avoiding doctors because they don't need care. Yale University cardiologist and researcher Dr. Harlan Krumholz believes the pandemic could be reducing stress for some heart patients, thus reducing heart attacks and strokes.
"After the nation shut down, the air was cleaner, the roads were less trafficked. And so, paradoxically, people say they were experiencing less stress in the pandemic, not more," said Krumholz, who wrote an April op-ed in The New York Times headlined "Where Have All the Heart Attacks Gone?" "While sheltering in place, they were eating healthier, changing lifestyles and bad behaviors," he said.
At least some medical experts agree.
"The shutdown may have provided a sabbatical for our bad habits," said Dr. Jeremy Faust, a physician in the division of health policy and public health at Boston's Brigham and Women's Hospital. "We're making so many changes to our lives, and that includes heart patients. If you go to a restaurant three times a week or more, do you realize how much butter you're eating?"
While some patients may be benefiting from a COVID-19 change of regimen, many people have urgent and undeniable medical needs. And some are pressing through their fear of the virus to seek care, after balancing the risks and benefits.
In March, when the virus took hold, Kate Stuhr-Mack was undergoing a clinical trial at Hoag for her stage 4 ovarian cancer, which had recurred after a nine-month relapse.
Members of her online support group considered staying away from the facility, afraid of contracting the virus. But Stuhr-Mack, 69, a child psychologist, had no choice: To stay in the trial, she had to keep her regular outpatient chemotherapy appointments.
"We all make choices, so you have to be philosophical," she said. "And I thought it was far more risky not to get my cancer treatment than face the off-chance I'd contract COVID on some elevator."
When COVID-19 smacked the United States in March and April, health plans feared medical costs could skyrocket, jacking up premiums drastically in 2021, when millions of the newly unemployed might still be out of work.
But something else happened: Non-COVID care collapsed as hospitals emptied beds and shut down operating rooms to prepare for an expected onslaught of patients sickened by the coronavirus, while fear of contracting it kept people away from ERs, doctors' offices and outpatient clinics. In many regions of the country, the onslaught did not come, and the billions of dollars lost by hospitals and physicians constituted huge savings for health plans, fattening their bottom lines.
But that doesn't mean consumers will see lower premiums next year.
Numerous insurers across the country have announced plans to hike rates next year, though some have proposed cuts.
Peter Lee, executive director of Covered California, appeared skeptical about premium reductions in the state's Affordable Care Act exchange, which is likely to announce 2021 health plan rates next week.
"Would we like zero increases? Absolutely. Would we like them negative? Yeah — but not if that means you're going to increase premiums in a year by 20%," Lee said in an interview with California Healthline this week. "We've been leaning on them to do what we always lean on them to do, and this is to have the lowest possible rates where you won't be on a rate roller coaster. We want health plans to price right — not to price artificially low or artificially high."
Covered California provides coverage for about 1.5 million residents who buy their own insurance.
If the insurance exchanges in other states offer any guidance for Covered California, it is in the direction of moderate premium increases for 2021, though there is wide variation.
A KFF analysislast week of proposed 2021 rates in the exchanges of 10 states and the District of Columbia showed a median increase of 2.4%, with changes ranging from a hike of 31.8% by a health plan in New Mexico to a cut of 12% in Maryland. (Kaiser Health News, which produces California Healthline, is an editorially independent program of KFF.)
Among the roughly one-third of filings that stated how much COVID-19 added to premiums, the median was 2%, with estimates ranging from minus 1.2% at a plan in Maine to 8.6% at one in Michigan.
The proposed premiums for ACA marketplace plans do not affect job-based coverage, but they may indicate how the pandemic is affecting premiums generally.
The consensus among industry experts is that COVID-19 has generated little pressure for rate rises, and health plans should err on the side of moderation. But some fear that many insurers will hold onto the reserves they've built up, citing the possibility of widespread vaccinations and concerns that the care forgone in 2020 could rebound with a vengeance next year.
