Center for Infectious Disease Research and Policy Outlook on Covid Data and New CDC ACIP Committee

I have a lot more faith in the infectious disease news from the University of Minnesota Center for Infectious Disease Research and Policy Outlook (CIDRAP) than most other news outlets. Their review of the so far 8 newly appointed CDC ACIP committee members is interesting. I plan to watch the upcoming June 25-27 CDC ACIP meeting.

They also provide updates on the CDC Covid-19 variant tracking data. While the LP.8.1 has been in the spotlight lately as the upcoming variant of note, the Nowcast estimates of the proportion of NB.1.8.1 are currently almost equal to LP.8.1. They report the NB.1.8.1 is minimally more immune evasive than LP.8.1. They are both descended from the JN.1 lineage. Overall, Covid-19 activity is low.

Can We Calm Down?

First of all, I want to make it clear that I am not now nor have I ever been pregnant. Now that I have your attention, I’ll add some context to that weird statement by saying how puzzled I am by all the controversy about whether or not there’s actually a federal recommendation against pregnant women getting the Covid-19 vaccine.

I admit, I actually did think about the movie “Signs” in which the lead character, Graham Hess, says “Everybody in this house needs to calm down and eat some fruit or something.” I think it fits.

I found a lot of news stories claiming that HHS and the CDC don’t recommend that pregnant women get the Covid-19 vaccine. What I actually found on the HHS web site says the opposite—the agency recommends it.

That seems to agree with the paper from the FDA leadership, published in the New England Journal of Medicine by Drs. Prasad and Makary (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.

“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, as described by the CDC (Figure 2).”

Figure 2 is a table which lists many medical conditions that are indications for getting the Covid-19 vaccine. Pregnancy is one of them, based on the idea that it could increase the severity of Covid-19 disease.

On the other hand, when I looked at the health care provider page on the CDC website, the table showing the clinical indications for the Covid-19 vaccine sends a confusing message by showing pregnancy as a condition for which there is currently “No Guidance/Not Applicable.”

Just in case this web page gets updated, I took a screenshot of that part of the table:

But elsewhere on the CDC website are pages which clearly recommend that pregnant women get the Covid-19 vaccine.

I’m not making any political statements here. I’m just an old guy who clearly does have an indication for getting the Covid-19 vaccine and I recently did just that last month.

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.

FDA Vaccines and Related Biological Products Advisory Committee Meeting May 22, 2025

The meeting of the FDA VRBPAC on the composition of Covid-19 vaccines will be tomorrow, May 22, 2025 at 8:30 am-4:30 pm EST. Some materials have recently become available on the FDA website.

The briefing document indicates that there will be a discussion of the most recent Covid-19 variants and whether the current vaccine needs to be modified as the viral antigenic strain has mutated.

The World Health Organization has formed a new technical advisory group: “Technical Advisory Group on COVID19 Vaccine Composition (TAG-CO-VAC) to review and assess the public health implications of emerging SARS-CoV-2 variants of concern (VOCs) on the performance of COVID-19 vaccines and to provide recommendations to WHO on proposed modifications to COVID-19 vaccine antigen composition. Recently, the TAG-CO-VAC advised that a monovalent JN.1 or KP.2 vaccines remain as appropriate vaccine antigen, while a monovalent LP.8.1 is a suitable alternative vaccine antigen (Ref: https://www.who.int/news/item/15-05-2025-statement-on-the-antigen-composition-of-covid-19-vaccines) to be included in the composition of COVID-19 vaccines (2025-2026 Formula).”

The VRBPAC meeting topics:

“On May 22, 2025, VRBPAC will meet in open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the U.S. The committee will be asked to discuss available evidence on recent and currently circulating SARS-CoV-2 variants, including data from virus surveillance and genomic analyses, antigenic characterization analyses, vaccine effectiveness and clinical immunogenicity studies of current U.S.- authorized/approved COVID-19 vaccines and nonclinical immunogenicity studies of candidate vaccines expressing or containing updated Spike antigens.”

The attendees include:

The TAG-CO-VAC presenter:

Kanta Subbarao, M.B.B.S., M.P.H. Professor Department of Microbiology and Immunology Faculty of Medicine Laval University (Laval University is in Quebec City, Quebec, Canada).

There’s an Iowa City member on the committee roster:

Stanley M. Perlman, M.D., Ph.D. Expertise: Pediatrics, Infectious Diseases Term: 08/23/2022 – 01/31/2026 Professor University of Iowa Distinguished Chair Department of Microbiology and Immunology Carver College of Medicine University of Iowa, Iowa City, IA 52242.

