AAIP logo

CDC issues statement on COVID-19 Vaccine Safety

  • For years, U.S. government agencies have used multiple, complementary safety monitoring systems to help detect possible vaccine statistical signals as early as possible and to facilitate further investigations, as appropriate.
  • As part of routine surveillance, CDC detected a preliminary signal for stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 bivalent mRNA vaccine. As a response to the signal, CDC and FDA examined several large databases including Medicare’s database of 5 million doses, the Veteran Association’s (VA) database of millions of veterans, and databases from Israel and European countries.
  • For the sake of transparency, CDC and FDA have issued a statement about the signal and the results of their investigation so far.
  • To date, they have not seen an association or increased risk in stroke from vaccines in these databases. The totality of the data currently suggests that it is very unlikely that the signal represents a true clinical risk.
  • CDC continues to believe that the updated bivalent vaccines are safe and effective and provide the best protection against COVID-19, and the agency continues to encourage Americans of all ages to get their updated COVID-19 vaccine right away.
Skip to content