"The tendency of health plans, when they are faced with any degree of uncertainty, is to be very conservative and price for the worst-case scenario," said Michael Johnson, an industry observer and critic who worked as an executive at Blue Shield of California from 2003 to 2015. "Actuaries are less likely to get fired if the plan prices too high than if the plan prices too low. But I think regulators really need to push back hard on that."
Lee said all 11 insurers participating in the exchange this year will remain in 2021, and no new ones will be added to the mix, though some of the current carriers will extend their coverage geographically. Ninety percent of consumers who buy their own health insurance get subsidies from the federal government or the state to help pay their premiums.
In January, California became the first state to offer subsidies to middle-income people who make too much money to qualify for federal subsidies. The lion's share of the state subsidies is earmarked for those who earn between 400% and 600% of the federal poverty level, or $51,040 to $76,560 a year for an individual and $104,800 to $157,200 for a family of four.
The rate proposals expected to be unveiled next week will be subject to scrutiny by state regulators before they are finalized. Sign-ups for the plans start Nov. 1 and run through Jan. 31. This year, the average Covered California rate increase statewide was 0.8%, the lowest since the exchange started providing coverage in 2014.
The benefits reaped by health plans so far in the pandemic can be seen in strong second-quarter earnings and reduced spending on care. UnitedHealth Group, the nation's largest health insurer, announced earlier this month that its net profit in the April-June quarter nearly doubled from the same period a year earlier. Its medical spending plummeted from 83.1% of premium revenue to 70.2% over that period.
Anthem, the parent company of Blue Cross of California, reported Wednesday that its net profit in the second quarter doubled from the same period in 2019, also on the back of plunging medical expenses.
Anthem said it offered one-month premium credits ranging from 10% to 50% to enrollees in individual, employer and group dental policies — including its Blue Cross plans in California.
UnitedHealth said it has provided $1.5 billion worth of financial support to consumers so far, including premium credits and cost-sharing waivers, and expects to pay out $1 billion in rebates.
But UnitedHealth, which does not participate in Covered California, is seeking a rate increase of 13.8% in the New York exchange. Anthem, which covers about 80,000 people in Covered California, is planning rate hikes of 16.6% in Kentucky and 9.9% in Connecticut.
On the other hand, Kaiser Permanente, which covers more than one-third of Covered California enrollees, plans rate cuts in other states, ranging from 1% in Hawaii to 11% in Maryland. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)
Lee downplayed the notion of a financial boon for California health plans, saying that, partly because of the use of telehealth, primary care has rebounded and the plans are paying for it. "So we don't see this as being at this point a bonanza year for health plans," he said. "Rather, it's a year in which there are lessons learned for how we can deliver care in a pandemic."
Still, the health plans are in a far stronger position than they had feared earlier this year.
In March, Covered California released a study showing that COVID-19's impact on 2021 premiums for individuals and employers could range from an increase of 4% to more than 40%. But less than three months later, projections commissioned by the industry's national advocacy group, America's Health Insurance Plans, showed that even in the worst-case scenario of a 60% COVID infection rate — far above where it stands now — the pandemic would increase medical costs in 2020 and 2021 by 6% at most, and could even decrease them.
That moderate effect is largely attributable to what Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation, called "a kind of yin and yang: If you have a lot of COVID, you don't have a lot of other healthcare spending."
Independent of the course the pandemic takes, emergency room and outpatient visits still lag behind pre-COVID levels and will probably continue to do so next year, to the continued benefit of insurers, predicted Glenn Melnick, a professor of healthcare finance at the University of Southern California's Sol Price School of Public Policy. That could be good news for consumers, he said, potentially leading to lower premium increases or even reductions next year.
On the other hand, hospitals and doctors have lost money, and the ones whose contracts with health plans are up for renewal will be looking to make up those losses, Melnick said.
"Providers could be asking for 20-25% increases next year," he said, "and if they've got market power, they can make it stick."
ST. LOUIS — Haley Organ thought she had everything figured out. After graduating from a small private college just outside Boston, she earned her master's degree, entered the workforce and eventually landed a corporate job here as a data analyst.
Life seemed to be going as planned until the national retailer that Organ worked for announced furloughs during the coronavirus pandemic. After nine weeks of mandatory leave, the 35-year-old was laid off. The company gave her a severance package and put an expiration date on her health insurance plan.
