What’s the Skinny on a Vaccine that Might Prevent or Slow Down Dementia?

You don’t want to just take my word for it but there seems to be conflicting messages on a live, attenuated shingles vaccine called Zostavax.

One message is that “the live, attenuated herpes zoster (HZ; shingles) vaccine” might prevent or slow down dementia, especially in women according to a study in Wales and Australia. The article doesn’t mention the name Zostavax (the trade name for the live, attenuated herpes zoster vaccine), which according to a Wikipedia article was “discontinued in the U.S. in November of 2020.”

The other message is that partly because of several lawsuits against Merck (the manufacturer, which faced a lot of Zostavax lawsuits) regarding possible severe, potentially life-threatening side effects alleged to be associated with it, production and marketing of the vaccine was discontinued in the United States as of 2020. The other reason was that Shingrix, a recombinant form of the vaccine, was developed.

Shingrix is said to be superior to Zostavax, although it is also associated with some side effects.

I don’t know why I don’t find any FDA or CDC notifications that Zostavax is no longer available in the United States. Both agencies have archived approval notices still on their websites.

CIDRAP doesn’t mention that residents of the U.S. can longer get Zostavax (in other words, the live attenuated vaccine against shingles) as of 2020.

One of the problems I find with web-based information is that some of the entries can be confusing. I found several articles on line from law firms including one which posted a report on November 14, 2024 that two Black Box Warnings were published by the FDA about Zostavax. I could find only one safety warning on the FDA website (not labeled as “Black Box”) and it was about the new recombinant vaccine, Shingrix. It’s been associated with Guillain Barre Syndrome (GBS) and it’s dated March 24, 2021—a year after Zostavax was removed from the market in the U.S.

OK, as an old retired doctor, my bottom line on this issue of live, attenuated herpes zoster vaccine being touted as an agent that could delay or prevent dementia is that it would be a lot more helpful to me as a consumer to know the whole story about the product. It might be scientifically interesting but it’s moot because the product is not even available in this country and for good reason. And even if it were, would the potential risk and benefit assessment be favorable to recommend its use? And how does this affect the ongoing disagreement dividing the country about the safety and effectiveness of vaccines? Only about 20% of Iowans are even getting the flu shot this season so far.

One thing people could do which might slow down some of the cognitive impairment is to take up the game of cribbage. As far as I know, it has almost no detrimental side effects unless you insist on playing the muggins rule.

CDC ACIP Meeting Agenda Posted

I just noticed that the CDC ACIP draft agenda for upcoming meeting on September 18th and 19th has been posted. There will be votes on the MMRV, Hepatitis B, and Covid-19 vaccines.

Upcoming CDC Advisory Committee Meeting in September 2025-Or Not?

I’ve been checking the Centers for Advisory Committee schedule on their website for weeks and the only way I found out there is an upcoming meeting is on the Federal Register schedule. Sena found it in a news outlet story. As of this morning around 9 a.m., there was no announcement on the CDC website yet. That may change later today.

According to the Federal Register, the CDC ACIP will hold a meeting on September 18, 2025, from 10 a.m. to 5 p.m., EDT, and September 19, 2025, from 8 a.m. to 4 p.m., EDT.

Under Supplementary Information:

“The agenda will include discussions on COVID-19 vaccines; Hepatitis B vaccine; measles, mumps, rubella, varicella (MMRV) vaccine; and Respiratory Syncytial Virus (RSV). The agenda will include updates on ACIP Workgroups. Recommendation votes may be scheduled for COVID-19 vaccines, Hepatitis B vaccine, MMRV vaccine, and RSV. Vaccines for Children (VFC) may be scheduled for COVID-19 vaccines, Hepatitis B vaccine, MMRV vaccine, and RSV. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda, visit https://www.cdc.gov/acip/meetings/index.html.”

However, I also noticed a news article posted by the Center for Infectious Disease Research and Policy (CIDRAP) indicating that the meeting might be postponed because of the recent upheaval around vaccine policy and personnel.

This meeting’s actual timing and schedule items could be moving targets.

Sena Gets her Measles Vaccine-and Will Not Be Defeated!

Sena got a measles vaccine booster today just to be on the safe side given the increase in the number of measles cases all over the country, including Iowa.

The history of the measles vaccine is fascinating by the way. It can make it challenging to figure out who might need a booster.

Despite the mild headache from the shot—she won our cribbage match again. She will not be defeated!

