President Trump said Friday the U.S. would halt its funding of the World Health Organization and pull out of the agency, accusing it of protecting China as the coronavirus pandemic took off. The move has alarmed health experts, who say the decision will undermine efforts to improve the health of people around the world.
In an address in the Rose Garden, Trump said the WHO had not made reforms that he said would have helped the global health agency stop the coronavirus from spreading around the world.
We will be today terminating our relationship with the World Health Organization and redirecting those funds to other worldwide and deserving urgent global public health needs, Trump said. The world needs answers from China on the virus.
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Its not immediately clear whether the president can fully withdraw U.S. funding for the WHO without an act of Congress, which typically controls all federal government spending. Democratic lawmakers have argued that doing so would be illegal, and House Speaker Nancy Pelosi threatened last month that such a move would be swiftly challenged.
The United States has provided roughly 15% of the WHOs total funding over its current two-year budget period. A WHO spokesperson declined to comment Friday.
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Trumps announcement came the same day that the U.S. mission in Geneva met with Tedros Adhanom Ghebreyesus, the WHO director-general, about the countrys demands for WHO improvements. A source familiar with the meeting described it as constructive.
Some congressional Republicans have echoed Trumps attacks on the agency, but in a statement Friday, Sen. Lamar Alexander, the chair of the Senates health committee, said he disagreed with Trump.
Certainly there needs to be a good, hard look at mistakes the World Health Organization might have made in connection with coronavirus, but the time to do that is after the crisis has been dealt with, not in the middle of it, said Alexander (R-Tenn.). Withdrawing U.S. membership could, among other things, interfere with clinical trials that are essential to the development of vaccines, which citizens of the United States as well as others in the world need. And withdrawing could make it harder to work with other countries to stop viruses before they get to the United States.
Lawrence Gostin, the faculty director at Georgetowns ONeill Institute for National and Global Health Law, called Trumps decision a dangerous move.
Its making an earth-shattering decision in the middle of the greatest health crisis weve experienced literally out of pique and whim, without any deliberative process, Gostin said.
The WHO has repeatedly said it was committed to a review of its response, but after the pandemic had ebbed. Last month, Robert Redfield, the director of the Centers for Disease Control and Prevention, also said the postmortem on the pandemic should wait until the emergency was over.
But as the Trump administrations response to pandemic has come under greater scrutiny, with testing problems and a lack of coordination in deploying necessary supplies, Trump has sought to cast further blame on China and the WHO for failing to snuff out the spread when the virus was centered in China. During his remarks, Trump alleged, without evidence, that China pressured WHO to mislead the world about the virus.
The world is now suffering as a result of the malfeasance of the Chinese government, Trump said. Chinas coverup of the Wuhan virus allowed the disease to spread all over the world, instigating a global pandemic that has cost more than 100,000 American lives, and over a million lives worldwide. (That last claim is not true; globally, there have been about 360,000 confirmed deaths from Covid-19, the disease caused by the coronavirus.)
Trumps phrasing highlights the buildup of China-U.S. tensions amid the pandemic. After a Chinese government spokesman suggested, without evidence, that the U.S. Army first brought the novel coronavirus to Hubei province, Trump retaliated by using the terms Wuhan virus and Chinese virus words widely condemned as racist, and which coincided with a rash of racist incidents targeting Asian Americans.
Experts say that if the U.S. leaves the WHO, the influence of China will only grow.
Global health was our bipartisan moral leadership that had been preserved through this administration, said Amanda Glassman, executive vice president of the Center for Global Development. And right now that falls apart. Its really to me tragic that this one space that was really about our moral leadership and our convictions and soft power that were now going to let that go in the midst of a pandemic.
Glassman said there are thousands of U.S. employees at the WHO and its regional body for the Americas, and that the U.S. is home to 82 WHO collaborating centers.
When Trump earlier this month threatened to yank U.S. funding in a letter, Tedros would only say during a media briefing that the agency was reviewing it. But he and other officials stressed that the agency had a small budget about $2.3 billion every year relative to the impact the agency had and what it was expected to do.
Mike Ryan, head of the WHOs emergencies program, said the U.S. funding provided the largest proportion of that programs budget. In addition to the pandemic, the program also works to combat HIV, tuberculosis, polio, and other diseases.
So my concerns today are both for our program and working on how we improve our funding base for WHOs core budget, Ryan said. Replacing those life-saving funds for front-line health services to some of the most difficult places in the world well obviously have to work with other partners to ensure those funds can still flow. So this is going to have major implications for delivering essential health services to some of the most vulnerable people in the world and we trust that other donors will if necessary step in to fill that gap.
This story has been updated with reaction to the presidents announcement.
Lev Facher contributed reporting.
In Wuhan, medical workers armed with coronavirus test swabs scoured construction sites and markets to look for itinerant workers while others made house calls to reach older residents and people with disabilities. Officials aired announcements over loudspeakers urging people to sign up for their own good.
