Two new pills created to treat COVID-19 face future FDA approval

Two pharmaceutical companies — Merck and Pfizer — have created pills claimed to effectively treat COVID-19 symptoms in adults. Graphic by HARRY LADA, Art Director

Two pharmaceutical companies have come forward with a pill to treat COVID-19. Merck & Co. and Pfizer-BioNTech have both announced their pills are effective in reducing the virus’ symptoms.

Merck, partnered with Ridgeback Biotherapeutics, announced Oct. 11 an Emergency Use Authorization to the Food and Drug Administration (FDA) for molnupiravir, the oral antiviral medication. An FDA advisory committee is set to discuss the use of the drug Nov. 30 for treating adults who have tested positive for COVID-19.

"The FDA is evaluating the safety and effectiveness of data submitted by Merck and Ridgeback in their emergency use authorization request for molnupiravir,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in an Oct. 14 statement. “We believe that, in this instance, a public discussion of this data with the agency’s advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating.”

The Medicines and Healthcare products Regulatory Agency in the U.K. approved use of molnupiravir Nov. 4 for patients with mild to moderate COVID-19, and the U.S. is already set to buy $1 billion worth of the pill in addition to the $1.2 billion already purchased in June.

In the clinical trials, molnupiravir reduced the risk of hospitalization or death from COVID-19 by approximately 50%. 7.3% of patients who received molnupiravir were either hospitalized or died from the virus through day 29 of the study, compared with 14.1% of placebo-treated patients. After day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received a placebo.

In the study, researchers tested the medication on unvaccinated adults who had tested positive for COVID-19 but had not been hospitalized. The 762 participants were randomly assigned to take either molnupiravir or a placebo.

The study was conducted globally in more than 170 planned cites in various countries. The study has not yet been peer-reviewed.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert M. Davis, chief executive officer and president of Merck & Co., said in an Oct. 11 statement.

Molnupiravir was originally created to treat the flu and works by disrupting the virus' reproduction when taken orally. If molnupiravir is approved by the FDA for emergency use, tens of millions of Americans will most likely be eligible to receive the drug if they contract COVID-19.

Pfizer also announced Nov. 5 its pill to treat COVID-19 has been found highly effective in clinical trials — even more than molnupiravir. 

The pill, called paxlovid, cut the risk of hospitalization or death from COVID-19 by 89% when given to patients within three days after the start of symptoms. This study was also conducted with 774 non-hospitalized adult patients who had contracted COVID-19. Participants were randomly assigned to receive paxlovid or a placebo.

The trial analysis showed 0.8% of patients who received paxlovid were hospitalized through day 28 of the study, compared to 7.0% of patients who received placebo and were hospitalized or died.

“These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections and eliminate up to nine out of 10 hospitalizations,” Albert Bourla, chairman and chief executive officer at Pfizer, said in a Nov. 5 statement. “Given the continued global impact of COVID-19, we have remained laser-focused on science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”

According to the statement, Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization as soon as possible.

This is a developing story. Follow The Panther on social media and at www.thepanthernewspaper.org for updates.

UPDATE: Nov. 19, 10:27 p.m. PT

Pfizer submitted paxlovid to the FDA for emergency approval Nov. 16. 

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world,” Bourla said in a Nov. 16 statement.

Gary Fong, infectious disease expert and professor in Chapman University’s School of Pharmacy, described how paxlovid and molnupiravir can make a difference in the world, especially in countries with low vaccination rates or underprivileged populations that are disproportionately affected by COVID-19.

Fong said most COVID-19 treatments — besides vaccination — are reserved for hospitalized or very sick patients. Monoclonal antibodies can be given to unhospitzalied adults who test positive for COVID-19, but the resource is typically expensive and difficult to access.

“People who are getting (monoclonal antibodies) typically are well-plugged into their healthcare systems or providers; they have good relationships and they know where to go,” Fong said. “People of color (and) underserved patients, they aren't the ones who have great healthcare and are constantly plugged in. Even if they are eligible, chances are they don't even know how to get there.”

Fong said the pills, if effective, create the opportunity to make a difference and create an easy-to-access treatment for hospitalized adults. The pills work by controlling viral replication, decreasing how much the virus replicates itself, while other treatments — like vaccines — focus on boosting someone’s immune system, Fong said.

Regarding vaccines and booster shots, some immunocompromised individuals may have to receive a fourth vaccine dose because their natural immune system is too weak to fight COVID-19 even after multiple doses.

“There are going to be some people that are so immunocompromised that even a third dose isn't going to protect them,” Sanghyuk Shin, an epidemiologist from the University of California, Irvine, said in an Oct. 28 interview with The Panther. “There are some people who have not been responsive to vaccines, because vaccines boost your natural immunity. If your natural immune system is depleted and not fully functioning, you may not respond to vaccines, regardless of how many doses you get.”

Fong said these pills could give people who don’t respond well to vaccines another option.

However, Fong emphasized vaccination is the most important and effective method in treating and preventing COVID-19.

“I wouldn’t want people to think there’s a miracle drug out there, and now they can skip vaccination,” Fong said. “Vaccines are still the best bet.”