/ en Fri, 25 Apr 2025 23:24:22 -0500 Mon, 28 Oct 24 15:05:10 -0500 /news/headline/2024-10-28-cdc-recommends-two-doses-covid-19-vaccine-older-individuals-lowers-pneumococcal-vaccine-age <p><br>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. <br><br>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. </p> Mon, 28 Oct 2024 15:05:10 -0500 COVID-19: CDC, FDA and CMS Guidance /news/headline/2024-10-22-cms-releases-final-guidance-hospital-respiratory-data-condition-participation-reporting-requirements <p>The Centers for Medicare & 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.<br> </p> Tue, 22 Oct 2024 15:42:48 -0500 COVID-19: CDC, FDA and CMS Guidance /news/headline/2024-08-22-fda-authorizes-combination-tests-flu-covid-19 <p>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. </p> Thu, 22 Aug 2024 14:16:22 -0500 COVID-19: CDC, FDA and CMS Guidance /news/headline/2024-08-20-cdc-covid-19-surging-across-us <p>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.<br><br>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>  on common respiratory viruses and available vaccines including flu, COVID-19 and respiratory syncytial virus (commonly known as RSV).</p> Tue, 20 Aug 2024 14:58:08 -0500 COVID-19: CDC, FDA and CMS Guidance /news/headline/2024-08-14-cdc-issues-advisory-increased-parvovirus-b19-cases-us <p>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.</p> Wed, 14 Aug 2024 14:28:42 -0500 COVID-19: CDC, FDA and CMS Guidance /project-firstline/evs-dashboard Thu, 11 Jul 2024 11:00:00 -0500 COVID-19: CDC, FDA and CMS Guidance /news/headline/2024-04-26-cdc-encourages-older-adults-get-additional-covid-19-vaccine-dose <p>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>. </p> Fri, 26 Apr 2024 14:11:06 -0500 COVID-19: CDC, FDA and CMS Guidance /news/headline/2024-01-29-fda-paxlovid-no-longer-labeled-emergency-use-after-march-8 <p>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.<br><br>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.<br> </p> Mon, 29 Jan 2024 16:02:00 -0600 COVID-19: CDC, FDA and CMS Guidance /news/headline/2023-09-12-fda-advisor-declares-ineffectiveness-widely-used-over-counter-decongestant-active-ingredient <p>The Food and Drug Administration’s independent <a href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-september-11-12-2023-meeting-nonprescription-drugs-advisory-committee-meeting-announcement#event-materials">Nonprescription Drugs Advisory Committee</a> Sept. 12 by unanimous vote declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.</p> Tue, 12 Sep 2023 15:36:31 -0500 COVID-19: CDC, FDA and CMS Guidance /news/headline/2023-07-20-senate-committee-advances-bill-reauthorize-preparedness-programs <p>The Senate Health, Education, Labor and Pensions Committee today 17-3 to pass as amended the Pandemic and All-Hazards Preparedness and Response Act (<a href="https://www.help.senate.gov/hearings/s-2333-pandemic-and-all-hazards-preparedness-and-response-act">S. 2333</a>), which would reauthorize the Hospital Preparedness Program at the current funding level of $385 million through fiscal year 2029. Among other <a href="https://www.help.senate.gov/imo/media/doc/pahpara_section_by_section2.pdf">provisions</a>, the bill would require drug makers to notify the Food and Drug Administration when they anticipate a meaningful shortage and report who makes the active pharmaceutical ingredients in their drugs. AHA has <a href="/system/files/media/file/2023/07/aha-responds-to-senate-help-committee-on-pahpa-reauthorization-letter-7-10-2023.pdf">urged</a> Congress to at least double current annual funding for the HPP, which it called “vastly insufficient,” as well as address drug and device shortages.</p> Thu, 20 Jul 2023 16:01:00 -0500 COVID-19: CDC, FDA and CMS Guidance