It was three months ago Tuesday that the Centers for Disease Control and Prevention announced the first confirmed coronavirus case in the U.S.
In the weeks since, health officials have confirmed hundreds of thousands of COVID-19 cases across the nation and tens of thousands of deaths. Millions more Americans have lost their jobs, and tens of millions are living under stay-at-home orders.
As we continue to learn more about the virusand grapple with the affects of the pandemic, here's a look back on how the outbreak began, and how it has unfolded in the U.S. so far.
The CDC began implementing public health entry screening at San Francisco (SFO), New York (JFK)and Los Angeles (LAX) airports. The CDC would later add screening at two more airports Atlanta (ATL) and Chicago (ORD).
The CDC confirmed the first U.S. case of a new coronavirus that had killed six people so far in China. The Washington state man in his 30s returned from Wuhana week earlier, on Jan. 15. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases, called the news "concerning," particularly in light of reports that the virus has begun to spread from person to person.
Chinese authorities locked down at least three cities with a combined population of more than 18 million in an unprecedented effort to contain the virusduring the busy Lunar New Year travel period.
Meanwhile, the World Health Organization declined to categorize the coronavirus as a global health emergency, saying there is no evidence of human-to-human infection outside China.
French health officials confirmed the first three cases in Europe.
In China, the Lunar New Year holiday began. Public transportation halted for roughly 36 million people in 13 cities in central China, including Wuhan. Authorities in Wuhan said they were constructing a 1,000-bed hospital like one built in Beijing during a SARS outbreak, a similar respiratory virus.
President Donald Trump thanked China on Twitterfor its efforts to contain the disease. "China has been working very hard to contain the Coronavirus. The United States greatly appreciates their efforts and transparency. It will all work out well. In particular, on behalf of the American People, I want to thank President Xi!" he said in a post.
Meanwhile, Sen. Rick Scott, R-Fla., urged the Trump administration to declare a public health emergency and sent a letter to the CDC requesting information about the agencys plan to combat the virus. "We have to get serious about the threat of coronavirus coming from China," Scott said in a press release.
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, comments on the risk to Americans."We don't want the American public to be worried about this because their risk is low," Fauci said."On the other hand, we are taking this very seriously and are dealing very closely with Chinese authorities."
Many health professionals argued that the flu poses a greater threat than the coronavirus.
Alex Azar, secretary of Health and Human Services and chairman of the coronavirus task force, told reporters during a press briefing that the U.S. has "been monitoring this virus and preparing a response since back in December."
The first group ofpassengers returned to the U.S. fromChina. They were expected to remain under observation for up to three days as they were screened, a CDC official said. The American passengers flew into California from Wuhan, with a stopover in Anchorage, Alaska, where they had also been screened.
The World Health Organization declared the coronavirus outbreak to be a "public health emergency of international concern." Dr. Tedros Adhanom Ghebreyesus, director-general of the WHO,praised China for its quick response to the crisis, saying the emergency declaration "is not a vote of no confidence in China."
Medical staff in protective clothes are seen carrying a patient from an apartment suspected of having the virus in Wuhan, in Hubei province on January 30, 2020.HECTOR RETAMAL, AFP via Getty Images
The CDC reportedthat thefirst case of person-to-person transmission in the U.S. is the husband of a Chicago woman who developed symptoms after visiting China. "We understand this may be concerning, but based on what we know now, our assessment remains that the immediate risk to the American public is low,"said Robert Redfield, director of the CDC.
The Trump administration declared the coronavirus outbreak to be a public health emergency in the United States, setting quarantines of Americans who have recently been to certain parts of China. CDC officials said it was the first quarantine order issued by the federal government in over 50 years.
Azar also announced a temporary suspension of entry into the United States of foreign nationals who had been in China in the previous 14 days.The ban was effective Feb. 2.
Meanwhile, officials began funneling all flights from China to the U.S. to one of seven airports that were designated ports of entry: New York, San Francisco, Seattle, Honolulu, Los Angeles, Chicago and Atlanta.
The outbreak had infected nearly 12,000 people, most of them in China, and killed more than 250 people, all in China.
A 44-year-old Chinese man hospitalized in the Philippines became the first known fatality outside China from the new virus that has killed more than 300 people.
Autopsies on the bodies of two people who died at home on Feb. 6 and Feb. 17 showed they were positive for the virus, a California county announced April 21.
Previously, the first U.S. death had been thought to occur Feb. 29 outside Seattle. The autopsy findings revealed that the virus may have been spreading in U.S. communites earlier than previously known. Thetwo people died during a time when very limited testing was available only through the CDC, and the agency's testing criteria restricted testing to only individuals with a known travel history and who sought medical care for specific symptoms.
TheChinese doctor who was reprimanded by security police for warning fellow doctors about the initial coronavirus outbreak died of the illness.
