Merck said Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat covid-19.
An approval for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with covid than the cumbersome antibody treatments currently being used.
The Biden administration is preparing for an authorization that could come within weeks. If approved, the pill is likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors' practices, senior administration officials said.
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If the pill wins authorization, tens of millions of Americans will most likely be eligible to take it if they get sick with covid-19 -- many more than the supply could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $700 per patient. That is about one-third the price that the government is paying for the monoclonal antibody treatments, which are generally given via intravenous infusion.
Merck, which is developing the pill with Ridgeback Biotherapeutics of Miami, expects to be able to produce enough pills for 10 million people by the end of this year. Governments have raced to lock up supplies since the strong clinical trial results were released this month; Australia, Malaysia, Singapore and South Korea have all announced agreements.
"The value here is that it's a pill, so you don't have to deal with the infusion centers and all the factors around that," said Dr. Nicholas Kartsonis, a senior vice president with Merck's infectious disease unit. "I think it's a very powerful tool to add to the toolbox."
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An antiviral pill being developed by Pfizer and one from Atea Pharmaceuticals-Roche will report study results in the next months and, if effective, could expand the overall supply.
Merck's pill is meant to be taken at home as four capsules twice a day for five days, for a total of 40 pills. It halved hospitalizations and deaths in a clinical trial that enrolled unvaccinated adults who had begun showing covid symptoms within the previous five days and were at high risk for bad outcomes from the disease.
Merck said it was seeking authorization for its pill to be given only to high-risk adults, which in the clinical trial was most commonly people older than 60 or younger people with obesity, diabetes or heart disease.
It was not clear whether the treatment would be available to vaccinated people, who were not eligible for the clinical trial. A company spokeswoman said that would be up to the FDA.
Side effects were similar between patients who got the drug and those in a testing group who received a dummy pill. But Merck has not publicly detailed the types of problems reported, which will be a key part of the FDA's review.
Top U.S. health officials continue to push vaccinations as the best way to protect against covid-19.
"It's much, much better to prevent yourself from getting infected than to have to treat an infection," Dr. Anthony Fauci said while discussing Merck's drug last week.
Still, some 68 million eligible Americans remain unvaccinated, underscoring the need for effective drugs to control future waves of infection.
The prospect of a covid-19 pill comes amid other encouraging signs: New cases per day in the U.S. have dropped below 100,000 on average for the first time in more than two months, and deaths are running at about 1,700 a day, down from more than 2,000 three weeks ago.
Also, the average number of vaccinations dispensed per day has climbed past 1 million, an increase of more than 50% over the past two weeks, driven by the introduction of booster shots and workplace vaccine requirements.
Still, heath authorities are bracing for another possible surge as cold weather drives more people indoors.
Since the beginning of the pandemic, health experts have stressed the need for a convenient pill. The goal is for something similar to Tamiflu, the 20-year-old flu medication that shortens the illness by a day or two and blunts the severity of symptoms such as fever, cough and stuffy nose.
Originally tested for influenza, Merck's drug works by stopping the coronavirus from replicating by inserting errors into its genetic code.
That mechanism is likely to make one high-risk group, people who are pregnant, ineligible to receive the pills if they are authorized, because of fears that the drug might cause mutations that could result in birth defects. In the clinical trial, volunteers had to agree to abstain from unprotected sexual intercourse for four days after they finished taking the pills, and some women of childbearing age had to have a negative pregnancy test to enroll in the study.
FORMULA GUARDED
Moderna, meanwhile, said Monday that it has no plans to share the recipe for its covid-19 vaccine because executives have concluded that scaling up the company's own production is the best way to increase the global supply.
In an interview, Noubar Afeyan, the company's chairman, also reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic.
"We didn't have to do that," Afeyan said. "We think that was the right, responsible thing to do." He added: "We want that to be helping the world."
