The upcoming election has huge implications for healthcare, far beyond how COVID is managed, ranging from how care is covered to how it’s delivered. The graphic above shows a continuum of potential policy outcomes of the November 3rd vote.
If President Trump wins a second termand Republicans control at least one house of Congress, there will likely be more attempts to dismantle the ACA, as well as continued privatization of Medicare coverage.
If Democrats win the presidency and sweep Congress, actions to expand the Affordable Care Act (ACA), or even create a national public option, are on the table—although major healthcare reform seems unlikely to occur until the second half of a Biden term.
In the short term, we’d expect to see more policy activity in areas of bipartisan agreement, like improving price transparency, ending surprise billing and lowering the cost of prescription drugs, regardless of who lands in the White House.
While healthcare emerged as the most important issue for voters in the 2018 midterm elections, the COVID pandemic has overshadowed the broader healthcare reform platforms of both Presidential candidates heading into the election. As shown in the gray box, many Americans view the election as a referendum on the Trump administration’s COVID response. Managing the pandemic is one of the most important issues for voters, especially Democrats, who now rank the issue above reducing the cost of healthcare or lowering the cost of drugs.
In many aspects, the COVID policies of Biden and Trump are almost diametrically opposed, especially concerning the role of the federal government in organizing the nation’s pandemic response.
The next administration’s actions to prevent future COVID-19 surges, ensure safe a return to work and school, accelerate therapies, and coordinate vaccine delivery will remain the most important aspect of healthcare policy well into 2021.
It’s still the early days of the coronavirus pandemic, but history, biology and the knowledge gained from our first nine months with COVID-19 point to how the pandemic might end.
The big picture:Pandemics don’t last forever. But when they end, it usually isn’t because a virus disappears or is eliminated. Instead, they can settle into a population, becoming a constant background presence that occasionally flares up in local outbreaks.
Many emerging viruses become part of the viral ecology. The four coronaviruses that cause the common cold are endemic, circulating in the population, and the influenza strains that cause seasonal flu predictably surge each year.
The SARS outbreak in 2003 didn’t go the same way due to biology and behavior: It was much less transmissible than the virus that causes COVID-19, countries contained it quickly, and it has pretty much disappeared.
One virus, smallpox, was eradicated through widespread vaccination, and polio may be close, after decades of effort and billions in funding.
What’s happening:The pandemic is deepening in the U.S., Europe and elsewhere in the world.
Experts — from the U.K.’s chief scientific adviser to pharmaceutical CEOs to the WHO — increasingly say SARS-CoV-2 is likely to circulate in the population on a permanent basis, mainly due to the foothold the virus has already established.
But what damage endemic COVID-19 causes will depend on different factors, including how often people are reinfected, vaccine effectiveness and adoption, and if the virus mutates in any significant way.
“If the vaccine is really effective,like the measles vaccine or the yellow fever vaccine, it’s just going to land like a ton of bricks and suffocate this. Maybe not quite eradicate it — yellow fever and measles are not eradicated — but it’ll be an utter game changer,” UC Irvine epidemiologist Andrew Noymer says.
But if the vaccines are less effective — as many experts expect for at least the first generation — COVID-19 may eventually behave more like the seasonal flu, Noymer says. (Still, the death rate of COVID-19 currently well eclipses that of the seasonal flu.)
Reinfection is “the big issue,” says Columbia University’s Jeffrey Shaman, who recently described how reinfection and other factors would affect the spread of SARS-CoV-2 if it became endemic.
So far, there are just a handful of documented reinfection cases, but evidence about whether people retain their antibodies after infection is mixed, and a lot of unknowns remain about the likelihood of reinfection.
The worst-case scenario would be that there isn’t a vaccine or long-lasting immunity and people get COVID-19 repeatedly and are just as likely to end up in the hospital as with initial infections, Shaman says.
“I would say COVID-19 is already endemic,” says Larry Brilliant, an epidemiologist who worked to eradicate smallpox and now chairs the nonprofit Ending Pandemics.
With about 59,000 new cases per day in the U.S. alone, Brilliant says “it is already everywhere.”
“It doesn’t really mean very much if it is endemic,” he adds. “The real question is: How does it all end?”
Eventually, COVID-19 could end up in “the retirement village of coronaviruses,” like HIV, which today can be treated to the point of elimination, or circulate at low levels and be kept in check with a vaccine, like measles, Brilliant says, laying out a handful of possible scenarios.