These are the front lines of an unprecedented campaign to screen virtually all 11 million people in Wuhan, the central Chinese city where the coronavirus pandemic began. Nearly two weeks in, the government is getting close to reaching its goal, with 6.5 million tested so far.
Our community was checked in a day, said Wang Yuan, a 32-year-old resident who lined up under red tents near her home and had her throat swabbed by medical workers wearing protective suits and face shields. She expected to get her results within two to four days.
While other governments have struggled to provide testing for their populations on a broad scale, China has embarked on a citywide campaign to prevent a resurgence of infections at all costs. It has succeeded, according to residents and Chinese news reports, by mobilizing thousands of medical and other workers and spending hundreds of millions of dollars.
The government, which is covering the cost of testing, sees the drive as key to restoring the public confidence that is needed to help restart the economy and return to some level of normalcy. But public health experts disagree on whether such a resource-intensive push is necessary when infections are low.
The drive which has reached more than 90 percent of the city after taking into account people who had been recently tested and children has largely confirmed that Wuhan has tamed the outbreak. By Tuesday, only around 200 cases were found, mostly people who showed no symptoms, though samples were still being processed.
The city has ramped up its testing capacity over the past two weeks, in sharp contrast with the early weeks of the outbreak when the government struggled to find enough testing kits. Lab technicians were able to speed up the process by pooling samples together to be tested in batches.
Laboratories went from processing around 46,000 tests a day, on average, before the drive, to as many as 1.47 million tests on Friday. By comparison, the state of New York has tested 1.7 million people since March 4, according to The Atlantics COVID Tracking Project.
The Wuhan government is determined to leave no person behind. Officials, ordered to check the leaks and fill the gaps, also went from door to door to register residents and usher them to nearby testing stations. In at least one neighborhood, officials warned in public announcements that residents who refused to get tested would see their government-issued health codes downgraded, potentially limiting a persons right to work and travel.
If you do not participate, you will not be allowed to enter supermarkets or banks, the announcement said. Your green code will turn yellow, which will cause inconvenience to your life.
The Wuhan government had urged the small number of residents who had still not submitted to testing to sign up for it before 5 p.m. on Tuesday. People were warned that if they did not do so before the deadline, they would have to pay to get tested in the future.
Many residents appeared to be supportive of the tests. But in a city where nearly everyone knew someone who was infected or died, there was also resistance and fear.
Herry Tu, a Wuhan resident, refused for days to sign up for a testing slot, despite the urging of officials from his neighborhood. How would so many people safely gather, he asked, while maintaining two meters of separation? Would the medical workers really change gear between each person they tested?
Were totally opposed to it, Mr. Tu said of his family. Because, even if you werent infected to begin with, this testing just means contact.
He ultimately agreed to be tested this past weekend, after his childrens school said they could not return to class without doing so. But he remained angry. In reality, the government isnt doing this for the benefit of the people, he said. Its for the outside world to see.
In the Hongshan district, more than 100 people waited in nearly 90-degree heat on May 18, said Zhou Chengcheng, a resident. But he declined to go.
I felt it was a mere formality, he said. The scene looked quite chaotic, and it increases the risk of silent infections.
The government sought to reassure that the testing drive would not be a source of infections. Each resident was given a time slot to avoid crowding. Testing was conducted in open spaces. Residents had to have their temperatures screened, wear masks and keep a distance from one another. Medical workers were required to change or disinfect their gloves after each test.
But with confirmed, symptomatic infections remaining in the single digits in Wuhan, some experts said the scale of Wuhans campaign was excessive. Jin Dongyan, a virologist at the University of Hong Kong, said it would be impossible to accurately test that many people in such a short period.
Under ordinary circumstances, nucleic acid tests for the coronavirus are difficult to administer in hospitals, even with well-trained nurses, Dr. Jin said. Trying to conduct so many of them, in quick succession, in makeshift testing tents, could produce many erroneous results.
There have also been questions about the reliability of Chinas testing kits and reagents, with some countries complaining that the rush by Chinese manufacturers to meet surging global demand has led to faulty exports.
For a city of around 10 million, Dr. Jin said, a sample of about 100,000 people would have been more than sufficient. He called Wuhans campaign to expand testing to every Wuhan resident kind of scary because it would overwhelm medical staff.
Even the chief epidemiologist of Chinas Center for Disease Control and Prevention, Wu Zunyou, has suggested that there is no need to test everyone in the city.
Wuhans approach is not necessarily replicable everywhere.
Batch testing involves combining a number of swabs from different people into a plastic tube to be analyzed using one test. A negative result means all the samples can be cleared, but if the batch comes back positive, medical workers can return to each person in the group to test them individually.
But it works only in places where there is a low prevalence of infections, researchers say. If the rate of infection is too high in a community, most of the groups would have to be retested, defeating the purpose of group testing.
