“I think things are going to be permanently changed coming out of this until we get to a vaccine and we can fully vanquish this,” former Food and Drug Administration commissioner Scott Gottlieb said on CBS News's “Face the Nation.”
The timing: As the death toll in the U.S. climbed past 9,500, President Trump on Sunday evening proclaimed that the U.S. is already “very far down the line on vaccines.” But a vaccine probably isn't imminent: Experts predict that developing a vaccine to distribute could be a 12 to 18 month process.
Still, that represents an unprecedented timetable in vaccine years. The process normally can take a decade or more to receive regulatory approval. Coronavirus has sparked the fastest vaccine-searching process in history as dozens of initiatives are already underway.
- A head start: “The race kicked off Jan. 10, when Chinese scientists published the complete 30,000-letter genetic code of SARS-CoV-2, the novel coronavirus that causes covid-19. That allowed scientists to make synthetic versions of the virus rather than waiting for sample shipments, and roughly 80 pharma giants, small labs, and government entities began chasing a cure,” per The Week.
- Another reason for the early jump: This is not the first coronavirus we have seen: “Though nobody could have predicted that the next infectious disease to threaten the globe would be caused by a coronavirus … vaccinologists had hedged their bets by working on 'prototype' pathogens,” reports The Guardian's Laura Spinney.
- “The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses,” Richard Hatchett, chief executive of the Oslo-based Coalition for Epidemic Preparedness Innovations, told Spinney.
The players: Boston-based biotechnology company, Moderna Inc., in partnership with the National Institutes of Health, became the first company to reach a clinical trial in mid-March.
- Still: “It’s difficult to put a specific date on things just because it’s a very dynamic situation,” Moderna Chairman Noubar Afeyan told CNBC’s Meg Tirrell last week. “We’ve entered phase 1 trials. … We’ll enter hopefully phase 2 trials, we expect that to happen in the spring, perhaps early summer.”
- Dr. Anthony S. Fauci, the nation's top infectious disease expert, has said the Moderna study was “launched in record speed” and an “important first step” toward finding a safe and effective vaccine.
Pharmaceutical giant Johnson & Johnson also jumped into the fight, announcing last week a partnership with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (BARDA) “with the goal of providing global supply of more than one billion doses of a vaccine.”
- The timeline: “The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a covid-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated time frame in comparison to the typical vaccine development process,” per the announcement.
Another promising test is by University of Pittsburgh School of Medicine, whose scientists said their potential vaccine, “when tested in mice … produces antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus,” per Pittsburgh Wire's Erin Hare.
Then there's this unlikely company: “Lucky Strike owner British American Tobacco PLC is developing a potential vaccine grown in tobacco plants, while Medicago Inc., a biotech firm partly owned by Marlboro maker Philip Morris International Inc., is pursuing a similar effort,” the Wall Street Journal's Saabira Chaudhuri and Denise Roland report.
The obstacles: The actual deployment of the vaccine could take a lot longer than the abbreviated timeline Trump has pushed. “So although this is the fastest we have ever gone from a sequence of a virus to a trial, it still would not be applicable to the epidemic unless we really wait about a year to a year and a half,” Fauci explained in early March.
But many experts say even that is too optimistic, given the normal FDA process requires that scientists prove a vaccine has no serious side effects. If the FDA grants an authorization for emergency use, as it has done with other products during the pandemic thus far, the typical process can be bypassed. But still, thousands of people must be tested to prove the vaccine's “efficacy and safety,” according to the FDA's product approval guidelines.
- “When Dr. Fauci said 12 to 18 months, I thought that was ridiculously optimistic,” Dr. Paul Offit, the co-inventor of the rotavirus vaccine, told CNN's Robert Kuznia. “And I'm sure he did, too.”
There's still the issue of scaling up a vaccine for mass distribution, even with fast-tracked development and approval.