"I haven't slept the whole night since about March," Organ said earlier this summer. "I can't turn my brain off, just worrying about everything."
Organ filed for unemployment, adding her claim to more than 40 million others nationwide since the pandemic took hold in mid-March, according to the Department of Labor. That's about 1 in 4 U.S. workers. As a result of the unemployment crisis, millions of people lost access to their private health insurance plans at a time when they might need it most.
Medicaid, the federal and state health insurance program for people with low incomes or disabilities, could have served as a safety net for Organ if she lived in one of the 38 states that have opted to expand under provisions of the Affordable Care Act. But in Missouri, Republicans who control both the governor's office and the legislature have said the state cannot afford its share of the cost of expansion and have been adamant foes of the ACA, helping lead a lawsuit now before the U.S. Supreme Court that may nullify the law.
That opposition by state leaders has meant adults like Organ who don't have dependent children or specific disabilities cannot qualify for Missouri's Medicaid program — even if their incomes are well below the poverty line.
"This is literally the first time in my life I've had to worry about healthcare coverage," Organ said. "It's kind of been a rude awakening for me."
Voters in Missouri will decide Tuesday whether to expand eligibility for MO HealthNet program (Missouri's Medicaid program) to provide insurance to more than 230,000 additional people in the state, including many who find themselves newly struggling for health coverage amid a national health crisis. More than 700,000 initial unemployment claims were reported in Missouri from mid-March through the first week of July.
If Medicaid expansion passes in Missouri, coverage for those newly eligible people would begin in 2021. Advocates for the measure say Medicaid expansion would also create jobs, protect hospitals from budget cuts and bring billions of federal taxpayer dollars back to the state.
But Missouri's Republican Gov. Mike Parson, who has said he opposes expanding Medicaid, moved the ballot measure from the general election in November to the primary election on Tuesday. Democrats criticized the shift, noting that fewer voters traditionally turn out for the primary and suggesting it could be easier to defeat in August. The ongoing threat of COVID-19 could also keep some voters away from the polls.
In a statement, Parson said changing the election date will allow the state to prepare for the potential cost of expansion. But an analysis from Washington University in St. Louis suggests that expanding the program could save the state money by lowering the amount it must pay for uncompensated care and bolstering efforts to prevent certain diseases, thereby reducing treatment costs to the state. Under the terms of the Affordable Care Act, the federal government picks up 90% of the coverage costs for newly eligible enrollees, as compared with the 65% it pays for people who qualify under regular Medicaid rules.
Backers of expansion are cautiously optimistic that Missouri voters will approve the measure Tuesday, heartened by Oklahoma's win last month and positive polling.
For people who qualify for the current Medicaid program, enrollment is open year-round, which means people can apply when needed.
"That's why we call them safety-net programs," said Jen Bersdale, executive director of Missouri Healthcare for All, a group that has advocated for Medicaid expansion since 2012. "When you get dropped from a job, dropped from insurance, they are there to catch you until you're back on your feet."
Amid the pandemic, Medicaid already appears to be helping people newly out of work. In 22 states, Medicaid enrollment increased by an average 5% from February to May, according to Georgetown University Health Policy Institute data. Newer data for May in those same states suggests enrollment growth is accelerating.
Even without expanding the program, Missouri leads the group with an 8.8% increase since February in total Medicaid enrollment. While economic recessions often contribute to increasing Medicaid enrollment, the early spike in Missouri could signify reenrollment of a large number of people, mostly children, who had been dropped from the program two years in a row. A federal rule blocks disenrollment during the pandemic.
Even some Missourians already on Medicaid are worried about the ballot measure not passing. Without expansion of the program, Sally Terranova fears that her 16-year-old son, Colin, will be ineligible for Medicaid when he ages out of the kids' coverage at age 19. He was diagnosed with Type 1 diabetes in 2016.
Terranova is concerned that her son wouldn't be able to afford the insulin he needs without insurance. She worries even more when she hears stories about diabetics rationing their insulin.
