This health alert provides an update on patient eligibility for EVUSHELD, a long-acting monoclonal antibody that is available under U.S. Food and Drug Administration Emergency Use Authorization for pre-exposure prophylaxis to prevent COVID-19 infection in persons with moderate to severe immunocompromise.
The Maine Center for Disease Control and Prevention (Maine CDC) relies on health care providers and laboratorians to report the occurrence of notifiable diseases. Without such surveillance data, Maine cannot accurately monitor trends, detect and respond to unusual occurrences of diseases (such as outbreaks), and evaluate the effectiveness of control and prevention activities.
On January 21, 2022, the U.S. Food and Drug Administration (FDA) granted full approval to the antiviral drug remdesivir (Veklury) to treat non-hospitalized patients 12 years of age and older with mild-to-moderate COVID-19 disease who are at high risk of hospitalization. This expanded approval provides another treatment option to reduce the risk of hospitalization in high-risk patients. The use of remdesivir was previously limited to patients requiring hospitalization, and treatment outside the hospital was off-label.
On January 14, 2022, Maine CDC issued a revised Standing Order ("Order"), effective date January 21, 2022, that authorizes health care providers or other trained personnel at a health care facility or medically supervised COVID-19 collection site (collection site) in the state to collect and submit specimens of SARS-CoV-2 for molecular or antigen-based testing.
As of January 2, 2022, the Maine Center for Disease Control and Prevention (Maine CDC) is using updated definitions for COVID-19 outbreaks and COVID-19-associated deaths.
This health alert provides updates on (1) the use of monoclonal antibody therapies and (2) the availability of oral antivirals and infusion therapies for outpatients with COVID-19. This alert also contains information on how healthcare providers and patients can access oral antivirals and infusion therapies, which must be started in the first few days after symptom onset. Finally, this alert provides information on a long-acting monoclonal antibody therapy for pre-exposure prophylaxis in immunocompromised patients.
The SARS-CoV-2 Omicron variant has quickly become the dominant variant of concern in the United States and is present in all 50 states. The Centers for Disease Control and Prevention (CDC) recommends that eligible individuals receive all vaccines and booster shots as the best preventive measure available against severe disease, hospitalizations, and death due to COVID-19. Therapeutics are also available for preventing and treating COVID-19 in specific at-risk populations.
Due to the increased transmissibility of the SARS-CoV-2 Omicron variant and concerns about potential impacts on the healthcare system, the U.S. Centers for Disease Control and Prevention (CDC) and the Maine CDC are updating recommendations to enhance protection for healthcare personnel, patients, and visitors, and ensure adequate staffing in healthcare facilities. The guidance is based on the limited information currently available about the Omicron variant and will be updated as needed as new information becomes available.
Maine CDC would like to remind providers and laboratories to immediately report all Urgent Notifiable Conditions on recognition or strong suspicion of disease by phone to Maine CDC at 1-800-821-5821.
The sustained ongoing challenges posed by the COVID-19 response elevates the importance of immediately reporting Urgent Notifiable Conditions by phone and not relying on electronic laboratory reports or faxing.
The attached HAN message titled Increasing Seasonal Influenza A(H3N2) Activity, Especially Among Young Adults and in College and University Settings, During SARS-CoV-2 Co-Circulation was sent by US CDC on November 24, 2021. Maine CDC is forwarding this federal HAN message to ensure widest visibility.