The approach has been adopted elsewhere in places like Nebraska and the San Francisco Bay Area, though not at the same scale attempted in Wuhan. A district in Beijing announced this month that it would test teachers and students in batches of three in preparation for schools to reopen.
Proponents of the testing push say it would give health officials a more comprehensive view of the situation in Wuhan, including of people who are asymptomatic. The campaign was initiated after the authorities discovered six infections following a month of no new confirmed cases.
Some supporters of the testing drive acknowledged that the true value of the campaign was not so much medical as psychological. While comprehensive testing would be expensive, the price of a paralyzed economy would be much higher, Guo Guangchang, the head of Fosun, a major Chinese conglomerate, told the Chinese media.
If there is no testing, everyone will still be scared, Mr. Guo said. Many companies will have no way to resume production, and the service industry will have no customers.
The loss in one day from the shutdowns in production and the service industry could be 6 billion yuan, or about $844 million, in Wuhan, he said.
Yang Zhanqiu, a virologist at Wuhan University, said he hoped that with citywide testing, more people would feel comfortable going out.
This push to test everyone would improve the vitality of the city and provide a scientific basis for the resumption of work, Dr. Yang said. It can also make people feel at ease and give everyone some peace of mind.
Amber Wang and Liu Yi contributed research.
It is hard to ask someone to socially distance if they have been forced out of their home. But in the middle of the worst pandemic in a century, we risk a new outbreak of evictions as 40 million Americans have lost their jobs and millions more struggle with reduced incomes.
Colorado residents are about to face rent due on June 1. Meanwhile, Colorados eviction moratorium, originally set to end today, lifts in just two weeks. If Congress does not act, data released yesterday by the COVID-19 Eviction Defense Project predicts that 416,000 Coloradans could face eviction by the end of September.
Every person removed from their home is another person forced to double-up with friends or family or crowd into a shelter. And each person who cant pay rent is another hit to the incomes of mom-and-pop landlords and small businesses. As our housing challenges grow, so do the challenges to our public health and economy.
To limit these risks, we must directly address the housing crisis in the next relief package. We can start by drawing from proposals in the bipartisan Evictions Crisis Act I introduced with Sen. Rob Portman of Ohio in December, which would help families stay in their homes during the pandemic and until they can get back on their feet.
Current policies will not be enough. Although federal, state and local moratoria on evictions and late fees have helped in the short-term, they cant stop an eventual wave of people losing their homes.
After all, these limits do not cover all renters, and many who are covered still wont be able to pay the accumulated rent when a moratorium ends. On top of that, many mom-and-pop landlords cant go without monthly rent while these limits remain in effect.
READ:Colorado Sun opinion columnists.
For all of these reasons, Congress needs to address the housing crisis in the next emergency package. That should start with at least $100 billion of immediate rental assistance to help low-income Americans and those who have been hit hardest with lost jobs and incomes.
We should design this assistance based on our bipartisan Eviction Crisis Act by providing the funding to local governments and nonprofits, which can then use the money to pay the landlords or utility companies directly to cover expenses like unpaid rent and utility bills.
For people who have suffered the most severe economic pain from the crisis, we should also provide short-term assistance for at least three months, and for families facing ongoing difficulties, longer-term support for up to two years.
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At the same time, we should provide at least $20 billion to fight homelessness and expand housing vouchers for those in greatest need, so people can have a stable roof over their heads and can socially distance as the pandemic continues.
Finally, we have to do more for state and local governments confronting massive budget shortfalls so they can maintain and expand critical, frontline human services.
Making sure the most vulnerable have a stable roof over their heads is not only the right thing to do, it is also critical to protecting our safety and our economy.
The last thing our hospitals and communities need is a new wave of families who become needlessly sick because they are forced from their homes and exposed. The last thing our economy needs is a wave of defaults from small landlords and businesses buckling from unpaid rent.
As Congress debates the next emergency relief package, we must have the wisdom to see that tackling the housing crisis and the pandemic are not distinct efforts they go hand-in-hand.
Michael Bennet, D-Colorado, is the states senior U.S. Senator.
The Colorado Sun is a nonpartisan news organization, and the opinions of columnists and editorial writers do not reflect the opinions of the newsroom.Read our ethics policy for more on The Suns opinion policyand submit columns, suggested writers and more to opinion@coloradosun.com.
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Hoping to draw tourists to Cyprus this summer, officials cite the "open-air lifestyle, abundance of personal space" and clean air. Here, rows of beach umbrellas await visitors on a nearly empty stretch of Nissi beach at the seaside resort of Ayia Napa earlier this month. Petros Karadjias/AP hide caption
Hoping to draw tourists to Cyprus this summer, officials cite the "open-air lifestyle, abundance of personal space" and clean air. Here, rows of beach umbrellas await visitors on a nearly empty stretch of Nissi beach at the seaside resort of Ayia Napa earlier this month.
If a visitor to Cyprus tests positive for the coronavirus this summer, the government will cover many of their expenses including food, drink and lodging according to a new plan that maps out how the island nation can revive its crucial tourism industry.
