Staff Contact: Keri Barclay

Last week, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices met to discuss reports of mild cases of inflammation of the heart muscle and surrounding tissue following COVID-19 vaccination among younger people. In response, the CDC, American Academy of Pediatrics, and several other organizations released a joint statement on the safety and continued support of the COVID-19 vaccination of adolescents.

“The facts are clear: This is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

While most individuals will recover without a significant course of treatment, the CDC released clinical guidance for this patient population. All suspected cases of mRNA vaccine-related myocarditis and pericarditis should continue to be reported to the Vaccine Adverse Event Reporting System.

Staff Contact: Jackie Gatz or Keri Barclay

The World Health Organization urges fully vaccinated people to continue wearing masks indoors and to practice social distancing due to Delta variant surges in many parts of the world. The Centers for Disease Control and Prevention gave no indication that it will change current masking guidance at this time. The Delta variant of COVID-19 continues to spread throughout the state and nation.

Staff Contact: Keri Barclay

The Office of the Assistant Secretary for Preparedness and Response and the U.S. Food and Drug Administration sent a memo to health care provider stakeholders regarding the use and distribution of bamlanivimab and etesevimab together in the U.S. The FDA recommended that U.S. health care providers use either the authorized REGEN-COV or sotrovimab monoclonal antibody therapy until further notice. ASPR will pause distribution of bamlanivimab and etesevimab together, and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) in the U.S.

Sotrovimab, under an emergency use authorization, remains a viable option in the treatment of patients infected with COVID-19 in the outpatient setting. The health care provider and patient handouts are available for use with this application.

The FDA granted an EUA to Roche’s intravenous Actemra (tocilizumab) to treat hospitalized adults and pediatric patients ages two years or above with COVID-19. The treatment is indicated for individuals who are on systemic corticosteroids and need additional oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. This treatment option can be obtained through typical pharmaceutical ordering channels. Handouts for patients and  health care providers are available.

Both Actemra (tocilizumab) and sotrovimab are not being procured or distributed by the government. However, tocilizumab is widely available and will be reimbursable, and the Health Resources and Services Administration uninsured patient fund still is operating.