{"id":4401,"date":"2022-05-08T15:58:05","date_gmt":"2022-05-08T15:58:05","guid":{"rendered":"http:\/\/wp.cov19longhaulfoundation.org\/?p=4401"},"modified":"2022-05-08T15:58:05","modified_gmt":"2022-05-08T15:58:05","slug":"fda-investigating-reports-of-covid-relapses-following-use-of-pfizers-pill","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=4401","title":{"rendered":"FDA Investigating Reports Of COVID Relapses Following Use Of Pfizer\u2019s Pill"},"content":{"rendered":"\n

Authors: Zachary Stieber\u00a0<\/a><\/em> May 8, 2022<\/p>\n\n\n\n

The U.S. Food and Drug Administration (FDA) is investigating reports of relapses among people who took Pfizer\u2019s COVID-19 pill.<\/strong><\/p>\n\n\n\n

The FDA \u201cis evaluating the reports of viral load rebound after completing paxlovid treatment and will share recommendations if appropriate,\u201d an agency spokesperson told The Epoch Times in an email.<\/p>\n\n\n\n

In a recent preprint case report<\/a>, Veterans Affairs researchers reported that a 71-year-old male who took the pill, also known as nirmatrelvir, experienced a \u201crapid and progressive reduction\u201d in the viral load of SARS-CoV-2, the virus that causes COVID-19.<\/strong><\/p>\n\n\n\n

But four days after completing the treatment course, there was a \u201csurprising rebound of viral load and symptoms,\u201d they reported.<\/strong><\/p>\n\n\n\n

The report \u201chighlights the potential for recurrent, symptomatic SARS-CoV-2 replication after successful early treatment\u201d with the pill, the researchers said.<\/p>\n\n\n\n

A number of others have said they saw renewed symptoms after taking paxlovid.<\/p>\n\n\n\n

In the FDA\u2019s evaluation (pdf<\/a>) of data on paxlovid, which the agency cleared on an emergency basis in 2021, the agency reported that in an ongoing phase 2\/3 trial<\/a> run by Pfizer, several participants \u201cappeared to have a rebound\u201d in viral load five to nine days after completing their treatment courses.<\/p>\n\n\n\n

In light of the new reports, additional analyses of the paxlovid trial data were performed and showed that 1 to 2 percent of the patients had one or more positive COVID-19 tests after testing negative, or an increase in the amount of viral load, after completing the treatment, Dr. John Farley of the FDA said in an interview the agency published on May 4<\/a>.<\/p>\n\n\n\n

\u201cThis finding was observed in patients treated with the drug as well as patients who received placebo, so it is unclear at this point that this is related to drug treatment,\u201d he said, adding that, at this time, the reports \u201cdo not change the conclusions from the paxlovid clinical trial which demonstrated a marked reduction in hospitalization and death.\u201d<\/p>\n\n\n\n

As part of the authorization agreement, the FDA said Pfizer must later submit information regarding \u201cprolonged virologic shedding or rebound in clinical trials.\u201d<\/strong><\/p>\n\n\n\n

Pfizer did not respond to a request for comment.<\/p>\n\n\n\n

The company told Bloomberg<\/a> that the rate of rebound in its trial was not higher among people who took paxlovid than in people who took a placebo.<\/p>\n\n\n\n

\u201cThis suggests the observed increase in viral load is unlikely to be related to paxlovid,\u201d the company said.<\/p>\n\n\n\n

Dr. Clifford Lane, deputy director for clinical research at the National Institute of Allergy and Infectious Diseases, told the outlet that the agency will study the issue, calling it \u201ca priority.\u201d<\/p>\n\n\n\n

Lane and the agency did not return queries.<\/p>\n\n\n\n

The FDA authorized paxlovid for the treatment of mild to moderate COVID-19 in Americans 12 years or older. To get the pill, a person must test positive for COVID-19 and be deemed at high risk of progressing to severe disease.<\/p>\n","protected":false},"excerpt":{"rendered":"

Authors: Zachary Stieber\u00a0 May 8, 2022 The U.S. Food and Drug Administration (FDA) is investigating reports of relapses among people who took Pfizer\u2019s COVID-19 pill. The FDA \u201cis evaluating the […]<\/p>\n","protected":false},"author":2,"featured_media":4402,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[910],"tags":[],"class_list":["post-4401","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-paxlovid"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/4401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4401"}],"version-history":[{"count":0,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/4401\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/4402"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}