"The Cyprus government is committed to taking care of all travelers who test positive during their stay, as well as their families and close contacts," the plan states. "The government will cover the cost of lodging, food, drink, and medication, in all cases mentioned above; the traveler will only need to bear the cost of their airport transfer and repatriation flight."
Nearly 4 million tourists visited Cyprus last year, according to government statistics, generating nearly $3 billion in revenue for the country. Cyprus has a population of about 1.28 million.
Cyprus say it will ease restrictions on international air travel on June 9. But the island has been returning to normal business activities for the past month. It's poised to restart its hospitality economy on June 1 one day after health experts expect the country to achieve full containment of the coronavirus.
The first visitors to the Mediterranean country next month will be required to pass coronavirus tests in their home nations within 72 hours of their trip. But that and other restrictions will be dropped for those from certain countries, depending on their "epidemiological status," according to a letter outlining the plan. It was signed by the ministers of tourism, foreign affairs and transportation.
Cyprus will conduct an "epidemic risk assessment" of countries on a weekly basis, using criteria that ranges from testing capacity to the rates of new cases and deaths. The first iteration of that list categorizes 13 countries as "low risk," from Malta, Israel and Greece to Germany, Norway and Slovakia.
The pitch for touring Cyprus in the pandemic age ranges from the general the ministers cite its "open-air lifestyle, abundance of personal space" and clean air to the clinical, as they also note the country's ratio of intensive care units per capita is one of the highest in the Mediterranean.
If tourists are diagnosed during their visit, they can use special facilities that are being reserved for them.
"A COVID-19 hospital with 100 beds will be made available exclusively for travelers who test positive," the plan states, adding that capacity can be expanded at very short notice.
The plan also includes a range of details about how the country's restaurants and beaches will work to reduce the chance of infection, from requiring more than 12 feet between beach umbrellas to disinfecting salt and pepper mills.
Several more drug manufacturers have joined the global effort to develop a coronavirus vaccine.
The announcements, from Merck and Novartis, follow earlier initiatives by pharmaceutical companies Moderna and Inovio, as well as from the United Kingdom's Oxford University.
However, experts remain unconvinced a vaccine proven to be safe and effective will be available this calendar year.
"I think we'll have to have one more cycle of this virus in the fall, heading into the winter, before we get to a vaccine," Dr. Scott Gottlieb, former head of the Food and Drug Administration, told CNBC this week.
"I really think a vaccine is probably a 2021 event, in terms of having wide availability of a vaccine for the general population."
Here is a roundup of the most notable vaccine news of the week.
Drug giant Merck announced this week that it's investigating two potential COVID-19 vaccines.
The first is from Themis, a Vienna-based company that Merck has acquired. The Themis candidate is based on a previously developed vaccine that contains a weakened version of the measles virus. Scientists are adding bits of the coronavirus to the vaccine in an effort to teach the body's immune system to recognize the virus.
"We are eager to combine our strengths both to develop an effective COVID-19 vaccine in the near term and to build a pandemic preparedness capability directed toward emerging agents that pose a future epidemic threat," Dr. Roger Perlmutter, president of Merck Research Laboratories, said in a statement.
Studies for safety and efficacy in humans could begin in the next month or so.
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Merck is also partnering with the nonprofit scientific research organization IAVI to re-engineer an existing vaccine for Ebola. Clinical trials are expected to begin this year.
Also this week, Novartis announced it plans to make a gene-based coronavirus vaccine, which is in development at the Massachusetts Eye and Ear hospital, the Massachusetts General Hospital and the University of Pennsylvania.
A subsidiary of Novartis called AveXis would manufacture the vaccine.
"The COVID-19 pandemic is the most urgent public health crisis of our time and we recognize the significance of evaluating the potential role of a gene-based vaccine," AveXis President Dave Lennon said in a statement.
The approach uses an inactive form of the coronavirus to deliver the virus's DNA into the body, teaching it to make proteins found on the surface of coronavirus particles. Those proteins are the spikes seen on microscopic images of the virus. (The coronavirus gets its name from the crown-like spikes on its surface. "Corona" is Latin for "crown.")
Manufacturing is expected to begin this month, and clinical trials could start later this year.
The Maryland-based biotechnology company Novavax said it's launched preliminary clinical trials of its coronavirus vaccine candidate. The first results, on whether the drug is safe and effective, could be released as soon as July.
The company aims to provide vaccines for those on the front lines of the COVID-19 pandemic: health care workers.
"If our phase two data support the safety and immunogenicity that we hope it will and we're able to see a signal for efficacy, it's possible that that first line would be vaccinated sometime in the fourth quarter of this year," Stanley Erck, CEO of Novavax told CNBC.
As scientists worldwide scramble to develop a vaccine for the virus that's killed more than 350,000 people globally in just five months, a poll from the Associated Press-NORC Center for Public Affairs Research finds many Americans would refuse the shot.
