FDA head still trying to clarify misleading comments on experimental convalescent plasma therapy for Covid-19
Dr. Stephen Hahn addresses the media during a news conference at the White House in Washington, DC on August 23. Pete Marovich/Getty Images
The head of the US Food and Drug Administration says he should have been more careful when explaining the benefits of convalescent plasma.
“I was trying to do what I do with patients, because patients often understand things in absolute terms versus relative terms,” Dr. Stephen Hahn told Bloomberg News in an interview Tuesday.
In a series of tweets Monday, Hahn admitted he had mischaracterized the benefits of convalescent plasma at a White House event announcing the emergency use authorization (EUA). He had said studies showed plasma could prevent 35 deaths out of 100 -- something that studies did not show.
“What I was trying to get to is that if you look at 100 patients who receive high titre, and a hundred patients who received low titre, the difference between those two particular subset of patients who had these specific criteria was a 35% reduction in mortality,” he told Bloomberg. “So I frankly did not do a good job of explaining that.”
A titer refers to the concentration of something -- in this case a specific antibody in a dose of convalescent plasma. The plasma is made using the blood of people who have recovered from coronavirus infections.
The misleading comments have caused concerns about how honest the FDA will be about any eventual authorization or approval of a Covid-19 vaccine.
Hahn admitted to Bloomberg he's worried that it could hurt the FDA’s reputation with the American public.
“Absolutely, I worry about that. I can only hope that being honest and straightforward lessens that impact,” he said. “We're in an incredibly politicized time, and these are really difficult concepts to explain to the American people.”
11:56 p.m. ET, August 25, 2020
Former CDC director says emergency use authorization for convalescent plasma was "politically driven"
From CNN Health’s Shelby Lin Erdman
Former director of the Centers for Disease Control and Prevention Dr. Tom Frieden speaks during a hearing on May 6 in Washington. Alex Wong/Getty Images
The former director of the US Centers for Disease Control and Prevention said he believes the US Food and Drug Administration’s emergency use authorization (EUA) for the use of convalescent plasma in coronavirus patients “was politically driven.”
FDA Commissioner Dr. Stephen Hahn admitted Monday to having mischaracterized the benefits of the plasma when he said plasma treatment had saved the lives of 35 out of 100 coronavirus patients.
In an interview with CNN’s Wolf Blitzer, Dr. Thomas Frieden called Hahn’s comments and subsequent apology “a substantial concern.”
“The substantial concern is this appears to have been a politically driven announcement,” he said. “The way it was announced, the headline, the framing.”
Convalescent plasma has promise, said Frieden, who is now president of the global health initiative Resolve to Save Lives.
“It may help some people if given at some dose, at a certain time in infection,” he said. “We don't know the answers to those questions, and just saying ‘use it’ means we may never learn the answers, or it'll take longer to learn the answers to those questions, so that's a big concern.”
Coronavirus vaccines: Frieden called the plasma EUA announcement a “huge concern” because it’s a “dry run” for the FDA and the Trump administration in how they’re going to inform Americans about a coronavirus vaccine.
Public health experts already worry that a significant number of people won't consent to any eventual coronavirus vaccine.
“This is a failure. The only way you can get people to take vaccines is to be completely transparent and we're relying on the FDA to be completely transparent about what we know, when we know it.”
Different vaccines will most likely become available and different vaccines will work differently in different people, Frieden said.
“We will know something about how well they work, how safe they work, how much of them we’ll have, who should get them,” he said.
“Fundamentally, people have to trust them (the FDA) or the best vaccine in the world won't be able to end the pandemic.”
Watch:
10:27 p.m. ET, August 25, 2020
Covid-19 cases among US children increased by 21% in just two weeks
From CNN Health’s Andrea Kane
Almost 443,000 children tested positive for the novel coronavirus in the United States between the start of the pandemic to August 20, according to an updated joint report from the American Academy of Pediatrics and the Children’s Hospital Association.
Since August 6, when the last report came out, there have been 74,160 new cases in children in the US, bumping the total from 358,469 to 432,629, an increase of roughly 21% in only 14 days.
The number of cases per 100,000 children has also been steadily rising, from 13 cases per 100,000 children in mid-April to 583.2 per 100,000 in the August 20 report.
And the percentage of child patients out of total coronavirus cases has also grown, from 2% to 9.3% in the same time period.
In New York City and the 21 states that reported on hospitalizations, children made up between 0.4% and 4.6% of total hospitalizations. That means between 0.2% and 8.6% of all pediatric Covid-19 cases resulted in hospitalization.
