FDA Advisory Committee to Discuss Pfizer COVID-19 Vaccine for Children 5 Through 11 Years of Age

On October 26, 2021 the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss the extension of the Pfizer EUA for the COVID-19 vaccine for children 5 through 11 years of age. Some event materials are already available. The meeting is scheduled for at 8:30 AM-5:00 PM, ET.

Advisory Committee on Immunization Practices Meeting on COVID-19 Vaccine Boosters

I still can’t make heads or tails out of what’s happening with the CDC Advisory Committee on Immunization Practices (ACIP) meeting today and tomorrow. The agenda is still in draft form and it’s dated “Draft—October 14, 2021.” I’m writing this as the ACIP web page is testing it’s incoming and outgoing audio at 8:40 AM, CDT. I’m updating today as the meeting proceeds.

I thought the meeting was going to be mainly about the Moderna and Janssen COVID-19 vaccine boosters, but there are no slides published yet and the agenda looks like it’s mainly about other vaccines. There is one presentation scheduled for this afternoon about influenza vaccines entitled “Phase II safety and immunogenicity study of the coadministration of Fluzone® High-Dose Quadrivalent Influenza Vaccine and a third dose of mRNA-1273 COVID-19 vaccine (Moderna).” I have a stake in the meeting as I wait for the Moderna booster to get the green light.

Tomorrow’s agenda still says “Coronavirus Disease 2019 (COVID-19) Vaccines, TBD.” The only votes so far pertain to the pneumococcal and zoster vaccines, which is for later this afternoon.

There’s also no FDA website update on the final decision regarding recommendations for the Moderna and Janssen booster vaccines. There have been media rumors that the FDA might recommend heterologous boosting (mix and match).

The meeting started on time at approximately 9:00 AM, CDT and the agenda was abruptly updated to final form (which looked like it contained a typo for the presentation about the combination injection of the Fluzone and Moderna booster (omitted after the words “…third dose of…” compare above). The final agenda revealed discussion of the boosters tomorrow starting at 9:15 AM, CDT. Also updated were some of the slide presentations (just for today). There will be a vote tomorrow afternoon on the Moderna and Janssen boosters. This will follow presentations on Moderna and Janssen booster data, NIH mix-and-match booster study, COVID-19 vaccine safety data including data about myocarditis, effectiveness of COVID-19 vaccines, evidence for recommendations, and policy questions.

There was an announcement that the FDA favored using heterologous boosting and that later today that would be posted on the FDA website.

I’ll probably only be spot-checking the proceedings during the day, since it looks like the main event for COVID-19 boosters will take place tomorrow.

Afternoon Update: The presentation “Phase II safety and immunogenicity study of the coadministration of Fluzone® High-Dose Quadrivalent Influenza Vaccine and a third dose of mRNA-1273 COVID-19 vaccine (Moderna)” started around 1:30 PM, CDT this afternoon. Fatigue was the most frequently reported systemic reaction. There were no serious adverse events. The combination can be given safely together without evidence of immunogenicity interference. The shots were given in different arms. All subjects had previously received the primary series (both shots) of the Moderna vaccine. The CDC website already has indicated on their website that the COVID-19 vaccine and the flu vaccine can be given at the same visit.

Waiting for Another Jab

I’m still waiting for my Moderna booster, which has to be blessed by the CDC Advisory Committee on Immunization Practices (ACIP). Every time I check the schedule for their next meeting on October 20, 21, I still see a draft agenda. The CDC still does not recommend heterologous boosting, although last week the FDA advisory committee discussed the preliminary results from an ongoing study about it and the data showed it was safe and resulted in impressive boosting. They had a discussion question about it, but there was no vote.  

My wife Sena, got her Pfizer booster last week. She had a sore arm for about a day and no other side effects. When I got my first Moderna shot, my left arm swelled up and got red and sore. If I had gotten another injection in the other arm, I would have looked buff.

I just remembered that when I was playing junior league baseball, I got hit with a bat in that same arm in the same spot. I think it took longer for that to heal up. I always struck out anyway. I think the pneumovax I got last month hurt more than the COVID shot.