About half of the more than 1,000 people surveyed in the U.S. said they would get a vaccine for the coronavirus.
Nearly a third were unsure whether they'd get it. Another 1 in 5 said they would refuse such a shot.
Older adults, who tend to be most vulnerable to COVID-19, were more likely than younger adults to say they'd get the vaccine. Sixty-seven percent of those over age 60, compared to 40 percent of younger people, confirmed they would be willing to be vaccinated.
Many are counting on the vaccine to get back to normal life. About 7 in 10 of those surveyed who said they would get the vaccine said it was necessary before lifting all restrictions.
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Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."
Beginning to end, vaccine development usually takes 10 to 15 years. There are various ways to shorten the time table. Phase three will go quicker, for example, if you vaccinate a lot of people. Thats why AstraZeneca plans to enroll about 30,000 U.S. volunteers in its phase three trials of AZD1222 starting this summer. Even in the best-case scenario, however, it will take several months for researchers to get the most preliminary sense of whether the vaccine is working or not.
Typically, you wait at least two weeks or a month later to characterize the immune response, says Mark Feinberg, president and CEO of Iavi, a nonprofit research organization developing its own vaccine. It just inherently takes time for the immune system to mount to maximal immune response, and then you have to follow those people with time to make sure that the immune response is maintained. Its not going to help anybody if you have a vaccine that might protect you for a month or two and then protection wanes.
Come October, AstraZeneca will likely have started supplying the United States with hundreds of millions of doses of a vaccine for which it will have only the most preliminary phase three data. If its efficacy is still unclear, but no evidence has emerged that it is immediately harmful, will the Trump administration greenlight its use?
In the past the answer would almost certainly have been no. The FDA always focus their decision on robust scientific evidence, says Bottazzi, who believes that the earliest robust data can be available is the end of 2021.
This administration is different. President Trump has consistently ignored scientific advice about the coronavirus, undermined his advisers health-policy recommendations, and urged the use of untested medications. After a Google Doc touting chloroquine went viral on the internet, Trump deemed it a potential miracle cure. His administration sidelined critics while spending tens of millions of dollars to buy and study the drug. Last week The Lancet published a study that found it provided no therapeutic benefits and increased the risk of death. That same week Trump declared, Im taking it, hydroxychloroquine. Right now, yeah. Couple of weeks ago, I started taking it. Cause I think its good, Ive heard a lot of good stories.
Just as the FAA has been criticized for being too lax in overseeing Boeings manufacturing of the 737 Max, the FDA has taken fire for loosening the reins on drug development. Janet Woodcock, the head of the agencys drug-approval department, has led efforts to make it more friendly to industry, and drew fire for pushing the agency to approve a $300,000-per-year treatment for muscular dystrophy that lacked any proven medical benefit. Last week she temporarily left her role to be part of Warp Speeds vaccine-development efforts.
With the coronavirus pandemic raging, the FDA is easing the rules further still. According to Soriot, AstraZeneca has worked with the agency to rewrite its vaccine-approval playbook. We are actually trailblazing here because we are not following the standard process, he told CNN. We are working hand in hand with the FDA. We are sharing data on a day-to-day basis, on a real-life basis, and basically they have committed themselves to help look at our data as they come, so that by the time we finish with our phase three program in August, they can rapidly approve the vaccine for emergency use.
On Wednesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN that he was optimistic about the administrations timeline. I still think that we have a good chance, if all the things fall in the right place, that we might have a vaccine that would be deployable by the end of the year, by December, November, he said.
The world waits with bated breath for a COVID-19 vaccine, which could effectively end the pandemic once its widely available. Until then, more people will die from the disease, and economies will struggle to fully recover.
With such intense pressureto get a vaccine quickly, many experts are contemplating a controversial shortcutto the usual vaccine testing protocol: human challenge trials.
Instead of vaccinatinghundreds to thousands of people and waiting to see if they naturally catch thevirus, scientists would purposely infect a smaller number of vaccinated volunteerswith COVID-19 in a controlled setting to see if a vaccine offered protection.If successful, such studies could fast-track vaccine evaluation, as well as ourunderstanding of COVID-19 immunity.
However, doctors andresearchers dont all agree on whether its ethical to infect people with adisease that remains poorly understood, and for which there is currently noreliable treatment. That leaves it to those bioethicists, researchers andregulators to weigh the pros and cons.
If scientists stick to theusual playbook, a licensed vaccine is at least 12 to 18 months away, expertssay. Thats not because it takes long to develop possible vaccines dozens are already in the testing stage (SN: 5/20/20) but because of the time that ittakes to be sure a vaccine is safe and actually works.
The final and most involvedstage of this process, Phase III clinical trials, requires thousands of volunteersto get the vaccine or a placebo. Then, scientists track them over months to seewhether vaccinated people are less likely to get sick compared withunvaccinated people.
