Paxlovid COVID Pill Moves Closer To Full US FDA Approval


Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from US health advisers on Thursday, clearing the way for full regulatory approval by the Food and Drug Administration.

The drug has been used by millions of Americans since the FDA granted emergency use authorization for the drug in late 2021. The agency has the final say on the full authorization of Pfizer’s drug and is expected to decided in May.

A panel of outside experts voted 16-1 that Paxlovid remains a safe and effective treatment for adults at high risk for COVID-19, who are more likely to hospitalized and died from the virus.

“We still have many groups that benefit from Paxlovid, including the unvaccinated, the unvaccinated, the elderly and the immunocompromised,” said Dr Richard Murphy of the Department of Veterans Affairs. pandemic.

The FDA says using Paxlovid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospital admissions per week.

The panel’s positive vote was expected by many, as Paxlovid is a treatment against COVID-19, especially since the entire class of antibody drugs has been dropped as the virus mutates.

The United States continues to report about 4,000 deaths and 35,000 hospitalizations weekly, the FDA noted.

The agency asked a panel of independent medical experts to address a number of outstanding questions regarding Paxlovid, including who is currently being treated and whether the drug plays a role. in cases of COVID-19 resurgence.

The panel agreed with assessments by both the FDA and Pfizer that found no clear link between Paxlovid use and return of symptoms, but said more information was needed from the studies and data. medical records. Famous cases that drew attention to the issue last year include President Joe Biden and first lady Jill Biden.

Between 10% and 16% of patients in many of the Pfizer studies had symptoms return, regardless of whether they took Paxlovid or a dummy pill. The FDA concluded such cases “likely reflect the natural progression of COVID-19”.

The federal government has purchased more than 20 million doses of Paxlovid and is encouraging health professionals to actively prescribe it to help prevent severe COVID-19. But that has led to concerns about overprescribing and the question of whether some patients need the medication.

Pfizer initially studied Paxlovid in patients most at risk for COVID-19: unvaccinated adults with other health problems and no evidence of previous coronavirus infection. But that doesn’t reflect the population of the United States today, where an estimated 95% of people are protected from at least one dose of vaccine, a previous infection, or both.

FDA review of Pfizer data showed that Paxlovid made no significant difference in healthy adults, regardless of whether they were previously vaccinated.

But when the FDA released data on high-risk adults — regardless of their immunization or infection history — Paxlovid still showed a significant benefit, reducing the likelihood of hospitalization or death by 60% to 85%, depending on individual circumstances. Patients in that group include seniors and people with serious health problems, such as diabetes, obesity, lung disease, and immune system disorders.

Given so many different factors, panelists said prescribing Paxlovid will remain a case-by-case decision.

University of Utah’s Dr. Sankar Swaminathan and other panelists emphasized the importance of managing potentially dangerous drug interactions between Paxlovid and other commonly used drugs.


The Associated Press Health and Science Division receives support from the Howard Hughes Medical Institute Science and Media Education Group. AP is solely responsible for all content.

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