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)?”

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.

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.”

Listen to Dr. Wes Ely, MD on Talk Radio Europe Discuss His Book: Every Deep-Drawn Breath

Listen to Dr. Wes Ely on the show Talk Radio Europe as he talks about the devastating consequences of severe disease that results in admission to critical care units, specifically in the context of the Covid-19 Pandemic.

The title of the presentation is “Understanding the Long Shadow of COVID and ICU Care.”

Rounding@Iowa Presentation on Covid-19 Bivalent Vaccine Boosters

Give a listen to the Rounding@Iowa presentation “Update on Covid-19 Bivalent Vaccine Boosters. While these presentations are mainly directed to health care providers, they are very helpful for members of the community at large.

CDC Advisory Committee Recommends Including Covid-19 Vaccine for Routine Immunization Schedule

Today, the CDC Advisory Committee on Immunization Practices recommended adding Covid-19 immunization to the routinely recommended vaccine schedule.

HHS Campaign for Updated Covid-19 Updated Vaccine Booster

See the HHS Campaign for the Covid-19 updated vaccine booster for older adults-a high risk group. We’re scheduled for both the flu shot and the updated booster.

I Say Omicron and You Say Ahmicron

Well, we tried the Miracle Whip salad dressing on egg salad sandwiches the other day. I thought they tasted better than the tuna fish sandwiches we had before.

But maybe it was the mustard in the egg salad. Anyway, Sena says we’ll be going back to Mayonnaise after the Miracle Whip is gone.

The difference between Mayo and Miracle Whip may be debatable. But the difference between the updated Covid-19 vaccine Omicron bivalent booster and the previous Covid-19 vaccines is more important than just the difference between the two pronunciations of Omicron. I say OH-muh-kraan, you say AH-muh-kraan. You say tuh-May-toh, I say to-MAH-toh, etc.

Some clinicians are worried about the risk for substituting the wrong vaccine for the new bivalent booster. That’s more than just fussiness; administration errors have already occurred with previous formulations of the vaccines and their boosters. These are nontrivial, reportable mistakes.

Some say the different colors of the vial caps should be enough to prevent mistakes. The CDC advisory committee members disagreed.

It doesn’t seem to be enough to simply read the vial labels. Busy workers in pharmacies and primary care clinics have grabbled the wrong ones and injected them.

One person at the CDC ACIP meeting on September 1, 2022 said, “Structural problems required structural solutions,” referring to the vials which have similar packaging, an opinion shared by others. The Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Boosters slide set makes the distinctions pretty clear.

I hope the pharmacies and other clinics get the pictures. Just because we’re all a little nervous about making mistakes doesn’t mean we have to call the whole thing off.

What is the Answer to Automated Answering Machine Recordings?

I’ve been calling local pharmacies in an effort to schedule getting the updated Covid-19 vaccine updated bivalent booster and the flu shot as well. I imagine I’m not the only one encountering the frustrating automated answering machines.

It’s confusing to find out that if I answer the question about how many Covid-19 vaccine shots I’ve gotten (which is 4, including the two initial doses and two boosters), the machine politely sort of congratulates me (“you’re good to go!) and then hangs up. That contrasts with the web-based organization message in large font against a bright red background which assures me that I can schedule a time to get both vaccines—if I set up an on-line account (which always makes me suspicious). It turns out that the old “continue as a guest” alternative puts my personal information at risk. I’m unable to get a live person on the line.

I found a few tactics on the web for bypassing these recordings, but I’m pretty sure they don’t work. Some of them have been around for over 15 years, like pressing zero once or even repeatedly. That can result in the recording automatically hanging up on you.

There are other suggestions for pressing various special characters on your smartphone, which some people swear by.

Speaking of swearing, I even found one suggestion for swearing repeatedly into the phone to get past the automated answering machine. I’m pretty sure that doesn’t work.

I think I’ll just sit tight and wait a while. There’s no rush. But I wish there were some polite and effective way to get a live person on the line when you get the automated answering machine from hell:

Drugs-R-Us Pharmacy: Hello, what would you like to do today? You can say, “vaccine,” “alien abductions,” or “triple fat burger with soggy fries and a cola.”

Customer: Vaccine.

Drugs-R-Us: Thank you! Would you like to do: schedule a new, review a scheduled time, cancel an appointment, or talk about the weather?

Customer: Schedule a new.

Drugs-R-Us: What vaccine would you like to schedule?

Customer: Updated Covid-19 booster.

Drugs-R-Us: Got it! And would you like any other vaccines?

Customer: Flu shot.

Drugs-R-Us: I see; I’ll make a note of that. You can ask the pharmacist at your visit for another vaccine, which would be administered as an intra-ocular injection in the eye of your choice. Now, a booster. I’ll need some more information, including your birthdate, phone number, number of previous vaccinations, distinguishing marks, social security number, all bank account numbers, record of previous arrests, and the name of your first-born child, if any. First, how many vaccines have you received?

Customer: Four.

Drugs-R-Us: You rock! You have all the vaccines you need and that means it’s Beer O’clock for you, dude. Is there anything else?

Customer: But I want the updated Covid-19 booster! Can’t you understand that it’s new and your company says it’s available now?

Drugs-R-Us: Good-bye (click).

Maybe I’ll have better luck next week.

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