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Covid treatment used by Trump authorized by FDA

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View of Corporate and Research and Development Headquarters of Regeneron Pharmaceuticals on Old Saw Mill River Road in Tarrytown, New York.

Lev Radin | LightRocket | Getty Images

The Food and Drug Administration on Saturday granted an emergency use authorization for Regeneron‘s Covid-19 antibody treatment, the experimental therapy given to President Donald Trump when he contracted the coronavirus in October.

Regeneron submitted an emergency use application that month after preclinical studies showed that the therapy, called REGN-COV2, reduced the amount of virus and associated damage in the lungs of non-human primates. The company said trial data also shows the drug reduces medical visits in patients with mild-to-moderate Covid-19.

“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn.

Regeneron’s therapy is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight infections. Monoclonal antibody treatments gained widespread attention after news that Trump received Regeneron’s antibody cocktail. As Trump’s health improved, he touted it as a “cure.” But Regeneron’s CEO, Dr. Leonard Schleifer, has stressed that more testing is required.

“Some people don’t know how to define therapeutic. I view it different. It’s a cure,” Trump said in a video posted Oct. 7 on Twitter. “For me, I walked in. I didn’t feel good. A short 24 hours later, I was feeling great. I wanted to get out of the hospital. And that’s what I want for everybody. I want everybody to be given the same treatment as your president because I feel great.”

Regeneron’s authorization comes after the FDA announced on Nov. 9 that it had authorized Eli Lilly’s antibody treatment – called bamlanivimab –for people newly infected with Covid and are at risk of developing a severe form of the disease. Officials said the treatment shouldn’t be used for hospitalized patients because there is no data to show the drug is helpful at that stage of the disease.

The authorization will expand the number of drugs at doctors’ disposal to fight the virus, which continues to rapidly spread across the United States and other parts of the world. Before the authorization, people could only get the drug as part of an FDA program that gives some patients limited access to investigational medical products. Gilead Sciences‘ antiviral drug remdesivir is the first and only fully approved treatment in the U.S. for Covid.


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‘We should be back to normal’ by summer 2021, says Operation Warp Speed advisor

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Operation Warp Speed’s Chief Science Advisor Moncef Slaoui told CNBC that Americans can expect to get back to ‘normal’ by summer 2021, as families across the United States spend Thanksgiving apart this year in order to keep their loved ones safe. 

“We hope that we would have vaccinated 70% to 80% of the U.S. population by May or June of 2021, so I would hope that by summer, we should be substantially back to normal,” Slaoui said in a Wednesday evening interview on “The News with Shepard Smith”

The coronavirus pandemic is ripping through cities and towns across the United States and the data shows that it has no signs of slowing down. There were 88,000 people hospitalized with Covid-19 on Tuesday, according to the Covid Tracking Project. Deaths are on the rise as well. The U.S. reported more than 2,100 deaths Tuesday, the most deaths since May, according to a CNBC analysis of Johns Hopkins data.

Doctors and scientists, however, are reassuring Americans that there will be a reprieve. Two weeks after Thanksgiving, the FDA will meet to discuss whether to green-light Pfizer’s vaccine. If it does, the government plans to ship out 6.4 million doses to communities around the country.

Slaoui said that inoculating all Americans will be a “challenge” but he thinks it is achievable. “People need to know that every year between 140 million to 180 million doses of flu vaccine are produced, distributed, and inoculated in the U.S. population in a period that goes between the month of August and the month of, maybe, January,” Slaoui said. “So, we may be doubling that number over the period of time, but it’s not from scratch, which was very different from the testing.”

Host Shepard Smith noted that another challenge will be convincing people that a vaccine is safe to take. A recent Gallup Poll showed that only 58% of Americans said they would take a coronavirus vaccine. 

“It’s a great concern and really it’s very unfortunate that the political context in which the development of this vaccine took place has exacerbated the hesitancy and the lack of trust that comes from the fact that we went very fast,” Slaoui said.

Slaoui explained that scientists did not “start from a blank piece of paper” and were able to jump off of 10 to 15 years of discovery and development work that took place around the platform technologies in which the vaccines are made. He said that although it normally takes 6 to 7 years to discover a vaccine, a lot of the groundwork had already been done because of the past years of research. Another factor that helped speed up the process were the large number of participants in the Covid vaccine clinical trials, Slaoui said.

“We will know more about these vaccines and their efficacy and safety than the ‘average’ vaccines in the shorterm,” Slaoui said. “What we will not know very much about is their safety in the long-term, just because the trials had to be conducted fast, and it is important that we immunize people. We have 2,000 people dying every day.”