"It's bad enough he has this illness hanging over him," Terranova said. "But he can live a good life and be healthy if he has access to healthcare."
That's one reason Terranova, 39, hopes to land a job with good benefits when she finishes graduate school in a year and half. She has studied social work for the past four years, so she understands the challenges low-income families face.
Terranova had moved from New York to Missouri to give her son a better life. They've called St. Louis home for 10 years, but the single mom is contemplating another big move for her son's health. She's thinking of going this time to a state that has already expanded the program.
Organ, whose health insurance expired in July, is now one of the lucky ones. She just got a new job and will get new health insurance when she starts next week. Still, she's hoping the Medicaid measure will pass, as she now appreciates more than ever how much it could mean for others who have lost their jobs and lack coverage amid the COVID-19 pandemic. Instead of heading to a polling place Tuesday, though, Organ is planning to vote by mail.
"I'm trying to do everything I can to keep me and others safe," Organ said. "But I want to make sure my voice is still heard."
Will Lightbourne sees his job as a chance to refocus Medi-Cal on improving health by linking people with behavioral health programs and getting them into housing.
When Will Lightbourne looked at the statistics behind California's coronavirus cases, the disparities were "blindingly clear": Blacks and Latinos are dying at higher rates than most other Californians.
As of Monday, Latinos account for 45.6% of coronavirus deaths in a state where they make up 38.9% of the population, according to data collected by the California Department of Public Health. Blacks account for 8.5% of the deaths but make up 6% of the population.
Lightbourne, who led California's Department of Social Services under Gov. Jerry Brown, describes this pandemic as one that "rips the bandage off" a healthcare system long riddled with inequity.
So, when Gov. Gavin Newsom asked Lightbourne, 70, to come out of retirement in June to lead the Department of Healthcare Services, he said, he couldn't say no.
"He has committed his whole professional life to public service," said Mike Herald, director of policy advocacy at the Western Center on Law & Poverty. "He's not joking when he talks about the importance of these issues and the important role that government plays in addressing societal inequities."
The Department of Healthcare Services oversees the state's Medicaid program for low-income people, called Medi-Cal, which provides healthcare to some 12.5 million Californians.
Lightbourne said he sees the job as a chance to refocus Medi-Cal on reducing disparities — improving people's health not only by providing better access to doctors, but also by linking them with behavioral health programs and using healthcare dollars to get them into housing.
He said the department also plans to amend contracts with health providers and use routine performance reviews to make sure providers are addressing disparities.
Healthcare advocates say Lightbourne has a track record of getting things done.
At the Department of Social Services, he persuaded Brown, a known penny pincher, to increase cash assistance to low-income families, restoring cuts lawmakers had made in the Great Recession. And he was instrumental behind the scenes in the repeal of the contentious policy that had prohibited Californians from receiving increased welfare income if they had more children while receiving public assistance, Herald said.
"Will is very purpose-driven and has made substantive changes in every role he has ever had," said Graham Knaus, executive director of the California State Association of Counties.
Before embarking on state service, Lightbourne served as director of the Santa Clara County Social Services Agency, the Human Services Agency of the City & County of San Francisco and the Santa Cruz County Human Services Agency.
Lightbourne's local and state experience give him a valuable skill set as state and county officials grapple with providing healthcare to some of California's most vulnerable residents during a pandemic, Knaus and other advocates said.
The task won't be easy. The previous director of the Department of Healthcare Services, Brad Gilbert, left the job after less than four months.
Lightbourne talked to California Healthline about why he returned to state government, how the department is responding to COVID-19 and how he hopes to improve access to healthcare for those who need it. The interview has been edited for length and clarity.
Q: Why did you come out of retirement to take a job that's difficult under normal circumstances — and even tougher during a pandemic?
Events of the past six months have made it blindingly clear that we've got structural inequities that are not just immoral but are, at an existential level, unsurvivable. It's a pandemic that landed on top of a pandemic of inequalities, opportunity and income that's been raging since the 1980s. And that pandemic has been enabled by a pandemic of racism that has rotted in our society for generations.
