Summary: President Trump announced that a coronavirus treatment that involves blood plasma from people who’ve recovered from the disease will be expanded to many more sick Americans after the FDA approved use of the therapy. “This is a powerful therapy,” Trump said during a White House press conference moments before futures opened. “Today’s action will dramatically expand access to this treatment.”
Trump said the FDA had concluded the treatment is "safe" and "very effective" although the therapy has yet to undergo the full set of clinical trials usually required of drugs seeking FDA approval.
As Bloomberg notes, the U.S. Food and Drug Administration confirmed Sunday, just ahead of Trump’s news conference, that it had cleared what’s known as convalescent plasma for use with certain patients. The move would make it easier for patients to get the product, which Trump has promoted even though its effectiveness remains unproven.
"Convalescent plasma has been a tried-and-true therapeutic treatment in prior outbreaks,” Health and Human Services Secretary Alex Azar said at the news conference, while FDA Commissioner Stephen Hahn said researchers had seen a 35% improvement in patients treated with the convalescent plasma.
"We dream in drug devlopment of something with a 35% mortality reduction,” Azar said. “This is a major advance in the treatment of patients."
Cynics have said that with the election
And here is the official statement from the FDA authorizing convalescent plasma as "Potential Promising COVID–19 Treatment "
FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.
Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.
Alex Azar, Health and Human Services Secretary:
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.”
Stephen M. Hahn, M.D., FDA Commissioner:
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
Scientific Evidence on Convalescent Plasma
Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.
The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.
The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.
Terms of EUA
The EUA requires that fact sheets providing important information about using COVID-19 convalescent plasma in treating COVID-19 be made available to health care providers and patients, including dosing instructions and potential side effects. Possible side effects of COVID-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
Mayo Clinic Expanded Access Program
The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications.
An Expanded Access ProgramExternal Link Disclaimer for convalescent plasma was initiated in early April to fill an urgent need to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma. As the number of single patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma.
The EUA was issued to the HHS Office of the Assistant Secretary for Preparedness and Response.
The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
* * *
Watch Live: President Trump's announcement is due to start at 1730ET:
"The FDA has issued an emergency use authorization ... for a treatment known as convalescent plasma. This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection," Trump said.
"It's had an incredible rate of success. Today's action will dramatically expand access to this treatment," the president said.
Meanwhile, Axios reports citing two sources, that Peter Navarro had aggressively confronted FDA officials, saying, "You are all Deep State and you need to get on Trump Time."
* * *
Update (2:30pm): Well, we can forget the speculation, discussed just moments ago, that Trump's 5:30pm news conference - conveniently 30 minutes before S&P futures open for trading - in which he will deliver "very good news" involves the fast-tracking of an AstraZeneca covid vaccine as an FT article hinted earlier...
Important White House News Conference at 5:30 (sharp) today. Very good news!— Donald J. Trump (@realDonaldTrump) August 23, 2020
... and instead both Bloomberg and StatNews report that Trump will announce that a new coronavirus treatment involving blood plasma from patients who have recovered from the disease, has received an emergency use authorization from the FDA, which is expected to clear for use with certain patients what’s known as convalescent plasma. The move, Bloomberg notes, would make it easier for patients to get the product, which Trump has touted even though its effectiveness hasn’t been proved.
Blood plasma is among a host of potential therapeutics that have been undergoing testing in clinical trials, StatNews notes adding that the hope is that infusions of antibody-rich plasma from those who have recovered from Covid-19 can be injected into ill patients, kickstarting their immune system and allowing them to fight off the virus until they can generate their own antibodies.
Trump's decision to forge ahead is predicated by a study conducted by the Mayo Clinic and the National Institutes of Health which found that plasma treatments appeared to have a small but statistically significant impact on reducing mortality in hospitalized Covid-19 patients who received the infusions within three days of the onset of symptoms, compared with those who got plasma later.
Pouring cold water on Trump's major announcement, however, Statnews notes that the decision, which Trump’s press secretary heralded ahead of time as a “major therapeutic breakthrough," likely falls far short of that description, "and could generate intense controversy inside the administration and the broader scientific community."
Convalescent plasma is neither "major" nor "breakthrough"— Andy Biotech (@AndyBiotech) August 23, 2020
It has already been given to >70,000 #COVID19 patients and this EUA won't significantly change standard of care.
Sadly we still don't convincing RCT data that demonstrate its effectiveness after >5M cases in US... https://t.co/AqHZDhob1l
Further indicating that the Trump announcement will lead to a firestorm of criticism among the scientific community, StatNews also adds that the move comes less than a week after officials at the National Institutes of Health staged a rare intervention to stop the FDA from issuing what is known as an “emergency use authorization” for blood plasma to treat Covid-19. NIH officials involved in the decision told the New York Times that more data, derived from randomized controlled trials, were needed.
The announcement also follows sustained pressure from the president on his own administration. Trump told reporters last week that U.S. officials were slow-walking clearance of blood plasma until after the November election. He also took to Twitter on Saturday to criticize the FDA for making it difficult to test vaccines and therapeutics, though he didn’t specifically mention plasma.
As Bloomberg further notes, Mark Meadows suggested part of the reason Trump tweeted about the FDA on Saturday is that he wants to make federal health agencies "feel the heat" to deliver results.
On “Fox News Sunday,” Meadows said “the announcement that’s coming today should have been made several weeks ago.”
“It was a fumble by a number of people in the federal government that should have done it differently, and having been personally involved with it, sometimes you have to make them feel the heat if they don’t see the light,” he said.
