(CN) — An experimental pill developed by Pfizer could save the lives of those battling the harshest bouts with Covid-19.
In treating those already infected with the coronavirus, Pfizer’s pill prevented 89% of hospitalizations and deaths, the drug company announced on Friday.
“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, Pfizer’s chairman and chief executive officer.
“Given the continued global impact of Covid-19, we have remained laser-focused on the science and fulfilling our responsibility to help health care systems and institutions around the world while ensuring equitable and broad access to people everywhere.”
Pfizer tested its drug candidate on 775 adults infected with Covid-19 who were at risk of serious illness due to conditions including diabetes, heart disease and obesity. Participants were given either a Pfizer pill or a placebo within three to five days of showing symptoms.
No one in the treatment group died, and fewer than 1% were hospitalized. In the control group, which received a placebo pill, 7% of participants were hospitalized and seven people died. Earlier treatment yielded better recovery results, according to the results, which are not yet published for external review.
Pfizer said it decided to halt its clinical trials and submit its data to the U.S. Food and Drug Administration “as soon as possible” after an independent expert panel recommended doing so, based on the strength of the study results. The FDA’s approval could take weeks to months.
After that, the United States is primed to have millions of doses of the pill in hand, President Joe Biden said following the announcement.
"If authorized by the FDA we may soon have pills that treat the virus in those who become infected," he said. "We've already secured millions of doses. The therapy would be another tool in our toolbox to protect people from the worst outcomes of Covid."
At a White House press briefing on Friday, Principal Deputy Press Secretary Karine Jean-Pierre said Pfizer’s report showed “incredible, promising data for its antiviral pill that treats Covid.”
“This is all subject to pending regulatory reviews,” Jean-Pierre said, “but our understanding is that this is an incredibly promising possible tool in our fight against the virus.”
Importantly, however, Jean-Pierre said, vaccination is still paramount in preventing the pandemic’s persistence.
“We don’t want anyone to get Covid in the first place,” she said.
Existing therapies for Covid-19 include monoclonal antibody treatments that have to be administered intravenously and an antiviral treatment, remdesivir, which is given via injection.
Pfizer will be the second drug company to ask the FDA to approve a Covid-fighting pill. The pharmaceutical giant Merck submitted its data to the FDA in October, showing a 50% reduction in hospitalization and deaths, compared with Pfizer’s nearly 90% reduction.
The FDA will meet to discuss emergency authorization of Merck’s pill at the end of November. The United Kingdom approved use of the pill on Thursday.
Dr. John Mellors, chief of infectious diseases at the University of Pittsburgh, said the two potential pill treatments still need to be compared against each other.
"It's too early to say who won the hundred meter dash," Mellors told AP. "There's a big difference between 50% and 90%, but we need to make sure the populations were comparable."
Still, he said, having an oral treatment for Covid-19 would be an important advance.
"If someone developed symptoms and tested positive we could call in a prescription to the local pharmacy as we do for many, many infectious diseases," Mellors said.
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