The CDC provides advice on myocarditis and pericarditis in adolescents and young adults who received an mRNA COVID-19 vaccine. Most cases have occurred in male patients 16 and older and patients responded well to treatment. The CDC continues to recommend vaccination of all patients 12 years and older due to the greater risk for complications from COVID-19. A preliminary FDA review found reported cases of myocarditis/pericarditis have been consistent with the Pfizer-BioNTech COVID-19 vaccine clinical trials. The reported cases were greater than expected in patients 16 to 24. After the second dose, the incidence is estimated to be 16 cases per million doses. At least 81% of affected patients fully recovered. HHS, CDC and several professional societies published a statement in support of continued vaccination of all eligible patients 12 and older.
Oxford University is examining the safety and efficacy of giving two different COVID-19 vaccines to provide evidence for when the use of two different vaccines is unavoidable and to determine optimal use of the vaccines. A preprint draft provides results from the first phase of the 830 patient, Com-COV trial, where the elicited immune response was measured after different combinations of Comirnaty (Pfizer/BioNTech COVID-19 vaccine) and Vaxzevria (AstraZeneca COVID-19 vaccine) were given 4 weeks apart and antibody levels measured 28-days after the second dose.
A preprint draft provides results from a study examining antibody levels after a delayed second dose or third dose of the AstraZeneca COVID-19 vaccine. Antibody titers were higher with longer intervals. A third dose of the vaccine produced higher antibody titers and T-cell response.
HHS and the FDA are pausing distribution of Lilly’s monoclonal antibody combination bamlanivimab and etesevimab and etesevimab alone, due to concerns over resistance with COVID-19 variants. Distribution of bamlanivimab had been paused in April 2021.
Emricasan is a pan-caspase inhibitor being developed by Histogen for the treatment of nonalcoholic steatohepatitis. Because of emricasan ability to reduce inflammation, Histogen is evaluating the drug for the treatment of COVID-19.
The FDA granted an EUA for tocilizumab (Actemra, Roche) to treat hospitalized adults and pediatric patients two years of age or older, with COVID-19 and who are receiving a systemic corticosteroid and require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
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