A more immediate solution: The timetable is a huge reason why experts such as Gottlieb insist that there should be as much of an effort toward developing a therapeutic drug to treat those who have the coronavirus, in order for people to resume life as usual as quickly as possible:
- “We're not going to see a V-shaped recovery or a quick snapback absent the ability to get a highly effective drug in the hands of doctors that can mitigate the risk — either used as a prophylaxis to prevent infection in people who get exposed to this virus, or treat people who get the virus and are likely at a high risk of a bad outcome,” Gottlieb said on CBS. “We can have that kind of drug by the summer and certainly by the fall.”
- “It’s time to place some firm bets and put resources behind these experimental treatments,” Gottlieb wrote in a Wall Street Journal op-ed on Sunday, calling on the FDA to “step up its pace” and collaborate with drug developers to move the “most promising therapies.”
- “One approach involves antiviral drugs that target the virus and block its replication,” Gottlieb wrote. “Think of medicines for treating influenza, HIV or cold sores. The drugs work by blocking the mechanisms that viruses use to replicate. Dozens of promising antiviral drugs are in various stages of development and could be advanced quickly. The one furthest along is remdesivir, from Gilead Sciences. There’s evidence from clinical experience with Covid-19 patients that it could be effective.”
- “The other approach involves antibody drugs, which mimic the function of immune cells. Antibody drugs can be used to fight an infection and to reduce the risk of contracting Covid-19. These medicines may be the best chance for a meaningful near-term success.”
Trump's apparent solution: There is one drug that Trump himself has aggressively pushed, despite the only limited research on its efficacy for people with covid-19: the anti-malarial hydroxychloroquine. “We don’t have time to go and say, ‘Gee, let’s take a couple of years and test it out,’" Trump told reporters. “I’d love to do that, but we have people dying today.” Trump said the federal government bought and stockpiled 29 million pills of the drug.
- “Trump’s recommendation of hydroxychloroquine, for the second day in a row at a White House briefing, was a striking example of his brazen willingness to distort and outright defy expert opinion and scientific evidence when it does not suit his agenda,” the New York Times's Michael Crowley, Katie Thomas and Maggie Haberman report.
- “Hydroxychloroquine has not been proved to work against Covid-19 in any significant clinical trials. A small trial by Chinese researchers made public last week found that it helped speed the recovery in moderately ill patients, but the study was not peer-reviewed and had significant limitations. Earlier reports from France and China have drawn criticism because they did not include control groups to compare treated patients with untreated ones, and researchers have called the reports anecdotal. Without controls, they said, it is impossible to determine whether the drugs worked,” per the Times.
- Illustrating a schism within the coronavirus task force, Trump prevented Dr. Fauci from weighing in on the drug that the administration's top public health officials have repeatedly declined to endorse.
- Axios's Jonathan Swan scooped on a spat between economic adviser Peter Navarro and Fauci on the issue of how aggressively to promote the use of the drug to fight covid-19.
In the Media
‘OUR PEARL HARBOR MOMENT’: “Americans are being advised to steel themselves for one of the most agonizing weeks in living memory, as [Trump] and his advisers predicted parts of the country were nearing a peak of cases of covid-19,” our colleagues Isaac Stanley-Becker, Aaron Gregg and William Booth report.
- Key quote: "This is going to be the hardest and saddest week of most Americans’ lives, quite frankly,” U.S. Surgeon General Jerome M. Adams said on Fox News. “This is going to be our Pearl Harbor moment, our 9/11 moment, only it’s not going to be localized. It’s going to be happening all over the country.”
- The death toll is almost certainly higher than is being reported, experts and government officials say: The Centers for Disease Control counts only deaths in which the presence of the coronavirus is confirmed in a laboratory test. But such postmortem testing varies around the country and some officials say testing the deceased is a misuse of scare resources, our colleagues Emma Brown, Beth Reinhard and Aaron C. Davis report.
Outside the Beltway
HEADLINES FROM THE HOT SPOTS: Power Up's continuing look at how the virus is affecting states and cities throughout the country.
