Category: Brief Messages or Announcements

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.

May Mental Health Awareness Month Calendar and Checklist (look below this sticky post for other new posts)

mental health checklist
mental health awareness calendar

May is Mental Health Awareness Month!

This is May and it’s Mental Health Awareness Month. I just found out about something exciting and it’s the Iowa Healthiest State Initiative.

See the Calendar of Events and the Checklist.

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.

Jim vs Donald Trump on Cribbage Pro

President Donald Trump and I made a deal about his plan to make Canada the 51st state of America. If President Trump wins, he goes ahead and tries it. If I win, he lets it go.

I won.

This is satire! Happy April Fool’s Day!

Stead Family Children’s Hospital NICU Gets a Wave from the AAP with New Designation

The University of Iowa Stead Family Children’s Hospital Neonatal Intensive Care Unit was recently recognized by the American Academy of Pediatrics (AAP) as one of only two such units in the U.S. having the highest levels of neonatal care.

It reminds me of the Iowa Hawkeye football games where, at the end of the first quarter, all the players and football fans wave from the field to the pediatric patients and their families watching the game from UI Stead Family Children’s Hospital. It’s called the Wave, one of the best traditions in college sports.

Well, the AAP waves to Stead Family Children’s Hospital NICU.

FDA Announces Clozapine REMS Program Eliminated

As of February 24, 2025, the FDA has eliminated the Clozapine Risk Evaluation and Mitigation Strategy (REMS) program. See the FDA link for details. Below is the announcement.

“Latest Update

February 24, 2025 – Beginning today, FDA does not expect prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategies (REMS) program for clozapine or to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine. FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. Information about severe neutropenia will remain in the prescribing information for all clozapine medicines, including in the existing Boxed Warnings.    

Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk. Eliminating the REMS is expected to decrease the burden on the health care delivery system and improve access to clozapine. FDA has notified the manufacturers that the clozapine REMS must be eliminated. FDA has instructed the clozapine manufacturers to formally submit a modification to eliminate the Clozapine REMS and to update the prescribing information, including removing mandatory reporting of ANC blood tests to the REMS program.  

In the coming months, FDA will work with the clozapine manufacturers to update the prescribing information and eliminate the Clozapine REMS.”–FDA

New Snow Shovels!

The new shovels were delivered today. Both required some assembly. I’m the least handy person when it comes to that. I did OK with the snow plow but Sena had to come to the rescue when it came to the cordless snow shovel. The handle was tricky for some reason.

The batteries for the electric shovel needed minimal charging and it roared to life. It doesn’t sound like a toy.

Now all we need is snow. I can wait.