After my second jab, I got pretty tired for about a day, but still exercised and didn’t really limit my activities beyond my usual laziness. I was still able to sprint away at top speed from Sena when she came looking for me to do some chores. She didn’t have any side effects at all from her primary series.

Before the vaccines were available about a year and a half ago and I was still working at the hospital as a psychiatric consultant, I saw patients who had COVID-19. In the general hospital, all of them were pretty sick, although at that time we were not supposed to see any ICU COVID-19 patients. I saw a patient with a catatonic-like syndrome, who didn’t respond to an intravenous benzodiazepine challenge test (see yesterday’s post about the catatonic variant of delirium). I always wore the proper Personal Protective Equipment (PPE).

Anyway, it sounds like more and more people are getting COVID-19 vaccines. I believe it’s the right thing to do. I’m not a big fan of mandates. Million-dollar lotteries didn’t seem to get the vaccination rates up very much. I don’t think scaring people is the ideal way to motivate them. I guess it’s up to you.

Thoughts on Transplant Psychiatry

I see in the news that organ transplant centers have removed a few patients from wait lists because they refuse COVID-19 vaccines. It may seem odd, but this reminds me of an even more difficult situation in organ transplantation. What do you do about those who just refuse organ transplant altogether?

I used to be a psychiatric consultant and that meant providing psychiatric consultations to the organ transplant service as well.

As anyone can imagine, refusing a transplant is uncommon. But it happens.

There are strong contraindications to transplant, among them severe psychiatric illness, medical noncompliance, absent social support, and active substance use.

There are not enough organs to go around. Many transplant candidates die every year while on the waiting list. Graft survival rates are usually shorter than survival rates, meaning some patients will need more than one transplant.

This means that selection criteria for candidates must be fair and realistic. More than 95% of transplant programs require psychosocial evaluations. There are usually not enough transplant psychiatrists to do this so a team approach is used in which social workers, nurse practitioners, psychologists, substance use disorders experts, and psychiatric consultants collaborate.

While it can be unsettling to remove a patient from the wait list, few people outside of the transplant center realize it can be even more upsetting to hear a patient say “no” to transplant. In all cases, the patient’s life probably has been saved many times. Often, all members of the team have invested a great deal of emotional energy to keeping the patient in the game.

There is also another incentive for transplant centers which must, in all fairness, be acknowledged. The government requires centers to do a certain number of transplant surgeries a year to retain their transplant Medicare certification. The procedure itself costs hundreds of thousands of dollars.

One typical letter from a transplant center can look like this:

“…specific outcome requirements must be met by transplant centers as outlined by the Centers for Medicare and Medicaid Services.  Programs are required to notify their patients if these requirements are not met.  Currently, Hospital X meets all requirements for transplant centers.”

There is a report by the Scientific Registry of Transplant Recipients (SRTR) which updates transplant statistics for all transplant programs. Anyone can look at the numbers.

This can become a point of pride and possibly some competition between centers. The older reference below is an example:

“Does Competition Among Transplant Centers Lead to Efficient Organ Allocation?” Scanlon D, Ubel PA, Loh E; Academy for Health Services Research and Health Policy. Meeting. Abstr Acad Health Serv Res Health Policy Meet. 2001; 18: 17. Short answer is-probably not, rather leads to inappropriate listing.

This means that an ethics consultation would be a good idea in many complicated organ transplant cases. The University of Washington has a “4 Boxes” tool that I used as a guide for years. The contextual features box merits close examination.

Anyhow, the patient who outright refuses transplant presents the transplant team with a singular question. Does this patient want to die? Usually that triggers a call to the psychiatric consultant. My role as an interdisciplinary collaborator was to focus on identifying psychosocial challenges to address in order to maximize postoperative chances of successful outcomes. That sentence was from the team’s perspective. However, my real goal was to listen to the patient and try to understand. In fact, I had a dual role. My main role, from the point of view of the transplant team, was to enhance the suitability of the patient for transplant—from a psychiatric standpoint.

It was never that easy, especially when the patient didn’t want a transplant. Suitability was out the window. Also, there are more or less discrete phases of transplant.

