Pfizer announced that its experimental treatment for Covid-19 reduces the risk of hospitalization or death by 89% if given to high-risk adults within a few days of their first symptoms.
The company plans to sell the pills under the name Paxlovid for people to take at home before they get sick enough to go to a hospital. The company combined an antiviral drug called nirmatrelvir and ritonavir, which is already on the market.
One month after follow-up, the study found 5 hospitalizations and no deaths among 697 people who received the drug within three days of symptoms. Among 682 who received placebo, 44 were hospitalized, including 9 who died. All of the adults in this study were unvaccinated.
If given within the first five days of symptoms, the efficacy was similar: 88%. These results hold up against a similar announcement from the company last month, when not all the data had come in yet.
The research also showed “an approximately 10-fold decrease in viral load at day 5, relative to placebo,” the statement said.
“This underscores the treatment candidate’s potential to save the lives of patients around the world, whether they have been vaccinated or not,” Pfizer CEO Dr. Albert Bourla said in a statement Tuesday. “Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”
The company says the drug will be able to stop the variant from replicating because it blocks an enzyme that is involved in viral replication. This is different from the spike protein on Omicron’s surface, whose numerous mutations have escalated global concern about the virus.
Pfizer has shared this latest data with the FDA as part of its ongoing application for emergency use authorization. “Full study data are expected to be released later this month and submitted to a peer-reviewed publication,” Pfizer’s statement added. No date has been set by the FDA advisory committee expected to weigh in on the treatment.
Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said on Tuesday that the treatment could be “another great tool in our toolbox,” but emphasized that getting vaccinated and boosted was still the best protection against Covid-19.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that it was “potentially a lifesaver” for both vaccinated and unvaccinated people “because as we know, even vaccinated people who are at a higher risk group, the elderly or those with underlying conditions, can have serious disease leading to hospitalization.”
Remdesivir, sold under the brand name Veklury, is the only antiviral approved by the FDA for treatment of Covid-19. It’s given intravenously, not as a pill that can be taken at home.