In the U.S., Secretary of State Mike Pompeo announced that his departmentfacilitated the transportation of nearly 17.8 tons of donated medical supplies to the China, including "masks, gowns, gauze, respiratorsand other vital materials."
A USA TODAY analysis later finds thatAmerican companies sold more than $17.5 million worth of face masks, more than $13.6 million in surgical garments and more than $27.2 million in ventilators to China during the first two months of the year, far exceeding that of any other similar period in the past decade.
The WHO announced a formal name for the coronavirus COVID-19. Meanwhile, China reported its highest daily coronavirus death toll, the 103 additional fatalities pushing the total past 1,100. "With 99% of cases in China, this remains very much an emergency for that country, but one that holds a very grave threat for the rest of the world," WHO'sDr. Tedros Adhanom Ghebreyesus said.
The CDC confirmed the 13th U.S. coronavirus case, and about 800 Americans evacuated from Wuhan remain under quarantine. At a rally in New Hampshire,Trumpsaidthat,"in theory" once the weather warms up,"the virus" will "miraculously" go away.
A 60-year-old U.S. citizen became what appears to be the first American fatality from the global virus outbreak. The American victim, who was not identified, died in China after being diagnosed with the coronavirus in Wuhan, according to the U.S. Embassy.
Dr. Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, told reporters that U.S. health officials are preparing for the coronavirus to become a pandemic. "We're not seeing community spread here in the United States, yet, but its very possible, even likely, that it may eventually happen,"she said.
Schools, businesses and restaurantswere closed in a dozen northern Italian towns following reports of two deaths tied to an outbreak of the coronavirus in the region. The virus would begin to spread rapidly through Europe and Iran.
The CDC confirmed an infection in California that would represent the first U.S. person to contract the virus despite not visiting a foreign country recently or coming in contact with an infected patient. This brings the number of coronavirus cases detected in the U.S. to 15, with 12 of them related to travel and the other two to direct contact with a patient.
Meanwhile, Trump announced that Vice President Mike Pence would lead the administration's coronavirus response. "We're very, very ready for this," Trump said at a press conference. "The risk to the American people remains very low."
Messonnier told reporters that the CDChas taken steps to address problems with flawed test kits mailed to state and local labs. The agency has also expanded criteria for coronavirus testing.
In an effort to increase testing, the Food and Drug Administration announced it would be opening up its emergency authorization process to allow new testing technologies at hospitals and health care facilities nationwide.
U.S. Surgeon General Jerome Adams echoed CDC guidance encouraging Americans not to buy face masks needed by medical professionals."They are NOT effective in preventing general public from catching #Coronavirus, but if healthcare providers cant get them to care for sick patients, it puts them and our communities at risk," he said on Twitter.
A man in Washington state died after contracting the coronavirus what was initially thought to be the first death from the new disease in the U.S.Gov. Jay Inslee declared a state of emergency in Washington hours later, saying that the outbreak "could likely be a worldwide pandemic."
While touring the CDC headquarters in Atlanta, Trump told reporters: "Anybody that wants a test can get a test. Thats what the bottom line is."
Trump addressed the nation on the coronavirus outbreak andoutlined strict travel restrictions on passengers arriving in the United States from hard-hit portions of Europe. Three days later, he added the United Kingdom and Ireland to the ban.
The WHO declared that the spread of COVID-19 hadbecome a pandemic, which theorganization has definedas "the worldwide spread of a new disease." Infections outside China have increased 13-fold in two weeks, WHO's director general said. In that same time, the number of countries hit by the outbreak has tripled.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the testing logjam constitutes a "failing" of the nation's health care system. "The idea of anybody getting (a coronavirus test) easily, the way people in other countries are doing it we're not set up for that," Faucitold Congress. "That is a failing."
Trump declared the coronavirus pandemic to be a national emergency. Trump said the movewouldfree up nearly $50 billion in additional disaster funding and would allow HHS to waive regulations and laws to deliver coronavirus testing quicker.
Trumpissued guidelines that called for Americans to avoid social gatherings of more than 10 people for the next 15 daysand to limit discretionary travel, among other guidelines. Trump said the country may be dealing with a number of restrictions through July or August as a result of the virus. He acknowledged the economy may be heading into a recession.
Trump invoked the Defense Production Act, a wartime authority that allows him to direct industry to produce critical equipment.
A study published in the New England Journal of Medicine found that viable virus could be detected up to three hours later in the air, up to four hours on copper, up to 24 hours on cardboard, and up to two to three days on plastic and stainless steel.
A CDCreportfoundthat among the roughly 12% of COVID-19 cases in the U.S. known to need hospitalizations, about 1 in 5 were among people ages 20 to 44.
China reportedno newdomestic cases on the mainland only cases in people returning from abroad.
