FDA VRBPAC Discussion Topics Today

The FDA VRBPAC 178th annual meeting on future Covid-19 vaccine regimens includes two main discussion topics:

“Future periodic vaccination campaigns:
Simplification of COVID-19 vaccine use:

  • Immunization schedule: Please discuss and provide input on simplifying
    the immunization schedule to authorize or approve a two-dose series in
    certain young children, and in older adults and persons with compromised
    immunity, and only one dose in all other individuals.
    Periodic update to COVID-19 vaccines:
  • Vaccine composition: Please discuss and provide input on the
    consideration of periodic updates to COVID-19 vaccine composition,
    including to the currently authorized or approved vaccines to be available
    for use in the U.S. in the fall of 2023.”

Among the members attending the web conference is University of Iowa Professor Stanley Perlman, MD, PhD, Departments of Microbiology and
Immunology, Professor of Pediatrics, Mark Stinski Chair in Virology.

The meeting is today from 8:30 AM to 5:30 PM ET.

Update: Dr. Stanley Perlman MD, PhD from the University of Iowa will be the acting voting chairman of today’s meeting.

Update: Dr. Jerry Weir gave a clarifying and practical bird’s eye view of the issue at hand which began at 2:30 PM on the live play today (the meeting is being recorded). The questions and comments for Dr. Weir by Offit, Levy, and Chatterjee were also helpful to hear.

Update: Voting Question is:

“VRBPAC 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)?”

Voting Result: Unanimously upvoted.

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.

Two Vaccine Jabs in One Arm or One in Each Arm?

There were headlines about whether it’s better to get the flu shot and the Covid-19 updated booster in one arm or one in each.

It doesn’t matter. Sena got both in one arm. Mine were split. I think it depended on the preference of the person giving the shots.

The main thing is that you consider getting them, at least. That part is up to you.

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