Noymer says he suspects that after its “cataclysmic emergence,” COVID-19 may eventually fade into a common cold after a decade or so.
What’s next: “We have to work with it as a virus that we will be contending with for years possibly,” Shaman says. “It doesn’t mean an effective vaccine or treatment won’t be developed. What it means is that holding out hope that we’re going to just get a vaccine and not doing anything else is not the level of preparation we need.”
Until we have an effective vaccine and better contact tracing and testing, Johns Hopkins University epidemiologist Justin Lessler says public health measures should continue encouraging the use of face masks and social distancing.
If the disease does become endemic, Lessler says it’s likely to eventually become more like a childhood infection because adults will gradually build an immunity. And since children tend to have fewer complications, “it will no longer be the same sort of burden to health that it is now.”
The good news: Viruses can sometimes become milder with time, treatments are already becoming more effective and vaccines can be improved.
“Right now we are frightened, depressed and on our back heels. We will be able to conquer this disease,” Brilliant says. “It will be a matter of time and science.”
President Trump repeated baseless claims at the final presidential debate that the coronavirus “will go away” and that the U.S. is “rounding the turn,” while Joe Biden argued that any president that has allowed 220,000 Americans to die on his watch should not be re-elected.
Why it matters: The U.S. is now averaging about 59,000 new coronavirus infections a day, and added another 73,000 cases on Thursday, according to the Covid Tracking Project. The country recorded 1,038 deaths due to the virus Thursday, the highest since late September.
What they’re saying: “More and more people are getting better,” Trump said. We have a problem that’s a worldwide problem. This is a worldwide problem. But I’ve been congratulated by the heads of many countries on what we’ve been able to do … It will go away and as I say, we’re rounding the turn. We’re rounding the corner. It’s going away.”
Trump later disputed warnings by public health officials in his administration that the virus would see a resurgence in the winter, claiming: “We’re not going to have a dark winter at all. We’re opening up our country.”
Biden responded: “Anyone responsible for that many deaths should not remain as president of the United States of America.”
“What I would do is make sure we have everyone encouraged to wear a mask all the time. I would make sure we move in the direction of rapid testing, investing in rapid testing.”
“I would make sure that we set up national standards as to how to open up schools and open up businesses so they can be safe and give them the wherewithal, the financial resources, to be able to do that.”
The bottom line:Biden and Trump are living in two different pandemic realities, but Biden’s is the only one supported by health experts.
Government spending on testing and contact tracing pays for itself more than 30 times over, according to yet another paper published in JAMA (good series!).
What they found: Harvard economists David Cutler and Lawrence Summers calculated the total cost of the coronavirus pandemic at more than $16 trillion in the U.S. alone. Of that, about $7 trillion is attributable to loss of life and long-term impairment from the disease, Axios’ Felix Salmon writes.
Enhanced testing and tracing would cost about $6 million per 100,000 inhabitants, they calculate. Out of that population, 14 lives would be saved, on which they place a value of $96 million, and 33 critical and severe cases would be avoided, representing savings of $80 million.
That adds up to $176 million in benefits from $6 million in costs — before taking into account any second-order effects from even fewer cases down the road.
The bottom line: “Currently, the U.S. prioritizes spending on acute treatment,” write Cutler and Summers, “with far less spending on public health services and infrastructure.”
Going forward, they write, “a minimum of 5% of any COVID economic relief intervention should be devoted to such health measures.”
The first coronavirus vaccinewill likely get authorized within months, but that will only be the beginning of what’s likely to be a long, chaotic vaccination process, the New York Times’ Carl Zimmer reports.
The big picture: The first vaccines probably will offer only moderate protection against the virus, meaning we can’t ditch our masks even if we get one. And we probably won’t have a good way to choose between these vaccines once several of them are on the market.
Some vaccines that are in earlier stages of development today may struggle to cross the finish line, even if they work better than earlier vaccines.
And some vaccines may be pulled off of the market because they’re unsafe.
Between the lines:Some of this is inherent to the breakneck speed of the vaccination effort, but some of it is a result of how that effort was designed.
Earlier this year, some government scientists had wanted to test vaccine candidates against each other, instead of testing all of them against a placebo. But these kinds of trials are risky for drug companies, because they show the value of one vaccine against another.
That information could be useful for patients, but is a business risk for manufacturers.