The International Olympic Committee and Japanese government agreed to postpone the 2020 Summer Olympics "to a date beyond 2020 but not later than summer 2021" due to the ongoing coronavirus pandemic. It is the first time in modern Olympic history that a global health issue has disrupted the Games.
The U.S. surged past China and Italy to become the planet's most infected nation. More than 1,296 people had died in the U.S.
President Donald Trump signed the largest stimulus package in U.S. history.The stimulus package was expected to provide $1,200 checks to many Americans and more for families while making available hundreds of billions of dollars for companies to maintain payroll through the crisis.
Trump alsoordered his administration to use its authority under the Defense Production Act to force General Motors to expedite government contracts to build ventilators.
The CDC issued a request asking residents of New York, New Jersey and Connecticut to curtail nonessential travel for 14 days.
Meanwhile,an infant younger than one year who tested positive for the virus in Chicago died.
Trump announcedthat the White House would be extending its social distancing guidelines through April 30. "The peak in death rate is likely to hit in two weeks," Trump said. "Nothing would be worse than declaring victory before the victory is won." Trump said that he expects that, by June 1, "we will be well on our way to recovery."
The worldregisteredmore than 1 million confirmed casesin less than five months. In reality,that markwas crossed much earlier because many more people have the virus but were not tested.
In the U.S., arecord 6.65 million Americans filed first-time jobless claims the previous week, the Labor Department said. That number would later be revised up by 219,000 to an all-time high of 6.86 million.
The Trump administration advisedpeople to start wearing face masks in public to stop the spread of the coronavirus, a reversal on previous guidance that urged people not to wear masks.
The city of Wuhan was lit up after midnight to celebrate the lifting of a 76-day lockdown.
More than 2,000 people in the U.S. died of coronavirus on Good Friday, a new daily high in the nation's fight against COVID-19. Dr. Deborah Birx, coordinator of the White House coronavirus task force, said that the U.S. has not "reached the peak" of the pandemic but that there were "encouraging" signs that the curves were flattening or lowering.
The United States passed Italy to become the country with the most coronavirus deaths. However, as a proportion of the total population in the U.S., virus deaths remain at about one-sixth of those in hard-hit Italy or Spain.More than 19,700 people in the U.S. had died due to complications from the coronavirus.Worldwide, the death count surpassed 104,000.
All 50 statesreported at least one death, and more than 23,000 Americans died. President Donald Trump said his administration will "halt" funding to the WHOas it conducts a review of the global organization's handling of the pandemic.
Demonstrators drove thousands of vehiclesto Michigan's state Capitol, protesting the state'sstay-at-home order. Protests also erupted in Kentucky, Oklahoma and North Carolina.
The White House issued guidelines to states aimed at easing social distancing restrictions and reopening parts of the country. About 14% of the U.S. workforce hadfiled for unemployment in the past month.
The governors of Tennessee, South Carolina and Georgia announced various measures aimed at easing restrictions on some businesses in their states.
LabCorp, a global life sciences company based in North Carolina, received FDA authorization for kits that enable people to collect nasal swab samples at home and mail them to a laboratory for testing.
PHOTOS Getty Images, AP; GRAPHICSKarl Gelles, Jim Sergent, Mitchell Thorsonand Veronica Bravo/USA TODAY
A federal appeals court says Arkansas can suspend abortions during the coronavirus pandemic.
As non-essential medical procedures are put on hold to help preserve medical supplies like surgical masks and hospital gowns, Republican officials in several states including Arkansas have tried to suspend abortions. Abortion rights opponents argue the procedure should be treated as non-essential.
Reproductive rights groups have accused Republican officials of using the crisis for political purposes. Theyve successfully persuaded courts to block or scale back pandemic-related abortion bans in most states, including Ohio and Alabama. Advocates point to statements from major medical groups who say the procedure is time-sensitive and shouldnt be delayed.
But now, in a reversal of a lower-court decision, the U.S. Court of Appeals for the Eighth Circuit says Arkansas can suspend abortions during the pandemic. In the opinion, a federal judge writes
Patients also have been turned away for the procedure in states including Texas, where abortion rights advocates have been engaged in multiple rounds of legal wrangling with the states governor and attorney general. In the aftermath of the ban in Texas, Planned Parenthood has reported a more than seven-fold increase in patients traveling to clinics in nearby states for abortions.
Most campuses in the United States are sitting empty. Courses are online, students are at home. And administrators are trying to figure out how to make the finances of that work.
"The math is not pretty," says Robert Kelchen, who studies higher ed finance at Seton Hall University in New Jersey. "Colleges are stressed both on the revenue side and on the expenditure side."
On one end of the equation, colleges are spending money to take classes online, in some situations purchasing software, training professors or outsourcing to online-only institutions. That's on top of refunds for room and board and parts of tuition. On the other side, money isn't coming back in, in the form of expected tuition and revenue from events such as athletics, conferences on campus and summer camps. College endowments, which can sometimes offer some insulation from hard financial times, have also taken a hit.