I think we have to use the moment to insist that our publicly financed healthcare system really partners up with our public health network and with our social safety-net system to address community and population health with a laser focus on reducing disparities.
Q: How has the department responded to COVID-19 to address the most vulnerable Californians?
The growth in telehealth is something that would not have occurred without this experience. There's work still underway to look at how we can come up with some approaches to reduce the number of people in skilled nursing facilities, where the rate of spread is so much more severe and with really mortal results.
I have the suspicion that we're never really going to get to a point where we say the effect of COVID is over. The mere fact that so much healthcare utilization is down now, particularly down in the places where people who start at a disadvantage normally seek care, we're going to find long-term health consequences into the future, even post-vaccine.
Q: In January, Gov. Newsom outlined a proposal to broaden a Medi-Cal program known as CalAIM that addresses physical and behavioral health needs in patients' care, and even pays for their housing with healthcare money. Can your department still move forward with those goals even though there isn't money in the budget for it?
We may be delayed to some extent. It was never intended initially as a big-bang system change. It was always going to be a degree of iterative development, and that remains true — whether some things have to go a little slower because of money reasons.
Q: You have talked about access to healthcare and how COVID-19 has really highlighted systemic disparities. In Medi-Cal, lack of access to care has long been a problem, especially in rural areas. So has inadequate care for children. Are those issues you intend to address?
One of the things we need is an adequate network of providers that really covers the medically underserved areas of the state. We need to work effectively with our rural health clinics, as well as our urban Federally Qualified Health Centers to expand access, particularly to the populations that historically haven't had that access.
In terms of services for children, that's a big part of that agenda both in physical and behavioral health and also the dental health system. There's a big focus on how to improve access and preventive services for children.
Q: In the Great Recession, California lawmakers made many deep cuts to safety-net programs, some of which have been restored only recently. The governor proposed a number of healthcare-related cuts this year that were ultimately rejected by the legislature. How will you ensure that Medi-Cal enrollees won't see their benefits scaled back in the future?
It's going to be my job to make the case not to reduce services that poor people rely on. That said, we live in the real world and if we ever have to reduce things, my approach would be to try to say, "How can we reduce things we can readily rebuild rather than destroy things that are foundational?"
Goal No. 1 at this point is to work very closely with our congressional delegation to really encourage the federal government to support the core services and activities so that we can meet the needs of the people of the state.
Desperate to continue the tradition of a family beach week, I hatched a plan that would allow some mask- and sanitizer-enhanced semblance of normality.
We hadn't seen my two 20-something children in months. They'd spent the lockdown in Brooklyn; one of them most likely had the disease in late March, before testing was widely available. My mother had died of COVID-19 in May.
So a few weeks ago, I rented a cute house on the Delaware shore. It had a screened-in front porch and a little cottage out back, in case someone needed to quarantine.
I asked my son, who had participated in several protests and had been at a small outdoor July Fourth gathering, to get tested before he came. Testing had been recommended by the governor and the mayor, and many centers were offering an anticipated 48-hour turnaround.
He got one and downloaded the app for results. And waited. And waited. And waited. For 12 days.
Coronavirus testing in the United States has been bungled in every way imaginable. The latest fiasco is perhaps the most Kafkaesque: Tests are now widely available in many places, but results are often taking so long to come back that it is more or less pointless to get tested.
If it takes up to two weeks to get results, we can't detect brewing outbreaks and respond with targeted shutdowns. We can't do meaningful contact tracing. We can't expect people to stay home from work or school for two weeks while they wait for the result of a screen. We have no way to render early treatment and attention to those who test positive, to try to prevent serious illness. It's a disaster.
Many doctors can do a rapid strep test in half an hour, and the "slow" test takes a day. Imagine if it took 12 days before doctors knew whether to prescribe an antibiotic. You'd end up with more cases of meningitis, pneumonia and rheumatic fever. Strep could spread through families and schools like wildfire.
One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it's testing theater.
For months the hue and cry was about testing not being more widely available. Even many sick people couldn't get one. The first tests proved faulty. Then good ones were not distributed to the hot spots. Then there were not enough swabs, personal protective equipment or ingredients like reagents needed to administer the tests.