The Evaluation Phase in which the patient is usually very sick, faced with a terminal illness, and eager to be transplanted.

The Waiting for Donor Phase, often a very stressful time, frequently marked by demoralization as others get transplanted sooner.

The Surgery and Postop Course Phase, which could be marked by difficulty accepting the new organ, fantasies about the life and death of the donor, and fear that one will take on the traits or identity of the donor.

Prior to coming up on the wait list, some factors which may influence transplant refusal:

  • Depression or grief
  • Denial
  • Delirium and dementia
  • Fear of transplant surgery or negative past experiences with surgeries
  • Concerns about postop quality of life
  • Ambivalence about surgery and/or survival
  • Acceptance of inevitability of death
    • Frierson, R. L., J. B. Tabler, et al. (1990). “Patients who refuse heart transplantation.” J Heart Transplant 9(4): 385-91.

Ambivalence is one factor that has been studied. It has been described as the tension between the wish for an extended life for which transplant holds out a promise as contrasted with the:

  • Need to confront the desperate seriousness of their situation
  • Need to fathom undergoing an operation which will remove the very organ physically and symbolically sustaining life
  • Need to accept postop quality of life that could be less than acceptable because of the amount of suffering it could inflict
    • Difficulty facing seriousness of situation
    • Fear of the surgery
    • Quality of life concerns

The tasks for the patients:

  • Realize they have a terminal illness
  • Accept the idea that a transplant is necessary to preserve life
  • Endure the uncertainty about acceptance or rejection for transplantation
  • Assimilate an enormous amount of information in a short period of time
  • Emotionally reinvest in the possibility of an extension of their lives

Even the normal person feels, as it were, two souls in his breast.”

E. Bleuler

How would this be addressed in a busy transplant center intent on saving lives and retaining certification?

Ironically, by acknowledging that refusal of transplant is an acceptable choice. Ambivalence is not necessarily a sign of mental illness. It’s probably fine to avoid trying to talk the patient into going ahead with the transplant. You can see that the psychiatric consultant is supposed to be the advocate for the patient, not necessarily always for the transplant team.

Try to help the transplant team tolerate their own emotional turmoil as well as the patient’s. Try to create a space in which the transplant team can debrief and grieve those “who choose not to be saved.”

  • Frierson, R.L., et al., Patients who refuse heart transplantation. J Heart Transplant, 1990. 9(4): p. 385-91.
  • Kuhn, W.F., B. Myers, and M.H. Davis, Ambivalence in cardiac transplantation candidates. Int J Psychiatry Med, 1988. 18(4): p. 305-14.

Stay in the chair.

Rather Fight Than Switch?

I wonder how many baby boomers remember those TV cigarette commercials featuring an actor holding a smoke, sporting a black eye and saying “I’d rather fight than switch.” I guess they ran those ads from the 1960s to 1981.

I think of those commercials when I read the news. There are a couple of Iowa news items about a University of Northern Iowa (UNI) professor requiring his students to wear masks or suffer the consequences to their lab grades. He’s suffering the consequences because he’s going up against policies of the state Regents and UNI, which prohibit mask mandates. He’s doing it to protect others from COVID-19 infection. It sounds like he’d rather fight than switch.

The Governor of Iowa has signed into law a ban on applying mask mandates. However, Iowa City Mayor Bruce Teague has just extended “until further notice” a city-wide mask mandate that started August 18 and was set to expire today. Iowa Attorney General Tom Miller has been studying the situation for weeks and has apparently made no decision, despite the Governor’s office saying the mandate is “illegal” and “unenforceable.” I guess Mayor Teague would rather fight than switch.

There has been an executive order by President Biden to mandate COVID-19 vaccines for the many hospitals which have over a certain number of employees and are paid by Medicare and Medicaid. Headlines indicate there are many who would rather quit their jobs than get the jabs, which would not make patient care any easier. I guess they would rather fight than switch.

A man in Germany recently walked into a convenience store to buy beer and when the clerk asked him to put on a mask, the man left angry, came back wearing a mask and shot the clerk dead. I guess he’ll do the rest of his fighting in prison.

