Regeneron Seeks Emergency Use Authorization for Antibody Cocktail
THURSDAY, Oct. 8, 2020 -- Regeneron Pharmaceuticals Inc. said Wednesday that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to President Donald Trump shortly after he was diagnosed with COVID-19.
Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an "unbelievable" effect on his recovery from coronavirus infection, the Washington Post reported.
"I think this was the key," Trump said, after acknowledging that the antibody cocktail was one of several drugs he was prescribed by his medical team. While there is no hard evidence yet proving the drug's effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.
In his video, Trump said, "I have emergency-use authorization all set, and we've got to get it signed now." However, an FDA spokeswoman told The New York Times Wednesday that the agency does not confirm or deny product applications.
Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.
The antibody cocktail is now in late-stage testing. The company has granted fewer than 10 "compassionate use" requests allowing people not enrolled in its trials to use the drug, the Associated Press reported.
The U.S. government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported.
Regeneron isn't the only company developing an antibody cocktail to battle COVID-19 infection: Eli Lilly and Co. announced earlier on Wednesday that it was seeking emergency-use authorization from the FDA for a similar cocktail. Both treatments use lab-made antibodies to give patients' immune systems a boost. In both cases, scaling up production to meet demand is expected to be a major challenge, the Post reported.
White House approves tougher vaccine development rules
Following weeks of delay, the White House on Tuesday approved tough new rules for coronavirus vaccine developers that will make it unlikely that a vaccine will be approved before Election Day.
The approval came only after the U.S. Food and Drug Administration published the updated guidelines on its website as part of briefing materials for outside vaccine advisers, the Post reported.
The standards, which would be applied to an emergency-use authorization for a vaccine, are similar to the standards for a traditional approval. But the White House has worried that the criteria would delay authorization of a vaccine beyond Nov. 3 and sat on the guidance, the Post reported.
The delayed clearance by the White House came only after White House Chief of Staff Mark Meadows demanded detailed justification from the agency about the tougher criteria, the Post reported. The FDA provided the White House with additional data, but nothing happened, according to a senior administration official who spoke on the condition of anonymity, the Post reported.
On Tuesday, the FDA circumvented the White House and published the criteria online as part of a briefing package for a meeting with its vaccine advisory committee that is scheduled for Oct. 22. Shortly after the standards were published, the White House approved the new vaccine guidance, the Post reported.
The guidelines recommend that participants in late-stage vaccine clinical trials be followed for a median of at least two months, starting after they receive a second shot. It is that provision that will almost certainly make it impossible for a vaccine to be authorized before the presidential election.
On Tuesday night, Trump tweeted and proclaimed that, "New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!" The president tagged FDA Commissioner Stephen Hahn at the end of the tweet.
Despite the pressure from Trump, the head of the FDA section that oversees vaccines has repeatedly said in public he would stick to the criteria, the Post reported. He has also said that he has already told vaccine companies what he was looking for to grant an emergency-use authorization.
"The companies know what we're expecting," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said last week, the Post reported. He noted the publication of the guidance was designed to reassure the American public that the FDA would use stringent standards in authorizing a vaccine.
President Trump battles COVID-19
After being treated for COVID-19 at Walter Reed National Military Medical Center over the weekend, Trump on Wednesday returned to working in the Oval Office of the White House as he continues to battle the virus.
Once discharged from the hospital on Monday evening, Trump flew in the Marine One helicopter to the White House lawn. He then climbed the steps to the White House entrance, removed his face mask and gave a thumbs up to reporters.
Public health experts immediately reacted with outrage to the removal of his face mask while he is still contagious.
"I am struggling for words -- this is crazy," Harald Schmidt, an assistant professor of medical ethics and health policy at the University of Pennsylvania in Philadelphia, told the Times. "It is just utterly irresponsible."
Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical School in Tennessee, told the newspaper that the president's decision to remove his mask was "dangerous" because it encourages Americans to ignore social distancing guidelines to keep themselves safe.
"It will lead to more casual behavior, which will lead to more transmission of the virus, which will lead to more illness, and more illness will lead to more deaths," Schaffner said.
Earlier on Monday, Trump's medical team delivered an update on his condition. In addition to remdesivir, Trump was given an experimental antibody cocktail and is taking the steroid dexamethasone, a drug typically used to treat severe COVID-19.
Notably, the president's physician, Dr. Sean Conley, evaded some key questions about the president's condition, including his lung function and the date of his last negative coronavirus test.
Some medical experts said that Trump should be closely watched for at least the first week of his infection, given that some patients can quickly deteriorate several days into their illness, the Times reported.
"I think it would be disastrous to be in a situation where he gets really sick at the White House, and you're having to emergency transfer him," Dr. Celine Gounder, a clinical assistant professor of medicine and infectious diseases at the NYU Grossman School of Medicine, told the Times. "To me, it's not safe."
Gounder also noted that dexamethasone can cause a false sense of euphoria in those who take it. "A lot of people will just feel really great. If you had any aches and pains, they will disappear. If you had a fever, that will disappear," she explained. "People can become somewhat manic, grandiose."
COVID continues to spread around the globe
By Thursday, the U.S. coronavirus case count neared 7.6 million while the death toll passed 211,700, according to a Times tally.
According to the same tally, the top five states in coronavirus cases as of Thursday were: California with over 843,700; Texas with more than 816,000; Florida with over 722,600; New York with over 472,900; and Illinois with more than 311,600.
Curbing the spread of the coronavirus in the rest of the world remains challenging.
By Thursday, India's coronavirus case count passed 6.8 million, just over one month after hitting the 3 million mark, the Times reported.
More than 105,500 coronavirus patients have died in India, according to a Johns Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India's younger and leaner population.
Still, the country's public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.
Meanwhile, Brazil passed 5 million cases and over 148,000 deaths as of Tuesday, the Hopkins tally showed.
Cases are also spiking in Russia: The country's coronavirus case count has passed 1.2 million. As of Thursday, the reported death toll in Russia was over 21,900, the Hopkins tally showed.
Worldwide, the number of reported infections passed 36.2 million on Thursday, with over 1 million deaths, according to the Hopkins tally.
© 2020 HealthDay. All rights reserved.
Posted: October 2020
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