It’s been six months since China first posted online the genetic sequence of the novel coronavirus. Yet already three companies have launched final-stage clinical trials for a vaccine – at record speed, by any standard – and another is on the verge of doing so.
This month, U.S. companies Moderna and Pfizer launched final Phase 3 trials involving tens of thousands of volunteers. A third company, AstraZeneca, partnered with Oxford University in the United Kingdom, has already been conducting final-stage trials for weeks. And a Chinese company, CanSino Biologics, is expected to announce Phase 3 trials next month.
These developers have found promising early results, allowing them to embark upon Phase 3 clinical trials in record time.
Their success keeps open the possibility of a vaccine being ready for wide dissemination in early 2021, although that also depends on countries having the infrastructure to administer shots to millions of people.
“The data so far has been on the high end of expectations,” Ronny Gal, a financial analyst with investment research firm Sanford C. Bernstein and Co., told me.
Anthony S. Fauci, director of the National Institute of Allergy and Infectious Disease, offered a similar analysis. On Monday, he told CNN he’s “cautiously optimistic” about the Moderna vaccine, which is being developed in collaboration with the National Institutes of Health.
Yet there’s still a long way to go before a coronavirus vaccine can be approved by the Food and Drug Administration.
And officials will face huge challenges in widely disseminating it and deciding who should get it first. Discussions are underway to identify priority groups for initial vaccination, my colleague Lena H. Sun reports.
“U.S. officials and experts are wrestling with one of the most difficult issues facing the country: Who should be first to get limited doses of a vaccine during one of the worst public health crises in a century?” Lena writes.
“Those discussions, involving federal health officials and outside experts, are based on planning developed during the 2009 H1N1 influenza pandemic. The highest priority would go to health-care and essential workers and high-risk populations. This proposed group would also include older adults, residents of long-term-care facilities and people with underlying medical conditions.”
In the meantime, here are four promising vaccine candidates to watch this fall:
On Monday, the first volunteers received shots for the company's Phase 3 trial. The trial will test 30,000 participants, half receiving the vaccine and half receiving a placebo. After they each get two doses, spaced several weeks apart, researchers will have to wait to see whether the participants get infected or sick from the coronavirus.
“What they hope to witness is a clear benefit: fewer infections in people who received the vaccine, or less severe episodes of covid-19,” Carolyn Y. Johnson reported. “There are many unknowns about how long it could take to see a clear signal of success or failure — including how fast the trials will recruit participants and how long it takes for enough people to become infected to observe whether there is an effect.”
Fauci said Moderna's earlier Phase 1 trial suggested its vaccine created antibody responses in volunteers comparable to what is seen in people who have recovered from actual cases of covid-19.
“We are participating today in the launching of a truly historic event in the history of vaccinology,” he said at a news conference, noting that the United States has never moved faster to develop a vaccine.
The company has announced it is initiating a 30,000-person vaccine trial at 120 sites globally. Volunteers will also receive two doses.
Both the Pfizer and the Moderna vaccines use a new technology called messenger RNA to produce a protein found on SARS-CoV-2, the virus that causes the disease covid-19. The promising technology has never been approved for use outside medical research, Carolyn explains.
“Either vaccine could become the first in a new class of medicines,” she writes. “The vaccines deliver a snip of genetic material that carries the blueprint for the spiky protein that dots the surface of the coronavirus. After a person is vaccinated, their cells will follow the genetic instructions to build the proteins, and their immune systems, confronted with the spike protein, learn how to recognize and mount a defense to the virus without ever being infected.”
AstraZeneca and Oxford University’s AZD1222
The organizations launched an initial Phase 3 trial in May, involving about 1,000 people. It generated a strong immune response in the volunteers, while also causing mild to moderate side effects in about 60 percent of patients, according to a study published July 20 in the Lancet, a prominent medical journal.
World Health Organization chief scientist Soumya Swaminathan has called it “probably the leading candidate.” Not only is the testing progressing the quickest of any candidate, but AstraZeneca also is conducting it around the world, including in the United Kingdom, Brazil and South Africa, she noted.
Governments are investing especially heavily in this vaccine.
“The U.S. government has pledged up to $1.2 billion toward the Oxford effort and secured a promise of 300 million doses by October,” Carolyn and William Booth reported. “A European alliance has claimed 400 million doses, while the British government has dibs on 100 million doses, alongside another possible candidate being developed by Imperial College London.”
British Prime Minister Boris Johnson was pumped about the early-stage results:
The vaccine's researchers expressed optimism they can stimulate the production of T cells that can stay in circulation for years and serve as a permanent praetorian guard against infection — although they acknowledged more research is needed on how long any protection lasts.
