COVID-19: CDC, FDA and CMS Guidance

COVID-19: CDC, FDA and CMS Guidance / en Thu, 31 Jul 2025 17:56:13 -0500 Thu, 17 Jul 25 14:52:32 -0500 FDA announces recall of cefazolin by Sandoz for mislabeling /news/headline/2025-07-17-fda-announces-recall-cefazolin-sandoz-mislabeling The Food and Drug Administration July 15 <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-sandoz-inc-issues-voluntary-nationwide-recall-expansion-one-additional-lot-cefazolin" title="FDA statement">announced</a> a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and potentially life-threatening health consequences. Sandoz has not received any reports of adverse events or injuries related to the mislabeling but has received a complaint of the mislabeled product being administered to a patient.&nbsp; Thu, 17 Jul 2025 14:52:32 -0500 COVID-19: CDC, FDA and CMS Guidance RFK Jr. says CDC will no longer recommend COVID-19 vaccine for healthy children, pregnant women /news/headline/2025-05-27-rfk-jr-says-cdc-will-no-longer-recommend-covid-19-vaccine-healthy-children-pregnant-women Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 <a href="https://x.com/seckennedy/status/1927368440811008138?s=46" title="COVID announcement">announced</a> in a post on X that the Centers for Disease Control and Prevention would no longer recommend the COVID-19 vaccine for healthy children and pregnant women.&nbsp; Tue, 27 May 2025 15:12:59 -0500 COVID-19: CDC, FDA and CMS Guidance CDC recommends two doses of COVID-19 vaccine for older individuals, lowers pneumococcal vaccine age /news/headline/2024-10-28-cdc-recommends-two-doses-covid-19-vaccine-older-individuals-lowers-pneumococcal-vaccine-age The Centers for Disease Control and Prevention last week endorsed a <a href="https://www.cdc.gov/media/releases/2024/s1023-covid-19-vaccine.html">recommendation</a> for people aged 65 and older and for immunocompromised individuals to receive a second dose of the 2024-2025 COVID-19 vaccine. The recommendation from the Advisory Committee on Immunization Practices, which calls for the second dose to be administered six months after the first dose, acknowledges the increased risk of severe disease from COVID-19 for older adults and immunocompromised individuals, along with the latest data on vaccine effectiveness and year-round circulation of COVID-19. It also provides clarity to health care providers on how many doses should be given per year to people who are moderately or severely immunocompromised and is intended to increase coverage of a second dose for that group.&nbsp; Additionally, the agency recommended lowering the age for initial pneumococcal vaccination from 65 to 50, as the risk for infection substantially increases at that age.&nbsp; Mon, 28 Oct 2024 15:05:10 -0500 COVID-19: CDC, FDA and CMS Guidance CMS releases final guidance on hospital respiratory data condition of participation reporting requirements /news/headline/2024-10-22-cms-releases-final-guidance-hospital-respiratory-data-condition-participation-reporting-requirements The Centers for Medicare &amp; Medicaid Services Oct. 22 released final <a href="https://www.cms.gov/files/document/qso-25-05-hospitals-cahs.pdf">guidance</a> detailing reporting requirements for the hospital respiratory data condition of participation. Under the new CoP, which takes effect Nov. 1, all Medicare- and Medicaid-participating hospitals and critical access hospitals (other than psychiatric hospitals, rehabilitation hospitals, psychiatric hospital distinct part units and rehabilitation hospital distinct part units) will electronically submit certain COVID-19, influenza and respiratory syncytial virus data to the Centers for Disease Control and Prevention on a weekly basis. CMS will evaluate compliance using monthly reports generated by the CDC. Psychiatric hospitals, rehabilitation hospitals, psychiatric hospital distinct part units and rehabilitation hospital distinct part units will report once, annually, beginning in January. AHA will share additional information with members in an upcoming Special Bulletin. &nbsp; Tue, 22 Oct 2024 15:42:48 -0500 COVID-19: CDC, FDA and CMS Guidance FDA authorizes combination tests for flu, COVID-19 /news/headline/2024-08-22-fda-authorizes-combination-tests-flu-covid-19 The Food and Drug Administration Aug. 22 granted emergency use <a href="https://www.federalregister.gov/public-inspection/2024-18973/emergency-use-authorization-certain-medical-devices-during-covid-19">authorization</a> for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-19 Dual Test is authorized for use by laboratories to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens. The Flowflex Plus COVID-19 and Flu A/B Home Test is authorized for home use for people aged two and older.