Tags: Coronavirus | Trump Administration | trump | coronavirus | pelosi

Trump To Announce 'Breakthrough' On COVID-19 Therapeutic

Trump To Announce 'Breakthrough' On COVID-19 Therapeutic

By    |   Sunday, 23 August 2020 02:11 PM


President Donald Trump will announce on Sunday that a new coronavirus treatment involving blood plasma donated by people who’ve recovered from the disease has received an emergency use authorization from U.S. regulators.

Trump will make the announcement at a press conference due to start at 5:30 p.m. EDT, said two people familiar with the situation who weren’t authorized to speak publicly.

The U.S. Food and Drug Administration is expected to clear for use with certain patients what’s known as convalescent plasma. The move would make it easier for patients to get the product, which Trump has touted even though its effectiveness hasn’t been proved.

Earlier story:

President Donald Trump is set to unveil Sunday night what his press secretary described as a “major therapeutic breakthrough” on COVID-19.

In a Saturday night tweet, White House press secretary Kayleigh McEnany said Trump would announce details at a 6 p.m. briefing on Sunday.

“News conference with President @realDonaldTrump at 6 pm tomorrow concerning a major therapeutic breakthrough on the China Virus,” she wrote, adding that Health and Human Services Secretary Alex Azar and Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, would attend.

The disclosure came hours after the president called out the FDA for “making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” suggesting it was playing politics.

“Obviously, they are hoping to delay the answer until after November 3,” he tweeted. “Must focus on speed and saving lives!” he demanded, tagging Hahn.

At a later press briefing, House Speaker Nancy Pelosi, D-Calif., branded Trump’s “attack” on the FDA “very dangerous,” The Hill reported.

"The FDA has a responsibility to approve drugs, judging on their safety and their efficacy, not by a declaration from the White House about speed and politicizing the FDA," Pelosi scolded, the news outlet reported.

"This was a very dangerous statement on the part of the president," she added. "Even for him, it went beyond the pale in terms of how he would jeopardize the health and well-being of the American people."

White House Chief of Staff Mark Meadows said on “Fox News Sunday” that the president’s Twitter comment reflected “frustration” with FDA bureaucrats.

“They want to do things they way they’ve always done it,” Meadows said on ABC’s “This Week” on Sunday. “This president is about cutting red tape. That’s what the tweet was all about.”

While Meadows didn’t provide details on the announcement, he suggested part of the reason is that Trump wants to make federal health agencies “feel the heat” to deliver results.

“We really need to make sure that we have good science and the proper protocols, but we also can’t wait around and assume that this virus is going to go away,” Meadows said. “This president wants real results and that’s why he took to Twitter.”

Last month, Hahn promised the United States wouldn’t “cut corners" in its race to develop a coronavirus vaccine.

Dr. Anthony Fauci, meanwhile, has said that he was “cautiously optimistic” a COVID-19 vaccine will be ready by the end of the year and widely distributed to Americans in 2021. Fauci is the nation’s top infectious disease doctor.

Several vaccine candidates are currently in clinical trials, and some look promising at providing a level of protection against COVID-19, according to experts.

An effective vaccine is considered pivotal to ending the pandemic. It would provide protection from the virus to healthy people, allowing them to go back to work, go to restaurants, return to school and resume most aspects of normal life.

To speed development, the White House has launched Operation Warp Speed, signing agreements with drugmakers worth more than $4 billion.

The industry has embarked on what’s likely the most ambitious research and development effort in its history. The biggest drugmakers in the world, as well as a number of innovative biotechnology companies, have developed vaccine candidates in record time and are putting them into human trials. Thirty vaccines are now in human testing, according to an Aug. 20 summary by the World Health Organization.

The FDA has been moving far faster than normal. The agency has tentatively scheduled an Oct. 22 meeting to consider a potential vaccine, and health officials across government are working on guidelines for who would first get any vaccine and how it would be distributed.

Any shot would likely be used first in a narrow group of high-risk people, like health workers, before being rolled out to the public in phases next year. But that timeline is still a fraction of the years it typically takes to develop, test and review a new inoculation.

One of the leading vaccines is being developed by New York’s Pfizer Inc. The company’s trial has been enrolling patients rapidly, with more than 9,000 volunteers as of Aug. 19, according to Philip Dormitzer, Pfizer’s vice president of viral vaccine research.

“Things are going very quickly,” Dormitzer said earlier this month. “We remain on target” to have results ready to submit to regulators in October. Another vaccine, being developed by Moderna Inc., has enrolled about 13,000 people in its 30,000-person trail.

A top FDA official who is overseeing COVID vaccine trials had vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, made his promise during a conference call earlier in the month with pharmaceutical executives, government officials and others, Reuters reported Friday.

It was not clear if that was what prompted Trump’s tweet.

The Trump administration also is considering fast-tracking an experimental COVID-19 vaccine being developed by AstraZeneca Plc and Oxford University ahead of the Nov. 3 elections, the Financial Times reported Sunday.

One option being explored would involve the FDA awarding “emergency use authorization” in October to the potential vaccine, which was developed by Oxford and licensed to AstraZeneca, the FT reported.

Material from Bloomberg news service was used in this story.

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President Donald Trump is set to unveil Sunday night what his press secretary described as as a "major therapeutic breakthrough" on COVID-19.In a Saturday night tweet, White House press secretary Kayleigh McEnany said Trump would announce details at a 6 p.m....
trump, coronavirus, pelosi
Sunday, 23 August 2020 02:11 PM
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