August 23 coronavirus news

By Julia Hollingsworth, Jenni Marsh, Angela Dewan, Fernando Alfonso III and Amir Vera, CNN

Updated 12:10 a.m. ET, August 24, 2020
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7:21 p.m. ET, August 23, 2020

Medical experts say there isn't enough data to know whether convalescent plasma works

From CNN Health’s Elizabeth Cohen, Naomi Thomas and Jamie Gumbrecht

Nurse Lina Acevedo checks the plasma donated by a man who recovered from Covid-19 on August 14 in Bogota, Colombia.
Nurse Lina Acevedo checks the plasma donated by a man who recovered from Covid-19 on August 14 in Bogota, Colombia. Guillermo Legaria/Getty Images

The US Food and Drug Administration gave emergency use approval to convalescent plasma as a treatment for coronavirus Sunday, but some experts say there is not a lot of solid data to support its use.

The problem is, we don't really have enough data to really understand how effective convalescent plasma is," Dr. Jonathan Reiner, a professor of medicine at George Washington University and a CNN medical analyst, told CNN Sunday.

Trump administration officials cited a Mayo Clinic-led study that showed a 35% improvement in survival among people given the highest doses of the treatment early on in their illness compared to those who were treated later. Reiner pointed out this is not the same as a randomized placebo-controlled clinical trial, medicine's gold standard, which can demonstrate whether the treatment really works better than not treating people.

"We don't know compared to a placebo whether convalescent plasma is effective but we have recent data that suggests that people who receive convalescent plasma early, or earlier do better than those that get it later. And there is some data from this," Reiner said. "This is the best data that we have and the best data that we have seems to suggest that it's safe. But as recently as four days ago, the FDA stated on their website that it has not been proven that this therapy is both safe and effective."

"While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment," said Dr. Thomas File, president of the Infectious Diseases Society of America. "For this reason, IDSA supports the continued collection of data in randomized clinical trials to better understand the benefits of convalescent plasma treatment before authorizing its wider use in patients with COVID-19."

Art Caplan, founding head of the Division of Medical Ethics at NYU School of Medicine, told CNN he did not think the evidence was sufficient for an emergency use authorization.

EUAs make sense when there's real, clear evidence of benefit, and they should be evidence about what that evidence is," Caplan told CNN. "From what I've seen, I don't think there’s enough evidence in hand to do this."

At a White House briefing Sunday night, President Trump and Health and Human Services Secretary Alex Azar urged coronavirus survivors to donate plasma.

Caplan said he's worried about whether there's a large enough supply of convalescent plasma, which relies on donations from Covid-19 survivors. Under an emergency use authorization, doctors will be more likely to give convalescent plasma without tracking data, so it will then be difficult to determine which donors have the most effective plasma, and which patients are the best candidates to receive it. 

We're going to get a gold rush towards plasma, with patients demanding it and doctors demanding it for their patients," Caplan said.
7:16 p.m. ET, August 23, 2020

FDA commissioner says there is a good rationale using convalescent plasma to treat Covid-19

From CNN Health’s Maggie Fox

Dr. Stephen Hahn, commissioner of the US Food and Drug Administration, speaks during a media briefing at the White House on Sunday, August 23.
Dr. Stephen Hahn, commissioner of the US Food and Drug Administration, speaks during a media briefing at the White House on Sunday, August 23. Alex Brandon/AP

US Food and Drug Administration Commissioner Dr. Stephen Hahn says studies have shown convalescent plasma is safe and the treatment has been given to patients with infectious diseases for more than a hundred years.

"There was a really good rationale for why this might work," Hahn said at a White House briefing called in part Sunday to announce the emergency use authorization. "In the independent judgment of experts and expert scientists at FDA who have reviewed the totality of data … more than a dozen published studies … those scientists have concluded that Covid-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization."

Emergency use authorization is not the same as full approval, but it will allow more people to try the treatment.

"We are waiting for more data," Hahn said. "We are very pleased with these results."

He described one Mayo Clinic-led study that showed that patients who got the highest doses of convalescent plasma were 35% more likely to survive that other patients, although the trial was not a randomized controlled trial – the gold standard for determining whether a treatment really works. The trial compared people who were treated earlier to those who were treated later – not people who were treated versus those who were not treated.

Some researchers have said trials haven't shown clearly how well the treatment works.

