Public Policy Updates

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

12/27/21 — OSHA announced that it is withdrawing the non-recordkeeping portions of the COVID-19 Healthcare Emergency Temporary Standard (ETS). The COVID-19 log and reporting provisions remain in effect. The agency urges healthcare employers to continue to implement the ETS’s requirements. It will also continue to enforce requirements under the existing PPE and Respiratory Protection Standards to … Continued

12/22/21 — The FDA issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including … Continued

12/21/21 — Federal courts have issued contradictory rulings on implementation of employee COVID-19 vaccination mandates issued by OSHA and CMS. While a stay on implementation of the OSHA vaccination mandate has been reversed, injunctions against implementation of the CMS healthcare personnal COVID-19 vaccination mandate are still in effect in 24 states. The OSHA vaccination mandate … Continued

12/16/21 — The FDA approved a manufacturing change for Comirnaty (COVID-19 Vaccine, mRNA) to include a formulation that uses a different buffer, which helps maintain a vaccine’s pH and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers. Read the FDA approval letter.

12/15/21 — FDA issued an EUA for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the prevention of COVID-19 in certain adults and children. Although vaccines have proven to be the best defense against COVID-19, some people may not have an adequate immune response or have a history of severe adverse reactions to the vaccine. … Continued

12/14/21 — Gilead Sciences Inc. announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level due to the presence of glass particulates. Veklury is used for the treatment of COVID-19 requiring hospitalization. Read the FDA notice.