“We hope this means the immune system will remember the virus, so that our vaccine will protect people for an extended period,” Andrew Pollard, lead author of the Oxford study, said in a statement. “However, we need more research before we can confirm the vaccine effectively protects against SARS-CoV-2 infection, and for how long any protection lasts.”
China is racing to approve a vaccine before either the United States or the United Kingdom. Its most promising candidate was developed by CanSino, a company that is working to recruit 40,000 people for Phase 3 trials it hopes to conduct in countries including Russia, Brazil and Chile.
The Lancet also published a study on this vaccine, which was tested in about 500 people in a Phase 2 trial. Most participants had an immune response, although some also had severe reactions to the shots. While the researchers suggested the vaccine has “a good safety profile,” some scientists were nonetheless disappointed in its early performance and worry it might not work on many people.
“The vaccine triggered the production of neutralizing antibodies that can block the virus in only about half the test subjects — 59 percent of those given a high dose and 47 percent given a lower dose,” William and Carolyn wrote. “Older people tended to respond less favorably.”
Ahh, oof and ouch
AHH: Negotiations over the latest coronavirus relief bill have hit a barricade, with no clear path in sight.
“A meeting between top White House officials and Democratic leaders ended with no agreement on extending emergency unemployment benefits that expire Friday or on reviving a moratorium on evictions that lapsed last week,” Erica Werner, Jeff Stein, Seung Min Kim and Rachael Bade report. “That means some 20 million jobless Americans will lose $600 weekly enhanced unemployment benefits that Congress approved in March, which could send the economy reeling.”
Trump said he would support a short-term solution for unemployment insurance as well as a moratorium on evictions, but Democrats shot down the idea.
The two parties remain far apart; Democrats insist on their wide-ranging $3 trillion proposal while Republicans struggle to coalesce around a $1 trillion bill released by Senate Majority Leader Mitch McConnell on Monday. The process overall has been overtaken by increasingly bitter partisanship.
“Each side said the other was to blame for the failure," Erica, Jeff, Seung Min and Rachael write. "Paying the price will be the unemployed at a moment of deep uncertainty and fear, with coronavirus cases spiking and states pulling back on reopening as deaths near 150,000 in the United States. The talks could get back on track in coming days, but the signs Wednesday were not promising.”
OOF: A federal judge has blocked the Trump administration from denying green cards to immigrants who have received Medicaid, food stamps or housing vouchers.
Judge George B. Daniels, who granted a nationwide temporary injunction on the new eligibility requirements, wrote that the policy “fails to measure up to the gravity of this global pandemic that continues to threaten the lives and economic well-being of America’s residents.”
“No person should hesitate to seek medical care, nor should they endure punishment or penalty if they seek temporary financial aid as a result of the pandemic’s impact,” he added.
In January, before the pandemic, the Supreme Court had ruled the Trump administration could move ahead with its new plan. New York and several other states had sued, calling it an illegal wealth test for immigrants.
New York Attorney General Letitia James:
OUCH: There’s growing evidence that young adults are infecting vulnerable elders, especially family members who may share the same home.
The trend seems confirm what many experts feared as young people returned to bars and restaurants as some cities and states eased social restrictions and healthy young people returned to work. Those young people then transmitted the coronavirus to others who are more vulnerable to the disease, Lenny Bernstein reports.
“The emerging trend highlights the difficulty of relying on the Trump administration’s strategy of sheltering the most vulnerable while the young and healthy return to work and school,” Lenny writes. “That approach runs the risk of transmitting the virus when two or three generations share the same home and when many lower-income workers have little choice but to brave exposure to do their jobs. Young adults are among the essential workers who may be returning home to parents and grandparents. High-school- and college-age children may expose teachers, parents and grandparents.”
Some areas with a surge in cases also have larger share of multigenerational families, leaving open more possibility for exposure.
Lenny adds: “A record 64 million people — about 20 percent of the U.S. population — lived in homes with at least two adult generations or grandparents and grandchildren under 25 in 2016, according to an analysis of census data by the Pew Research Center. That is even more true for Hispanics, who have large populations in Florida, the Southwest and California. About 27 percent live in multigenerational households. The figure is similar for black people (26 percent) and Asians (29 percent), Pew found.”
The editor of the Lancet has become an outspoken critic of how government leaders responded to the pandemic.
In a new book, Richard Horton accuses Trump of a “crime against humanity” for cutting WHO funding during the crisis and also points a finger at Johnson, the British prime minister, for thousands of excess deaths.
In an interview with William Booth, he lauded the quick response by the scientific community but chided the inability of governments to heed necessary advice.
“I was seeing the research community immediately kicking into action, gathering actionable evidence, for use by policymakers and politicians. And nothing was happening,” he said. “That’s not just a failure of politicians. It’s the failure of those medical and science advisers who are giving advice to governments, because I don’t think they picked it up quickly enough, either.”
