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Overnight Health Care: Regeneron asks for emergency authorization of coronavirus treatment Trump received | McConnell says he hasn’t visited White House in two months due to coronavirus

Welcome to Thursday’s Overnight Health Care.



Donald Trump wearing a suit and tie: Overnight Health Care: Regeneron asks for emergency authorization of coronavirus treatment Trump received | McConnell says he hasn't visited White House in two months due to coronavirus | Employer-sponsored health insurance premiums rise 4 percent


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Overnight Health Care: Regeneron asks for emergency authorization of coronavirus treatment Trump received | McConnell says he hasn’t visited White House in two months due to coronavirus | Employer-sponsored health insurance premiums rise 4 percent

Regeneron filed for emergency authorization of its antibody COVID-19 treatment drug, just hours after President Trump claimed it basically cured him. Mitch McConnell hasn’t been to the White House in months, and a new analysis shows Americans’ job-based health care is continually getting more expensive.

We’ll start with Regeneron:

Regeneron asks for emergency authorization of coronavirus treatment Trump received

Biotech company Regeneron late Wednesday applied for emergency authorization for an experimental antibody treatment praised by President Trump.

“Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for our REGN-COV2 investigational antibody combination for COVID-19,” the company said in a news release.

The move came just hours after the president praised the efficacy of the treatment in a short video message posted on Twitter.

“They gave me Regeneron, it’s called Regeneron,” Trump said in the five-minute video Wednesday afternoon. “It was unbelievable. I felt good immediately. I felt as good three days ago as I do now.”

Why it matters: Trump was taking several drugs for his illness, so it’s not clear which helped him feel better. He claimed he has the “emergency use authorization all set,” but the FDA is supposed to make decisions based on science and not demands from the president. Regeneron’s drug is still undergoing clinical trials, and while early results seem promising, the company has not released data to back up its claims.

Read more here.

McConnell says he hasn’t visited White House in two months due to coronavirus

Senate Majority Leader Mitch McConnell (R-Ky.) said on Thursday that he hasn’t visited the White House in two months because of how it has responded to the coronavirus.

Speaking in Kentucky, McConnell said that while he talks to President Trump frequently, he hasn’t been to the White House in person since Aug. 6.

“Because my impression was their approach to how to handle this was different from mine and what I insisted we do in the Senate, which was to wear a mask and practice social distancing,” he told reporters.

McConnell’s comments come in the week after President Trump and roughly two dozen people in his orbit have tested positive for the coronavirus.

The Senate doesn’t have a mask mandate, though most senators wear masks around the Capitol and there are also signs to remind people to socially distance.

Unlike the Senate, the White House has rapid testing for those in contact with the president. But there have also been several events where the White House did not require social distancing and most people at the event did not wear masks.

McConnell on Thursday appeared to take a veiled jab at the White

Regeneron asks for emergency FDA approval for COVID-19 antibody treatment

Oct. 8 (UPI) — Biotechnology company Regeneron has requested emergency use authorization from federal regulators for a COVID-19 antibody treatment.

The REGN-COV2 treatment is a combination of two antibodies that’s designed to “block infectivity” of the SARS-CoV-2 virus that causes COVID-19.

“The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population,” the company said in a statement.

Regeneron, which asked the Food and Drug Administration for the emergency authorization, said it has doses available for 50,000 patients and will have enough for another 300,000 in the coming months.

“If [emergency use authorization] is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the company added.

President Donald Trump took a dose of the Regeneron cocktail last week after he tested positive for COVID-19, even though it hasn’t been approved by the FDA.

Regeneron said if its request is approved, it will distribute the treatment in the United States and partner Roche will distribute overseas.

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DC health dept asks WH attendees to get tested

WASHINGTON — The Washington D.C. Department of Health has released an open letter appealing to all White House staff and those attending a Sept. 26 event in the Rose Garden to seek medical advice and take a coronavirus test.

The letter indicates a lack of confidence in the White House medical team’s contact tracing efforts for the virus outbreak that infected President Donald Trump, multiple senior staff members and two U.S. senators, among others.