Slaoui said there was a thorough system of surveillance in place to keep track of people once the population starts taking the vaccines. Slaoui added that if there was any sign of long-term issues, those issues will be dealt with “immediately.” 

“Please keep your ears open and your mind open, listen, and then judge on the facts and the data,” Slaoui. said. “I feel confident that if we do that, most Americans will agree to be vaccinated. 95% efficacy is insurance against this pandemic.”


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CDC expected to shorten recommended time

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The U.S. Centers for Disease Control and Prevention is considering shortening its recommended two-week quarantine period for people who have come in contact with people who have it — a change welcomed by some medical experts who say the relaxed guidelines would be easier for people to follow.

Current CDC guidelines recommend that anyone exposed to a person with the coronavirus quarantine at home for 14 days, even if they test negative for the virus. Scientists say that helps prevent further spread of the disease before they start showing symptoms or from those who don’t develop any symptoms.

However, CDC Director Robert Redfield said in late October that those guidelines were made when diagnostic testing wasn’t as readily available as it is today. At the time, Redfield said the agency was trying to determine whether a quarantine period could be shortened to as little as seven days with a negative Covid-19 test.

“It’s data driven, it’s under evaluation, obviously we don’t want people to be quarantined for 14 days unnecessarily,” Redfield said during an Oct. 21 press briefing at the CDC’s headquarters in Atlanta.

Dr. Henry Walke, the CDC’s incident manager for Covid-19 response, said the agency is now finalizing those new guidelines to recommend a quarantine period for seven to 10 days with a negative Covid-19 test, according to The Wall Street Journal. Agency officials are still determining the exact length of the quarantine and what type of test would be needed to end it, the Journal reported on Tuesday.

“CDC is always reviewing its guidance and recommendations in the light of new understandings of the virus that causes COVID-19, and will announce such changes when appropriate,” CDC spokesperson Belsie Gonzalez told CNBC on Wednesday.

Adm. Brett Giroir, assistant secretary of health who leads the federal government’s testing efforts as part of the White House coronavirus task force, said during a press call on Tuesday that there’s beginning to be “a preponderance of evidence that a shorter quarantine complemented by a test might be able to shorten that quarantine period from 14 days” to a shorter period.

“We are actively working on that type of guidance right now, reviewing the evidence, but we want to make absolutely sure,” Giroir told reporters. “These kind of recommendations aren’t willy-nilly. They’re worked on with a variety of experts.”

‘Should have done this sooner’

The shorter quarantine period could make it easier for people to follow the CDC’s recommendations since most people were likely shortening the two-week period on their own, Dr. Scott Gottlieb, the former Food and Drug Commissioner, said on Wednesday.

For people who have Covid-19 but are asymptomatic, meaning they never develop symptoms, chances are they will no longer be very contagious after seven to 10 days, Gottlieb said. The number of people who will contract the infection two weeks after their exposure is also “very small,” he said.

“I mean, frankly, we probably should have done this sooner,” Gottlieb told CNBC’s “Squawk Box.” “Asking people to quarantine for a full two weeks, to self-isolate for a full two weeks because of an exposure is just going to drive people not to comply with the rules. We’re better off doing something that’s practical.”

Former CDC Director Dr. Tom Frieden, who served under President Barack Obama, told NBC News that the U.S. “needs to optimize quarantine” and that the biggest risk is from four to seven days and then it drops off after that.

Dr. Carlos del Rio, an Emory University professor of medicine, told CNBC that the move “makes sense” and recommended that people get tested immediately after being exposed to Covid-19, quarantine for at least seven days and then get tested again to ensure they’re negative.

“We’ve been talking to CDC and others about how do we incorporate testing into a way out of quarantine,” he told CNBC’s Meg Tirrell.

White House coronavirus advisor Dr. Anthony Fauci told ABC News’ “Good Morning America” on Wednesday that a two-week quarantine makes people reluctant to get tested for Covid-19 because a positive result could put them out of work.

“They don’t want to say, ‘Well, I’m tested, and now I have to stay out of work, I may lose money, I’m not getting subsidized, and I might even lose my job,'” Fauci said. “So, it might be that the balance — the better part of this equation — would be to encourage people more to get tested so that they’re not out of whatever it is that they need to be, their job, their employment, their source of income. That’s the real reason for it.”

— CNBC’s Kevin Stankiewicz contributed to this report.


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