“You have to have the total cooperation of the pharmaceutical companies to get involved in a master protocol,” top infectious disease expert Anthony Fauci told NYT. “That — I don’t know what the right word is — didn’t turn out to be feasible.”
The head of the World Health Organization said Monday that allowing the novel coronavirus to spread in an attempt to reach herd immunity was “simply unethical.”
The remark was a sharp rebuke of the approach amid mounting new infections around the world. Recent days have seen the most rapid rise in cases since the pandemic began in March.
“Never in the history of public health has herd immunity been used as a strategy for responding to an outbreak, let alone a pandemic,” WHO Director-General Tedros Adhanom Ghebreyesus said at a Monday media briefing. “It is scientifically and ethically problematic.”
In a public health context, herd immunity typically describes a scenario in which a large enough share of the population is vaccinated against a disease to prevent it from spreading widely, thereby providing default protection to a minority of people who have not been vaccinated.
But as there is still no vaccine for the coronavirus, achieving herd immunity in the current environment would require a large number of people to contract the virus, survive covid-19, and then produce sufficient antibodies to provide long-term protection.
While the scientific community has roundly rejected herd immunity the approach, public interest in it has waxed and waned amid pressure to reopen schools and economies.
Last month, President Trump appeared to praise the idea during a town hall in Pennsylvania.
“You’ll develop herd — like a herd mentality,” he said. “It’s going to be — it’s going to be herd developed — and that’s going to happen.”
British Prime Minister Boris Johnson’s government initially expressed interest in the theory before backtracking amid public outcry over the dangers of letting the virus spread. Johnson himself was hospitalized with a severe case of covid-19, which he said could have killed him.
Tedros, noting that there had been “some discussion” about the concept recently, told reporters Monday that allowing people to be exposed to a deadly virus whose effects are still not fully known was “not an option.”
“Most people who are infected with the virus that causes covid-19 develop an immune response within the first few weeks, but we don’t know how strong or lasting that immune response is, or how it differs for different people,” he said.
Though rare, there are multiple documented instances of people being infected for a second time after recovering from covid-19. An 89-year-old woman in the Netherlands died after being infected with the coronavirus for a second time, Dutch news reported Monday.
Antibody studies suggest that less than 10 percent of people in most countries have contracted covid-19, Tedros said, which is nowhere near the majority that would be needed for herd immunity.
With the “vast majority” of the world’s population susceptible, letting the virus spread “means allowing unnecessary infections, suffering and death,” he said.
Just in the last four days, Tedros said Monday, the global coronavirus count has continued to break its daily record for the number of new confirmed infections.
“Many cities and countries are also reporting an increase in hospitalizations and intensive care bed occupancy,” he added.
Tedros has urged governments to pursue comprehensive plans that include widespread testing, social distancing, and other preventive measures, such as face-mask wearing, alongside a global push to develop a vaccine. The WHO is spearheading an effort to distribute coronavirus vaccines equitably once they are available, which Trump declined to join.
A new wave of Covid-19 cases is building across the United States, a harbinger of difficult winter months ahead.
America is now averaging nearly 48,000 new confirmed cases every day, the highest numbers since mid-August, according to the Covid Tracking Project. More than 34,500 Americans are currently hospitalized with Covid-19 in the US, up from less than 30,000 a week ago. Nearly 700 new deaths are being reported on average every day, too — and while that is down from August, when there were often more than 1,000 deaths a day, deaths are going to eventually start increasing if cases and hospitalizations continue to rise. It’s a pattern we have seen before.
Public health experts have been warning for months that fall and winter could lead to a spike in Covid-19 cases. Why? Because the best way to slow down the coronavirus’s spread is to keep your distance from other people and, if you are going to be around others, to be outside as much as possible — and both become harder when the weather gets cold.
We may now be seeing those predictions start to come true. The US already has more than 7.7 million confirmed cases and 214,000 deaths. Both numbers will continue to climb.
Eight months into the pandemic, America’s failures to contain Covid-19, and states’ eagerness to reopen even if they haven’t gotten their outbreaks under control, is once again leading to a surge in cases and hospitalizations.
Covid-19 cases are rising everywhere across the country
Earlier in the year, there was limited value to discussing “waves” because some states would have a decline in cases while other states were experiencing surges. What distinguishes this autumn wave is that it seems to be happening everywhere.
