there’s one more pill to treat COVID-19 that is expected to qualify for federal approval after Pfizer announced Friday that its new antiviral drug is 89% effective in reducing hospitalizations and deaths from the virus in high-risk adults.
Pfizer, the company behind one of three COVID-19 vaccines approved for use in the United States, said the clinical trial for the drug paxlovid will be halted “because of the overwhelming efficacy demonstrated in these results.” The company said it is seeking emergency use approval from the U.S. Food and Drug Administration.
Last month, Merck and Florida-based Ridgeback Biotherapeutics filed a similar request for their drug, molnupiravir, after it reduced the risk of hospitalization or death from COVID-19 by about 50% in adults believed to be likely to progress to serious illness because they are older or have certain medical conditions, such as heart disease.
The United Kingdom was the first country to approve the use of the Merck pill on Thursday.
The pills, the first drug for COVID-19 patients that can be taken orally instead of injected or given intravenously, such as monoclonal antibody treatments, are now in its second year being called a game changer for a pandemic.
But dr. Brandon Webb, an infectious disease physician at Intermountain Healthcare, said that while the new antiviral treatments are “good news,” the pills should not be seen as a substitute for vaccinating against the virus and taking other preventive measures such as wearing a mask .
“Treatments should be seen as a safety net or band-aid for individuals who unfortunately get COVID,” Webb said. “But they are not a solution to the pandemic.”
The doctor said detailed data is yet to come on how safe the pills are to take and how well they are tolerated by patients. The Pfizer line of pills contains a protease inhibitor, part of the “cocktail” drug treatment for HIV patients that has been used for years.
“There will be some really important practical practicalities,” he said. “From the fact that we have treated patients with HIV with protease inhibitors, we know that they are very commonly associated with nausea, vomiting and diarrhea, as well as a number of other drug interactions and other things to watch out for.”
The pills were initially studied in at-risk patients who had not been vaccinated, Webb said, the group likely to see the greatest benefit. Initially, the pills are expected to be approved only for adults at high risk of hospitalization or death from COVID-19, and administered under a doctor’s care, he said.
“Before we crown it a game changer, I think it’s important to recognize that these oral medications may not be for everyone. Not everyone will tolerate them,” Webb said, and some may be taking other medications for medical conditions that can cause problems. cause.
“All drugs have side effects and all drugs have a risk versus benefit profile,” he said, adding that it’s important for people to understand that “at this point, we don’t know that the safety of the pills is better than the safety of the vaccines.” .”
Concerns have been raised about treatments seen as an alternative to vaccination, considered key to stopping the spread of the deadly virus, Webb said. In Florida and other states, people have skipped vaccines and other cheaper methods of preventing COVID-19 in favor of monoclonal antibody treatments that cost $2,100.
“In the current political environment, there is always a concern that the role of treatments for COVID will be misinterpreted as a primary therapy rather than a secondary therapy intended to complement preventive measures and vaccinations,” Webb said.
Only developing immunity to the virus through widespread vaccination can prevent the emergence of new variants — such as the delta variant that has increased cases, hospitalizations and deaths since last summer — and halt the pandemic, the doctor said.
Pfizer Chairman and Chief Executive Officer Albert Bourla praised the pills in a press release because it “has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of 10 hospitalizations.”
Bourla called the news of the clinical trial results “a real game changer in the global effort to halt the devastation of this pandemic.”
A Pfizer director who led the drug’s development, Annaliesa Anderson, said, “The results are beyond our wildest dreams,” the New York Times reported. She said he hopes the new drug can “have a big impact on helping all of our lives return to normal and see the end of the pandemic.”