WASHINGTON (AP) — Drugmaker Merck asked U.S. regulators Monday to authorize its pill against COVID-19 in what would add an entirely 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 COVID-19. All other FDA-backed treatments against the disease 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 would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
Keep scrolling for a closer look at who's eligible for Pfizer booster shots
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 are used.
People are also reading…
"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.
U.S. officials continue to push vaccinations as the best way to protect against COVID-19. But with some 68 million eligible Americans still unwilling to get the shots, effective drugs will be critical to controlling future waves of infection.
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."
Kenilworth, New Jersey-based Merck has said it is in purchase talks with governments around the world and will use a sliding price scale based on each country's economic means. Also, the company has signed licensing deals with several Indian generic drugmakers to produce low-cost versions of the drug for lower-income countries.
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.
Eventually some experts predict various COVID-19 therapies will be prescribed in combination to better protect against the worst effects of the virus.
Here's who is eligible for Pfizer booster shots in the US. An explainer.
Who should get the Pfizer booster?
Who else can consider getting it?
What are the side effects?
Weren't some people already eligible for a third dose?
What if I got Moderna? Can I get a Pfizer booster?
What if I got J&J?
Where can I get my booster?
Are boosters free?
Am I 'fully vaccinated' without a booster?
Why were boosters so hotly debated?
Are other countries offering boosters?
US booster shots start, even as millions remain unprotected
The U.S. launched a campaign to offer boosters of Pfizer's COVID-19 vaccine to millions of Americans on Friday even as federal health officials stressed the real problem remains getting first shots to the unvaccinated.
“We will not boost our way out of this pandemic,” warned Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention — even though she took the rare step of overruling the advice of her own expert panel to make more people eligible for the booster.
The vast majority of COVID-19 cases and hospitalizations are among the unvaccinated, Walensky noted. And all three COVID-19 vaccines in the U.S. offer strong protection against severe illness, hospitalization and death despite the extra-contagious delta variant that caused cases to soar. But immunity against milder infection appears to wane months after initial vaccination.
People anxious for another Pfizer dose lost no time rolling up their sleeves after Walensky ruled late Thursday on who's eligible: Americans 65 and older and others vulnerable because of underlying health problems or where they work and live — once they're six months past their last dose.
Jen Peck, 52, of Eau Claire, Wisconsin, qualified because of her job as an education math and science consultant. She was vaccinated back in March but worries about unknowingly picking up and spreading an infection. She travels between rural schools where many students and teachers don't wear masks and the younger children can't yet be vaccinated.
“I don’t want to be COVID Mary carrying it around to buildings full of unvaccinated kiddos. I could not live with myself if I carried it from one building to another. That haunts me, the thought of that,” said Peck, who got the extra shot first thing Friday morning.
Health officials must clear up confusion over who should get a booster, and why. For now, the booster campaign is what Walensky called “a first step.” It only applies to people originally vaccinated with shots made by Pfizer and its partner BioNTech. Decisions on boosters for Americans who received Moderna or Johnson & Johnson vaccines are still to come.
President Joe Biden said if you're vaccinated, “You’re in good shape and we’re doing everything we can to keep it that way, which is where the booster comes in.” He urged those now eligible for an extra shot to “go get the booster," saying he'd get his own soon — and that everyone should be patient and wait their turn.
Exactly who should get a booster was a contentious decision as CDC advisers spent two days poring over the evidence. Walensky endorsed most of their choices: People 65 and older, nursing home residents and those ages 50 to 64 who have chronic health problems such as diabetes should be offered one once they're six months past their last Pfizer dose. Those 18 and older with health problems can decide for themselves if they want a booster.
But in an extremely unusual move, Walensky overruled her advisers' objections and decided an additional broad swath of the population also qualifies: People at increased risk of infection — not serious illness — because of their jobs or their living conditions. That includes health care workers, teachers and people in jails or homeless shelters.
“This was scientific close call,” Walensky said Friday. “In that situation it was my call to make.”
Experts say it was only the second time since 2000 that a CDC director overruled its advisory panel.
Health care workers can't come to work if they have even a mild infection and hospitals worried about staffing shortages welcomed that decision.
But some of the CDC's advisers worry that offering boosters so broadly could backfire without better evidence that it really will make a difference beyond the most medically vulnerable.
“My hope is that all of this confusion – or what may feel like confusion – doesn’t send a message to the public that there is any problem with the vaccine,” said Dr. Beth Bell, a University of Washington expert. "I want to make sure people understand these are fantastic vaccines and they work extremely well.”
Dr. Anthony Fauci, the U.S. government’s top infectious disease specialist, cautioned against seeking a Pfizer booster before the recommended six-month mark.
“You get much more of a bang out of the shot” by letting the immune system mature that long so it’s prepared to rev up production of virus-fighting antibodies, he explained.
The U.S. had already authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, such as cancer patients and transplant recipients. Other Americans, healthy or not, have managed to get boosters, in some cases simply by asking.
About 182 million Americans are fully vaccinated, or just 55% of the total population. Three-quarters of those 12 and older — the ages eligible for vaccination — have had a first dose.
Associated Press writers Jonathan Lemire in New York, Zeke Miller in Washington and Todd Richmond in Madison, Wisconsin contributed reporting.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.