"This will touch every sector of higher education. Every size of institution, every region of the country," says Dominique Baker, a professor of education policy at Southern Methodist University in Dallas.
And it already has. The University of Michigan estimates it may lose up to $1 billion by the end of the year. For the University of Kentucky, it's $70 million. Hundreds of schools including some with endowments of more than a billion dollars, like Duke University, Virginia Tech and Brown have announced hiring freezes. Other institutions have cut pay and have laid off staff and contractors. In Vermont, state officials have floated potential college shutdowns.
Despite the fact that no institution will be spared, says Baker, the pandemic will affect different institutions in disproportionate ways. "For some colleges, this is an existential threat that means they'll have to close," she says, while others will have the financial backing to weather the storm. What keeps her up at night? Those institutions that serve more vulnerable populations and are in more remote or rural places. Because, she says, they have the potential to feel the financial pain even more. There, students rely on colleges for services such as health care, campus jobs, child care and free food. Baker says those places, which have already been largely underfunded, will be hard-pressed to stay afloat.
The federal government did attempt a buoy: In the CARES relief package passed in March, Congress allocated about $14 billion for colleges and universities, though many have said that's not enough. "Woefully inadequate" is what the American Council on Education called it. The group, along with 40 other higher education organizations, have lobbied Congress for about $46 billion more. And that's a conservative ask, they say.
Additional state funding for higher education also seems unlikely, considering revenues are way down across the country from an economy on hold. In most states, funding for higher education isn't constitutionally required, so when states are strapped to balance their budgets, it's often an easy target. "When state budgets take a hit, higher ed really takes a hit," says Kelchen. This happened in the last recession, more than a decade ago, and in many places, state funding for higher education never rebounded.
With less funding, colleges have continued to lean on tuition. But over the past eight years, college enrollment nationwide has fallen about 11%. Every sector public state schools, community colleges, for-profits and private liberal arts schools has felt the decline. Over the years, international students, who often pay full tuition, have helped. But now with travel restrictions in play, schools are expecting very few of them this fall.
And we're still waiting for colleges to answer the biggest question: What will the fall look like?
"I don't think there's any scenario under which it's business as usual on American college campuses in the fall," says Nicholas Christakis, a sociologist and physician at Yale University who is studying how the coronavirus spreads. "This idea that we can somehow just get back to normal and go back to school in the fall, because we always have, it's not reasonable, actually. I think we're going to have to figure out other ways of doing this."
Colleges need to have a contingency plan ready, says Bryan Alexander, an educational futurist at Georgetown University. The pandemic, he says, is "going to change things, and the degree depends on the shape of the pandemic in the fall semester."
There are many ways a reconstructed fall might look, including the option of continuing everything online, though many colleges that teach in-person still think of that as a last resort. They cite online learning growing pains and an ambivalent faculty. Plus there's some fear that students and their families won't be willing to pay as much for an online offering. Among the ideas being floated for tweaking the in-person model is changing the traditional academic calendar. Instead of starting in August or September, school might open in October or even January. Instead of 16-week semesters, colleges could shift to quarter systems or even shorter, four-week courses to allow flexibility.
Others have floated a hybrid model, with some smaller classes remaining in-person and larger classes going online. Kim Weeden, a sociologist at Cornell, along with colleague Benjamin Cornwell, set out to study this idea using network modeling on enrollment data on Cornell. She was hoping that if they eliminated large lecture classes, students would have less interaction with each other. It turns out, it didn't matter. The close-knit community often touted as the hallmark of residential campuses persisted. The researchers found that tight networks existed regardless.
"Just eliminating those 100-person or more classes didn't seem to reduce the small-world nature of the network all that much," Weeden says. Their research which was published recently in a white paper, but not peer reviewed was only looking at classes and didn't factor in dorm life or campus events such as social gatherings and athletics.
"There's just so much uncertainty," says Weeden. "You know, a big piece of this, of course, is whether there is going to be [coronavirus] testing available and what those tests can and cannot tell us. And you know, everybody wants to know the answer to that question."
Still, some colleges will be affected less, says Christakis. He points to urban campuses or community colleges that have a large number of commuter students without a residential component. Those schools may be able to thin out the number of students in a classroom and space out when those classes are offered, in order to cut down on crowding and adhere to a semblance of social distancing.
For residential colleges, the question is even harder, since opening campus is more than just classes it's students living in close quarters, often in a dorm. College campuses are also ripe for outbreaks if the disease doesn't fade, like we've seen happen in the past.
With that risk comes liability. If an outbreak occurred on campus, could the administration be on the hook for lawsuits?
