CDC Identifies Preliminary Covid-19 Vaccine Safety Signal

The CDC announced that a prelimary Covid-19 Vaccine Safety signal has been identified in a recent update on their website:

“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

  • A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
  • A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
  • The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
  • Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
  • Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines”

The CDC says it’s “very unlikely  that the signal in VSD represents a true clinical risk…” The data and additional analyses will be discussed at the January 26, 2023 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No changes are recommended to the current Covid-19 vaccination practice:

“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. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:

  • Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
  • Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
  • Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.

Overall safety data for the bivalent COVID-19 vaccines are available here.

Once again, no change is recommended in COVID-19 vaccination practice, which can be found here.”

Bivalent Covid-19 Booster Protects Us

University of Iowa Health Care participated in research which demonstrates that people over age 65 who got the updated bivalent Covid-19 vaccine booster:

  • “84% less likely to be hospitalized with COVID-19 compared with unvaccinated people 
  • 73% less likely to be hospitalized with COVID-19 compared with people who received monovalent mRNA vaccination alone but had not received the bivalent booster dose.”

Stories from University of Iowa Health Care to Remember 2022

Here’s a link to University of Iowa Health Care stories to remember in 2022. The one which triggers a memory in me is the one about learning medical Spanish-which I never did, actually.

Oh, like all college freshman, I took elementary Spanish because it was required. I could mimic the Spanish accent because, while growing up, my childhood next door neighbor’s family were Spanish-speaking. I didn’t learn any Spanish from them, but I somehow absorbed the accent.

My pronunciation impressed teachers–but my conversational ability, not so much.

Dr. Donald Warne, MD, MPH to Deliver MLK Jr Distinguished Lecture January 18, 2023

The University of Iowa Hospitals & Clinics welcomes Donald Warne, MD, MPH, co-director of Johns Hopkins Center for Indigenous Health, on January 18, 2023 when he will deliver the Dr. Martin Luther King Jr Distinguished Lecture in the Prem Sahai Auditorium in Iowa City, Iowa.

Martin Luther King, Jr. Celebration of Human Rights Week 2023

The Martin Luther King, Jr. Celebration of Human Rights Week 2023 begins January 16, 2023. See the University of Iowa Healthcare list of events, which will be updated.

Christmas Day 2022 Antics!

Christmas Day at our house was a lot of fun. I got a coffee mug that specifies the importance of cribbage. Sena got a throw that sort of complements the throw she got me on our anniversary.

Those throws add a lot to the ambience in the room. And the coffee mug really speaks to the “importanter feature” of cribbage in our life nowadays.

This was the one of the best Christmases ever. We’re up to our ears in gratitude. And that’s the most importantest thing of all.