Pfizer\u2019s 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.<\/p>\n\n\n\n
The medication has been used by millions of Americans since the FDA granted it emergency use authorization<\/strong>in late 2021. The agency has the final say on giving Pfizer\u2019s drug full approval and is expected to decide by May.<\/p>\n\n\n\n A panel of outside experts voted 16-1 that Paxlovid remains a safe and effective treatment for high-risk adults with COVID-19 who are more likely to face hospitalization and death due to the virus.<\/p>\n\n\n\n \u201cWe still have many groups that stand to benefit from Paxlovid, including unvaccinated persons, under-vaccinated persons, the elderly and the immuno-compromised,\u201d said Dr. Richard Murphy of the Department of Veterans Affairs.<\/p>\n\n\n\n The FDA said using Paxlovid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospitalizations per week.<\/p>\n\n\n\n The panel\u2019s positive vote was widely expected, given that Paxlovid has been the go-to treatment against COVID-19, especially since an entire group of antibody drugs<\/strong> has been sidelined as the virus mutated.<\/p>\n\n\n\n The U.S. continues reporting about 4,000 deaths and 35,000 hospitalizations weekly, the FDA noted.<\/p>\n\n\n\n The agency asked its panel of independent medical experts to address several lingering questions involving Paxlovid, including which people currently benefit from treatment and whether the drug plays a role in cases of COVID-19 rebound<\/strong>.<\/p>\n\n\n\n The panel agreed with assessments by both the FDA and Pfizer that found no clear link between the use of Paxlovid and returning symptoms, but said more information is needed from studies and medical records data. High-profile cases drew attention to the issue last year, including President Joe Biden<\/strong> and first lady Jill Biden<\/strong>.<\/p>\n\n\n\n Between 10% and 16% of patients across multiple Pfizer studies had symptoms return, regardless of whether they\u2019d received Paxlovid or a dummy pill. Such cases \u201clikely reflect natural COVID-19 progression,\u201d the FDA concluded.<\/p>\n\n\n\n The federal government has purchased more than 20 million doses of Paxlovid and encouraged health professionals to prescribe it aggressively<\/strong> to help prevent severe COVID-19. But that\u2019s led to concerns of overprescribing and questions of whether some patients are needlessly getting the drug.<\/p>\n\n\n\n Pfizer originally studied Paxlovid in the highest-risk COVID-19 patients: unvaccinated adults with other health problems and no evidence of prior coronavirus infection. But that doesn\u2019t reflect the U.S. population today, where an estimated 95% of people have protection from at least one vaccine dose, a prior infection or both.<\/p>\n\n\n\n The FDA reviewed Pfizer data showing Paxlovid made no meaningful difference<\/strong> in otherwise healthy adults, whether or not they\u2019d been previously vaccinated.<\/p>\n\n\n\n But when FDA teased out data for high-risk adults \u2014 regardless of their vaccination or infection history \u2014 Paxlovid still showed a significant benefit, reducing the chance of hospitalization or death between 60% and 85%, depending on individual circumstances. Patients in that group included seniors and those with serious health problems, such as diabetes, obesity, lung disease and immune-system disorders.<\/p>\n\n\n\n With so many different factors, panelists said prescribing Paxlovid will remain a case-by-case decision.<\/p>\n\n\n\n Dr. Sankar Swaminathan of the University of Utah and other panelists stressed the importance of managing potentially dangerous drug interactions between Paxlovid and other commonly used medications.<\/p>\n","protected":false},"excerpt":{"rendered":" Pfizer\u2019s 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. The medication has been used by millions of Americans since the FDA granted it emergency use authorizationin late 2021. The agency has the final say on giving Pfizer\u2019s […]<\/p>\n","protected":false},"author":8,"featured_media":30172,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_post_source_name":"","_post_source_url":"","footnotes":""},"categories":[64],"tags":[5178,7960,8924,5313,5222,5200,7396,7234,6999,11403,11273,6144,2944,6496,6410,2264,12634,7713,6277,2471,9683,6998,11973,13228,7533,5956,9374,3805,11625,5807,7294,8206,9262,214,6081,5223,6662,3954,594],"class_list":["post-30171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-fitness","tag-biden","tag-case","tag-chance","tag-coronavirus","tag-covid","tag-covid-19","tag-data","tag-death","tag-diabetes","tag-disease","tag-drug","tag-drugs","tag-first-lady","tag-food","tag-food-and-drugs-authority","tag-government","tag-health","tag-health-problems","tag-jill-biden","tag-joe-biden","tag-millions","tag-obesity","tag-one","tag-patients","tag-paxlovid","tag-pfizer","tag-population","tag-president","tag-professionals","tag-risk","tag-symptoms","tag-treatment","tag-united-states","tag-university","tag-utah","tag-vaccination","tag-vaccine","tag-will","tag-who"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/posts\/30171","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/comments?post=30171"}],"version-history":[{"count":1,"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/posts\/30171\/revisions"}],"predecessor-version":[{"id":51000,"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/posts\/30171\/revisions\/51000"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/media\/30172"}],"wp:attachment":[{"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/media?parent=30171"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/categories?post=30171"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nsemgh.com\/api-json\/wp\/v2\/tags?post=30171"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}