Category: Brief Messages or Announcements

Reminder: FDA Advisory Committee Meeting Thursday January 26, 2023 on Future of Covid-19 Vaccination Regimens

Remember, the 178th Annual Meeting of the FDA Advisory Committee on the future of Covid-19 Vaccination Regimens is this Thursday from 8:30 AM-5:30 ET.

The details so far include the voting question:

“Simplification of current COVID-19 vaccine use:

  • Vaccine composition: Does the committee recommend harmonizing the
    vaccine strain composition of primary series and booster doses in the U.S.
    to a single composition, e.g., the composition for all vaccines administered
    currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

More Crazy Announcements!

Here are crucial announcements.

Sena bought me Bigfoot pajamas. They clearly show Bigfoot doing the Patty walk, which refers to the historic sighting of Bigfoot caught on video decades ago in the Patterson-Gimlin film.

The Amaryllis leaves have grown to about 11 inches! There is no flower.

Cattle ranchers are now putting diapers and masks on their cows to reduce methane emissions. Soon there will be statutes requiring humans who fart and belch in public to take Beano gummies several times daily. You know who you are.

FDA Advisory Committee Meeting to Discuss Future Covid-19 Vaccine Regimens

The FDA 178th Meeting of the Vaccine and Related Biological Products Advisory Committee will meet in open session January 26, 2023 to discuss future Covid-19 vaccination regimens. The meeting will run between 8:30 AM-5:30 PM ET.

National Day of Racial Healing Today

I just found out about the National Day of Racial Healing, which is today. It follows the National MLK Day, which this year was yesterday. The annual National Day of Racial Healing was started in 2017. The website tells what the event is about:

“The National Day of Racial Healing is a time to contemplate our shared values and create the blueprint together for #HowWeHeal from the effects of racism. Launched on Jan. 17, 2017, it is an opportunity to bring ALL people together in their common humanity and inspire collective action to create a more just and equitable world.”

Read more about the origins of the National Day of Racial Healing here.

My Two Cents on The Embrace Sculpture Honoring MLK Jr and Coretta Scott King

I first saw a photo of the sculpture honoring Dr. Martin Luther King Jr and Coretta Scott King, called “The Embrace” a couple of days ago. I remember my first impression being that it would have been nice to see a full sculpture of the couple rather than disembodied arms.

Sena mentioned it today because it was unveiled at Boston Commons. This was just before my mindfulness meditation, so I just told her that I saw the picture of it and said I would have to think about it some more.

As I sat in meditation, it occurred to me that “The Embrace” expressed what I think is a basic abstract idea, which is the challenge for us to embrace the notion that we’re all humans who ought to accept each other, and be kind and generous to one another.

That’s what I think the Kings did. That’s why Dr. King won the Nobel Peace Prize.

You could make a sculpture of the King as a couple embracing each other after he won the Nobel Prize. It would have been beautiful. On the other hand, you could make a sculpture which tries to do more than that. How difficult would it be to make a representation of what it might look like if all of us embraced our humanity—and each other?

It sounds too difficult. Yet the artist managed to do just that. Anyway, that’s my two cents.

Corn Removal Comedy

Sena does a lot of gardening, which means she uses a shovel frequently. She has quite a few corns on her feet for which she’s tried a number of remedies that run the gamut from scraping with a variety of simple tools to—sand paper. There, I said it and I’m glad.

Maybe a little foot scrub?

The old shovel probably contributed to her developing a number of corns on her feet. She got a new shovel with a special footstep which we hope will cut down on corns.

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.”