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The federal government plans to immediately begin distributing a new monoclonal antibody cocktail from Regeneron, the same drug Donald Trump received when he was hospitalized with Covid-19 in October, officials said in a press call.
The two-drug cocktail with the tongue-twisting generic names casirivimad and imdevimab will be used to treat people who are at high risk of being hospitalized with Covid-19, but still have mild to moderate disease.
“We expect to distribute about 30,000 doses of the Regeneron product tomorrow with more to come in the ensuing weeks,” said the US health and human services secretary Alex Azar.
The federal government’s contract with Regeneron currently covers 300,000 doses, which will be distributed to states based on the number of people who test positive and are hospitalized for Covid-19. At such extremely limited quantities, demand will far outstrip supply.
More than 142,000 people were diagnosed with Covid-19 the day before the announcement. More than 12.3 million Americans have now been diagnosed with Covid-19 since the beginning of the pandemic, and more than 257,000 people have died, according to the Johns Hopkins University Coronavirus Resource Center.
The US Food and Drug Administration gave Regeneron emergency permission to distribute its antibody cocktail over the weekend. The emergency use authorization is far short of a formal approval, but will allow doctors another option when treating Covid-19, for which there are still few tailored therapies. However, because of the extremely limited quantities, it will not stop the pandemic on its own.
“Much of the attention, rightfully, has gone to vaccine development,” said Dr Janet Woodcock, director of the FDA’s center for drug evaluation and research. “We also have been working to develop a wide range of therapeutics to try to cover the time before we have the vaccine, as well as those individuals who are not protected by a vaccine.”
Officials said they hoped the antibody cocktail would help high-risk individuals, such as people who are older than 65 or obese, before they need to be hospitalized, and are approved in people older than 12. The drugs were designed off the back of another successful therapy for Ebola virus.
While the drug’s distribution will give some Americans access to the same drug that Trump received, they will not access it in the same dose. Regeneron’s FDA emergency authorization is for a 2.4-gram infusion, where Trump received a higher 8-gram dose.
This may be at least partly because of concerns around manufacturing capacity. Even at full manufacturing Regeneron will only be able to make 2m doses a year.
In October, Regeneron’s chief scientific officer, George Yancopoulos, said if he had only one patient, “I’d give the high dose,” but, “from a societal point of view and the need to treat as many people as possible, I’d give the lower dose,” according to Science Magazine.
In another point of difference from the president’s treatment, Americans will still probably shoulder the administrative costs of receiving the intravenous drug, even though the federal government has paid for the pharmaceutical itself.
Under normal circumstances, monoclonal antibodies are among the most expensive drugs on the market. The family of drugs is often used to treat cancer, and the average price over the last 20 years of drug approvals was more than $96,000. Officials did not immediately respond to questions about the likely cost of those services.
“It’s vital Americans be aware of these expanding options,” said Azar later in a press call. “We are now seeing positive news on the therapeutic and vaccine front nearly every day.”
Azar said the news should also be a reminder for Americans to “double down” on “masks, hand-washing and social distancing”, especially ahead of the upcoming Thanksgiving holiday. “There is light at the end of the tunnel,” he said.
While surveys show a majority of Americans have scaled back holiday plans, a meaningful minority appears to be traveling against health officials’ advice, raising the potential for “a surge superimposed upon a surge,” according to Dr Anthony Fauci, in a separate appearance on Washington Post Live.
Because of surging cases, Azar also urged Americans who have recovered from Covid-19 in the last three months to give convalescent plasma, which is used to treat people with active coronavirus infection.
Source: The Guardian
Keyword: US to distribute Covid-19 antibody cocktail that Trump received | World news