- Note: All numbers are of late last night. All cases are confirmed and recorded on The Washington Post's tracker. Numbers in parentheses are adjusted for population per 100,000 people.
NEW YORK: 123,160 cases (628 per 100k) | 4,159 deaths (21 per 100k)
Gov. Andrew M. Cuomo says the crisis may be plateauing, but cautions that it's still too early to tell: “The number of deaths in the state has reached 4,159, Mr. Cuomo said. But, notably, there were slightly fewer fatalities on Saturday than on Friday,” the New York Times reports.
- But the governor caution that New York is extremely low on supplies: “I can’t say to a hospital, ‘I will send you all the supplies you need, I will send you all the ventilators you need,’” he said. “We don’t have them. It’s not an exercise. It’s not a drill. It’s just a statement of reality,” Cuomo (D) told reporters.
A Bronx zoo tiger tests positive: “It’s the first time, to our knowledge, that a [wild] animal has gotten sick from covid-19 from a person,” Paul Calle, chief veterinarian for the Bronx Zoo told National Geographic's Natasha Daly. “The Malayan tiger, named Nadia, likely contracted the coronavirus from an infected — but unknown — asymptomatic zookeeper.”
- Nadia may not be alone: “The U.S. Department of Agriculture says six other big cats are exhibiting symptoms of illness. It's unknown how the tiger contracted the illness.”
NEW JERSEY: 37,505 cases (422 per 100k) | 917 deaths (10 per 100k)
Gov. Phil Murphy (D) says his state is just about a week behind New York: “Hospitals in the state are scrambling to convert cafeterias and pediatric wings into intensive care units. Ventilators are running low. One in three nursing homes has at least one resident with the virus,” the Times's Tracey Tully reports.
- Murphy says the worst is “at least two or three weeks away": “This is certainly going to be a huge challenge for us — April through May. There’s no question that the evidence is increasingly showing this is going to spill meaningfully into the summer,” the governor told CNN's Wolf Blitzer last night.
Even with the second-most cases nationally, it's unclear just how many residents are infected: That's “because the state officials say test results are backed up by as much as two weeks and the state is not reporting how many people have recovered so far,” NJ Advance Media for NJ.com's Matt Arco reports.
LOUISIANA: 13,010 cases (279 per 100k) | 477 deaths (10 per 100k)
Gov. John Bel Edwards says his state could run out of ventilators by the end of the week: “Every day we get new information that informs our modeling. We now think it's probably around the 9th of April before we exceed our ventilator capacity based on the current number on hand and that we're a couple of days behind that on ICU bed capacity being exceeded,” Edwards (D) told CNN's Jake Tapper.
Makeshift morgues are being set up in New Orleans: “One funeral home director compared the body storage situation with Hurricane Katrina. Others said it brought to mind the yellow fever epidemic of the 1800s, when undertakers became overwhelmed and the Crescent City became known as the nation’s ‘necropolis,’” the Times-Picayune | New Orleans Advocate's Della Hasselle and Bryn Stole report.
- The virus has now killed more people in the New Orleans metro than gun violence did in 2019: “By Thursday, Orleans Parish's 125 deaths, which have accumulated in only a month's time, eclipsed the total of 120 killed by gun violence in 2019,” the Times-Picayune | New Orleans Advocate's Katelyn Umholtz reports.
MICHIGAN: 15,718 cases (158 per 100k) | 617 deaths (6 per 100k)
Gov. Gretchen Whitmer slammed a patchwork response to the pandemic: “Not having a national strategy where there is one policy for the country, as opposed to patchwork, based on whomever the governor is, is something that I think is creating a more porous situation where covid-19 will go longer and more people will get sick and, sadly, more lives will get lost,” Whitmer (D) told Chris Wallace on “Fox News Sunday.”
- Pence says Michigan is on the White House's mind: “Trump briefly stood in front of a bar graph of covid-19 cases in Metro Detroit … as his administration highlighted efforts to combat the virus's spread in Michigan,” the Detroit News's Craig Mauger reports. Vice President Pence later told reporters during the news briefing, “Michigan and Illinois are in the forefront of our thinking.”
