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FDA Approves Wider Use of Plasma as Coronavirus Treatment

By Robin Foster and E.J. Mundell
HealthDay Reporters

MONDAY, Aug. 24, 2020 (HealthDay News)

The U.S. Food and Drug Administration on Sunday cleared the way for more hospitalized coronavirus patients to be treated with the blood plasma of COVID-19 survivors.

President Donald Trump announced the emergency approval as a “breakthrough” treatment during a news briefing Sunday — even though many scientists said the approval was rushed through.

The FDA move will broaden use of a treatment that has already been administered to more than 70,000 patients, The New York Times reported. But unlike a new drug, plasma must come from the blood donations of COVID-19 survivors. So, Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.

However, there are as yet no randomized trials that have yet shown benefit from convalescent plasma, the Times reported. Still, the FDA said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients,” in particular those who receive it early.

Scientists took issue with the approval soon after Trump announced it.

“I watched this in horror,” Eric Topol, director of the Scripps Research Translational Institute, told the Washington Post. “These are basically just exploratory analyses that don’t prove anything. It’s just extraordinary to declare this as a breakthrough. All this does is jeopardize ever getting the truth.”

The Infectious Diseases Society of America also released a statement that stressed while there are “some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19,” the society believes that clinical trials that randomly assign patients to receive either plasma or a placebo should be conducted before it is authorized for wider use.

Meanwhile, hopeful signs emerged that the spread of coronavirus is slowing after surging in June and July: The number of new reported cases in the United States has begun to drop, the Times reported.

Of the states that are driving the decrease, all have at least some local mask mandates and most have paused or reversed their reopenings, the newspaper noted. Many of the states with the biggest decreases per million people also had some of the country’s worst outbreaks in July.

Statewide bar closures and local mask mandates in Florida are among the policies that helped reverse the trend in that state, Mary Jo Trepka, chair of the Florida International University epidemiology department, told the Times. Arizona and Louisiana have also seen cases drop after putting mask mandates and other measures into force, the Times reported.

Parents overwhelmed as school year starts

A new survey also shows most parents are feeling overwhelmed and abandoned as the school year starts.

Just 1 in 7 parents said their children would be returning to school full time this fall, and most children need help with remote schooling, Times survey released recently found. Yet, 4 in 5 parents said they would have no help in that endeavor, whether from relatives, neighbors, nannies or tutors. As well, more than half of parents said they will be taking on this burden while still holding down paid jobs.

Of course, when both parents are wage earners who need to work outside the home, they cannot be in two places at once. But three-fourths of these parents said they will be overseeing their children’s education, and nearly half plan to handle child care, according to the survey of more than 1,000 parents polled between Aug. 4 and Aug. 8.

Of the parents who are both working remotely during the pandemic, 80 percent will also handle child care and education, the survey showed. One in five are considering hiring a private teacher or tutor to help with remote learning.

“All the choices stink,” Kate Averett, a sociologist at the University at Albany in New York who has been interviewing parents since the spring, told the Times. “There is a lot of stress, a lot of anxiety. Parents tell me about not being able to sleep because they’re so anxious, or tell me they’ve been crying a lot. There’s been a lot of actual crying during interviews.”

By Monday, the U.S. coronavirus case count passed 5.7 million as the death toll eclipsed 176,600, according to a Times tally.

According to the same tally, the top five states in coronavirus cases as of Monday were: California with nearly 670,000; Texas with more than 602,000; Florida with more than 600,500; New York with over 434,000; and Georgia with over 237,000.

Nations grapple with pandemic

Elsewhere in the world, the situation remains challenging.

India has passed Britain to have the fourth-highest death toll in the world from the coronavirus, after the United States, Brazil and Mexico, the Post reported.

By Monday, India had more than 3.1 million confirmed cases of the infection and over 57,500 deaths, a John Hopkins tally shows. Britain remains the worst-hit country in Europe, the Post reported.

Brazil is also a hotspot in the coronavirus pandemic, with over 3.6 million confirmed infections by Monday, according to the Hopkins tally. It has the second-highest number of cases, behind only the United States.

Cases are also spiking in Russia: As of Monday, that country reported the world’s fourth-highest number of COVID-19 cases, at over 959,000, the Hopkins tally showed.

Even New Zealand, a country that hadn’t seen a new coronavirus case in 100 days, hasn’t been spared.

On Monday, Prime Minister Jacinda Ardern extended a lockdown in Auckland until Sunday night, the Times reported. The restrictions had been set to expire Wednesday, but Ardern said the extra time was necessary to ensure that a virus cluster in Auckland had been brought under control. Eight new confirmed or probable cases connected to the cluster were announced on Monday, bringing the total to 101. Arden also said masks were now mandatory on public transportation nationwide.

Worldwide, the number of reported infections passed 23.4 million on Monday, with over 809,000 deaths, according to the Hopkins tally.

Copyright © 2020 HealthDay. All rights reserved.

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