Policy Updates

1/7/22 — The FDA amended the EUA for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.The CDC followed suit by updating its recommendation for getting the a Moderna … Continued

1/11/22 — The FDA is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, … Continued

1/6/22 — CDC has released updated guidance for schools regarding COVID-19. Click on the links below to learn more. Guidance for COVID-19 Prevention in K-12 Schools – CDC update 1/6/22 Overview of COVID-19 Isolation for Schools – CDC update 1/6/22 Overview of COVID-19 Quarantine for Schools – CDC update 1/6/22 Responding to COVID-19 Cases in K-12 Schools: Resources … Continued

1/4/22 — The CDC has updated isolation and quarantine recommendations for the public. These recommendations do not apply to healthcare personnel. New recommendations state the people with COVID-19 should isolate for 5 days, and if they are asymptomatic or their symptoms are resolving, follow that by 5 days of wearing a mask when around others. … Continued

1/3/22 — Covidien, LP is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended. Read the FDA recall notice.

1/3/22 — The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. The revised EUA: Expands the use of a single booster dose to include use in individuals age 12 through 15 Shorten the time between the completion of the primary vaccination series and a booster dose to at least five months … Continued

12/28/21 — The FDA updated the emergency use authorization (EUA) of convalescent plasma to limit the authorization to plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment. These patients may be treated in outpatient or inpatient settings. Additionally, to help assure the manufacture of … Continued

12/29/21 — The HHS Assistant Secretary for Preparedness and Response (ASPR) and the FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies. Data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. … Continued

12/28/21 — The FDA issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with confirmed COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. Molnupiravir is available … Continued