The auto industry is in the midst of greatest effort since WWII: “Hundreds of autoworkers and engineers and thousands of global suppliers are answering the call for help with remarkable speed in an effort becoming known as the “Arsenal of Health,” a reference to Detroit's military production surge during World War II,” the Detroit News's Breana Noble and Kalea Hall report.
MASSACHUSETTS: 12,500 cases (183 per 100k) | 231 deaths (3 per 100k)
Gov. Charlie Baker (R) announced the state has received 100 ventilators from the federal government: The state requested 1,000. “We are planning for a variety of scenarios,” Baker told reporters, the Boston Herald's Erin Tiernan reports. “Now obviously we’d love to have every single piece of gear we need, as we come into it — but we’re going to make adjustments as we go.”
Boston Mayor Marty Walsh institutes citywide curfew: “Walsh (D) said the recommended curfew will be in place between 9 p.m. and 6 a.m. starting [today] and running at least through May 4,” the Boston Globe's Andy Rosen reports. Walsh is also directing Bostonians to wear masks when they are outside their homes.
THE LATEST FROM THE DMV: “The Washington region’s battle with the novel coronavirus intensified, as the number of confirmed cases soared to more than 7,000,” our colleagues Ian Shapira, Rachel Chason, Fenit Nirappil and Hannah Natanson report.
Maryland announced its largest single-day increase in confirmed cases at 484: Gov. Larry Hogan (R) issued an emergency order concerning nursing homes: Nursing home staff are now required to wear protective gear and segregate infected patients to halt the spread of the disease following outbreaks in the state’s long-term care facilities, our colleagues write.
- A nursing home in Mount Airy is the site of the state's largest outbreak: At least 99 residents and staff had tested positive and 10 residents have died. “The crisis at Pleasant View is an East Coast version of the tragedy at Life Care Center of Kirkland in Kirkland, Wash., where scores of elderly patients were sickened by covid-19, and 40 died,” our colleagues Rachel Chason, Ovetta Wiggins and Rebecca Tan report in their detailed look at the facility.
D.C. Mayor Muriel Bowser (D) said that the city's estimates projected that 93,000 Washingtonians could eventually become infected: The city uses a different model than the federal government, which our colleague Fenit Nirappil explained last week. As of Sunday morning, The District has over 1,000 confirmed cases.
- The Wharf fish market is now closed: Bowser ordered the popular open-air market closed through at least April 24 after too many people defied social distancing orders on Saturday.
The outbreak could also worsen class divisions in the region: “The economic damage … has hit the region’s middle- and low-income residents hardest, and for now it has crushed the hopes of many to improve their lot,” our colleague Robert McCartney reports. “The sudden shutdown of large sectors of the local economy will widen the gap between affluent households and those living paycheck to paycheck, according to urban experts, economists and other analysts.”
JOHNSON HOSPITALIZED, THE QUEEN SPEAKS: Prime Minister Boris Johnson was admitted to the hospital after suffering “persistent” symptoms of the virus, our colleague William Booth reports from London. He tested positive for the virus just 10 days ago.
- Johnson was one of the first world leaders to contract the virus: “The spokeswoman did not offer more details on why Johnson was admitted to the hospital — whether it was for further tests, such as chest X-rays, or to spend the night. Friends and political foes expressed sympathy and wishes for a speedy recovery,” our colleague writes.
Queen Elizabeth II gave a rare televised speech to the British people: She urged the British people “to show their self-discipline and quiet resolve during the coronavirus pandemic that has taken nearly 5,000 lives here,” our colleague writes.
- This was just the fifth such address the queen has given in her 68-year reign: “I hope in the years to come everyone will be able to take pride in how they responded to this challenge,” the queen said during her four-minute speech. “And those who come after us will say that the Britons of this generation were as strong as any. That the attributes of self-discipline, of quiet good-humored resolve and of fellow-feeling still characterize this country.”