And it could take longer nowthat lockdowns and social distancing have flattened the curve of new cases.You can only test vaccine efficacy if incidence [of the disease] is highenough, says Helen McShane, a vaccine biologist at the University of Oxford.The less the disease is spreading, the longer traditional Phase III trials willtake.
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Challenge trials might shavemonths off the process. Human challenge trials have been done for hundreds ofyears, says Seema Shah, a bioethicist at Northwestern University MedicalSchool in Chicago. They come with a lot of promise, but also with seriousethical concerns.
For example, in 1796, Englishphysician Edward Jenner, an earlier popularizer of vaccination, demonstratedthat inoculation with cowpox worked as a vaccine against smallpox by injectinghis gardeners 8-year-old son with cowpox and then exposing him to the disease.Clearly, thats problematic, Shah says.
Nowadays, challenge trialsare typically done on diseases about which scientists know a lot, and for whichthere are numerous treatment options, such as influenza or malaria. But therescurrently no established drug safety net for COVID-19, though some drugs show promise (SN: 4/29/20).And much still remains unknown about the virus, including all the risk factors for severe disease (SN: 4/22/20).Consequently, most advocates are calling for such trials to be done only onyoung and healthy volunteers, who seem least at risk for serious illness.
Still, researchers,clinicians, bioethicists and policymakers are debating the ultimate utility ofhuman challenge trials for COVID-19. The ethical calculus could change as welearn more about the virus and continue developing treatments, but some expertsare already putting out rough plans for how to minimize risk to participants.
Here are two perspectives onthe issue, from scientists weighing both the risks and potential benefits.
We face a worldwideepidemic with a high mortality, and the only thing likely to stop it is vaccination,says Stanley Plotkin, a vaccine developer at the University of Pennsylvania.Human challenge trials have the potential to get us an effective vaccine soonerand thus save lives, Plotkin says, and we should start planning how to do themethically now.
I would, of course, notwant to subject anyone to harm, but the fact is that harm is accumulating allover now, and if we can reduce the total amount of harm, I think its worthdoing, Plotkin says. Extraordinary circumstances require extraordinary solutions.
Human challenge trials couldhelp scientists answer important unknowns about the virus more quickly thananimal studies can, Plotkin says. A human challenge trial could tell uswhether prior infection is protective or not, as well as what sort of immuneresponses are protective, Plotkin says. Both of those have very largeimplications in terms of whether people with prior infection could take care ofthe sick, as well as our ability to evaluate the efficacy of vaccine candidatesoutside of challenge trials.
Plotkin acknowledges thepotential risks to participants. Giving someone an infection can cause seriousharm, he says, but the usual way of doing things also means that many peoplewill become ill and possibly die. To minimize risk, Plotkin says such trialsshould only be carried out on young, healthy people who understand the risksand give their full consent. There are thousands of people willing to bevolunteers for such studies on moral grounds, with knowledge of the risks.
A vaccine shown to work in achallenge trial on young people may not work in older people, or may be lesseffective, Plotkin says. But a challenge trial could allow us to more easilydetermine whether the immune responses we see in younger people are also seenin older people, who get the experimental vaccine but arent subjected to achallenge virus. Even if the vaccine only worked in younger folks, that couldstill protect older people simply because they wouldnt be getting infected byyounger [vaccinated] people, he says.
While some have argued that challenge trials could replace Phase IIIclinical trials, Plotkin doesnt seehuman challenge trials as a full substitute for normal safety trials. He also doesntexpect them to result in regulators licensing a vaccine for widespread use.But it could allow for emergency use among high-risk people or health careworkers, he says. It could also help us determine which vaccine candidatesshow signs of working, which could allow manufacturers to get a potentiallylifesaving head start on mass production.
This is not an exclusivepathway, he says, its a supplementary pathway to try to speed things up. Ifnormal vaccine trials revealed a candidate, or we learn more about the risks tovolunteers, Plotkin says challenge trials should be stopped. But if we dontstart planning human challenges now, they wont be available if we decidemonths from now that it wouldve been a good idea.
I still havent beenpersuaded that a human challenge trial would be informative enough to make afinal decision about which vaccine is the right vaccine to roll out at scale,says Angela Rasmussen, a virologist at Columbia University.
The hallmark of any humanchallenge trial is fully informed consent from participants. But Rasmussenquestions whether thats possible at this stage. I dont know that we canactually inform them of all the risks because theres still so much thats justunknown about this virus, she says.
Evidence suggests thatyoung, healthy people are least likely to suffer severely from COVID-19infection, but were still learning about different types of disease that itmay cause, Rasmussen says. Reports of young people suffering strokes, andtaking damage to the kidneys, heart and other organs have emerged in recentmonths, making it difficult to quantify the actual risks. I just dont see howa subject could provide their fully informed consent.
Accepting those risks may resultin more harm than good, Rasmussen says. By design, any COVID-19 challenge trialwould be done on a small, homogenous group. That could limit its broaderapplicability, she says, and could miss issues with the vaccine that can onlybe caught in a larger, more diverse study population.
