Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from U.S health advisers Thursday, clearing the way for its full regulatory approval by the Food and Drug Administration.
Paxlovid was found to be a safe and effective treatment for COVID-19 high-risk individuals (16-1 vote), who are more likely to experience hospitalization and death as a result of the virus.
Dr Richard Murphy of the Department of Veterans Affairs stated that there are still numerous populations that could benefit from Paxlovid, including those who are immunosuppressed, elderly, unvaccinated, or under-vaccinated.
Using Paxlovid in high-risk patients, according to the FDA, might avert 1,500 COVID-19 fatalities and 13,000 hospital admissions per week.
Millions of Americans have been taking the medicine since the FDA authorized it for emergency use in late 2021. The agency will decide by the end of May whether to fully approve Pfizer’s medication.
The panel’s decision to approve Paxlovid as a treatment for COVID-19 was widely anticipated, especially in light of the fact that the virus changed, rendering an entire class of antibody medicines ineffective.
According to the FDA, the United States continues to report 35,000 hospital admissions and 4,000 fatalities each week.
To assist 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 over prescribing and the possibility that some patients are receiving the medication pointlessly.
Paxlovid was initially tested by Pfizer on people who were unvaccinated, had 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, however, 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 hospitalisation or death by 60% to 85%, depending on the specific conditions. Seniors and people with major health issues like diabetes, obesity, lung illness, and immune system diseases were among the patients in that group.
The panelists agreed that because there are so many variables, prescribing Paxlovid will always be a case-by-case choice.
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.