Pfizer Confirms COVID-19 Pill’s Results, Potency Versus Omicron
WASHINGTON — Pfizer said today that its experimental pill to treat COVID-19 appears effective against the omicron variant.
The company also said full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89% among high-risk adults when taken shortly after initial COVID-19 symptoms.
The company stated that separate laboratory testing showed the drug’s potency against the Omicron variant. This was consistent with what many experts expected. Pfizer tested an antiviral drug against the man-made protein used by the omicron to reproduce.
These updates are coming as COVID-19 deaths, hospitalizations, and cases continue to rise. The U.S. is currently at 800,000. This latest spike, driven by the Delta variant, is increasing due to colder temperatures and more indoor gatherings. Health officials are also bracing for the potential impact of the emerging Omicron mutant.
The Food and Drug Administration is expected to soon rule on whether to authorize Pfizer’s pill and a competing pill from Merck, which was submitted to regulators several weeks earlier. The pills, if approved by the FDA, would become the first COVID-19 treatment that Americans can pick up at their local pharmacy and then take home.
Pfizer’s data could help reassure regulators of its drug’s benefit after Merck disclosed smaller-than-expected benefits for its drug in final testing. Merck announced late last month that the pill had reduced deaths and hospitalizations by 30% among high-risk patients.
The drug companies first studied the drugs on unvaccinated adult patients who are most at risk from COVID-19.
Pfizer is also studying its pill in lower-risk adults—including a subset who are vaccinated—but reported mixed data for that group on Tuesday.
Pfizer reported that its drug did not achieve its primary study goal of providing sustained relief from COVID-19 over four days, or any other treatment. The drug achieved a secondary goal of reducing hospitalizations in that group by 70%. This included healthy adults who were not vaccinated and those with one or more medical conditions. Patients receiving the drug received less than 1% hospitalizations compared to patients who were provided with a dummy.
A board composed of independent medical professionals reviewed the data, and Pfizer was recommended to continue with the research in order to obtain the complete results.
Across both of Pfizer’s studies, adults taking the company’s drug had a 10-fold decrease in virus levels compared with those on placebo.
The prospect of new pills to fight COVID-19 can’t come soon enough for communities in the Northeast and Midwest, where many hospitals are once again being overloaded by incoming virus cases.
Both the Merck and Pfizer pills are expected to perform well against omicron because they don’t target the coronavirus’ spike protein, which contains most of the new variant’s mutations.
Centers for Disease Control and Prevention Director Rochelle Walensky, appearing on NBC’s “Today” on Tuesday, said the best way for people to protect themselves against COVID-19 is to get vaccinated and get a booster shot. She said the Pfizer pill, if authorized by the FDA, “will be another great tool, but we need to diagnose people early.”
The U.S. government has agreed to purchase enough of Pfizer’s drug to treat 10 million people and enough of Merck’s to treat 3 million, pending FDA authorization.