As an aside, the FDA has previously issued dozens of EUAs during the course of the coronavirus pandemic, for both diagnostic tests and some drugs, but at times has been forced to reverse course. Most notably, the FDA revoked an EUA for the malaria drug hydroxychloroquine, which was personally touted by Trump as a treatment for Covid-19.
In any case, the fact that Trump's announcement is the fast-tracking of a treatment - and not a vaccine - will not lead to a Trump popularity hit within his core base, because as we discussed earlier there is a sizable contingent within the US population - at least 36% according to a recent Gallup, most of whom Republicans - who have said they would not take a covid vaccine even if it was mandatory by law.
* * *
Update (9:05ET): President Trump is expected to hold a press conference Sunday evening regarding a major therapeutic "breakthrough" for treating COVID-19, the White House said late Saturday night.
White House Press Secretary Kayleigh McEnany tweeted:
"News conference with President @realDonaldTrump at 6 pm tomorrow concerning a major therapeutic breakthrough on the China Virus. Secretary Azar and Dr. Hahn will be in attendance," McEnany tweeted.
News conference with President @realDonaldTrump at 6 pm tomorrow concerning a major therapeutic breakthrough on the China Virus. Secretary Azar and Dr. Hahn will be in attendance.— Kayleigh McEnany (@PressSec) August 23, 2020
The press conference comes as the president on Saturday morning suggested the Food and Drug Administration (FDA) was 'deliberately' slowing down clinical trials for therapeutics and vaccines for coronavirus.
House Speaker Nancy Pelosi responded to the president's comments, calling them "dangerous:"
"This was a very dangerous statement on the part of the president," Pelosi said.
"Even for him, it went beyond the pale in terms of how he would jeopardize the health and well-being of the American people."
The FDA must approve drugs or vaccines based on their safety and effectiveness – NOT political pressure from the White House.— Nancy Pelosi (@SpeakerPelosi) August 22, 2020
The President’s dangerous attempt to inject himself into the scientific decisions of @US_FDA jeopardizes the health & well-being of all Americans. https://t.co/Dt7CBVjX1D
President Trump's planned press conference this evening begins as US equity futures open for trading. Is Trump trying to jawbone markets higher? Or is this another push for HCQ?
* * *
President Trump took a swipe at the Food and Drug Administration (FDA) in a pair of Saturday tweets, accusing the "deep state, or whoever, over at the FDA" of delaying human vaccine trials by "making it very difficult for drug companies to get people" (test subjects) so that trial results aren't known until after the 2020 election.
"Must focus on speed, and saving lives!" Trump concluded, tagging FDA Commissioner Stephen Hawn, who he appointed to the role.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA— Donald J. Trump (@realDonaldTrump) August 22, 2020
Trump also slammed the FDA, rubbing the agency's nose in their June decision to revoke its emergency authorization of hydroxychloroquine (HCQ) for the treatment of COVID-19.
"Many doctors and studies disagree with this!" tweeted Trump - resurrecting a June 15th 'Twitter moment' noting the revocation.
Many doctors and studies disagree with this! https://t.co/fpLVJZMvHS— Donald J. Trump (@realDonaldTrump) August 22, 2020
Hydroxychloroquine - used by many countries as both a front-line early treatment and a prophylactic against COVID-19 - saw sharp pushback from public health officials and Democrats after President Trump recommended it, almost as if the need to prove him wrong and push new treatments was more important than exploring whether HCQ was indeed effective if used early, particularly in conjunction with zinc and the antibiotic azithromycin.
Indeed, the first wave of studies on HCQ focused on mid-to-late stage COVID-19 infections, and found marginal improvement - or in one study, harm, from the use of the popular antimalarial drug. Since then, studies have emerged that HCQ is extremely effective when used early -
In July, the state of Ohio withdrew their ban on the use of HCQ to treat COVID-19.
he anti-HCQ push has infected Silicon Valley as well - as tech giants have been labeling pro-hydroxychloroquine content as 'misinformation' - most recently banishing a press conference by a group of doctors touting the drug from just about every platform.
To that end, Yale epidemiologist Dr. Harvey Risch has accused Dr. Anthony Fouci of waging a "misinformation campaign" against the drug - appearing on "Good Morning America" in late July where he further downplayed the drug - claiming that "the overwhelming prevailing clinical trials that have looked at the efficacy of hydroxychloroquine have indicated that it is not effective in [treating] coronavirus disease."
Several new studies have shown efficacy if used early, while countries that have deployed HCQ in just that manner have significantly fewer deaths per million residents (via c19study.com, which tracks HCQ studies).
HCQ's efficacy was known by mid-July, when the FDA removed its authorization:
It's not perfect as HCQ was also used in Belgium and Spain and later in Italy, but the idea is that Western Europe as a whole never embraced the 'treat early and often' strategy. Mostly they tried it with sick patients, didn't work..moved on— Gummi Bear (@gummibear737) July 16, 2020
They mainly followed the WHO position
Meanwhile, over 700 physicians from all 50 states have called on President Trump to issue another Emergency Use Authorization on HCQ.
The physician signatories specialize in the following kinds of medicine:— Jenny Beth Martin (@jennybethm) August 22, 2020
Women’s health: 30
Dr. Fauci's NIH is suppressing #Hydroxycholoroquine. @RealDonaldTrump should ask Dr. Fauci about NIH's refusal to conduct or support real research on HCQ despite the likely efficacy of this safe drug as a #coronavirus treatment and preventative.— Tom Fitton (@TomFitton) August 22, 2020