New EUA and dose guidelines for COVID-19 released, ACIP reviewed myocarditis reports

On June 24, the FDA issued an emergency use authorization (EUA) for tocilizumab to treat hospitalized COVID-19 patients who are receiving systemic corticosteroids and requiring oxygen. The recommended dosage for most patients is a single 60-minute IV infusion at 12 mg/kg. The EUA is based on four clinical trials in COVID-19 patients (RECOVERY, EMPACTA, COVACTA and REMDACTA). In outpatient treatment, the NIH COVID-19 guidelines panel updated its dose recommendations for monoclonal antibodies in high-risk outpatients with COVID-19 on June 17. The authorized dose has been reduced from casirivimab 1,200 mg plus imdevimab 1,200 mg to casirivimab 600 mg plus imdevimab 600 mg. A recent study found significant benefit from these antibody treatments, according to results published by Clinical Infectious Diseases on June 24. The retrospective comparison of 707 COVID-19 patients who received bamlanivimab or casirivimab and imdevimab with 1,709 controls found lower hospitalization rates, shorter length of stay if hospitalized, and fewer ED visits within 30 days in the former group.

The Advisory Committee on Immunization Practices met on June 23 to discuss the safety of the COVID-19 vaccines, including reports of myocarditis and pericarditis in younger recipients. Following their discussion, the Department of Health and Human Services released a statement, co-signed by the CDC and medical groups including ACP, saying that myocarditis and pericarditis are extremely rare side effects of vaccination and most cases are mild. The statement strongly encourages everyone 12 years and older to get vaccinated. The FDA, meanwhile, updated the fact sheets for the Moderna and Pfizer-BioNTech vaccines to note that “reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with onset of symptoms within a few days after vaccination.” In other vaccine side effect news, a case report published by Annals of Internal Medicine on June 29 described a fatal case of vaccine-induced thrombosis with thrombocytopenia or thrombocytopenia with thrombosis syndrome after receipt of the Moderna vaccine. An accompanying editorial noted that it is difficult to establish a link to the vaccine “from 1 case report among the hundreds of millions of vaccine doses administered” and urges more research and vigilance by clinicians “because prompt recognition and treatment are likely to improve outcomes.” Facial nerve palsy does not appear associated with COVID-19 vaccination, according to a case-control study published by JAMA Otolaryngology-Head & Neck Surgery on June 24.

Finally, there was some good news for patients with prolonged anosmia after COVID-19 infection from a study published by JAMA Network Open on June 24. Researchers did subjective and objective olfactory testing in 51 patients who had acute smell loss beyond seven days. At eight months, objective olfactory assessment confirmed full recovery in 49 of 51 patients. Two patients remained hyposmic at one year.