Pfizer announced Tuesday that clinical trials revealed that its COVID-19 pill significantly decreased hospitalizations and deaths in high-risk individuals by nearly 90%.
According to Pfizer, recent laboratory findings indicate that the medicine - a novel form of treatment that should be resistant to alterations associated with the Omicron variant - retains its efficacy against the rapidly expanding coronavirus strain.
The statement, which was lauded by U.S. President Joe Biden, came as a real-world research conducted in South Africa revealed that two doses of the Pfizer-BioNTech vaccine were 70% effective at preventing serious sickness caused by the virus.
Two antiviral medications, one from Merck and one from Pfizer, are currently undergoing regulatory review - and further safe and effective therapeutic alternatives cannot come soon enough. Both pills' data have not been peer evaluated or published.
In the United Kingdom, Merck's molnupiravir has previously been approved. Two weeks ago, a U.S. panel of experts narrowly voted in favor of the Merck pill, but approval by the U.S. Food and Drug Administration is still pending.
Oral antiviral therapies are urgently needed in light of an increase in delta variant infections and the yet-to-be-identified threat posed by the omicron variation.
Based on recent laboratory tests, the omicron type that is rapidly gaining ground in South Africa and Europe will likely avoid - or substantially decrease - many versions of the primary treatments physicians have, known as monoclonal antibodies. Antiviral tablets may contribute to the restocking of the therapy toolkit with fresh possibilities.
The novel antiviral was developed using data from over 2,200 people and is backed up by preliminary findings announced in November.
"I am heartened by Pfizer's announcement today that their antiviral medication is effective at lowering the risk of serious disease in people infected with COVID-19," Biden stated.
"This is an extraordinary result," Pfizer Chief Scientific Officer Mikael Dolsten said in an interview.
The United States has placed an order for 10 million courses of the medication ahead of a possible FDA approval this month, according to Pfizer Chief Executive Officer Albert Bourla.
The Pfizer pills are combined with the older antiviral ritonavir and are administered every 12 hours for five days, beginning shortly after symptoms begin. If approved, the medicine will be marketed under the brand name Paxlovid.
Additionally, Pfizer revealed preliminary findings from a second study indicating that the medication decreased hospitalizations by almost 70% in a smaller trial of standard-risk adults, which included some higher-risk vaccinated individuals.
Meanwhile, the World Health Organization reported that the omicron form is "most likely" present in the majority of countries today.