In New York City and the 45 states that reported on mortality, children represented between 0% and 0.3% of all Covid-19 deaths; 21 states reported zero child deaths. Overall, between 0% and 0.7% of all children diagnosed with Covid-19 died.
“At this time, it appears that severe illness due to COVID-19 is rare among children. However, states should continue to provide detailed reports on COVID-19 cases, testing, hospitalizations, and mortality by age so that the effects of COVID-19 on children’s health can be documented and monitored,” the report notes.
The report summarizes publicly reported data from 49 states, New York City, the District of Columbia, Puerto Rico and Guam. The report does not include data from Alabama.
3:03 a.m. ET, August 26, 2020
Brazil reports more than 47,000 new Covid-19 cases
From Rodrigo Pedroso in São Paulo and CNN’s Sharif Paget
Soldiers from the 4th Military Region of the Brazilian Armed Forces take part in the cleaning and disinfection of the Municipal Market in the Belo Horizonte, Brazil on August 18. Douglas Magno/AFP/Getty Images
Brazil’s Health Ministry reported at least 47,134 new Covid-19 cases over the past 24 hours on Tuesday, bringing the country's total to 3,669,995.
The ministry also reported 1,271 new coronavirus fatalities, raising the country’s death toll to 116,580.
This comes as Brazilian President Jair Bolsonaro's eldest son, Flávio Bolsonaro, tested positive for Covid-19 on Tuesday, according to his press officer. Bolsonaro's son, who is a senator, has not reported symptoms and is currently working from his home in Brasilia.
Brazil continues to be second only to the United States in the highest total number of coronavirus cases and deaths in the world.
11:47 p.m. ET, August 25, 2020
Fauci: We "certainly don’t know the whole story" about Covid-19
From CNN's Amanda Watts
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, testifies during a House Select Subcommittee on the Coronavirus Crisis hearing on July 31 in Washington. Erin Scott/Pool/Getty Images
Dr. Anthony Fauci said because Covid-19 is such a new disease, we "certainly don’t know the whole story."
"I think we learned the lesson that I think we should have known from our experience with other outbreaks -- is that when you're dealing with a work in progress, things change," Fauci said during an interview with the Infectious Diseases Society of America released Tuesday.
We are still “learning things in real time,” Fauci said.
"And you've got to keep an open mind -- that you certainly don't know the whole story -- in the first or the second or the third or even the fourth month," he added.
Even today, we’re learning about Covid-19’s transmissibility, asymptomatic transmissibility and the long-range, chronic residual effects, Fauci said.
“As scientists and public health officials, we need to be humbled to realize that any given moment, there may be a lot that we still do not know,” he said.
11:46 p.m. ET, August 25, 2020
World’s fastest man Usain Bolt tests positive for coronavirus
From CNN’s Ravi Ubha and Aleks Klosok in London
Usain Bolt of Jamaica celebrates during a lap of honour following finishing in third place in the mens 100m final during day two of the 16th IAAF World Athletics Championships London 2017 at The London Stadium on August 5, 2017. Michael Steele/Getty Images
Usain Bolt has tested positive for the coronavirus, and the government in his native Jamaica says the fastest man on the planet won’t be spared punishment if he broke the rules stemming from a party held for his 34th birthday on Friday, according to Jamaica’s Health minister.
“It is now public knowledge that Mr. Bolt has been tested positive,” Dr. Christopher Tufton, the Jamaican Minister of Health and Wellness, said in a virtual news conference on Monday.
“He has been formally notified -- I’m told -- by the authorities and in keeping with standard protocols once there is a positive case, irrespective of the individual, it triggers an approach to questioning, interrogation if you will, which would then follow through with contact tracing.” Tufton said.
Ricky Simms, Bolt’s agent, confirmed his positive test to CNN.
“The Covid test was positive, but Usain is not showing any symptoms,” he wrote to CNN in an email.
Bolt, the world-record holder in the 100m and 200m and an eight-time Olympic gold medalist, had posted a video on social media earlier Monday prior to the test results.
He had been given the test on Saturday, he said, and wasn’t showing any symptoms. He intended to quarantine and urged those who had been around him to also isolate.
“I did a test on Saturday because I have work,” Bolt said. “I'm trying to be responsible so I'm going to stay in and stay in for my friends. Also, I’m having no symptoms.”
“I'm going to quarantine myself and wait to see what the protocol is … Until then … I'm quarantined by myself and just taking it easy. Be safe out there.”