Case numbers are up in the Northeast, the Midwest, and the West. The South appears to be, at best, plateauing at a level even higher than that which the Northeast endured during the worst of New York’s outbreak.
What’s so worrisome is that no one state or region can be blamed for this new wave. Just 13 states have seen their number of new Covid-19 cases drop over the last two weeks, according to Covid Exit Strategy. Cases are up in all the others.
Raw case numbers can, of course, obscure important differences in population; 100 new cases means something different for California than it does for Wyoming. Experts will use another metric — new cases per million people — to gauge how saturated a given state is with Covid-19.
The goal would be to have fewer than 40 new cases per million people. But just three states — Maine, Vermont, and New Hampshire — meet that threshold. Meanwhile, North Dakota (627 cases per million), South Dakota (596), Montana (474), and Wisconsin (434) are some of the states seeing very high levels of new infections.
As Vox’s German Lopez reported this week, just one state — Maine — meets all of the benchmarks established by experts for a state to consider its Covid-19 outbreak contained. And yet, most states have reopened many of the businesses that were closed in the spring: 40 or so states have reopened restaurants, bars, gyms, movie theaters, and nonessential retail.
“Part of the problem is America never really suppressed its Covid-19 cases to begin with,” Lopez wrote, explaining why experts were anticipating a new surge in cases. “Think of a disease epidemic like a forest fire: It’s going to be really difficult to contain the virus when there are still flames raging in parts of the forest and small embers practically everywhere. The country always risks a full blaze with each step toward reopening and with each failure to take precautions seriously.”
Too many Covid-19 tests are coming back positive right now
Another closely watched indicator for renewed Covid-19 spread is the percentage of coronavirus tests that come back positive. The number of tests being conducted doesn’t actually tell you all that much; if a high percentage of them are positive, that suggests that many others aren’t being caught at all and the virus could continue to spread unchecked.
So while the US is now averaging nearly 1 million tests every day, that is not quite the triumph it might sound like (or President Donald Trump would like to believe it is). The country’s positive test rate is 5 percent, right at the threshold experts say would reflect adequate testing. Ideally, it would be even lower, 2 percent or less.
But even with that passable national positivity rate, most states are still not conducting nearly enough testing. Here are the 10 states with the highest positive test rates, according to Covid Exit Strategy:
Idaho (25 percent)
South Dakota (20.6 percent)
Wisconsin (19.5 percent)
Iowa (17.1 percent)
Kansas (16.1 percent)
Wyoming (15.5 percent)
Utah (14.7 percent)
Nevada (14.4 percent)
Indiana (13.6 percent)
Alabama (13.3 percent)
It’s really only a handful of better-performing states — namely, New York, with more than 115,000 tests conducted per day and a 1.2 percent positivity rate — that’s keeping the US’s overall positive test rate from looking a lot worse.
America has never had a cohesive Covid-19 testing strategy. Since February, there have been regular supply shortages delaying test results. States have been fighting each other for precious testing resources. Contact tracing has not been a priority for the federal government, and most states have still not hired nearly enough people to perform that work.
Wealthy countries like Germany and South Korea have used effective test-trace-isolate programs to keep their Covid-19 outbreaks in check. The US, meanwhile, is still struggling to perform enough tests or scale up its contact tracing capabilities. Just 11 states, plus the District of Columbia, could realistically expect to perform adequate contact tracing, according to Covid Exit Strategy, considering their positivity rate.
Without improvement in both of those areas, it will continue to be difficult for the US to contain the coronavirus before a vaccine becomes available.
More Americans are being hospitalized with Covid-19 too
Both case numbers and the positive test rate can be a little deceptive, depending on how many tests are being performed. They suggest what’s happening on the ground — in this case, Covid-19 is spreading — but they do have their limitations. There is some truth to the president’s claim that more tests will mean more cases, though that is not a reason to stop testing.
Hospitalizations, on the other hand, are more concrete. If more people are developing symptoms severe enough to warrant being hospitalized, that is a strong indicator that the real number of people being infected with Covid-19 is growing, regardless of whether they are getting tested.
And after a dip in September, the number of Americans currently in the hospital with Covid-19 is higher than it’s been in a month. That trend has been seen across the country.
The worry becomes that if hospitals take in too many patients, they’ll have to turn other people away, or that overwhelmed staff and facilities could lead to some patients receiving substandard care. According to Covid Exit Strategy, 20 states currently have reduced ICU capacity that puts them in a danger zone; 21 states have an elevated occupancy rate in their regular hospital beds.