CDC Advisory Committee Meeting on Vaccines Starts Tomorrow

The CDC ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) is scheduled to begin their meeting tomorrow at 10:00 AM ET despite US Senator Bill Cassidy’s recommendation that it be postponed due to concerns about the lack of experience of the committee members and because there is not yet confirmation of a new CDC Director.

In fact, the CDC Director nominee, Dr. Susan Monarez, of Wisconsin, is scheduled for her confirmation hearing at the same time as the start of the CDC ACIP meeting tomorrow morning at 10:00 AM ET. Dr. Monarez would be the first CDC director “…in decades…” (according to a report posted in The Hill in May) who has neither previously worked at the CDC “…nor obtained a Doctor of Medicine degree…”

As of this morning around 10:00 AM, the meeting agenda has not yet been finalized. So far, it looks like there will be no vote on the Covid-19 vaccine update, although there will be a vote on Thimerosal in flu vaccines about which the FDA has previously published an extensive summary.

Dept of Health & Human Services to Reconstitute CDC Advisory Committee on Immunization Practices

HHS announced the removal and replacement of the current members of the CDC Advisory Committee on Immunization Practices in a press release today. The CDC ACIP meeting for vaccine recommendations is still scheduled for June 25-27. According to the Federal Register announcement under Supplementary Information:

“SUPPLEMENTARY INFORMATION:

Purpose: The Advisory Committee on Immunization Practices is charged with advising the Director, Centers for Disease Control and Prevention (CDC), on the use of immunizing agents. In addition, under 42 U.S.C. 1396s, the Committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program, along with schedules regarding dosing interval, dosage, and contraindications to administration of vaccines. Further, under applicable provisions of the Affordable Care Act and section 2713 of the Public Health Service Act, immunization recommendations of ACIP that have been adopted by the Director, CDC, and appear on CDC immunization schedules generally must be covered by applicable health plans.

Matters To Be Considered: The agenda will include discussions on anthrax vaccines, chikungunya vaccines, COVID-19 vaccines, cytomegalovirus (CMV) vaccine, Human papillomavirus (HPV) vaccine, influenza vaccines, Lyme disease vaccine, meningococcal vaccines, pneumococcal vaccines, Respiratory Syncytial Virus (RSV) vaccines for adults, and RSV vaccines for maternal and pediatric populations. Recommendation votes are scheduled for COVID-19 vaccines, HPV vaccine, influenza vaccines, meningococcal vaccine, RSV vaccines for adults, and RSV vaccine for maternal and pediatric populations. Vaccines for Children (VFC) votes are scheduled for COVID-19 vaccines, HPV vaccine, influenza vaccines, and RSV vaccines. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda, visit https://www.cdc.gov/acip/meetings/index.html.

Meeting Information: The meeting will be webcast live via the World Wide Web. For more information on ACIP, please visit the ACIP website: https://www.cdc.gov/acip.“

So, I Got the Covid-19 Booster Today

After giving the Covid-19 summer booster a lot of thought, I got it today. What the heck. I’m an old guy and the experts all agree that the summer surge is real, including the current leaders of the FDA Center for Biologics Evaluation and Research (Vinay Prasad, M.D., M.P.H and Martin A. Makary, M.D., M.P.H.).

I read their article “An Evidence-Based Approach to Covid-19 Vaccination” published in the New England Journal of Medicine on May 20, 2025. It sounds like they’re going to require placebo-controlled trials for new vaccines for almost everybody except those over age 65 and high risk because they’re not recommending it for certain other groups such as healthy children.

I didn’t think it was worth the wait for the upcoming CDC ACIP meeting on June 22, 2025 in order to decide whether or not to get the summer vaccine. It’s the same one I got last fall and the same one the FDA advisory committee decided at this month’s meeting would be appropriate going forward (the JN.1 lineage).

It wasn’t like there was a long wait time to get the vaccine today. There wasn’t a line. I scheduled it but I didn’t have to because I got right in.

It’s true that vaccine uptake has been low. However, I think on balance they’ve been proven to be safe and effective so I’m not sure that placebo-controlled trials are warranted. I guess we’ll just have to agree to disagree.

Reference:

An Evidence-Based Approach to Covid-19 Vaccination

Authors: Vinay Prasad, M.D., M.P.H., and Martin A. Makary, M.D., M.P.H.Author Info & Affiliations

Published May 20, 2025

DOI: 10.1056/NEJMsb2506929

The FDA VRBPAC Meeting Today on Covid-19 Vaccines for 2025-26

The FDA VRBPAC meeting today on the Covid-19 vaccines for 2025-26 is so far leading me to believe that the best choice for the voting question-

Based on the evidence presented, please discuss considerations for the selection of JN.1 and/or a specific JN.1-lineage strain for COVID-19 vaccines (2025-2026 Formula) to be used in the U.S.