Still, very few colleges are publicly admitting other options. Cal State Fullerton announced Monday that it was assuming it would be virtual in the fall. "Of course that could change," said the school's provost, Pamella Oliver, in a virtual town hall, "but at this point that's what we're thinking." Boston University shared that it was making plans in the event it couldn't reopen come fall, and the story gained worldwide attention. The school has since backpedaled and clarified, announcing that "Boston University is planning to resume its on-campus, residential program in the fall of 2020, following the recommended best health practices around the coronavirus pandemic."
In an environment with declining enrollments, says Alexander, schools are competitive. If one school announces plans to remain online, another might flaunt its gorgeous campus in an attempt to steal away students. Every student who agrees to enroll matters in this environment, he says, and higher ed isn't big on working collaboratively.
Planning in the background, without making any public declarations, seems to be the winning play right now.
"I think we're still 50/50 on whether the fall semester looks normal," says W. Joseph King, the president of Lyon College, a small private school in Arkansas. There, he says, his administration is currently planning two, very different options: the typical residential experience they've always had, or a totally virtual one. Regardless of what happens, there's really no scenario, King says, where it doesn't hurt financially. "We're not in a situation where we've been running a surplus," he says. The college has long struggled with its endowment and enrollment, but this spring, he says, was actually shaping up to be pretty good: The number of students who have committed and sent in deposits is higher than expected.
"But the question is, do those deposits, those intentions that we've heard so far, ring true to a final decision?" he says, So much can happen over the summer, especially given how much economic uncertainty and disruption families are facing. Will students actually be there in the fall? That's the question every college in America is wondering right now.
Whats new: Facebook has released a map showing the proportion of people who say they have experienced coronavirus symptoms in each state in the US. The data was gathered from more than one million Facebook users who filled in a survey created by Carnegie Mellon University about whether they were experiencing symptoms like a cough or a fever. The map, which goes down to county level, will be updated every day. Facebook says it will create similar maps for other countries in the coming days and weeks, also based on survey responses.
How it could be used: Knowing who is experiencing symptoms and where could help health officials and governments to prepare for surges of hospital cases and decide where to allocate resources like ventilators, face masks, and personal protective equipment. Given the shortage of tests, and long delays for results, this map could be useful in helping to predict where covid-19 hot spots are forming across the US.
Limitations: Obviously, the map is only as good as the data thats used to create it, and as you can see for yourself, vast swaths of the map dont have enough participants to yield reliable data. The map is part of Facebooks work with CMU and the CDC to predict the coronaviruss spread.
Tiger King is one of the streaming service's smash hits during the coronavirus pandemic, which has forced billions globally to remain home. Netflix/Courtesy of Netflix hide caption
Tiger King is one of the streaming service's smash hits during the coronavirus pandemic, which has forced billions globally to remain home.
A day after the eye-popping announcement that nearly 16 million new subscribers signed up for Netflix in the first quarter of the year, the video streaming giant said it wants to take on more debt so it can acquire and produce more content.
The company plans to offer $1 billion in new bond sales, according to a Netflix statement on Wednesday. Proceeds will go towards items including potential acquisitions, strategic transactions and general corporate business.
Netflix has been one of the rare businesses that has flourished during the coronavirus pandemic as billions of people worldwide are stuck at home and are turning to streaming services for entertainment or a brief escape from reality.
As Bloomberg News reports, Netflix is sitting on a record level of cash and generated more money than it spent running business operations in the first quarter for the first time in six years.
The company also sought $2 billion in bond sales in October.
Netflix has been bolstered by hits like Tiger King and Love Is Blind and announced on Tuesday that it has $162 million in free cash flow. However, this comes in part from halting most production due to the pandemic.
"When it comes to production, almost all filming has now been stopped globally," except in a few countries including Korea and Iceland, Netflix said in a letter to shareholders.
"This has been devastating for millions of workers in the TV and film industry electricians, hair and make-up artists, carpenters and drivers who are often paid hourly wages and work project-to-project," the company said.
Netflix also said it gained 15.8 million net subscribers in the first quarter of the year, though it projects slower growth in subscribers for the next three months, anticipating 7.5 million in what it calls "global paid additions."
Still, Netflix co-founder and CEO Reed Hastings said in a Netflix Q1 2020 Earnings Interview that even with the recent growth in subscribers, it's difficult to know when the company will be able to start new projects because of the coronavirus pandemic.
"It's super hard to say if there's strategic long-term implications," Hastings said, because "we've just been scrambling to keep our service running well."
Still, he added, "Our small contribution in these difficult times is to make home confinement a little more bearable."
NPR's Shannon Bond contributed to this report.
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY
The Seattle volunteers who got shots in the first trial of a possible coronavirus vaccine are now getting the second shot an indicator the early trial is progressing well.
While the doctors at Kaiser Permanente'sVaccine Treatment and Evaluation Unitin Seattle dont know the results of the first round of tests, the fact that it has continued and that the second round of injections are now being given is good news, said Lisa Jackson, who is leading the study.