After all these missteps, the political pressure to provide widespread free testing was enormous. And with little help from the White House, many states turned somersaults and delivered. Voilà!
But there was far less pressure to make sure that labs receiving the swabs had the capacity to process all those collected specimens.
Now, in cities like New York and Washington and Los Angeles, there are dozens if not hundreds of clinics where anyone who wants a test can walk in and get the famous stick up your nose or some variant. Though the simple tests are by law "free" to patients, the clinics bill insurers (or the government) hefty fees — sometimes hundreds of dollars — for administering them. This gives clinics the incentive to throw open the doors and do as many tests as possible.
Some hospitals, clinics and cities that run the specimens themselves or outsource to an array of different labs can deliver results in a timely fashion. State labs in Texas, which is experiencing a major outbreak, say their turnaround time is two to three days. But many results take far longer.
LabCorp and Quest, the two biggest commercial labs, have both acknowledged sometimes long delays in processing the vastly increased volume of tests. Governors are furious. Gov. Jared Polis of Colorado said that the nine days it sometimes took to get a result from these companies rendered them "almost useless."
A coronavirus test is not really a test if the result is too late to act on. So labs need to ramp up capacity, as they've vowed to do. More important, all those centers offering free testing need to take responsibility for delivering results within 48 or, maybe, 72 hours. That means contracting with labs that can guarantee turnaround.
"Anyone who wants a test can get one" is a nice-sounding political promise, but it's not helping anyone. Sick people need to know if they're sick with the coronavirus. Those who have been seriously exposed need to know if they got it. And others will need tests to be cleared for work, school or a family visit with vulnerable relatives.
This is how the coronavirus played out in my family's vacation: While my son arrived on schedule, his test results did not. So he was consigned to the quarantine cottage. He wore a mask in the house and the car. We ate outdoors and he sat at the far end of a picnic table. We even squirted the ketchup on his burger for him, so that he wouldn't have to touch the bottle. Each morning we checked the app, hoping for deliverance. It never came.
Finally, 12 days after my son's last potential exposure at the Independence Day picnic, I agreed he could take off the mask. He had no symptoms and at that point he was most likely no longer contagious, either way. We hugged and enjoyed our last two days of vacation. Then he returned to New York.
The next morning, I got his text: "Test came back negative!"
The vaccine trial that Vice President Mike Pence kicked off in Miami on Monday gives the United States the tiniest chance of being ready to vaccinate millions of Americans just before Election Day.
It's a possibility that fills many public health experts with dread.
Among their concerns: Early evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the Food and Drug Administration. That conflict between science and politics might cause some people to not trust the vaccine and refuse to take it, which would undermine the global campaign to stop the pandemic. Or it could lead to a product that is not fully protective. Confidence in routine childhood vaccinations, already shaken, could decline further.
"The fear is that you wind up doing to a vaccine what [Trump has] already done with [opening] school," said Dr. Joshua Sharfstein, a former FDA deputy commissioner and a professor at Johns Hopkins University in Baltimore. "Take an important, difficult question and politicize it. That's what you want to avoid."
On Monday at 6:45 a.m., the first volunteer in the landmark phase 3 trial for the Moderna Therapeutics vaccine received a shot at a clinic in Savannah, Georgia. Clinicians at 88 other sites, stretching from Miami to Seattle, also administered the experimental shot in a trial that aims to enroll 30,000 people.
Dr. Anthony Fauci, the country's leading infectious disease expert, told reporters he hoped 15,000 could be vaccinated by the end of the week, although he provided no information about progress toward that goal. All volunteers would receive a second shot 29 days after their first inoculation. (Half will receive a placebo containing saline solution.)
Another vaccine, produced by Pfizer with the German company BioNTech, also entered a large phase 3 U.S. trial this week. It's being tested independently of the National Institutes of Health, which is partially funding the Moderna trial as well as tests for an Oxford University/AstraZeneca vaccine trial, and others in the future. AstraZeneca has said some doses of its vaccine might be ready as early as September.