She points to previousexamples, like the mid-2000s HIV vaccine candidate that actually increased risk of HIV infection in those who got the vaccine, or a SARS classicstudy in which older vaccinated mice experiencedmore severe disease after beinginfected.
My concern is that youcould have a major safety issue like that if you are doing only human challengetrials in young, healthy volunteers, Rasmussen says. A robust response inyoung people could mask harmful effects that emerge in older people or adifferent population, she says.
While a challenge trialcould identify promising vaccine candidates more quickly, it might also prop upthe wrong one based on limited results. If serious issues come up for otherpopulations, the consequences could be dire, Rasmussen says. And wed have wastedresources that could have been devoted to standard Phase II and III trials.
Other unknowns limit achallenge trials potential utility, too, Rasmussen says. We dont know theinfectious dose for COVID-19, she says, meaning the amount of virus that someonemust get to kick-start an infection. If a challenge trial got the dose or routeof infection wrong, it might not be comparable to pathogenic SARS-CoV-2, thevirus that causes COVID-19. A vaccine would appear to work under thoseconditions, but it might not be applicable to how people actually need to beprotected in the real world.
Rasmussen doesnt rule outthat challenge trials could be helpful. Its important to keep an open mindabout anything that can speed our way to a vaccine, but we need to be cautiousand be humble, Rasmussen says. Theres a lot more we dont know about thisvirus than what we do know. If a human challenge trial goes wrong, it could gocatastrophically wrong, which could ultimately be harmful for all vaccinedevelopment efforts.
Exactly who gives the green light for a COVID-19challenge trial remains unclear. Normally the decision to proceed with such a triallies with the funder of the research (the U.S. National Institutes of Health,for example) and ethics boards at the research institutions or regions wherethe study will be done.
But given the extraordinary nature of the currentsituation, the World Health Organization, as well as leaders of the NIH, have called for an additional layer of review for anyCOVID-19 challenge trials, which could include an independent panel ofethicists, clinical trial researchers and vaccine development experts.
In the United States, the Food and DrugAdministration would license a vaccine for widespread use, and they would haveto decide whether results of a human challenge study would weigh on theirultimate decision. Its not a given that the agency would take those resultsinto consideration.
Meanwhile, people are already volunteering to take part in COVID-19 human challenge trials, were they to happen. Already, over 20,000 people around the world have expressed interest in participating in COVID-19 challenge trials through 1 Day Sooner, a campaign to collect volunteers.
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BUFFALO, N.Y. (WKBW) Health experts say a vaccine to help develop immunity to COVID-19 will be key to helping us rebound from this pandemic. One Western New York man is doing his part when it comes to developing a vaccine that works.
Ray Grosswirth is 70-years-old and lives in Pittsford, near Rochester. He saw on social media that Rochester General Hospital was one of four sites across the country to test one potential vaccine, so he decided to reach out.
"Being in good health I feel it's the least I can do to help others who might not be so lucky if they were to contract the coronavirus," he said.
Ray will be part of a research study involving two companies, Pfizer and BioNTech. They're working together to develop a vaccine for COVID-19. He's one of 90 volunteers taking part in the study in Rochester.
"It's not a live virus, obviously. It will be a vaccine that over time will hopefully produce antibodies," he explained.
No one in Ray's life has been directly affected by COVID-19, but he says, he has an idea of what families of sick loved ones are going through. Two years ago Brenda, his wife of 25 years, came down with pneumonia, and got so sick she ended up on a ventilator.
"She had multiple organ failures. She was on a ventilator in an intensive care unit for about six weeks," he explained.
Thankfully, Brenda was able to eventually recover from the ordeal, but Ray says it's something that will never leave him. He says he feels for the loved ones of people who are sick with COVID-19.
"It was a horrible experience, but at least I was able to visit her every day," he said. "Unfortunately for a lot of people with family members experiencing terminal complications in hospitals - they're not allowed to visit them."
That's part of the reason why Ray decided to take part in the trial. He's already undergone an evaluation and has been approved for the study. Soon, he'll be tested for antibodies. If he doesn't have them, he'll move on to the first stage of the test, and be given either the vaccine or a placebo. Ray and all the participants will then have 11 follow-up visits. The hope is to see if and when they develope antibodies to COVID-19, and how long they stay in his system.
Ray is retired now, but he worked at Rochester's City Hall for 23 years where he was in charge of accounts payable. He also was ordained a married priest and performs marriage ceremonies for others. He was also the President of the Rochester Chamber Orchestra for years. It's clear that community service is important to him, and this is just another way he's giving back.
"If I can do anything at all to lead toward a better future with this virus, I certainly want to do that," he said.
If you'd like to learn more about the study taking place at Rochester General Hospital, click here.