The trial hasnt been stopped. We know from the study protocol that if adverse events had happened, the protocol would have required that, she said.Therefore we presume those things havent happened.
The volunteers are taking part in the first investigational vaccine study to fight coronavirus. The studylaunched on March 16.
U.S. researchers have given healthy volunteers the first shot of an experimental coronavirus vaccine as anxiously awaited testing opens. The Associated Press observed as the study's first participant received the injection inside an exam room. (March 16) AP Domestic
The vaccine, called mRNA-1273, was developed by scientists at the National Institute of Allergy and Infectious Diseases and at theCambridge, Mass.-based biotechnology company Moderna, Inc..
It is being given in two doses because the SARS-CoV-2 virus, which causes COVID-19, is new and no one had been exposed to it before it appeared in December, said Jackson.
Humans are a "naive" population when it comes to the virus. The first shot is a primer to set the immune system up, giving it a first look at the virus, Jackson said.
The second shot, administered 28 days later, builds on that protection so the body can more rapidly produce antibodies if it is later exposed to the virus.
After the first set of volunteers was enrolled in Seattle, the trial was expanded on March 27 to include volunteers at Emory University in Atlanta, Georgia. The initial group included 28 in Seattle and 17 at Emory.
The volunteers will be followed for 13 months to ensure they have no side effects or other reactions to the vaccine.
Jennifer Haller, left, smiles as the needle is withdrawn after she was given the first-stage safety study clinical trial of the potential vaccine.(Photo: Ted S. Warren, AP)
The experimental Moderna vaccine uses messenger RNA to get the bodys own cells to produce a protein found on the spikes on the surface of the SARS-CoV-2 virus it uses to infect human cells.
The hope is that the body will respond to those proteins by mounting a robust immune response to the virus.
The National Institutes of health is now expanding the trial to include 60 adults over the age of 56, Jackson said. Some will be tested in Seattle, some in Atlanta at some at the NIH in Bethesda, Maryland.
The test is part of Phase I trial of the possible vaccine. The goal is to test the safety of various doses and whether these doses produce an immune response.
Phase I trials dont study whether the vaccine is effective in preventing COVID-19 infection. That comes in Phase II.
There are no vaccines or treatments that have yet been approved for COVID-19. The Moderna vaccine was the first of more than 70 candidate vaccines currently being tested worldwide, according to the World Health Organization.
In terms of treatment, thus far the most promising but still not yetapproved as it's in the testing phase may be Remdesivir, an antiviral drug from Gilead Sciences. Leaked data from a test at the University of Chicago appeared to indicate it might help those infected. The company has cautioned that until all data is analysized, it's impossible to draw any conclusions from the trial.
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As the world waits anywhere from 18 months to years for the first effective coronavirus vaccine, some lawmakers, scientists, and bioethicists are calling for a radical push to speed up the process deliberately infecting volunteers with the virus.
On Tuesday, vaccine expert Stanley Plotkin of the University of Pennsylvania and bioethicist Arthur Caplan of New York University released an outline for these challenge studies of a coronavirus vaccine in the journal Vaccine. That followed a bipartisan group of nearly three dozen members of the House of Representatives on Monday calling on the FDA to consider such trials.
Every week of delay in the deployment of a vaccine to the seven billion humans on Earth will cost thousands of lives, said the letter, spearheaded by Rep. Bill Foster of Illinois, a scientist, and Rep. Donna Shalala of Florida, a former HHS chief. In the case of accelerated human trials, justifiable risks may be taken, they wrote, potentially by challenge trials that involve deliberately infecting volunteers who have received candidate vaccines or placebos.
Normally, deliberately giving someone an infection that is potentially lethal would be unacceptable, Caplan told BuzzFeed News. But in extreme times, like a plague, you might look to extreme measures.
The approach is unusual but not unprecedented. Still, some scientists argue that it may be too drastic of a measure given the number of unknowns with the new coronavirus.
As of Wednesday, there have been more than 2.5 million confirmed cases of COVID-19 and nearly 180,000 deaths worldwide. More than 70 novel coronavirus vaccines are now in development, according to the World Health Organization. A March Journal of Infection report estimated that about 70% of the US population, more than 220 million people, would need to recover and gain some immunity to the virus or get vaccinated for the country to have herd immunity to future outbreaks.
Some biotech industry observers suggest that past vaccine development times could mean waiting until 2023 or 2024 for a novel coronavirus vaccine to reach enough people to blunt the spread of COVID-19. On Wednesday, FDA Commissioner Stephen Hahn said on CBS This Morning that the agencys expectation is a vaccine will become available in March of 2021, but we are really trying to accelerate the efforts. NIAID Director Anthony Fauci told BuzzFeed News in February that if everything went perfect, starting to distribute a vaccine widely would take at least 18 months, a delivery date more like August of 2021.