Co-signed by nine other local health departments from neighboring jurisdictions in Maryland and Virginia, the letter says contact tracing on the outbreak has been insufficient and “there may be other staff and residents at risk for exposure to COVID positive individuals.”


The move highlights the public health dilemma faced by Mayor Muriel Bowser’s administration regarding the current outbreak. The Trump White House has operated for months in open violation of several D.C. virus regulations, hosting multiple gatherings that exceeded the local 50-person limit and where many participants didn’t wear masks.

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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— Washington DC health department asks Rose Garden attendees to get tested

— Paris hospitals on emergency footing as ICUs fill with coronavirus patients

— Am I immune to the coronavirus if I’ve already had it?

— President Trump says he’s ready to hold campaign rallies, credits an experimental drug treatment with helping recovery from COVID-19.

— Coronavirus infections in Ukraine began surging in late summer, hospitals are ‘catastrophically short of doctors.’

— The NFL’s Tennessee Titans had another positive test, bringing the team’s outbreak of COVID-19 to 23.

— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

TRENTON, N.J. — New Jersey added 1,300 new coronavirus cases overnight, the highest level since late May.

Health Commissioner Judy Persichilli says most of the positive cases in Ocean County stem from Lakewood, predominantly among white men ages 19-49 and could be related to religious services or celebrations that occurred in late September.

Hospitalizations also increased to 652, the highest level since early August.

Eleven more people died in the last day, bringing the statewide confirmed total to 14,373. The positivity rate for testing stood at 3.69%, while the rate of transmission fell to 1.22, down from 1.27.

The state has stockpiled personal protective equipment, ventilators and the therapeutic drug Remdesivir, Persichilli says.

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MADRID — Spain’s health ministry is reporting 12,423 new coronavirus cases and 126 confirmed deaths Thursday, the day a court struck down a partial lockdown in hard-hit Madrid.

With 848,324 infections since the start of the pandemic, Spain has the highest caseload in Europe. The official death toll rose to 32,688, although limits on testing early in the year means the actual number of victims is likely much higher.

The country’s 14-day rate of 256 new cases per 100,000 inhabitants varies greatly from region to region, with Madrid’s 563 topping the charts. That’s five times the European average rate as of Sept. 27, according to data of

Regeneron Asks FDA for Emergency Use Authorization of Coronavirus Therapy Used to Treat President Trump | Health News

Regeneron announced Wednesday night that it has asked the Food and Drug Administration for emergency use authorization for the experimental coronavirus antibody therapy used to treat President Donald Trump after he tested positive for the virus.

The biotechnology company said in a statement that it made that emergency use request for its REGN-COV2 investigational antibody combination for COVID-19. If the emergency authorization is granted, the government has committed to making it available to Americans at no cost and would be responsible for its distribution, the statement said.

Enough doses are currently available for 50,000 coronavirus patients, and the company expects to have 300,000 doses within the next several months.

Cartoons on the Coronavirus

The experimental treatment is still in large-scale clinical trials but has been available for compassionate use, something the FDA approves on a case-by-case basis, such as the case with the president.

REGN-COV2 is a combination of two monoclonal antibodies designed specially to block SARS-CoV-2, the virus that causes COVID-19. Regeneron scientists sorted through thousands of human antibodies, including from people who recovered from COVID-19, to choose ones that fought the virus most effectively.

Scientists chose two virus-neutralizing antibodies, scaled them up and put them into a medication in hopes that it could treat virus symptoms and possibly be used as a preventative measure.

The president received an 8 gram dose of the treatment on Friday at Walter Reed National Military Medical Center following his coronavirus diagnosis. Trump called the treatment “unbelievable” and said he “felt good immediately.”

Early data from the company’s clinical trials have shown that the treatment is effective and safe, with few side effects.

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Regeneron asks FDA for emergency authorization of its Covid-19 antibody therapy that was given to Trump last week

Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus.



a woman preparing food in a kitchen: New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.


© Regeneron
New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.

The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night.

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“Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the statement said. “At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.

Regeneron’s experimental antibody treatment is still in large-scale clinical trials, but has been available for compassionate use, something the FDA has to approve on an individual basis, like it did for the President.

The antibody therapy is a combination of two monoclonal antibodies that is designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19, according to the company’s statement.

