Pfizer said Tuesday that its antiviral COVID-19 medication is highly effective at preventing severe illness causing hospitalization or death.
“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,” Pfizer CEO Albert Bourla said.
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A final analysis of clinical trial data found that Pfizer’s antiviral pill regimen was 89% effective at preventing death or severe symptomatic illness requiring hospitalization in adults already at increased risk due to underlying health conditions. The medication works best in those who take it within three days of symptom onset.
The company has already requested emergency use authorization from the Food and Drug Administration. It submitted the application to market the medication last month after interim trial results showed a high rate of efficacy at preventing hospitalization and death. If granted an EUA, the medication would be marketed under the name Paxlovid.
The FDA still has not scheduled a meeting of its panel of vaccine experts, known as VRBPAC, to consider the company’s application.
Pfizer is also continuing analysis of other interim results showing the medication’s efficacy at preventing severe illness in people who are not at high risk. Those interim results showed that the medication regimen, consisting of three antiviral medications taken twice daily for five days, was 70% effective.
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The introduction of an antiviral medication, which decreases the amount of virus in a person, could help stem transmission of the newly discovered omicron variant. The new strain has spread rapidly since its discovery in South Africa in November. Already, it has been detected in at least 19 U.S. states and 57 countries.
Much remains unclear about omicron, particularly how its spread will affect hospitalization rates. The strain is believed to be less virulent than the still-dominant delta variant. Still, a marginal increase in new hospitalizations could place strains on capacity. Most patients currently hospitalized with COVID-19 are unvaccinated, though omicron has proven able to infect people who have been fully vaccinated.
