On Thursday, U.S. health advisers gave the COVID-19 medication Paxlovid another vote of confidence, paving the road for the Food and Drug Administration to give it full regulatory approval.
Since the FDA authorized its emergency usage in late 2021, the medicine has been used by millions of People. The FDA has the final say on whether to approve Pfizer’s medication fully, and a decision is anticipated in May.
Paxlovid is still a safe and effective treatment for high-risk adults with COVID-19 who are more likely to experience hospitalization and mortality due to the virus, according to a 16-1 vote by a panel of outside experts.
Dr. Richard Murphy of the Department of Veterans Affairs states, “We still have numerous categories that stand to gain from Paxlovid, including unvaccinated folks, under-vaccinated persons, the elderly, and the immunocompromised.
According to the FDA, Paxlovid use in high-risk patients might stop 1,500 COVID-19 fatalities and 13,000 hospital admissions each week.
The panel’s decision to approve Paxlovid as a treatment for COVID-19 was widely anticipated, especially since a whole class of antibody medications had to be discontinued as the virus evolved.
The FDA observed that the U.S. reports 35,000 hospital admissions and 4,000 fatalities weekly.
The organization requested its panel of impartial medical experts to address several unanswered issues about Paxlovid, such as who is now benefiting from therapy and whether the medication is involved in incidents of COVID-19 rebound.
The panel concurred with analyses by the FDA and Pfizer that revealed no conclusive connection between the use of Paxlovid and the recurrence of symptoms, but it emphasized the need for more data from studies and data from medical records.
Last year, high-profile cases involving Jill and Joe Biden, the vice president and first lady, brought attention to the problem.
Regardless of whether they had taken Paxlovid or a fake pill, between 10% and 16% of individuals across several Pfizer studies experienced a return of symptoms.
These incidents “likely represent natural COVID-19 development,” the FDA said.
To avoid severe COVID-19, the federal government has purchased more than 20 million doses of Paxlovid and encouraged medical providers to prescribe it aggressively.
Yet, this has raised issues with overprescribing and the possibility that some patients are receiving the medication pointlessly.
Pfizer initially tested Paxlovid on unvaccinated people with other health issues and showed no signs of prior coronavirus infection—the COVID-19 patients with the highest risk.
However, that is not representative of the current U.S. population, where it is believed that 95% of persons have immunity from at least one vaccination, a prior illness, or both.
The FDA examined Pfizer data that demonstrated Paxlovid had no appreciable impact on otherwise healthy persons, regardless of whether they had received a prior vaccination.
Paxlovid continued to demonstrate a significant effect when the FDA teased out data for high-risk persons — independent of their immunization or infection history — lowering the risk of hospitalization or death by 60% to 85%, depending on the specific conditions.
Seniors and people with significant health issues like diabetes, obesity, lung illness, and immune system diseases were among the patients in that group.
The panelists agreed that prescribing Paxlovid will always be a case-by-case choice because of so many variables.
The speakers, including Dr. Sankar Swaminathan of the University of Utah, emphasized the significance of controlling potentially harmful drug interactions between Paxlovid and other widely used drugs.