Wisconsin,where the number of hospitalized Covid-19 patients has risen over the last month from about 300 to 876 today, recently established a new field hospital on its state park fairgrounds over fears that the state’s hospitals wouldn’t have enough beds given the recent surge in cases.
Fortunately, hospitals have gotten much better at treating Covid-19. They have proven treatments, like remdesivir and dexamethasone, that reduce the length of hospital stays and reduce mortality in patients with severe symptoms. They have learned techniques like putting patients on their stomach to improve breathing. Hospitals that have endured multiple spikes of Covid-19 cases report patients in the later waves are spending less time in the hospital and dying less frequently.
Nevertheless, more people developing severe symptoms, as we are starting to see, will inevitably lead to more deaths. Over the summer, people wondered why deaths were falling while cases and hospitalizations rose — until deaths did start to increase. There is a long lag between cases rising and deaths rising, because it can take a month or more between when a person first contracts Covid-19 and, if they die, when their death is reported.
That’s why these new Covid-19 trends in the US are so worrisome. Cases are rising, as are hospitalizations. It could be only a matter of time before deaths start to spike as well.
An otherwise healthy 25-year-old Nevada man is the first American confirmed to have caught COVID-19 twice, with the second infection worse than the first.
He has recovered, but his case raises questions about how long people are protected after being infected with the coronavirus that causes the disease, and potentially how protective a vaccine might be.
“It’s a yellow caution light,” said Dr. William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee, who was not involved in the research.
Respiratory infections like COVID-19 don’t provide lifelong immunity like a measles infection. So, Dr. Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia, said he’s not at all surprised people could get infected twice with the coronavirus, SARS-CoV-2.
It’s too soon to know whether the man from Washoe County, Nevada, who had no known health problems other than his double infection, was highly unusual or if many people could easily get infected more than once with SARS-CoV-2, Schaffner said.
“There’s hardly an infectious disease doctor in the country who hasn’t encountered a patient who thinks they’ve had a second infection,” he said. “Whether that’s true or not, we don’t know. There are lots of respiratory infections out there.”
How rare is he?
There have been at least 22 documented cases of reinfection worldwide since the start of the pandemic, but it’s unclear how many cases there have actually been, and how common it may be among people who don’t even know they’re infected.
“It could be a one in a million event, we don’t know,” said Akiko Iwasaki, an immunologist at Yale University and an investigator with the Howard Hughes Medical Institute, who wrote a commentary with the study.
With millions of people infected, it’s hard to know if case studies like the new one represent very rare events or the tip of an iceberg, she said. “It’s possible that the vast majority of people are completely protected from reinfection, but we’re not measuring them, because they’re not coming to the hospital.”
Also, many people don’t know they are infected the first time, so it’s hard to say whether they’re getting re-infected.
In one of the recent cases, a Hong Kong man only knew he was reinfected because it was caught during a routine screening when he returned from outside the country, months after he had cleared an infection and tested negative.
One reason there may not be more documented cases of reinfection: It’s tough to prove, said Mark Pandori, a pathologist at the University of Nevada, Reno School of Medicine, and senior author on the new study.
His team coordinated early in the pandemic with members of the Washoe County Health District to look for repeat infections. They had the benefit of sequencing equipment on campus, as well as microbiologists, he said. And they got lucky finding someone who had been tested both times he was infected and cleared in between.
Why his infection was worse the second time remains unclear, said Pandori, director of the Nevada State Public Health Laboratory. “I can’t tell you if it tells us anything in particular about the biology of this virus.”
The man caught a slightly different version of the virus the second time, according a genetic analysis of the man’s infections. It’s possible the second version was more dangerous, though there is no evidence of that, or that it was just different enough that his body didn’t recognize it, the paper said.
Implications for vaccination
Iwasaki said the study raises questions about how long immunity lasts after a natural infection. Protection with a vaccine is likely to be quite different, she said.
“Vaccines can be designed to induce much higher levels of antibody and much longer lasting immunity,” she said. Just because the natural infection doesn’t give you protection doesn’t mean the vaccines cannot. It’s a separate issue.”
Offit, also a vaccine expert at the Perelman School of Medicine at the University of Pennsylvania, said he expects protection from vaccines will likely last at least a year or two.