The United Nations health agency has pressed Moderna to share its vaccine formula. Afeyan said the company analyzed whether it would be better to share the messenger RNA technology and determined that it could expand production and deliver billions of additional doses in 2022.
"Within the next six to nine months, the most reliable way to make high-quality vaccines and in an efficient way is going to be if we make them," Afeyan said. Asked about appeals from the World Health Organization and others, he contended that such pleas assumed "that we couldn't get enough capacity, but in fact we know we can."
Moderna "went from having zero production to having 1 billion doses in less than a year," Afeyan said, referring to the Massachusetts-based company's sprint to develop the vaccine and produce it in large quantities. "And we think we will be able to go from 1 to 3 billion" next year.
"We think we are doing everything we can to help this pandemic," Afeyan added, citing the company's increasing output and its pledge on patent infringement.
He noted that $2.5 billion and 10 years were spent to develop the platform that makes Moderna's vaccine.
"Others joined the hunt when covid-19 came along, and we're glad to see that the capacity therefore has been increased considerably beyond what Moderna would have been able to do" by itself, Afeyan said.
Asked how successful he thought others might be if they started from scratch using Moderna patents, he declined to speculate. But "it's hard for me to imagine that they would be able to get any meaningful scale in a short time frame at the quality we would be able to do as a certainty" for 2022.
Asked about recent criticism that Moderna has been furnishing its vaccine mainly to wealthy countries while low-income countries clamor for the product, Afeyan said the company supplied a "quite significant" output to poorer nations, mostly through its work with the U.S. government, which contracted with the company early in the pandemic.
Moderna is working with multiple governments "to help them secure supplies for the express purpose of supplying to low-income countries," he said.
"There is more supply in the EU and the U.S. government than they will be able to use," said Afeyan, who is also a co-founder of Moderna.
BOOSTERS ENDORSED
Meanwhile, an advisory committee recommended Monday that severely or moderately immunocompromised people who have been vaccinated should be offered an additional dose of the seven coronavirus vaccines that the World Health Organization has authorized,
People whose immune systems are diminished should get another shot if they initially received vaccines made by Pfizer-BioNTech, Moderna, AstraZeneca, the Serum Institute of India, Johnson & Johnson, Sinopharm or Sinovac, members of the Strategic Advisory Group of Experts on Immunization told reporters on a call.
Dr. Alejandro Cravioto, the committee's chairman, said people with compromised immune systems "need a third dose as an additional priming process so that they're fully protected."
The officials also recommended a third vaccine dose for people 60 and older who were inoculated with China's Sinopharm and Sinovac vaccines, ideally of the same brand as their first course of treatment.
WHO officials have previously said they supported additional doses for immunocompromised people who were not sufficiently protected from a standard vaccination regimen, and some countries, including the United States, already administer them.
Separately, Texas Gov. Greg Abbott issued an executive order Monday to prohibit any entity, including private businesses, from enforcing a covid-19 vaccine mandate on workers and called on state lawmakers to pass a similar ban into law.
The move comes as the Biden administration is set to issue rules requiring employers with more than 100 workers to be vaccinated or test weekly for the coronavirus. Several major companies, including Texas-based American Airlines and Southwest Airlines, have said they would abide by the federal mandate.
"No entity in Texas can compel receipt of a covid-19 vaccine by any individual, including an employee or a consumer, who objects to such vaccination for any reason of personal conscience, based on a religious belief, or for medical reasons, including prior recovery from covid-19," Abbott wrote in his order.
Abbott, who was vaccinated but later tested positive for covid-19, noted in his order that "vaccines are strongly encouraged for those eligible to receive one, but must always be voluntary for Texans."
Abbott previously barred vaccine mandates by state and local government agencies, but until now had let private companies make their own rules for their workers. It was not immediately clear if Abbott's latest executive order would face a quick court challenge.
Information for this article was contributed by Rebecca Robbins and Daniel E. Slotnik of The New York Times; and by Matthew Perrone, Jim Vertuno and Frances D'Emilio of The Associated Press.