Company also stated that full results from its 2,250-person study showed promising early results: The drug decreased combined hospitalizations by approximately 89% among high risk adults when it was administered shortly after first 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 had expected. Pfizer tested the antiviral medication against a man-made variant of a key protein used by omicron to reproduce.
These updates are coming as COVID-19 deaths, hospitalizations, and cases are all on the rise again, and the U.S. is hovering around 800,000. The delta variant is driving the latest surge. This is despite the fact that there are more indoor gatherings and colder weather, while health officials prepare for the potential impact of the omicron mutant.
Pfizer's and Merck's competing pills will soon be approved by the Food and Drug Administration. The decision was made several weeks ago. If granted, the pills would be the first COVID-19 treatments that Americans could pickup at a pharmacy and take at 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% in high risk adults.
Both companies first studied their drugs in adults who were not yet vaccinated. These individuals are most at risk from COVID-19 due to old age and other health issues such as obesity or asthma.
Pfizer is also evaluating its pill among lower-risk adults, including those who have been vaccinated. However, Pfizer reported mixed results for this 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 second goal, however. It reduced hospitalizations by 70% in that group. This included healthy adults who were not vaccinated and those with one or more medical conditions. Patients who received the drug were hospitalized less than 1%, as compared to 2.4% for patients who took a placebo pill.
A board of independent medical experts reviewed the data, and recommended that Pfizer continue its study to obtain the full results.
In both studies by Pfizer, the virus levels of adults who took the drug showed a 10 fold decrease in their risk of contracting the disease than those who received placebo.
Communities in the Northeast and Midwest need new drugs to combat COVID-19. Many hospitals are being overwhelmed by new cases.
Because they don't target coronavirus spike protein (which contains most of the mutations in the new variant), both Merck and Pfizer pills should be able to fight omicron.
On Tuesday, Centers for Disease Control and Prevention Director Rochelle Wilensky said that the best way to protect yourself against COVID-19 was to get vaccinated and receive a booster shot. The FDA may approve the Pfizer pill. However, it will be a great tool. We need to get people diagnosed early.
In the meantime, FDA approval is required for the U.S. government to purchase enough Pfizer's drug to treat 10,000,000 people and enough Merck's drug treatment to treat 3,000,000.