The protection provided by infection or vaccination isn’t 100% perfect until the day it disappears completely, he said. Instead, protection fades gradually, so someone exposed to a huge dose of the virus might get re-infected within months, while others could be protected for years, Offit said.
It’s also possible the Nevada man has an undiagnosed problem with his immune system. “He probably should be seen by an immunologist,” Offit said.
The length of time an infection will be protective remains one of the key open questions about the virus.
Infected twice, two months apart
The Nevada man, considered an essential worker, started feeling ill in late March, with a sore throat, cough, headache, nausea and diarrhea. His workplace had been hit with an outbreak early in the pandemic, before safety measures like masks could be put in place, said Heather Kerwin, senior epidemiologist at the Washoe County Health District and a co-author on the paper.
He went for testing on April 18 and his infection with the coronavirus was confirmed.
On April 27, he reported his symptoms had all resolved and he felt fine, but at the time, employees were required to test negative for COVID-19 twice before they would be allowed back to work, Kerwin said. So he remained isolated at home.
A month later, he began feeling poorly again. At the same time, there was an outbreak where one of his parent’s, also an essential worker, was employed, Kerwin said.
On May 31, he went to an urgent care center, reporting fever, headache, dizziness, cough, nausea and diarrhea. On June 5, he went to see a doctor who found his oxygen levels dangerously low and had him hospitalized. Again, the man tested positive for the virus, even though he still had antibodies to the virus in his bloodstream, Kerwin said.
Genetic differences between the viruses responsible for each of his infections suggested he was infected two separate times. The virus doesn’t mutate quickly enough within a single person to explain the differences between the two infections, the researchers found.
A parent living with the man also caught COVID-19 and was diagnosed on June 5.
Mark Pandori, pathologist
The paper reports it’s possible the man was reinfected because he was exposed to a higher dose of the virus the second time, perhaps from the family member.
His cough lingered and he suffered from shortness of breath and mental fog, and was on oxygen for six weeks after the second infection, Kerwin said. He has now fully recovered.
Reinfections imply so-called herd immunity cannot be obtained just through natural infection. If natural infection protects for only a few months, then it will be impossible for enough people to be protected simultaneously to reach herd immunity.
The moral of the case study, said co-author Pandori, is even people who already have been sick with COVID-19 need to protect themselves by wearing a mask, avoiding large gatherings, washing hands frequently and maintaining social distance.
“You’re not invulnerable to this,” Pandori said. “In fact, you could get it worse the second time.”
Along with the many political and public health questions raised by President Trump’s recent and very public bout with COVID-19 is the issue of when the public might have access to the same monoclonal antibody therapy that he received from doctors last week.
Having seen the President tout the benefits of Regeneron’s experimental antibody cocktail, COVID patients have reportedly been asking physicians about participating in clinical trials of the therapy, which is only available on a “compassionate use” basis outside of ongoing studies.
On Wednesday, Regeneronannounced it had submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for the treatment, claiming that early data from ongoing trials showed promise in moderating coronavirus symptoms.
Eli Lilly, which is developing a similar antibody therapy, also announced plans to apply for an EUA, saying its drug has shown the ability to reduce hospitalizations among those infected with the virus.
The US government has already paid Regeneron $450M to access up to 300,000 doses of the therapy, and on Friday a spokesman for the Department of Health and Human Services (HHS) said the government would acquire up to a million doses from Regeneron and Eli Lilly by the end of the year, which it will allocate to hospitals in a similar approach to the way it has distributed Gilead Science’s antiviral drug remdesivir, which the President was also given last week.
News on the availability of potentially effective therapies to mitigate the impact of COVID-19 is welcome, particularly as thetimeline for COVID vaccines appears to be lengthening.
In guidance released this week, the FDA said it would require pharmaceutical companies to submit two months’ worth of data on vaccine safety and efficacy after patients received their final dose, as part of the EUA application process. The data requirement effectively means that, despite repeated promises from the White House, none of the vaccine candidates being developed will be available before the November 3rd Presidential election.
The head of the government’s vaccine program said separately this week that he expects data on vaccines being developed by Pfizer and Moderna to be available by December. As many have predicted, it will take months beyond that for a safe and effective vaccine to be distributed and administered to a majority of Americans.
Challenges will abound: ensuring sufficient manufacturing capacity, managing a complex supply chain, setting up specialized distribution and vaccination centers, and tracking those vaccinated (especially if two shots will be required). A massive public education campaign will also be needed to overcome vaccine hesitancy and ensure widespread immunization. And all of that will take time, and money.