"We have seen a great deal of demand for this from doctors around the country," Hahn said

The FDA has encouraged coronavirus survivors to donate their blood in the hope that immune system proteins they developed while fighting off infection will help newly infected patients.

More than 90,000 -- close to 100,000 Americans -- have enrolled in this program and more than 70,000 have received the treatment," Hahn said.
7:00 p.m. ET, August 23, 2020

Trump says "political reasons" held up plasma authorization

From Kevin Liptak

President Donald Trump points to reporter to ask a question during a briefing at the White House on Sunday, August 23.
President Donald Trump points to reporter to ask a question during a briefing at the White House on Sunday, August 23. Alex Brandon/AP

President Donald Trump told reporters Sunday he believed "political reasons" created a slowdown of approval for a coronavirus treatment at the Food and Drug Administration -- but said he "broke the logjam" over the last week.

Trump's remarks amount to tacit confirmation that he applied pressure on the agency ahead of its announcement Sunday that it was issuing an emergency use authorization for convalescent plasma to treat Covid-19.

I think there might have been a hold up, but we broke the logjam over the last week to be honest," Trump said at a late afternoon news conference announcing the new authorization.

He said he believed there were officials at the FDA and in the Department of Health and Human Services "that can see things being held up and wouldn't mind so much."

It's my opinion, very strong opinion, and that's for political reasons," Trump said.

Trump insisted his focus on treatments for coronavirus -- which has slowed the American economy and caused his poll numbers to sink -- was apolitical.

"This has nothing to do with politics," he said. "This has to do with life and death. So we are being very strong, and we are being very forthright, and we have got some incredible answers, and we're not going to let them be held up because every day is lives."

Earlier in the briefing, Trump seemed enthusiastic when asked by a reporter from Fox News whether patients should have access to treatments or vaccines before they reach the end of trials.

"We have all of these great, seemingly great answers that are ready to come out, but because of the process it takes -- can we use some of this early under right to try?" he asked, referring to legislation that allows patients access to drugs that are still in the investigational phase.

FDA Commissioner Stephen Hahn declined to answer when asked by Jim Acosta as the briefing concluded whether there was pressure on him to approve the emergency use of convalescent plasma.

6:43 p.m. ET, August 23, 2020

Trump says FDA made "independent determination" that convalescent plasma use is safe and effective

From CNN Health’s Jamie Gumbrecht

President Donald Trump said Sunday the emergency use authorization of convalescent plasma to treat Covid-19 patients was a "truly historic announcement" that will "save countless lives."

Today's action will dramatically increase access to this treatment," Trump said during a briefing.

On Sunday, Trump thanked Dr. Stephen Hahn, the Food and Drug Administration commissioner, saying the agency had really stepped up "especially over the last few days" in getting the authorization done.

Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective," Trump said.

Last week, Trump accused some health officials of playing politics regarding the emergency authorization for convalescent plasma. When asked about the FDA not having granted one, Trump said the reason was political.

 

6:48 p.m. ET, August 23, 2020

University of Kentucky retesting fraternity and sorority members due to higher Covid-19 rate

From CNN’s Evan Simko-Bednarski

The University of Kentucky began a second phase of Covid-19 testing Sunday, testing 5,500 students who belong to fraternities and sororities, according to a letter from the university’s president.

The university previously mandated Covid-19 testing for all students on campus, offering testing between August 3 and 22.

The second-phase of testing comes following a roughly 3% positivity rate for Covid-19 among fraternities and sororities in initial testing, approximately triple the roughly 1% positivity rate for the general student population. Of the 49 students currently in isolation following a positive Covid test, 30 come from two fraternity houses, university spokesman Jay Blanton said in a news release.

In a letter written to the campus community and provided to CNN, University President Eli Capilouto cautioned against blaming the students for the higher positivity rate.

Let me be clear: This is not an act to blame the students who reside in these facilities or who belong to these organizations," he wrote. "We believe a number of factors associated with communal living spaces likely contributed to the high positivity rates in these residences."

"Retesting has always been a part of our restart plan," Capilouto wrote. "We will begin that process with the students for whom the data indicate retesting is most appropriate."

Capilouto said that 21,000 students had been tested in the initial phase. The university lists its enrollment as "more than 30,000 students."