&nbsp; Thu, 22 Aug 2024 14:16:22 -0500 COVID-19: CDC, FDA and CMS Guidance CDC: COVID-19 surging across the U.S. /news/headline/2024-08-20-cdc-covid-19-surging-across-us The Centers for Disease Control and Prevention's COVID-19 <a href="https://covid.cdc.gov/covid-data-tracker/#datatracker-home">data tracker</a> shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been since January 2022. Wastewater <a href="https://www.cdc.gov/nwss/rv/COVID19-nationaltrend.html">surveillance</a>, “an early warning sign of COVID-19’s spread in communities,” demonstrates “very high” viral activity for COVID-19 across the U.S. indicating positivity rates could be even higher than reported test results. CDC <a href="https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html">recommends</a> that everyone ages six months and older receive a 2024-2025 COVID-19 vaccine. In advance of the respiratory virus season, the Department of Health and Human Services Aug. 19 launched a new <a href="https://www.hhs.gov/about/news/2024/08/19/hhs-launches-national-public-education-campaign-ahead-respiratory-virus-season.html">public education campaign</a> &nbsp;on common respiratory viruses and available vaccines including flu, COVID-19 and respiratory syncytial virus (commonly known as RSV). Tue, 20 Aug 2024 14:58:08 -0500 COVID-19: CDC, FDA and CMS Guidance CDC issues advisory on increased parvovirus B19 cases in the U.S. /news/headline/2024-08-14-cdc-issues-advisory-increased-parvovirus-b19-cases-us The Centers for Disease Control and Prevention Aug. 13 issued an <a href="https://emergency.cdc.gov/han/2024/han00514.asp">advisory</a> alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a seasonal respiratory virus spread by respiratory droplets through symptomatic or asymptomatic individuals. Many people are asymptomatic, but immunocompetent children and adults with symptomatic disease typically develop a biphasic illness, CDC said. The first phase lasts approximately five days and includes symptoms of fever, myalgia and malaise, which develop about a week after infection. During the second phase, children often develop a facial rash which may be followed by reticulated body rash or joint pain one to four days later. For immunocompetent adults, the most common symptoms of parvovirus B19 disease typically occur during the second phase and include a reticular rash on the trunk and joint pain. Parvovirus B19 infection could also lead to adverse health outcomes among people without pre-existing immunity who are pregnant, immunocompromised or have chronic hemolytic disorders. Wed, 14 Aug 2024 14:28:42 -0500 COVID-19: CDC, FDA and CMS Guidance EVS Resource Tool Dashboard /project-firstline/evs-dashboard Thu, 11 Jul 2024 11:00:00 -0500 COVID-19: CDC, FDA and CMS Guidance CDC encourages older adults to get additional COVID-19 vaccine dose /news/headline/2024-04-26-cdc-encourages-older-adults-get-additional-covid-19-vaccine-dose Adults age 65 and older are encouraged to receive an updated dosage of the COVID-19 vaccine, the Centers for Disease Control and Prevention <a href="https://www.cdc.gov/mmwr/volumes/73/wr/mm7316a4.htm?s_cid=mm7316a4_w ">announced</a> April 25. The update provides protection against the JN.1 and other circulating variants of the virus, and should be administered at least four months following the previous dosage. The CDC's Advisory Committee on Immunization Practices recommended the additional dose in <a href="/news/headline/2024-02-28-congressional-leaders-release-new-continuing-resolution">February</a>.&nbsp; Fri, 26 Apr 2024 14:11:06 -0500 COVID-19: CDC, FDA and CMS Guidance FDA: Paxlovid no longer labeled for emergency use after March 8 /news/headline/2024-01-29-fda-paxlovid-no-longer-labeled-emergency-use-after-march-8 Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-letter-authorization-emergency-use-authorization-paxlovid">announced</a>. Providers may dispense unexpired Paxlovid labeled for emergency use to patients through March 8, after which Paxlovid labeled for emergency use must be returned to the manufacturer or disposed of in accord with regulations, the agency said. The FDA last May approved a new drug application for Pfizer’s Paxlovid to treat adults at high risk of progressing to severe COVID-19. Paxlovid labeled under the new drug application will continue to be authorized for emergency use to treat eligible pediatric patients, the agency said. &nbsp; Mon, 29 Jan 2024 16:02:00 -0600 COVID-19: CDC, FDA and CMS Guidance