Pfizer confirms efficacy vs. omicron as a result of COVID pills

Washington-Pfizer said Tuesday that drugs to treat COVID-19 appear to be effective against the Omicron variant.

The company also said that the complete results of a study of 2,250 people confirmed the promising early results of the pill against the virus.

As many experts predicted, another laboratory study showed that the drug retained its potency against the Omicron variant, the company announced. Pfizer tested antiviral drugs against artificial versions of the major proteins that Omicron uses to replicate itself.

The latest information comes from the fact that COVID-19 cases, deaths and hospitalizations have all increased again, with the United States having about 800,000 pandemic deaths. The latest surges caused by delta variants are accelerating due to cold weather and more indoor rallies. health Authorities are preparing for the effects of the newly emerging Omicron mutants.

The Food and Drug Administration will soon decide whether to approve Pfizer’s tablets and Merck’s competing tablets, which were submitted to regulatory authorities a few weeks ago. If permitted, the pill will be the first COVID-19 treatment that Americans can receive at a pharmacy and take at home.

Pfizer’s data may help reassure regulators of the drug’s benefits after Merck discloses lower-than-expected benefits of the drug in final trials. At the end of last month, Merck said the pills reduced hospitalization and mortality in high-risk adults by 30%.

The two companies initially studied the drug in unvaccinated adults who are at significant risk of COVID-19 for the elderly or older. health Problems such as asthma and obesity.

Pfizer is also studying pills in low-risk adults, including vaccinated subsets, and reported mixed data for that group on Tuesday.

In the interim results, Pfizer stated that, as reported by the patient, he failed to achieve the primary research goal of sustained mitigation from COVID-19 during or after treatment for 4 days. However, the drug achieved its second goal by reducing hospitalization for that group by about 70%. healthy Unvaccinated adults and vaccinated adults with one or more health problems. Less than 1% of patients who took the drug were hospitalized, compared to 2.4% of those who took the dummy pill.

An independent medical expert committee reviewed the data and recommended that Pfizer continue its research to obtain complete results before proceeding to regulatory agencies.

In both Pfizer studies, adults taking the company’s medication had a tenth reduction in virus levels compared to adults taking placebo.

The outlook for new pills to fight COVID-19 cannot come fast enough for the northeastern and midwestern communities, where many hospitals are overloaded with re-entering viral cases.

Both Merck and Pfizer tablets are expected to work well against Omicron as they do not target the coronavirus peplomer, which contains most of the new mutant mutations.

Rochelle Warrensky, director of the Centers for Disease Control and Prevention, who starred in NBC’s Today on Tuesday, said the best way for people to protect themselves from COVID-19 is to get vaccinated and get booster shots. Said that. She said that Pfizer tablets, if approved by the FDA, “would be another great tool, but people need to be diagnosed early.”

The US government has agreed to wait for FDA approval to buy enough Pfizer medicine to treat 10 million people and enough Merck medicine to treat 3 million people.

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Follow Matthew Perrone on Twitter: @ AP—FDAwriter

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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.