And the acting chair of the meeting will once again be: Arnold Monto, M.D. Expertise: Epidemiology Term: 02/01/2022 – 01/31/2026 Thomas Francis Jr. Collegiate Professor Emeritus of Public Health and Epidemiology School of Public Health University of Michigan Ann Arbor, MI 48109.

Vaccine manufacturer presentations will be from Moderna, Pfizer, Novavax, and Sanofi.

FDA VRBPAC Meeting to Discuss Covid-19 Vaccines

The FDA VRBPAC meeting to discuss Covid–19 vaccines is scheduled for May 22, 2025, 8:30 a.m. – 4:30 p.m. ET. The committee will meet in open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.

I couldn’t see any specifics about the forthcoming meeting. I assume there will be updates.

Procrastinate on Getting the Covid Vaccine?

This post is sort of my thinking out loud about whether or not I should get the Covid vaccine ahead of this summer that was approved last year as being appropriate to get twice a year by the CDC—once in the fall along with the flu shot and once to protect against the Covid summer surge that some experts argue has been happening every summer since the pandemic onset.

The trouble is that the dominant subvariant is no longer the JN.1 or KP.3.11. The currently dominant circulating bug is LP.8.1 according to the CDC Nowcast chart.

And what confuses me is that one expert still recommends getting the September 2023 updated vaccine, but recommends getting the “bivalent booster.”

And a recent article from the University of Minnesota Center for Infectious Disease Research and Policy (CIDRAP) says that a preprint study (not yet peer-reviewed) says the current Covid vaccine was only 53% effective against hospitalization and 39% medically attended Covid-19. Most patients got the vaccine targeting the XBB.1.5 variant. I think that’s related somehow to the KP.2 variant. I have a vague memory of hearing about the XBB.1.5 during the CDC meeting in September 2023.

I’m a retired psychiatrist, not a retired virologist. The information available to the public seems confusing to me and I imagine I’m not the only one so affected.

The CDC is recommending the 2024-2025 Covid-19 vaccines, which target the JN.1 variant, which is now 0% of circulating variants on the list. But I’m not sure whether the current vaccines would be as protective against the different variants now dominant.

The CDC April indicators show downward trends for test positivity, ER visits, hospitalizations, and deaths.

On the other hand, an August 2024 article from Johns Hopkins warns that Covid-19 rates have consistently risen in July-August risen since 2020. The author says that it’s still unclear whether Covid-19 will continue to have dual seasonality. Other factors that affect this in addition to the emergence of more transmissible variants are human behavior, such as staying in air-conditioned spaces more and traveling.

My big question is should an old guy get the 2024-2025 Covid-19 vaccine or just wait and see, especially in light of the difficult political situation with HHS sounding like it might require new, placebo-controlled trials of some vaccines before “tweaking” them to target more current variants—which could take several months.

But it doesn’t look like there’s a plan to tweak the 2024-2025 Covid-19 vaccine in any case. I’m probably worrying too much, but I’m on the fence. I’m already too good at procrastinating.

Proposed Bill Would Ban mRNA Vaccines in Iowa

Sena just alerted me to a bill in the Iowa legislature right now that proposes mRNA vaccines (like the Covid vaccine for example) be banned in Iowa. Part of it says that any person who provides or administers such a vaccine would be guilty of a simple misdemeanor and subject to a $500 fine. I do not support it although I also support the right of others to disagree.

The bill advanced out of subcommittee yesterday and I’m not sure how although, admittedly, I don’t know what exactly that means about its chance of being ultimately passed into law. There were hundreds of comments against it. It moves for further consideration to the Iowa Senate Health and Human Services Committee according to a story in the Daily Iowan.

This sent me to the web to find out what other silly laws Iowa has passed. A few of them are below:

“Any person who attempts to pass off margarine, oleo, or oleomargarine as real butter is guilty of a simple misdemeanor in Iowa. This one originated in 1943, but is still in force today.”

“In Marshalltown, horses are forbidden to eat fire hydrants.”

“It is illegal for a mustached man to kiss a woman in public.”

All of the above are on this Iowa State University web page.

CDC Meeting Results in Recommending a 2nd Covid-19 Vaccine Dose for Those 65yr and Older and for the Immunocompromised

I missed the October CDC meeting which resulted in a decision to recommend a 2nd dose of the Covid-19 vaccine for those 65 years and older and for the immunocompromised.

The Evidence to Recommendations (EtR) slides by Roper indicated Covid-19 circulates year round, peaking in late summer and winter.

The recommendation that those in the above-named populations should get 2 doses of Covid-19 vaccine spaced 6 months apart seems based on reasonable considerations.

It looks like the vaccine would be the same as the one previously recommended for this year.