Covid 19 – Go Retire Psychiatrist

CDC ACIP Highlights on Covid 19 Vaccine

There was a lot to digest in today’s CDC ACIP meeting on Covid-19 vaccines. I missed the morning sessions but managed to see a few of the afternoon presentations.

The presentation by Dr. Retsef Levi, PhD, MIT, ACIP Work Group Chair, the Covid -19 Vaccine Discussion Framing Work Group (WG) was basically pretty critical of the Covid-19 vaccines in general.

The opposing reply to this (favorable to vaccines) was put together by University of Iowa’s Dr. Stanley Perlman, Dr. H. Bernstein, and Dr. M. Miglis, Additional Workgroup Considerations in Covid-19 Vaccination Policy and Practice.

For a change, I listened to the Public Comment section. I usually have not paid attention to them because most of the speakers were opposed to vaccines. Today was different. All of them were strongly supportive of vaccines.

There is a bottom line to this. I watched the voting session, which was very interesting. There were 4 voting questions. I had to take pictures of them because they were not included in the on-line schedule. It was easily the most interesting session of the afternoon, at least for me.

Voting question 1: all but one member voted “yes,” the committee chair Kulldorff voted “no.”

Voting question 2: one member suggested striking this one, but they voted anyway. What’s worrisome is that it was split between the yes and no votes; only the chair, Kulldorff, could break it and he voted “no.” Looks like common sense won; otherwise it would have made access very difficult.

Voting question 3: The video lost audio for a long time, but eventually it turned out that the votes were “yes” unanimously on the assumption that pharmacists counted as “health care providers.”

Voting question 4: The votes were all “yes,” mainly because they decided that pharmacists could make this work. One member questioned the wording which suggested that you needed to talk to your doctor about getting the vaccine because of the wording “shared clinical decision-making.” They glossed over it.

It looks like access to the Covid-19 vaccine will remain mostly open for now.

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.

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

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 Approves Updated Covid-19 Vaccines to Better Protect Against Currently Circulating Variants

On August 22, 2024, the FDA authorized new Covid-19 vaccines (2024-2025) “to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.”

CDC Covid Information

Often, I see news agency headlines claiming to have insider information about what’s going on with the Centers for Disease Control (CDC), FDA, etc. I respect the opinions of others about government agencies. On the other hand, I like to get information straight from the horse’s mouth.

With that in mind, here’s what the CDC says is important to know about the Covid-19 situation.