Tag Archives: Merck & Co

Analysis – COVID-19 pills are coming, but no substitute for vaccines, disease experts say

By Julie Steenhuysen

CHICAGO (Reuters) – Oral antiviral pills from Merck & Co and Pfizer Inc/BioNTech SE have been shown to significantly blunt the worst outcomes of COVID-19 if taken early enough, but doctors warn vaccine hesitant people not to confuse the benefit of the treatments with prevention afforded by vaccines.

While 72% of American adults have gotten a first shot of the vaccine, according to a Kaiser Family Foundation poll, the pace of vaccination has slowed, as political partisanship in the United States divides views on the value and safety of vaccines against the coronavirus.

Vaccine mandates by employers, states and the administration of U.S. President Joe Biden have helped increase vaccinations but also fueled that controversy.

Some disease experts fear the arrival of oral COVID-19 treatments may further impede vaccination campaigns. Preliminary results of a survey of 3,000 U.S. citizens by the City University of New York (CUNY) School of Public Health suggest the drugs could “hamper the effort to get people vaccinated,” said Scott Ratzan, an expert in health communication at CUNY, who led the research.

Ratzan said one out of every eight of those surveyed said they would rather get treated with a pill than be vaccinated. “That is a high number,” Ratzan said.

The concern follows news on Friday from Pfizer, maker of a leading COVID-19 vaccine, that its experimental antiviral pill Paxlovid cut the risk of hospitalization and death from the disease by 89% in high-risk adults.

Pfizer’s results followed news from Merck and partner Ridgeback Biotherapeutics on Oct. 1 that their oral antiviral drug cut hospitalization and death by half. That drug, known as molnupiravir, won conditional approval in the UK on Thursday. Both need clearance from U.S. health regulators but could be on the market in December.

“By relying exclusively on an antiviral drug, it’s a bit of a roll of the dice in terms of how you will do. Clearly, it’s going to be better than nothing, but it’s a high-stakes game to play,” said Dr. Peter Hotez, a vaccine expert and professor of molecular virology and microbiology at Baylor College of Medicine.

Six infectious disease experts interviewed by Reuters were equally enthusiastic about the prospect of effective new treatments for COVID-19 and agreed they were no substitute for vaccines.

Even in the face of the highly transmissible Delta variant of the virus, the vaccines from Pfizer/BioNTech remain effective, cutting the risk of hospitalization by a combined 86.8%, according to a government study of U.S. veterans.

They said some unvaccinated people have already relied on monoclonal antibodies – drugs that need to be delivered through intravenous IV infusions or injections – as a backstop in case they become infected. “I think the Pfizer news is terrific news. It goes hand in hand with vaccination. It doesn’t replace it,” said Dr. Leana Wen, an emergency physician and public health professor at George Washington University and Baltimore’s former health commissioner.

Choosing not to get vaccinated “would be a tragic mistake,” said Albert Bourla, chief executive officer of Pfizer Inc. “These are treatments. This is for the unfortunate who will get sick,” Bourla told Reuters in an interview on Friday. “This should not be a reason not to protect yourself and to put yourself, your household and society in danger.”

ANTIVIRAL CHALLENGES

One main reason not to rely on the new pills, the experts said, is that antiviral medications, which stop the virus from replicating in the body, must be given in a narrow window early in the disease because COVID-19 has different phases.

In the first phase, the virus rapidly replicates in the body. A lot of the worst effects of COVID-19, however, occur in the second phase, arising from a defective immune response that gets triggered by the replicating virus, said Dr. Celine Gounder, an infectious disease expert and the CEO and founder of Just Human Productions, a non-profit multimedia organization.

“Once you develop shortness of breath or other symptoms that would lead you to be hospitalized, you are in that dysfunctional immune phase where the antivirals are really not going to provide much benefit,” she said. Hotez agreed. He said getting treated early enough could be challenging because the window when the virus transitions from the replication phase to the inflammatory phase is fluid. “For some people, that will happen earlier; for some, later,” Hotez said. Hotez said many people in the early phase of the illness feel surprisingly well and may be unaware that their oxygen levels are dropping, one of the first signs that the inflammatory phase of the disease has started. “Oftentimes, you’re not going to realize that you’re getting sick until it’s too late,” he said.

(Reporting by Julie Steenhuysen; Additional reporting by Josephine Mason in London, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; editing by Caroline Humer and Grant McCool)

Merck pill seen as ‘a huge advance’, raises hope of preventing COVID-19 deaths

By Deena Beasley and Carl O’Donnell

(Reuters) -An antiviral pill developed by U.S. drugmaker Merck & Co could half the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, with experts hailing it as a potential breakthrough in how the virus is treated.

If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

Merck and partner Ridgeback Biotherapeutics said they plan to seek U.S. emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.

“An oral antiviral that can impact hospitalization risk to such a degree would be game changing,” said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.

Current treatment options include Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.

“This is going to change the dialogue around how to manage COVID-19,” Merck Chief Executive Robert Davis told Reuters.

Existing treatments are “cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that,” Adalja added.

The results from the Phase III trial, which sent Merck shares up more than 9%, were so strong that the study is being stopped early at the recommendation of outside monitors.

Shares of Atea Pharmaceuticals Inc, which is developing a similar COVID-19 treatment, were up around 20% on the news.

Shares of COVID-19 vaccine makers Pfizer Inc and Moderna Inc were off more than 2% and 14%, respectively.

Michael Yee, a biotechnology analyst at Jefferies, said the share move indicated that investors believe “people will be less afraid of COVID and less inclined to get vaccines if there is a simple pill that can treat COVID.”

Pfizer and Swiss drugmaker Roche Holding AG are also racing to develop an easy-to-administer antiviral pill for COVID-19. For now, only antibody cocktails which have to be given intravenously are approved for non-hospitalized patients.

A planned interim analysis of 775 patients in Merck’s study looked at hospitalizations or deaths. It found that 7.3% of those given molnupiravir were hospitalized and none had died by 29 days after treatment, compared with hospitalization of 14.1% of placebo patients. There were also eight deaths in the placebo group.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said in a statement.

‘WORK WITH ALACRITY’

Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world.

“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID,” said Peter Horby, a professor of emerging infectious diseases at the University of Oxford.

In the trial, which involved patients from around the world, molnupiravir was taken every 12 hours for five days.

The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus including the highly transmissible Delta, which has driven the recent worldwide surge in hospitalizations and deaths.

It said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age in the study could be pregnant and also had to use birth control.

Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more coming next year.

The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.

Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on country income criteria.

Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a Phase III trial for preventing infection in people exposed to the coronavirus.

Merck officials said it is unclear how long the FDA review will take, although Dean Li, head of Merck’s research labs, said, “They are going to try to work with alacrity on this.”

(Reporting by Deena Beasley; Additional reporting by Josephine Mason, Editing by Lincoln Feast, Kirsten Donovan, Alexander Smith and Bill Berkrot)