Pfizer’s COVID-19 pill, Paxlovid, has received another vote of confidence from U.S. health advisers, paving the way for its full regulatory approval by the Food and Drug Administration (FDA). Since receiving emergency use authorization in late 2021, millions of Americans have benefited from this medication. The FDA holds the final decision on granting Pfizer’s drug full approval, and a decision is expected in May.
A panel of external experts voted 16-1 in favor of Paxlovid, affirming its safety and efficacy as a treatment for high-risk adults with COVID-19 who are susceptible to hospitalization and death. Dr. Richard Murphy of the Department of Veterans Affairs emphasized that there are still many groups, such as unvaccinated individuals, those who are under-vaccinated, the elderly, and the immuno-compromised, who can benefit from Paxlovid.
Using Paxlovid in high-risk patients could potentially prevent 1,500 COVID-19 deaths and 13,000 hospitalizations per week, according to the FDA. The positive vote from the panel was expected as Paxlovid has become a go-to treatment for COVID-19, especially since certain antibody drugs have become less effective due to the mutating virus.
The U.S. continues to report approximately 4,000 deaths and 35,000 hospitalizations weekly, highlighting the urgent need for effective treatments. The FDA asked an independent panel of medical experts to address remaining questions concerning Paxlovid. These questions included which individuals currently benefit from treatment and whether the drug contributes to cases of COVID-19 rebound.
The panel agreed with the assessment by both the FDA and Pfizer that there is no clear link between Paxlovid and returning symptoms. However, they believe that more information is required from studies and medical records to fully understand this issue. Notable cases from last year, involving President Joe Biden and first lady Jill Biden, drew attention to this potential concern.
Some studies conducted by Pfizer revealed that regardless of whether patients received Paxlovid or a placebo, between 10% and 16% experienced a return of symptoms. This suggests that these cases are likely part of the natural progression of COVID-19, as determined by the FDA.
The federal government has purchased over 20 million doses of Paxlovid and is encouraging healthcare professionals to prescribe it aggressively to prevent severe COVID-19 cases. However, concerns have arisen regarding overprescribing and whether some patients are unnecessarily receiving the drug.
Initially, Pfizer studied Paxlovid in the highest-risk COVID-19 patients, including unvaccinated adults with underlying health conditions and no evidence of prior infection. However, this demographic does not accurately represent the current U.S. population, where an estimated 95% of individuals have protection from at least one vaccine dose, prior infection, or both.
The FDA’s review of Pfizer’s data showed no significant difference in otherwise healthy adults, regardless of their vaccination or infection history. However, when specifically analyzing high-risk adults, Paxlovid demonstrated a significant benefit by reducing the chances of hospitalization or death by 60% to 85%, depending on each individual’s circumstances. This group included seniors and individuals with underlying health issues like diabetes, obesity, lung disease, and immune-system disorders.
Given the numerous factors at play, panelists emphasized that prescribing Paxlovid should be a case-by-case decision. Managing potentially dangerous drug interactions between Paxlovid and other commonly used medications was highlighted as an important consideration by Dr. Sankar Swaminathan of the University of Utah and other panelists.
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