COVID-19 Medical Products Supply Chain Week in Review – June 2021 #5

Last week, the FDA added new heart health risk information to mRNA vaccines’ fact sheets. In addition, the U.S. seized unauthorized COVID-19 drugs en route from Bangladesh and India to Mexico. Please see details for these and other supply chain developments below:

  • On June 23, the Wall Street Journal reported that the U.S. government had seized at U.S. airports unauthorized versions of the COVID-19 treatment remdesivir, which were en route from Bangladesh and India to Mexico.
  • On June 24, the FDA issued an emergency use authorization (EUA) for Actemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
  • On June 24, President Biden announced that 66 percent of all American adults have received at least one shot of COVID-19 vaccine, including over 150 million Americans fully vaccinated.
  • On June 25, the FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer/BioNTech COVID-19 vaccines to include information regarding risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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