How to Make Sense of the U.S. Government’s Convalescent Plasma Decision
The Food and Drug Administration (FDA)’s decision yesterday to grant emergency use authorization for convalescent plasma to treat COVID-19 patients will allow doctors to transfuse plasma donated from recovered patients into currently sick patients, in the hopes that part of the immune response against the virus can be transferred as well.
The decision was certainly a bit of an about-face. Just days before, the authorization was put on hold after leading infectious disease and public health experts, including National Institutes of Health (NIH) Director Dr. Francis Collins and White House Coronavirus Task Force member Dr. Anthony Fauci, said that while the early data from critically ill patients who were transfused with convalescent plasma were encouraging, they were not strong enough to justify EUA—yet.
Other doctors, however, who are currently taking part in ongoing trials, believe the EUA is justified. “I think there is a crucial role for convalescent plasma right now,” says Dr. James Musser, chair of pathology and genomic medicine at Houston Methodist whose team has transfused several hundred COVID-19 patients as part of its study. More than 2,800 other hospitals are part of an ongoing trial of more than 35,000 patients, called the National Convalescent Plasma Study. So far, it has shown (among other findings) that patients who got the convalescent plasma within three days of their diagnosis had lower mortality rates after 30 days compared to those who received the plasma later. Musser and others say that, for the sickest patients, convalescent plasma makes sense.
There’s also a long history of success in transferring some type of passive immunity from a recovered patient to a sick one that is nearly a century old, dating back to the 1918 influenza pandemic, when plasma from recovered patients was used to treat those infected with flu. In the years since, the practice has proved itself in other emerging infectious diseases including other coronavirus diseases like SARS and MERS, as well as Ebola. “There is a very rich literature that is well documented over the years,” says Musser. “Importantly, there is a theoretical reason to think it may work, and pretty good justification that it is probably safe as well.”
But one issue with the National Convalescent Plasma Study data is that there was no control group—in other words, all of the participants were transfused with plasma from recovered patients. The NIH is funding studies that compare the treatment to a placebo, but we haven’t yet seen any results.
Convalescent plasma, in theory, works because recovered patients typically have built up lots of antibodies for COVID-19, defensive immune cells that fight off the virus. Beyond plasma transfusions, researchers are also looking into isolating the most potent and efficient of these antibodies, and turning them into drug treatments that might not only control the disease but maybe even prevent it if given to patients at the right time after their infection. If they work, antibody-based therapies could even serve as a bridge for protecting populations until a vaccine is approved and distributed. And even after vaccines are available, they may not provide 100% protection, so antibodies could play an important role in filling any gaps in immunity.
The flip-flop naturally raises questions about what role politics may be playing in the FDA’s decisions, especially after President Donald Trump touted hydroxychloroquine as a treatment before scientists determined it did little to help COVID-19 patients. It also reflects the unprecedented pace at which new therapies are being developed and tested in the race to control SARS-CoV-2, and the competing and often conflicting pressures of social urgency, political demand and scientific rigor.
More than 23.4 million people around the world had been sickened by COVID-19 as of 1 a.m. eastern time today, and more than 808,000 people have died.
Here is every country with over 300,000 confirmed cases:
Hong Kong has confirmed the first-ever case of COVID-19 reinfection, with a young and otherwise healthy patient suffering a second infection four and a half months after recovering from a first. The patient, a 33-year old man, suffered symptoms the first time he was infected, but is so far asymptomatic in his second go-round. He tested positive after undergoing mandatory screening upon returning to Hong Kong after visiting Spain. The case raises more concerns about how long antibodies against SARS-CoV-2 last after an initial infection.
A cross-Channel tit for tat is developing between the United Kingdom and France over COVID-19 quarantine rules, The Guardian reports . Since Aug. 15, travelers from France to the U.K. have been required to quarantine for 14 days upon arrival, and today Clément Beaune, a French junior minister for foreign affairs, announced that the country would impose identical—and reciprocal—restrictions on British visitors. “We will have a measure called reciprocity so that our British friends do not close the border in one single way,” he told France 2 TV. But France may want to focus more on cleaning up its own house. The report of the new restrictions comes at the same time that French health officials reported a “very worrying” outbreak of COVID-19 among 150 vacationers at a nudist resort on the Mediterranean coast, with test results from another 310 guests still pending.
While the world awaits the development of a coronavirus vaccine, China is using one already—and has been since July 22, according to CNN. The experimental vaccine was approved for medical personnel, border inspectors and others who work in “high risk” jobs. Use of the vaccine was revealed by Zheng Zhongwei, the director of the Science and Technology Development Center of the National Health Commission, in an interview with official state media.