A cocktail antibody therapy uses two or more lab-engineered antibodies. Regeneron’s cocktail includes a monoclonal antibody that targets the spike protein the virus uses to drill into healthy cells, and another antibody that targets a different part of the novel coronavirus. With two, the hope is to trap and shut down viral replication.

“When you weigh the potential benefit versus the risks, the downsides are very low here because we have not seen any safety concerns,” Regeneron CEO Dr. Leonard Schleifer told CNN in an interview after Trump received an 8 gram dose of the treatment.

Early data from the company’s antibody trials released recently showed it worked fairly safely with few side effects.

“This class of drugs is an extremely safe class,” Schleifer said.

Dr. Richard Besser, a former acting director of the US Centers for Disease Control and Prevention who now heads the Robert Wood Johnson Foundation, said it makes sense that a treatment that gives a patient antibodies would help the immune system, but he said peer review will find any holes or pitfalls.

“I would withhold judgment on this until we see the data,” Besser said. “You know these early results that keep coming out from companies in press releases strike me as being … much more about the stock price than they are about science.”

But Dr. Thomas Frieden, also a former CDC director, disagreed with Besser.

Although Regeneron’s antibody therapy is unproven, it is “a promising treatment,” Frieden told CNN.

“There’s a report that only fewer than 300 patients have received it,” he said. “It seems to be most effective early in the disease, especially before patients make antibodies of their own.”

“We don’t know if it’ll be

U.S. Government Asks Vaccine Makers To Hold Filing for Authorization Until They Have Enough Doses to Distribute

President Trump Makes Statement On Vaccine Development
President Trump Makes Statement On Vaccine Development

Moncef Slaoui, head of the White House’s “Operation Warp Speed” project to develop a coronavirus vaccine, listens to U.S. President Donald Trump deliversremarks about vaccine development in the Rose Garden of the White House on May 15, 2020 in Washington, DC. Credit – Drew Angerer—Getty Images

As the COVID-19 pandemic enters its 10th month, the pressure to develop an effective vaccine, or vaccines, continues to mount. Speaking at the Johns Hopkins University and University of Washington Vaccine Symposium online, Dr. Moncef Slaoui, scientific head of Operation Warp Speed—the government organization funding and supporting development and distribution of COVID-19 vaccines—provided the latest updates on when a vaccine (and how many doses) might be available in coming months.

Perhaps most strikingly, Slaoui said that the government has told vaccine manufacturers not to seek authorization of their drugs from the Food and Drug Administration (FDA) until they have enough doses to provide to a desperate public. “We have recommended to companies that if they achieve efficacy demonstration while no vaccine doses are available at industrial scale of several million doses to at least immunize a relevant fraction of the population, then they should refrain or consider refraining from filing an emergency use authorization, because the populations would have a major disappointment [over] expectation of the availability of the vaccine,” he said.

Emergency use authorization (EUA) is an accelerated review and authorization process by the FDA that would allow vaccine makers to distribute vaccines that are safe and effective but not fully approved by the agency.

Slaoui also supported the FDA in its recent conflict with the White House over stringent guidelines proposed by the agency for evaluating data from vaccine studies, which include a recommendation that all vaccine trial volunteers be followed for two months for any potential side effects. Vaccine makers supported the guidelines, but after initially rejecting them, arguing they would delay availability of the vaccines, the White House has accepted them.

At this point, meeting demand would not be a problem if an EUA were given to the two vaccines, made by Moderna and Pfizer, that are currently furthest along in testing. The companies began late-stage testing for these vaccine candidates in the summer, and Slaoui said the manufacturers have been manufacturing doses at large scale in parallel to testing. The government began stockpiling doses of these unapproved but promising vaccines “in the single digit millions” in September, and will continue to do so in October, he said, and both Moderna and Pfizer will likely have 20 to 30 million doses produced by November and December this year.

Two of the other most promising vaccines in development are from AztraZeneca and J&J, both of which are quickly enrolling participants in late stage studies outside of the U.S., and may deliver first hints of safety and effectiveness by late October or early November. However, even if those results prove positive, these companies would likely have to consider waiting until their manufacturing capabilities