“IT COULD SAVE A LIFE”

by Sharon Rondeau

https://www.facebook.com/WhiteHouse/videos/718574865359809

(Aug. 23, 2020) — Approximately 30 minutes earlier than initially scheduled Sunday, President Trump, HHS Secretary Alex Azar, and FDA Commissioner Dr. Stephen Hahn held a press conference to announce that the FDA has issued an Emergency Use Authorization for convalescent plasma for treatment of the novel coronavirus.

The video of the presser is difficult to locate through media sources but is available on the White House’s Facebook page.

At approximately 2:00 p.m. EDT, Trump tweeted that the “very good news” would be announced at 5:30 p.m. rather than at 6:00 p.m. EDT.

Trump spent the first 3+ minutes providing updates on two major California wildfires which have resulted in loss of life and property and for which Trump issued an emergency declaration Saturday.  Also of concern, Trump said, are oncoming Tropical Storm Laura and Hurricane Marco, both of which are expected to make landfall in Louisiana in quick succession early next week.  Puerto Rico has been readied for impact from the storms, Trump said, with FEMA standing by to provide assistance to both locales.

Transitioning to the subject of the “China virus,” Trump said the FDA issued an Emergency Use Authorization for convalescent plasma in coronavirus patients.  “Today’s action will dramatically expand access to this treatment,” Trump said, thanking the FDA for its decision.  “It’s only made possible because of ‘Operation Warp Speed,’ he said, invoking the program his administration launched to rapidly develop vaccines and therapeutics to combat the novel coronavirus, also known as COVID-19.

On Friday, the FDA declined to issue an EUA for the treatment.

Trump reported that the federal government supplied $48 million to the Mayo Clinic to conduct a clinical trial for convalescent plasma involving 100,000 Americans, which Trump said “has proven to reduce mortality by 35%…the FDA, MIT, Harvard and Mt. Sinai Hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease…”

In response to a government campaign, many Americans who have recovered from the coronavirus have donated plasma, Trump said.  Since the end of July, he said, “weekly plasma donations have doubled, and today I once again urge all Americans who have recovered from the virus to go to coronavirus.gov and sign up and donate plasma today, please…”

He described those who have donated plasma “incredible.”

Just after the 9:00 mark in the video, Azar took to the podium and thanked Trump for his “bold leadership,” which he said made the EUA for convalescent plasma possible.  “President Trump is the ‘right to try’ president,” Azar said, “and he’s fought hard to ensure that Americans can have access to promising COVID-19 treatments.”

He termed convalescent plasma “a tried-and-true therapeutic method” for responding to historical pandemics. “But the president wanted to ensure that we developed the data to support its use, and this FDA authorization is one result of that effort,” Azar said.  He said the data gathered show that patients treated early in the course of the disease, who were under 80 years of age and not “on artificial respiration” showed the most improvement.

Azar described the results gleaned thus far as “a major advance in the treatment of patients” and added that “other new results and new options” are expected to made available “as soon as this fall” in coordination with the FDA.

“Know if you donate plasma, you could save a life,” he said.

At 12:08, Hahn assumed the podium, thanking Trump for his “leadership” and “the more than 17,000 men and women who work at FDA.”  “They’ve worked day and night to in fact do that,” Hahn said.

He then explained that plasma is “the liquid portion of the blood” which “contains the natural immunity that someone develops in response to an infection.”

Based on historical precedent, Hahn said, “there was a really good rationale for why this might work.”

An “expanded access” program was launched in April for convalescent plasma, Hahn said, with “over 70,000” people now treated with it.  “In the independent judgment of experts and expert scientists at FDA who have reviewed the totality of data…those scientists have concluded that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an Emergency Use Authorization.”

Hahn said that more data continues to be gathered on the treatment method but that the “35% improvement in survival” reduction in fatalities is very encouraging from a clinical point of view.

“We’ve seen a great deal of demand for this from doctors around the country, and what this Emergency Use Authorization today does — it allows us to continue that and meet the demand.”

He echoed Trump’s invitation to recovered COVID-19 patients to donate plasma.  “It could save a life,” he said.

At 15:15, Hahn returned the presser to Trump, who opened it to reporters’ questions.

 

 

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