In a rare glimmer of good COVID-19 news for Brazil, the disease seems to be in sudden retreat in the northwestern city of Manaus, which as recently as May seemed to be the ground zero city in a ground zero country. But, as The Washington Post reports, since then hospitalization rates have plummeted by 75% and deaths have fallen from a high of 120 per day to nearly zero. Manaus never imposed a lockdown even during the peak of the crisis and health officials are looking at the possibility that the city may simply have reached such a saturation level of infection that natural herd immunity was achieved.
The Situation in the U.S.
The U.S. had recorded more than 5.7 million coronavirus cases as of 1 a.m. eastern time today. More than 176,000 have died. Here's where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:
On August 23, there were more than 34,000 new cases and 449 new deaths confirmed in the U.S. Here's how the country as a whole is currently trending:
More proof that masking up is a wise move: While the U.S. continues to lead the world in coronavirus cases, the new infection rate is falling. That trend is being led by former hot spots including Louisiana, Arizona and Florida, all of which have implemented local mask mandates and halted or slowed their earlier reopenings, according to a new survey by The New York Times. Infection rates are falling in those states independent of testing rates, with the critical metrics of decreased hospitalizations and a lower percentage of tests coming back positive both proving that the apparent trend lines are real.
The environment—at least in the U.S.—is being hit hard by the pandemic too. In March, the AP reports, the Trump Administration was pressured by the oil and gas industry to relax environmental rules, arguing that social distancing made it difficult to adhere to inspection and compliance requirements. The Administration agreed, and it’s not just the fossil fuel companies that have gotten a break. Also excused from strict environmental regulations are an Army depot in Kentucky dismantling warheads loaded with nerve gas, and livestock farms in Iowa and Minnesota, where manure and carcasses are piling up.
Airlines may find it easier to keep their planes free of coronavirus thanks to a new long-acting disinfectant given emergency approval by the U.S. Environmental Protection Agency, Reuters reports. The disinfectant spray, produced by Allied BioScience Inc. can reportedly keep surfaces at least relatively safe for up to seven days. The EPA stresses that the spray does not eliminate the need for regular deep cleaning of airplanes, only that it helps reduce the incidence of later contamination of surfaces.
The one-two punch that potential hurricanes Marco and Laura may inflict on the Gulf Coast could become a one-two-three punch when the pandemic is factored into response planning. As The Washington Post reports, residents of Louisiana are being urged to include masks and sanitizers in any emergency evacuation kits. Mississippi Governor Tate Reeves warned residents that public shelters will not operate at peak capacity due to the state’s recent spike in infection rates. “What we can’t have happen is, if this thing is to strengthen on Sunday or Monday, to have a mad rush of people to our sheltering space,” Reeves said.
The Gulf Coast isn’t alone. As the economies of South Florida, Phoenix and the Rio Grande Valley have been pounded by the pandemic, experts warn that the current suffering is just a taste of the long-term economic woes the regions will face as a result of the heat waves, rising sea levels and more caused by climate change.
All numbers unless otherwise specified are from the Johns Hopkins University Center for Systems Science and Engineering, and are accurate as of August 24, 1 a.m. eastern time. To see larger, interactive versions of these maps and charts, click here.
WHAT ELSE YOU SHOULD KNOW
Vaccine Safety for Moms and Babies
Health experts are worried that because vaccine testing is typically not conducted on children or pregnant women, it could lead to a gaping hole in both safety and efficacy data on those populations once a COVID-19 vaccine is approved, STAT news reports. Read more here.
Tracking the Eye of Hurricane COVID
In the U.S. the pandemic swept from one part of the country to the other in much the way a storm moves, with waves of infection passing through state after state. The reason: 50 different state jurisdictions have meant 50 different response plans. Read more here.
Homemade Masks Are Not All the Same
There’s a right way and a wrong way to make and care for an effective face mask. The key is fit, layers and the kind of material you use. Read more here.
Soda and COVID-19
A health official in Mexico is blaming the country’s high COVID-19 mortality rate at least partly on the country’s love of soda, reports USA Today. Mexico leads the world in per capita soda consumption contributing to an epidemic of underlying conditions including obesity, diabetes and hypertension. Read more here.
Racism and the History of Home Health Care
Health care workers who provide services to the elderly and otherwise housebound have been declared “essential” during the pandemic—a label that is long overdue. Historians offer a reminder that the job had its roots in slavery in the antebellum south, and even in the later Jim Crow era, when Congress debated the Fair Labor Standards Act in the 1930s and Southern lawmakers refused to sign on if the law covered home health workers and other Black majority professions. Read more here.
—Jeffrey Kluger
Thanks for reading. We hope you find the Coronavirus Brief newsletter to be a helpful tool to navigate this very complex situation, and welcome feedback at coronavirus.brief@time.com.
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Today's newsletter was written by Jeffrey Kluger and Alice Park, and edited by Elijah Wolfson.
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