Pfizer said on Tuesday that its experimental COVID-19 pill appears to be effective against the omicron variant.
The company also said that the full results of its 2,250-person study confirmed the drug’s early promising results against the virus: when the drug is taken shortly after the initial symptoms of COVID-19, the drug will affect the total number of hospitalizations and deaths of high-risk adults. A reduction of about 89%.
The company announced that, as predicted by many experts, separate laboratory tests have shown that the drug retains its efficacy against the omicron variant. Pfizer tested antiviral drugs against a man-made version of a key protein used by omicron to reproduce itself.
As the update is released, the number of COVID-19 cases, deaths, and hospitalizations has risen again, and the pandemic death toll in the United States is hovering around 800,000. Due to colder weather and more indoor gatherings, the latest surge driven by the delta variant is accelerating, even as health officials prepare for the effects of the emerging omicron mutant.
It is expected that the US Food and Drug Administration will soon make a ruling on whether to approve Pfizer’s pills and Merck’s competing pills, which Merck had submitted to the regulatory agency a few weeks ago. If approved, these pills will be the first COVID-19 treatment that Americans can buy at a pharmacy and take home.
After Merck disclosed in the final test that the benefits of its drugs were lower than expected, Pfizer’s data may help reassure regulators about the benefits of its drugs. At the end of last month, Merck stated that its pills have reduced the hospitalization rate and mortality of high-risk adults by 30%.
Both companies initially studied their drugs on unvaccinated adults who are at the most serious risk of COVID-19 due to older age or health problems such as asthma or obesity.
Pfizer is also studying its pills for low-risk adults-including some vaccinated people-but on Tuesday reported mixed data for this population.
In the interim results, Pfizer stated that its drug failed to meet its main research goal: as reported by patients, sustained relief from COVID-19 during or four days after treatment. But the drug did achieve the second goal. The number of hospitalizations in this group was reduced by about 70%, including healthy unvaccinated adults and vaccinated adults with one or more health problems. Less than 1% of patients taking this drug were hospitalized, compared with 2.4% of patients taking fake drugs.
An independent committee of medical experts reviewed the data and recommended that Pfizer continue research to obtain complete results before further cooperation with regulatory agencies.
In two Pfizer studies, adults who took the company’s drug had a 10-fold reduction in virus levels compared to adults who took a placebo.
For communities in the Northeast and Midwest, the prospects for new pills to fight COVID-19 are not fast enough, and many hospitals there are again overloaded with incoming virus cases.
Both Merck and Pfizer’s pills are expected to fight omicron because they do not target the spike protein of the coronavirus, which contains most of the mutations of the new variant.
The US government has agreed to purchase enough Pfizer drugs to treat 10 million people and Merck drugs enough to treat 3 million people, pending FDA authorization.