Congress on coronavirus
Rep. Louie Gohmert (R-Tex.), who was meant to travel with Trump, tested positive for the coronavirus.
The Texas Republican has often refused to wear a mask or maintain social distancing around the Capitol. Now, House Speaker Nancy Pelosi (D-Calif.) said she would announce a new mask mandate for lawmakers on the House floor.
The news has prompted senior lawmakers to reconsider their opposition to mandatory coronavirus testing for members of Congress, and White House Chief of Staff Mark Meadows said the Trump administration is standing by to help should leaders on Capitol Hill agree on a plan,” Felicia Sonmez, Paul Kane and Josh Dawsey report.
In one video that appeared to be filmed from his office, Gohmert suggested wearing a mask could increase the chances of contracting the virus.
“It is interesting, and I don’t know about everybody, but when I have a mask on, I’m moving it to make it comfortable, and I can’t help but wonder if that puts some germs in the mask,” Gohmert said.
Following the news, House Majority Leader Steny Hoyer (D-Md.) said House leaders aren't mandating coronavirus testing for members of Congress, but have discussed it in the past, Politico’s Heather Caygle and Sarah Ferris report.
“We’re not mandating testing at this point … but we’re discussing that,” he told reporters. “We have discussed it in the past. This is a moment, I think, where we ought to be discussing it again.”
Amazon logistics, usually handled by artificial intelligence algorithms, have been thrown into disarray under the pandemic.
“Honed on billions of sales and deliveries, these systems accurately predict how much of each item will be sold, when to replenish stock at fulfillment centers, and how to bundle deliveries to minimize travel distances,” Gizmodo’s Ben Dickson reports. “But as the coronavirus pandemic crisis has changed our daily habits and life patterns, those predictions are no longer valid.”
That’s in part because of people’s tendency to panic buy in large quantities, said Rajeev Sharma, senior vice president and global head of enterprise AI solutions and cognitive engineering at AI consultancy firm Pactera Edge.
“Artificial intelligence algorithms are behind many changes to our daily lives in the past decades. They keep spam out of our inboxes and violent content off social media, with mixed results. They fight fraud and money laundering in banks,” Ben writes. “They help investors make trade decisions and, terrifyingly, assist recruiters in reviewing job applications. And they do all of this millions of times per day, with high efficiency—most of the time. But they are prone to becoming unreliable when rare events like the covid-19 pandemic happen."
“Among the many things the coronavirus outbreak has highlighted is how fragile our AI systems are,” he continues. "And as automation continues to become a bigger part of everything we do, we need new approaches to ensure our AI systems remain robust in face of black swan events that cause widespread disruptions.”
Trump has repeatedly bragged about his score on a cognitive test, using as a political tool a test meant to detect early signs of dementia.
“He has used it as a cudgel, attacking the mental acuity of former vice president Joe Biden, the presumptive Democratic nominee for president, goading him to take the assessment and saying Biden would not fare as well as him,” William Wan reports. “But for many Americans, the test Trump keeps trumpeting is one of the most fraught, traumatic turning points in their lives — that moment when they realize their mind is beginning to fail and glimpse the troubled path ahead for them and their families.”
The test includes about 30 questions to test cognitive skills such as short-term memory, visual cues, language and orientation. It’s a widely used test and an effective screening for the early stages of dementia.
“I don’t understand why he keeps bringing it up as a taunt or threat,” said Melissa Susser, a clinical social worker, who regularly administers the test to senior citizens in the D.C. area. “It’s not like a political thing.”
Susser’s colleague Julia Pruitt told William it could further stigmatize the test among older people who are already nervous and ashamed over taking it.
In the states:
- An internal report compiled for the White House coronavirus task force says at least 17 of 21 states flagged as “red zones” are not following federal recommendations, according to a special congressional panel formed to review the administration’s coronavirus response, Hannah Knowles writes for The Washington Post’s live blog.
- Florida pediatricians released new guidelines for school reopenings, which include staggering start times, instituting strict hand-washing and disinfecting protocols, and keeping children and teachers six feet apart, Valerie Strauss reports.
- Maryland Gov. Larry Hogan (R) expanded the state’s face mask mandate. Now, all residents age 5 and older must wear face covers in indoor public spaces as well as outside when social distancing is not possible, Ovetta Wiggins, Michael Brice-Saddler, Patricia Sullivan and Dana Hedgpeth report.
- Health insurance provider Humana announced it will partner with a telehealth start-up in a $100 million investment toward expanding medical services for aging Americans, including those with chronicle illnesses who want to see a doctor in their own home, Hamza Shaban reports for The Post’s live blog.