Pfizer’s COVID pill reportedly offered no measurable benefit for adults 40 to 65, according to a study published on Wednesday.
The Israeli study was conducted among 109,000 patients who were 40 years old or older.
“Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not,” the study published in the New England Journal of Medicine concluded. “No evidence of benefit was found in younger adults.”
The research affirmed the benefits of Paxlovid among certain older adults but showed little difference among middle-aged adults who received the treatment.
The conclusion was based on the results of the study that found the rate of hospitalization due to COVID for 40-64-year olds was “15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients.”
Under an emergency use authorization order, the U.S. Food and Drug Administration authorized the use of Paxlovid to treat the coronavirus in December for adults and children 12 and older who are considered at high risk due to conditions like obesity, diabetes, and heart disease.
The FDA’s decision was based on a Pfizer study of patients who were unvaccinated or untreated for prior coronavirus infection.
The Associated Press reported that 3.9 million prescriptions for the drug have been filled since it was authorized late last year. The treatment includes three pills taken twice daily for five days.
Pfizer CEO Albert Bourla noted that he was personally using Paxlovid after testing positive for the coronavirus earlier this month. President Joe Biden also reportedly used Paxlovid after he tested positive for COVID.
Biden tested negative days later but then quickly tested positive again in a “rebound” case. First Lady Jill Biden shared a similar rebound positive test on Wednesday.
“After testing negative on Tuesday, just now, the first lady has tested positive for COVID-19 by antigen testing. This represents a ‘rebound’ positivity,’” the first lady’s deputy communications director, Kelsey Donohue, said in a statement.
“The first lady has experienced no reemergence of symptoms, and will remain in Delaware where she has reinitiated isolation procedures. The White House Medical Unit has conducted contact tracing and close contacts have been notified,” she added.
In addition to Paxlovid, Pfizer and BioNTech requested on Monday that the FDA grant an emergency use authorization for its COVID vaccine adapted to the BA.4/BA.5 versions of the Omicron variant.
The new booster dose is intended for individuals 12 years of age and older and would be available to ship immediately, according to a news release from the company.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Bourla said. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.”