President Trump’s recent and unfortunate illness underscores the importance of paying equal attention to the development of therapies and treatments—which are essentially a holding maneuver to get us through the coming winter and spring, and eventually to the promise of immunity that lies beyond.
The COVID-19 pandemic is rife with scientific and medical uncertainty, including debates about the ethics of using experimental treatments.
The big picture: As the global pandemic continues, the tension between providing the best available care for patients and performing trials to determine whether that care is effective risks complicating the medical response.
The big question: Is it unethical to withhold a possible treatment from someone who instead receives a placebo, or to continue to administer that treatment without having collected data on whether it works?
Driving the news: President Trump received an experimental monoclonal antibody cocktail via expanded access or “compassionate use,” which allows someone to access a treatment outside of a clinical trial before it is approved, provided their doctor, the drug company and the FDA agree.
Experts say his subsequent claims of the treatment being a cure risks reducing enrollment in clinical trials, flooding companies with requests for access to a limited number of doses andcreating false hope for patients.
“It’s important that we not say the president got access to a beneficial experimental intervention because we don’t know if it is beneficial or if there are adverse events associated with it,“ says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University.
He and other ethicists say the president’s treatment highlights a broader question about the ethical obligation doctors have to the science needed to determine if those treatments are effective.
Between the lines: Offering patients experimental COVID-19 drugs via emergency use authorizations, expanded access programs and compassionate use can slow needed clinical trials.
Researchers have struggled to enroll people in clinical trials in which they may receive a placebo if patients can access a drug directly.
One example: “There’s been some hiccups with the expanded access use for convalescent plasma, because it was something that precluded people from enrolling in a randomized control trial, so it took longer, and we still don’t quite know how well convalescent plasma works,” says Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security.
More than 100,000 COVID-19 patients at almost 2,800 U.S. hospitals received convalescent plasma from people who survived the virus and developed antibodies to it.
“It’s easy for people to say you enrolled 100,000 people, there should have been a trial. But a small number of those 2,800 hospitals would have been capable of doing those trials,” says the Mayo Clinic’s Michael Joyner, who leads the program.
There are now smaller trials taking place to answer questions about the effectiveness of plasma in treating the disease in different stages.
But if this happens again, Joyner says programs at academic medical centers should be peeled off earlier to form clinical trials run in parallel.
The gold standard for determining whether a treatment works is through randomized controlled trials in which people are randomly assigned to receive a treatment or to be in a control group.
In the uncertainty and urgency of a pandemic, some physicians argue randomizing people to receive a placebo goes against physicians’ ethics and that it is better to do something to help patients than do nothing.
“That’s a false dichotomy because the question is, what should we do?” says London.
From a doctor’s perspective, it’s important to weigh the collective value of theearly drug data and the individual needs of the patient, Adalja says.
“I do think you have to be extra careful when you’re thinking about drugs that you don’t have strong randomized control trial data for, or the data is incomplete or inconclusive,” he adds.
“What people have to ask themselves is what constitutes evidence or proof and where do you want to make the bets in a pandemic?” says Joyner.
“There is a moral, legal and public health obligation to do those trials before people use those products,” says Alison Bateman-House, a professor of medical ethics at NYU’s Grossman School of Medicine who co-chairs an international working group on pre-approval access to treatments.
She says she understands the emotional pull on doctors to help patients whose health is quickly deteriorating, “but it is not evidence-based medicine.”
“There is no ethical obligation to give anyone an unproven substance.”
— Alison Bateman-House, NYU Grossman School of Medicine
In a forthcoming paper, London argues that when medical professionals don’t have the knowledge they need to treat patients, it is their responsibility “to band together and run studies to get evidence to discharge [their] very ancient medical obligation.”
Medical ethics should be updated to include a responsibility to learn in the face of uncertainty, says London, who was part of a committee that called for research to be incorporated into the response to the Ebola outbreak in West Africa in 2014.
The U.K.’s large randomized RECOVERY trial is based in part on the Ebola experience, says London. “Because of it, we know dexamethasone is effective and hydroxychloroquine is not.”
What to watch: How the FDA’s handling of treatments during the pandemic influences other drugs and diseases once the pandemic ends.
The bottom line: “Medicine doesn’t have a good handle on uncertainty, and that is a problem,” says London.
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HENRY KOTULA 