COVID-19 Vaccine Provider Weekly Updates

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COVID-19 Vaccine Provider Weekly Updates

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Minnesota Department of Health

January 19, 2023


CDC and FDA identify preliminary COVID-19 vaccine safety signal for persons aged 65 years and older

On Jan. 13, in an effort to be transparent regarding COVID-19 vaccine safety, the Centers for Disease Control and Prevention (CDC) announced that the Vaccine Safety Datalink (VSD) detected a slight increase in the risk of ischemic stroke in people age 65 and older who had received the Pfizer-BioNTech COVID-19 bivalent booster vaccine within 21 days of the stroke. Per CDC, the increased risk “just exceeds statistical significance” but triggered further investigation in order to determine whether there were other reasons for this finding. No increase has been detected associated with the Moderna bivalent booster vaccine.  

It is important to note that, to date, no other safety systems have found this signal and multiple subsequent analyses have not validated this signal, which is reassuring.  

  • There are no other observed patterns that are concerning for ischemic stroke, which makes it very unlikely that this signal finding represents a true clinical risk of the Pfizer-BioNTech COVID-19 bivalent booster.  
  • No change in vaccination practice is recommended. CDC continues to recommend that everyone ages 6 months of age and older stay up to date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine.   

For further details: CDC & FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older

Upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on COVID-19 vaccines

On Jan. 26, the Food and Drug Administration (FDA) will hold a VRBPAC meeting to discuss whether and how the composition for primary doses of COVID-19 vaccines should be modified. The committee is also scheduled to discuss how and whether the composition and schedule for booster doses should be adjusted moving forward. 

Additional information can be found in FDA’s News Release: Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19.

Pfizer COVID-19 vaccine webinars now on demand

Beginning the week of Jan. 6, Pfizer’s COVID-19 Vaccine Immunization Site Training webinars will transition from live events to ON DEMAND content for all health care providers.  

LIVE sessions will still occur, as needed, to address new vaccine information so visit Pfizer and BioNTech’s COVID-19 Vaccines Training Resources frequently for the latest schedule and to access webinars.

Find previous bulletins at COVID-19 Vaccine Provider Updates.