Conclusions from data safety monitoring

IDSociety/CDC weekly call presented conclusions from data safety monitoring to date.
  • 23.5 million COVID-19 vaccine doses have been administered in the US
  • During this time, the U.S. government has implemented the most intense and comprehensive vaccine safety monitoring program in history
  • Overall, the safety profiles of COVID-19 vaccines are reassuring and consistent with that observed from the pre-authorization clinic trials
  • Anaphylaxis has been observed following mRNA COVID-19 vaccines, though rarely
  • The data do not suggest a signal with respect to overall safety or deaths following vaccination in older adult residents of LTCFs
  • Additional population-based monitoring systems will continue to gather safety data as vaccination increases and the immunization program broadens (- CDC's vaccine safety datalink, FDA monitoring in CMS data, VA electronic health record)