Fauci said he expects the Moderna trial to provide an answer about whether that vaccine works by the end of the year — and it's "conceivable" an answer could come in October. "I doubt that, but we are leaving an open mind that it is a possibility."
Such a fast pace worries some experts.
"I don't see how that's remotely possible unless the thing I most fear happens, a truncated phase 3 trial with just an idea of efficacy, an idea of common side effects, and then it rolls out," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
Pence downplayed such fears Monday, telling reporters: "There will be no shortcuts. There will be no cutting corners."
Officials are pressing for an open and transparent process.
Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, is preparing to release a bill requiring the FDA to have an expert panel review any COVID vaccine and issue a recommendation before FDA Commissioner Stephen Hahn makes a decision.
With past vaccines, the FDA has generally relied on such a committee, made up mostly of vaccine experts and appointed by the FDA commissioner. They typically conduct a painstaking examination of all evidence before voting on whether the FDA should approve a vaccine. The commissioner has rarely, if ever, gone against the committee's decisions.
Hahn undercut confidence in the FDA's independence earlier in the year, many observers felt, when he issued an Emergency Authorization Use declarationfor hydroxychloroquine, a drug used to treat malaria that President Donald Trump and members of his administration have continued to tout, erroneously, as a cure for COVID-19. The FDA later revoked the authorization, which was made without consulting an independent committee.
"FDA's independence has been threatened, no question, by the hydroxychloroquine issue," said Dr. Jesse Goodman, a Georgetown University professor who led the FDA's biologics division and later was chief scientific officer.
The agency must give outside scientists and the public the opportunity to see the data and the FDA's reasoning before coming to such a decision, he said.
Concerns about political interference arose recentlywhen Trump talked excitedly about a vaccine, and Treasury Secretary Steven Mnuchin confidently told reporters there would be a vaccine by the end of the year for emergency use.
To be sure, it's unlikely the FDA would be tempted to issue an emergency release without data that showed a vaccine was working and not causing serious side effects.
The massive coronavirus outbreaks in Texas and other hard-hit areas where the Moderna vaccine is being tested should provide an answer, although exactly when is an open question.
In theory, scientists might get a handle on a vaccine's efficacy before all 30,000 people are enrolled, vaccinated and studied.
In fact, an answer could become clear after only 150 to 160 cases of disease are reported among the trial participants, Fauci said. If roughly two-thirds of those cases occurred in non-vaccinated people, it would show statisticians that the vaccine had above-60% efficacy, he said.
If the vaccine is 80% to 90% effective and the annual rate of infection in the places where it's being tested is above 4%, scientists could get a signal of efficacy in such a trial with just 50 cases, or in as little as three months, said Ira Longini, a University of Florida biostatistician who designs vaccine trials.
The Moderna vaccine trial would hit that three-month threshold on Oct. 27.
The trial's fate is partly in the hands of its 30-member Data and Safety Monitoring Board, whose members can see unblinded data about the participants in real time — pinpointing who was vaccinated with the actual vaccine and got sick, for example. The board will alert the NIH and vaccine maker if it sees surprising data — either dangerous side effects or powerful efficacy. Some fear that if the vaccine seems to work in an early review, the FDA would be pressured to stop the trial.
Offit said NIH should not accept anything less than a completed trial of 30,000 people. Fifty cases "is a very small number" to use as evidence for releasing a vaccine that could be administered to tens of millions, he said.
The public might clamor for the release of any vaccine that seemed to work. Moderna said it has already begun producing millions of doses of vaccine "at risk," banking on the vaccine's success. The FDA could release those under powers provided when the country declared a public health emergency in March.
With more than half the country deeply mistrustful of Trump, according to recent polls, any federal decision could be resisted and lead to widespread rejection of even a promising vaccine. Sharfstein worries about a "knee-jerk" reaction against the vaccine by Democrats if Trump touts it before the election.
Experts also worry about releasing a vaccine that shows some positive effects but isn't robustly protective. A slide presented by FDA deputy director Philip Krause at the World Health Organization earlier this month said a weak vaccine could fail to protect the public adequately, leading to a false sense of security in those who've received it, while making it harder to test future vaccines.