An antiviral pill co-developed by Merck & Co. and Ridgeback Biotherapeutics...

An antiviral pill co-developed by Merck & Co. and Ridgeback Biotherapeutics would be the first pill to treat COVID-19, if approved by the FDA. Credit: TNS/Co.

An experimental pill produced by Merck that treats COVID-19 could have a substantial impact on patients, but the ultimate solution to the pandemic remains mass vaccinations, medical experts on Long Island said Monday.

Merck asked U.S. regulators Monday to authorize its pill for treating COVID-19 in what would add a new and easy-to-use weapon to the world's arsenal against the pandemic.

If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat the illness. All other FDA-backed treatments against COVID-19 require an IV or injection.

An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on U.S. hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It also would bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.

But medical experts said the pill will not slow or stop transmission of the virus, something that only vaccinations can do. Others also expressed worry about the pill’s safety, though overall they said it stands as a positive development.

"I think it’s good. I think any additional help to treat the virus is an advancement," said Dr. David Hirschwerk, an infectious disease specialist with the Northwell health care system.

Hirschwerk added that getting a larger share of the population vaccinated would bring greater benefits. "That remains first and foremost the priority to getting the best control of the pandemic," he said.

Dr. Sharon Nachman, chief of the division of pediatric diseases at Stony Brook Children’s Hospital, said: "When we think about infections, we think about preventing them and we think about treating them. So both categories of medications are critical."

Merck’s drug would not replace the need for people to get vaccinated against COVID-19, she said.

"That’s like saying, ‘Well, when I'm driving my car, I'm not going to wear a seat belt. Because if I get into an accident, the air bag will protect me,’ " she said. "That doesn’t mean you won’t suffer injury and be ill."

She said both the vaccine and medications like Merck’s are critical to controlling the pandemic.

"It's going to be great to have a medication that will cut down on how many days you're sick, but it's not going to make you miraculously better within a minute," she said. "It's still going to take days to get you better. And you will still be out of work for a couple of days and not be able to care for your family and go anywhere and do anything. So we don't want to get you to that point."

Concerns about increasing vaccine hesitancy

Dr. Alan Bulbin, director of infectious diseases at St. Francis Hospital in Roslyn, said the pill would be a major breakthrough in the treatment of people infected with COVID-19, but could also discourage some from getting vaccinated.

"It’s always going to be welcome if we have some better outpatient management strategy with an oral antiviral," he said. "That could be a complete game-changer in terms of keeping people out of even the emergency department, which is essential."

But "it could further add to that vaccine hesitancy," he said. People may think "I would rather just be treated and take my chances than get vaccinated, which I think in the end has a greater public health impact overall."

The FDA will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before rendering a decision.

Merck and its partner, Ridgeback Biotherapeutic, said they specifically asked the agency to grant emergency use for adults with mild to moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs — through an IV or injection — are used.

"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."

The company reported earlier this month that the pill cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.

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.

Still, some 68 million eligible Americans remain unvaccinated, underscoring the need for effective drugs to control future waves of infection.

Bulbin said he has some concerns about the safety of the pill, and wants to see how the FDA rules.

"There may still be some toxicity concerns about the drug because of the class of drug that it is and whether it’s really safe. That has to be vetted further by the FDA," he said.

"My biggest concern is safety with the drug right now," he added.

How the pill might be distributed

If the pill is approved, people would pick it up at their pharmacy like most prescriptions, and take it twice a day for five days, Bulbin added.

The prospect of a 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.

State data released Monday showed the virus continues to circulate on Long Island, with more than 600 new cases reported.

Nassau County registered 265 new cases in test results from Sunday, while Suffolk County logged 349, for a total of 614. New York City had 1,345 new cases.

The seven-day average for positivity in testing for COVID-19 remained below 3%, registering 2.71% on Long Island. It was above 4% for much of the summer, though as low as 0.35% in late June before the delta variant took off.

Across the state, 30 people died on Sunday of causes linked to COVID-19, including three fatalities in Suffolk.

Health authorities nationwide are bracing for another possible surge as cold weather drives more people indoors.

Nachman said vaccinated people who still get COVID-19 and take the medication could recover quicker.

"You’re going to stop shedding as much virus and you are not going to be as contagious," Nachman said. "At the end of the day, both are needed."

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 like fever, cough and stuffy nose.

Three FDA-authorized antibody drugs have proved highly effective at reducing COVID-19 deaths, but they are expensive, hard to produce and require specialty equipment and health professionals to deliver.

Assuming FDA authorization, the U.S. government has agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment. That's less than half the price of the antibody drugs purchased by the U.S. government — over $2,000 per infusion — but still more expensive than many antiviral pills for other conditions.

Merck's Kartsonis said in an interview that the $700 figure does not represent the final price for the medication.

"We set that price before we had any data, so that's just one contract," Kartsonis said. "Obviously we're going to be responsible about this and make this drug as accessible to as many people around the world as we can."

Several other companies, including Pfizer and Roche, are studying similar drugs and are expected to report results in the coming weeks and months. AstraZeneca is also seeking FDA authorization for a long-acting antibody drug intended to provide months of protection for patients who have immune-system disorders and do not adequately respond to vaccination.

With AP

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