Normally, vaccines require safety studies conducted in lab animals, followed by three phases of progressively larger and longer experiments on people, first to prove the vaccines are safe and then to prove that they are effective at preventing infection. Four vaccines are currently undergoing Phase 1 safety trials in small numbers of human volunteers, and one Phase 2 trial involving 500 volunteers is underway in Beijing.
If the vaccines prove safe and effective in these trials, they would move on to Phase 3 trials involving thousands of volunteers studied for around six months. Those trials require giving one group of volunteers the vaccine and another group a placebo, then waiting for the months to elapse to see how many catch the disease and how many dont, and then comparing between the two groups to figure out the efficacy of the vaccine.
If the Phase 3 trials proved successful, the vaccines would be allowed for widespread public use, but would require more time to manufacture and distribute the billions of doses needed.
A March Journal of Infectious Diseases report led by Nir Eyal of the Center for Population-Level Bioethics at Rutgers University proposed collapsing this time frame by running small challenge trials in people alongside the Phase 3 one. Essentially small groups of volunteers at low risk of dying of the disease, healthy 20- to 45-year-olds perhaps already in dangerous occupations, would be divided into two groups. One group would receive a candidate vaccine and one would get a placebo shot. They would then be exposed to increasingly large doses of the coronavirus until most of the patients in the placebo group were infected but didnt have symptoms more severe than a typical case for their age group. Intense immunological monitoring would look for any signs of dangerous side effects seen in past SARS coronavirus vaccine tests, where a mistargeted vaccine caused immunopathology in lab mice actually made the disease more deadly.
Not only would the results point to whether a vaccine works, but they would tell researchers what amount of virus exposure is needed to trigger an infection, a still undetermined data point amid debates about masks and PPE needs in hospitals and daily life.
There are plenty of young people who want to help, Caplan said. The key thing is that they have to be fully informed about the risk, and their consent should be managed by someone completely completely independent of the people running the experiment. The separate ethics board could tell volunteers, "Look, we will give you a medical exemption to get out of this if you really dont want to do it," said Caplan, to eliminate the risks of coercion or pressure to volunteer.
A Covid Challenge website noted by researchers such as Marc Lipsitch of Harvards T.H. Chan School of Public Health has been established to enlist challenge trial volunteers.
Plotkin and Caplans study design would limit volunteers to healthy 18- to 29-year-olds, noting a 0.3% death rate among patients that age in China, and start by first exposing people who had recovered from past infections to the virus. That could potentially help answer questions about how much protection antibodies from a past infection give to those who recover, another unknown.
Europe is also weighing whether to undertake challenge trials, Pieter Neels of Belgiums University of Namur and chair of the International Alliance for Biological Standardizations human vaccine committee, told BuzzFeed News. The problem is that with COVID-19, a huge knowledge is lacking, he said by email, unlike other diseases where challenge trials are used, like malaria, cholera, or influenza. There are two commercial companies in Europe that would like to perform challenge trials, he noted: hVivo in the United Kingdom and SGS in Belgium.
Not everyone in medicine thinks that deliberately infecting people with a little-understood and deadly disease with no cure is a great idea: Where youre going to give somebody a virus on purpose, you really want to understand the disease so that you know that what youre doing is a reasonable risk, Matthew Memoli of the US National Institute of Allergy and Infectious Diseases told Science magazine in March.
People have died in challenge experiments. In 2001, Ellen Roche, a 24-year-old lab technician at Johns Hopkins, died after volunteering for an asthma treatment experiment.
The sheer logistics of setting up an ethical challenge trial is another reason for caution, vaccine expert Peter Hotez of Baylor College of Medicine, told BuzzFeed News. It would require evaluating different virus doses to determine what qualifies as a minimal dose, standardizing the challenge virus and how it would be delivered, ensuring volunteers received the newest antiviral treatment, and many other considerations absent in standard trials. His own team took years to create a model for human challenge trials of a parasite vaccine.
While Im sure these timelines can be accelerated, it still wont be easy to do this very quickly, said Hotez, It doesnt mean we shouldnt do it, it would certainly help down the line, but I dont see how it happens very fast.
A related concern is a hypothesis that there is a relationship between disease severity and the size of infectious dose they receive, biostatistics professor Natalie Dean of the University of Florida told BuzzFeed News by email. The theory raises questions about how to determine the appropriate dose to use in a human challenge trial, she asked. I don't come down firmly on either side, but I am not as clearly for it, she said.
The World Health Organization also has preparations underway to run truly massive, multinational Phase 3 trials of vaccines, where a huge number of participants could help speed up the timeline needed to determine whether the inoculation was working. The NIH announced a partnership with major drugmakers on Friday to speed vaccine development as well.
In February, Fauci told BuzzFeed News one big roadblock to developing vaccines was assuring drugmakers they wont lose money on a vaccine as happened with the Zika virus vaccine. With a worldwide pandemic and trillions of dollars in stimulus package spending later, that seems like less of a concern.