According to the most recent data from Kentucky Public Health, the state has had a total of 43,529 Covid-19 cases since the pandemic began.

NOTE: These numbers were released by the state of Kentucky, and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.

6:45 p.m. ET, August 23, 2020

Peru reports more than 3,700 new coronavirus cases

From CNN’s Claudia Dominguez and Samantha Beech

Peru’s Health Ministry reported 3,706 new coronavirus cases on Sunday, bringing the total number of cases in the country to 594,326.

The ministry reported 210 new deaths, bring the number of coronavirus-related deaths to 27,933 since the pandemic started.

On Saturday, at least 13 people were killed in a stampede at a nightclub in Lima, as partygoers attempted to escape a police raid on the venue. Police were called to shut down an illegal party with more than 120 people in attendance.

Social distancing measures are mandated in Peru, large social gatherings are banned and there is a nationwide 10 p.m. curfew to slow the spread of the virus.

6:40 p.m. ET, August 23, 2020

Brazil reports more than 23,000 new coronavirus cases

From journalist Rodrigo Pedroso in São Paulo

Brazil’s Health Ministry has reported 23,421 new Covid-19 cases over the past 24 hours, bringing the total number of cases in the country to 3.6 million.

The ministry reported 494 new coronavirus deaths on Sunday, raising the country’s death toll to 114,744.

Brazil is second only to the United States in the highest total number of coronavirus cases and deaths worldwide.

6:05 p.m. ET, August 23, 2020

University of Alabama president says "there is an unacceptable rise" of Covid-19 cases on campus  

From CNN’s Lori Daniel 

A statue outside of Bryant-Denny Stadium at the University of Alabama before a football game on September 22, 2018, in Tuscaloosa, Alabama.
A statue outside of Bryant-Denny Stadium at the University of Alabama before a football game on September 22, 2018, in Tuscaloosa, Alabama. Wesley Hitt/Getty Images

University of Alabama President Stuart R. Bell asked students, faculty and staff to work together to follow safety protocols so the university can finish the fall semester with in-person classes. Bell said there will be consequences, including suspension, for not following the rules on and off campus.

This is a critical moment for The University of Alabama. Despite the robust testing, training, health and safety measures we carefully and clearly implemented, there is an unacceptable rise in positive COVID cases on our campus," Bell wrote in a letter released Sunday.

According to the letter, university police and the Tuscaloosa Police Department will partner to monitor bars, restaurants and off-campus housing to ensure the city's Covid-19 ordinances and university guidelines are followed.

Violations to our health and safety protocols, both on and off campus, are subject to harsh disciplinary action, up to and including suspension from UA," the university president said.
6:04 p.m. ET, August 23, 2020

British Prime Minister urges parents to send children back to school next week

From CNN’s Hilary McGann and Hira Humayun

British Prime Minister Boris Johnson attends a ceremony in Alrewas, England, on August 15 to mark the 75th anniversary of Victory over Japan Day.
British Prime Minister Boris Johnson attends a ceremony in Alrewas, England, on August 15 to mark the 75th anniversary of Victory over Japan Day. Anthony Devlin/AFP/Getty Images

British Prime Minister Boris Johnson said Sunday that it is "vitally important" to get children back in the classroom when schools reopen next week.

Referring to comments made earlier Sunday by Chris Whitty, the UK's chief medical adviser, Johnson said it is "far more damaging" than the virus itself for pupils to stay out of school for any longer.

It's vitally important that we get our children back into the classroom to learn and to be with their friends. Nothing will have a greater effect on the life chances of our children than returning to school," Johnson said.

The Prime Minister thanked school staff who have been making preparations for a full return in September and reiterated his previous statements about "the moral duty to reopen schools to all pupils safely."

On Sunday, the chief medical officers and deputy chief medical officers of England, Scotland, Northern Ireland and Wales released a statement on risks and benefits of schools and child care centers reopening.

"We are confident in the extensive evidence that there is an exceptionally small risk of children of primary or secondary school age dying from Covid-19," the statement read, adding that they are also confident that there is "clear evidence of a very low rate of severe disease in children of primary and secondary school ages compared to adults, even if they catch Covid-19."

The statement also said international real-world evidence suggests that schools reopening have usually not been followed by a surge of Covid-19.

In a timescale that implies schools are the principal reason for the surge," but also adds there has "not been sufficient time to say this with confidence," the statement said.