-might just be sticking with last year’s Covid-19 JN.1 lineage vaccine rather than targeting the newest LP.8.1 strain. The strains so far aren’t suggesting a seasonal pattern. Some strains only last for weeks and it seems getting or making a vaccine for a Covid-19 strain that disappears by the time the manufacturer rolls out a vaccine for it could turn out to be a waste of time.

Neverthe less, all three of the industry presenters are calling this a “seasonal” update to their Covid-19 vaccine products. They’re hedging their bets, so to speak, and would be ready to market a vaccine targeting LP.8.1 if the FDA decides to license the product.

I’ve held off getting the JN.1 vaccine so far in anticipation of today’s meeting, to see if there’s any reason not to get it based on today’s decision.

But the day is young. I’ll probably be making periodic updates to this post today. I think Dr. Jerry Weir’s slides are excellent, as usual.

“Voting Question
For the 2025-2026 Formula of COVID-19 vaccines in the U.S., does the committee recommend a monovalent JN.1-lineage vaccine composition?
Please vote “Yes” or “No” or “Abstain”

“Discussion Topic
Based on the evidence presented, please discuss considerations for the selection of
JN.1 and/or a specific JN.1-lineage strain for COVID-19 vaccines (2025-2026 Formula) to be used in the U.S.”

Update: Of course, the committee voted unanimously for the JN.1 lineage because there was no alternate choice. The only choice for the members was to vote for the JN.1-lineage or against it. Although I agree with the “vote,” I think they should have had the alternate of LP.8.1 available, otherwise why have a vote at all? I wonder what the FDA will do now.

CDC ACIP Meeting Today on Vaccines

There’s a CDC ACIP Meeting scheduled to start at 8:00 AM EST today (caught me off guard). The slides are here.

Noteworthy: Dr. Denise Jamieson, MD, MPH is chair of the CMV Working Group. She is Vice President for Medical Affairs and the Tyrone D. Artz Dean, Roy J. and Lucille A. Carver College of Medicine at University of Iowa. In the Q&A session following the Covid-19 vaccine presentation, Dr. Jamieson expressed a preference for a universal recommendation (citing implementation and uptake challenges, which other attendees mentioned as well) for the Covid-19 vaccine as opposed to a risk-based or permissive recommendation. See slide labeled “Discussion” below:

There was no vote scheduled for today’s meeting on the Covid-19 vaccine.

The presentation by Moderna on the new Covid-19 vaccine, mRNA-1283, was helpful. I gather there will be an FDA meeting about it in June.

What Does “Design Defect” of a Vaccine Mean In the Iowa Bill to Require Vaccine Manufacturers to Waive Immunity from Lawsuits?

Beats me. Sorry, just kidding. I’m just a little bleary from looking at the web sites about the definition of “design defect” related to vaccines as it applies to the Iowa bill to make vaccine manufacturers waive their immunity from lawsuits about vaccine related injuries.

I am sympathetic to anyone who in fact has suffered a vaccine related injury.

That term “design defect” has been bugging me for days now and I just found out that this has been the subject of states vs federal legal wrangling for years. I’m not up to explaining all the legalese but there is a really tangled trail of cases in Georgia and Pennsylvania roughly around 15 years ago that ultimately led to a U.S. Supreme Court decision saying, essentially, the Vaccine Injury Compensation Program and the federal Childhood Vaccine Injury Act of the 1980s preempts all state level vaccine design defect claims.

I think that explains why the Iowa bill says that vaccine manufacturers have to waive their immunity from suits if they want Iowans to get their vaccines.

I can hear the groans and shouts of dissent even as I write this. Hey, you can’t make this up. Talk to your legislator or lawyer about it.

I’m not sure why Iowa would want to repeat the grind that Georgia and Pennsylvania went through which led to the conclusion that you can file vaccine design defect claims at the state level and not have to repeat history which would likely lead to any decisions made there being reversed in federal court.

And I’m not sure why any vaccine manufacturer would want to fight that battle in Iowa either. They might just steer around us and take their vaccines elsewhere.

The beginning of the Georgia story.

The end of the Georgia story.

The beginning and the end of the Pennsylvania story.

Vaccines aren’t perfect. They are neither 100% safe nor 100% effective. However, I support having vaccines available to help keep us healthy and the right to choose getting a vaccine. That’s why I don’t support a bill that I believe would make them less accessible.