For practical reasons, challenge trials might focus only on vaccines that could be quickly made in millions of doses, said Caplan, rather than equally promising ones that dont offer an easy way to scale up. Why put people at risk for something that wont be available easily?
One other reservation that Caplan also acknowledged was concern that an authoritarian country might start challenge trials without prioritizing patient consent. He called for international standards and oversight of trials to prevent such abuses.
I do worry about that, he said. It doesnt have to happen in the US, but it should be done with independent oversight and a lot of care, wherever it happens.
Momentum is building to speed the development of coronavirus vaccines by intentionally infecting healthy, young volunteers with the virus. A grass-roots effort has attracted nearly 1,500 potential volunteers for the controversial approach, known as a human-challenge trial.
The effort, called1Day Sooner, is not affiliated with groups or companies developing or funding coronavirus vaccines. But co-founder Josh Morrison hopes to show that there is broad support for human-challenge trials, which have the potential to deliver an effective coronavirus vaccine more quickly than standard trials.
Typical vaccine trials take a long time because thousands of people receive either a vaccine or a placebo, and researchers track who becomes infected in the course of their daily lives. A challenge study could in theory be much faster: a much smaller group of volunteers would receive a candidate vaccine and then be intentionally infected with the virus, to judge the efficacy of the immunization.
We want to recruit as many people as possible who want to do this, and pre-qualify them as likely to be able to participate in challenge trials should they occur, says Morrison, who is also the executive director of organ-donation advocacy group Waitlist Zero. At the same time, we feel that the public policy decisions around challenge trials will be better informed if they highlight the voice of people interested in participating in such trials.
Morrison says that the people who have signed up to be part of a challenge trial tend to be young and live in urban areas, and are highly motivated to do something constructive to address the coronavirus pandemic. Many note that they recognize the risk but believe the benefits of vaccine acceleration are so tremendous that it is worth it to them, he says.
Challenge studies have been conducted before for diseases including influenza and malaria. A team led by bioethicist Nir Eyal at Rutgers University in New Brunswick, New Jersey,argued that a human challenge trial could be conducted safelyand ethically, in a paper inThe Journal of Infectious Diseaseslast month.
The approach is also gaining some political support. This week, 35 members of the US Congress, led by Bill Foster (Democrat, Illinois) and Donna Shalala (Democrat, Florida),called on Department of Health and Human Services director Alex Azarto consider human-challenge trials of coronavirus vaccines.
Charlie Weller, head of the vaccines programme at Wellcome, a biomedical-research funder in London, says the charity has begun discussing the ethics and logistics of a human-challenge trial for a coronavirus vaccine. But she says it is unclear whether such a trial could actually speed vaccine development. Researchers first need to determine how to expose humans to the virus as safely as possible, and to consider how and even whether such studies can be done ethically. I think theres potential, Weller adds, but weve got so many questions to work through to understand whether it can help in the timelines we have.
This article is reproduced with permission and was first published on April 22 2020.
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The chances of securing an effective vaccine or treatment for the coronavirus this year are "incredibly small," the UK's top medical adviser has warned.
Professor Chris Whitty, the chief medical officer, said on Wednesday that the UK would have no choice but to retain at least some of the social distancing measures currently in place.
"In the long run, the exit from this is going to be one of two things, ideally," Whitty said at the UK government's daily coronavirus press briefing.
"A vaccine, and there are a variety of ways they can be deployed ... or highly effective drugs so that people stop dying of this disease even if they catch it, or which can prevent this disease in vulnerable people."
He added: "Until we have those, and the probability of having those any time in the next calendar year is incredibly small, we should be realistic that we're going to have to rely on other social measures, which of course are very socially disruptive as everyone is finding at the moment."
Whitty said the government's focus should be on ensuring the so-called "R number" the average number of people one infected person transmits the virus to remains below one. If it rises above one, the number of people infected with the virus would rise exponentially and threaten to overwhelm the NHS.
The social distancing measures introduced by Boris Johnson in March brought the R number below one within the general population,the government believes. Ministers and scientific advisers are currently considering which measures they can lift without taking it above one again.
"What we are trying to work out is what are the things that add up to an R of less than one," Whitty said.
"That narrows our options quite significantly. We are going to have to do a lot of things for really quite a long period of time, the question is what is the best package. If you release more on one area you have to keep onboard more of another area so there's a proper trade-off, and this is what ministers are having to consider."
His comments came after the chief executive of the Swiss pharmaceutical giants Roche said this week that scientists would be unlikely to secure a vaccine before the end of 2020.
"I'm afraid that the most likely scenario is that we will not have a vaccine before the end of next year," Severin Schwan said on a Wednesday conference call, adding that an 18-month timeline is "very ambitious."
