U.S. CDC Presents COVID-19 Vaccine Booster Safety Review
During today's U.S. CDC Advisory Committee on Immunization Practices (ACIP) digital meeting, Tom Shimabukuro, MD, MPH, MBA, Vaccine Safety Team, presented 'COVID-19 vaccine 3rd booster dose safety data.'
Booster dose vaccinations are recommended as primary two-dose primary series protection is waning.
As of mid-November 2021, there have been 26.3 million booster doses administered in the U.S.
Led by Dr. Grace Lee, the CDC staff stated they are 'unaware of the potential benefit of booster doses on reducing SARS-CoV-2 coronavirus transmission. But third vaccine protection remains high for severe disease.'
Dr. Shimabukiro's presentation was based on V-safe surveillance findings and the Vaccine Adverse Event Reporting System (VAERS) monitoring.
V-safe is a CDC smartphone-based monitoring program for COVID-19 vaccine safety. Patterns of vaccination for 725,917 v-safe participants reported receiving a booster dose.
Generally, Moderna (SpikeVax) booster presents to be more reactogenic than PfizerBioNTech (Comirnaty) booster, regardless of the primary series manufacturer.
For Pfizer-BioNTech and Moderna, local and systemic reactions and health impacts were reported less frequently following a booster dose than dose #2 of the primary series.
The VAERS system is different, as it includes reports regardless of the plausibility of the vaccine causing the event or the clinical seriousness of the event.
There were 82 initial reports of death submitted to VAERS: Pfizer-BioNTech (60), Moderna (22), Janssen (0).
The median age of these deaths was 79 years.
Furthermore, there were 54 preliminary reports of myocarditis and myopericarditis submitted by November 5, 2021. But, only 12 reports met the CDC case definition.
All of these heart health cases were after Pfizer-BioNTech or Moderna vaccination.
And the median age of these cases was 51 years.
Based on data from Israel, myocarditis risk after a booster dose of Pfizer-BioNTech COVID-19 vaccine appears to fall between rates seen after dose one and dose 2.
Myocarditis risk after a booster dose of Moderna is unknown.
In summary, the VAERS data found most reports (≥93%) were non-serious; Almost half of the reports were among persons ≥65 years of age; two-thirds in females; No unusual or unexpected patterns were observed concerning reports of deaths following COVID-19 booster vaccination.
In conclusion, the CDC's Sara Oliver, MD, MSPH, presented the final dataset and 'Updates to the Evidence to Recommendation Framework: Pfizer-BioNTech and Moderna COVID-19 vaccine booster doses.'