As the COVID-19 epidemic drags on with no end in sight, the U.S. economy in tatters, and reopening going haltingly, many observers have come to the realization that we might need to learn to live with the virusmeaning with ongoing new infectionsuntil a vaccine is available.
Thus, there is an understandable hunger for one, and some95 vaccinesto prevent COVID-19 are now in various stages of development. Some of the reports of progress on this front have been encouraging, and there is a remarkable amount of R&D under way.
[May 15], the White House announced an unprecedented crash program, Operation Warp Speed, to develop coronavirus vaccines. It will be led by Gen. Gustave F. Perna, who is in charge of the Armys readiness as the current head of the Army Materiel Command, and Moncef Slaoui, a former chairman of vaccines atGlaxoSmithKline, serving as the chief scientific advisor.
At the announcement, President Trump said the goal would be to have300 million dosesof a vaccine available by the end of this year, which, if achieved, would likely halt the spread of COVID-19.
The problem, however, is that vaccine development is not as straightforward as, say, building a hotel.
For one thing, there are potential, unknown safety issues, particularly with the new technologies that are being used to make virtually all of the COVID-19 vaccine candidates. And just organizing clinical trials for the necessary large-scale testing will be a massive logistical effort. Furthermore, the medical, ethical, and regulatory bar is high for a vaccine intended for billions of healthy people.
Expecting a coronavirus vaccine in the near future may be the triumph of hope over experience.
OVERLY OPTIMISTIC, AT BEST
Dr. Anthony Fauci, the long-time director of the National Institute of Allergy and Infectious Diseases, and a senior member of the White House coronavirus task force, hasput into perspectivethe overly optimistic predictions that a vaccine can be available even in the oft-cited target window of 12-18 months: a vaccine that you make and start testing in a year is not a vaccine thats deployable.
Even Mr. Slaoui, who is directing Warp Speed,concededin an interview with the New York Times, that, Frankly, 12-18 months is already a very aggressive timeline I dont think Dr. Fauci was wrong.
Dr. Fauci is well aware of the complexity of vaccine development, testing, and approvalincluding the Food and Drug Administrationsmistake in approving a vaccine to prevent swine flu in the 1970s, which resulted in four hundred and fifty people developing a serious adverse reaction, the rare, paralytic Guillain-Barr syndrome. What made the situation even worse for regulators then is that the predicted epidemic never materialized, so the vaccine wasnt even needed.
There are other potential safety issues, particularly with novel, unproven technologieswhich, again, virtually all the COVID-19 candidate vaccines use. One potential problem was revealed in preclinical testing: they actuallymade the disease worsedue to the induction of infection-enhancing antibodies in vaccinated animals, a phenomenon called antibody-dependent enhancement, which has also been seen in humans who have been infected withdengue virus.
Once burned, twice shy, the old saying goes, and regulators have a long memory, which is why the FDAs regulation of vaccines is especially conservative for vaccines that would be administered to large numbers of healthy people. For example, before approval, thefirst successful rotavirus vaccine(RotaTeq) was tested on 72,000 healthy infants; the firsthuman papillomavirus vaccine(Gardasil) on more than 24,000 people; and thenewest shingles vaccine(Shingrix) on about 29,000 subjects. And the agency was woefully slow, lagging behind other countries, in approving the firstvaccine against meningococcus B, a life-threatening bacterial infection.
Just planning and getting clinical trials of that magnitude underway for a potential COVID-19 vaccine is a major undertaking. First, researchers would need to recruit medical practitioners and research institutions and obtain permission from local Institutional Review Boardsto say nothing of actually producing sufficient amounts of vaccines for the trials that meet the FDAsCurrent Good Manufacturing Practicesstandards. Then comes the accumulation, organization, and analysis of the data, first by the sponsors of the vaccine, then by regulators themselves.
Moreover, to demonstrate a vaccines efficacythe ability to actuallypreventthe coronavirus infectionthe trials would need to be done in places where the disease occurs in relatively large numbers so as to attain sufficient statistical power and sample size to show a difference between vaccine-treated and placebo groups.
One might think that ascertaining efficacy is simpleyou give the vaccine to one group of subjects, a placebo to a second, and then count how many people develop COVID-19 in each group, right?
Its actually much more complicated. How much of the vaccine should be in each dose? Does one dose suffice to elicit immunity, or do you need two (as is the case for Shingrix)? How well does it work in the elderly, who are highly vulnerable to COVID-19 infection but who tend to mount a poor immune response? Does immunity last long enough to make immunizing billions of people worthwhile?
Overly optimistic estimates of vaccine availability are a disservice.
They cause some members of the public, as well as politicians, to think that if we can just temporize and hold off the apocalypse until a year from now, all will be well and well have a Hollywood happy ending. If only that were true.
Henry I. Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute. He was the founding director of the FDAs Office of Biotechnology. You can find him online or on Twitter at @henryimiller
A version of this article was originally published at Human Events and has been republished here with permission. Human Events can be found on Twitter @humanevents