There a few songs about fighting and switching. I don’t remember Ruby Johnson’s version of “I’d Rather Fight Than Switch.” There was another version done by a group called The Tomboys, a group of female vocalists I’ve never heard of who were also performing in the 1960s. It looks like country star George Jones did a reversal of it with “I’d Rather Switch Than Fight.”

I wonder how things would be if people would start saying “I’d Rather Talk Than Fight.”

CDC Statement on COVID-19 Vaccine Boosters

The CDC published a media statement this morning that outlines the amended Advisory Committee on Immunization Practices (ACIP) recommendations for COVID-19 vaccine boosters. Late last night, CDC Director Rochelle Walensky restored the recommendation that ACIP voted down yesterday: “People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.” This is consistent with the FDA regulatory recommendations made on Wednesday.

Now, to my understanding, at least in Iowa, according to University of Iowa Hospitals & Clinics (UIHC) and others, it’s up to the Iowa Department of Public Health (IDPH) to green-light the booster rollouts locally.

ACIP Meeting on COVID-19 Vaccine Boosters: Day Two

It must have been after 8:00 PM last night that the FDA posted the COVID-19 Booster EUA authorization. The ACIP took that ball and ran with it all day long. Today was the second day of the ACIP meeting and the committee covered a lot of ground and ran over the schedule by more than an hour by the time voting on recommendations ended.

In a nutshell:

The committee voted unanimously to give boosters for people 65 and over as well as nursing home residents. Most of them voted to give boosters to those 50-64 with medical conditions that raise the risk for severe COVID-19 infection. A smaller majority voted to give boosters to those 18-49 with based on individual benefit and risk given underlying medical conditions. The committee voted down a proposal to give boosters to those 18-64 who would be at elevated risk of infection because of occupational or other setting, including health care workers, prison guards, and people who live or work in homeless shelters.

Nobody was happy about not giving an option to “mix and match” vaccines. If you got Pfizer in the initial series, you got Pfizer. But if you got Moderna or J&J—you couldn’t get Pfizer. More data is coming about heterologous vaccine dosing, but it’s not immediately available. On the other hand, the 6-month mark for getting the booster is anything but a hard line. You could wait months longer and still retain adequate vaccine effectiveness.

I thought it was interesting that, according to a survey in unpublished data, about a third of unvaccinated respondents said that offering a booster would make them even less willing to get vaccinated at all. See slides 52 and 53 in the presentation “Evidence to Recommendation Framework: Pfizer -BioNTech COVID-19 Booster Dose” by Dr. Sara Oliver. Despite that, several members of the committee stressed the critical importance of continuing to attempt vaccinating them.

There’s going to be a lot of flux in the next several weeks as more data is obtained. These recommendations are subject to updates and there will likely be several more meetings ahead, according to attendees.

I know that in Iowa, a lot of people are counting on the Iowa Department of Public Health (IDPH) to give the word on when to roll out the boosters. The University of Iowa Hospitals & Clinics and Story County officials have said that. I have not seen boosters even mentioned on the IDPH website, though. I inquired about what their plans are for the booster rollout this morning on their website contact form. I expect it may be a while before I get a reply, if I get one at all. They’re incredibly busy.

I heard one expert say that in his community, they were offering the vaccine to people in a way that emphasized the individual’s benefit only. I think that’s certainly one way to “sell” it. Altruism has a place here, though. I get regular email messages from Hektoen International, hekint.org.

They almost always contain some essay or quote that’s thought-provoking and inspiring. Here’s one I got this morning that included a public domain photograph of Bertrand Russell as well as his thoughts on the receding ego:

Bertrand Russell on life from Hektoen International hekint.org

Make your interests gradually wider and more impersonal, until bit by bit the walls of the ego recede, and your life becomes increasingly merged in the universal life. An individual human existence should be like a river — small at first, narrowly contained within its banks, and rushing passionately past rocks and over waterfalls. Gradually the river grows wider, the banks recede, the waters flow more quietly, and in the end, without any visible break, they become merged in the sea, and painlessly lose their individual being.

“How to Grow Old,” from Portraits from Memory and Other Essays by Bertrand Russell

Bertrand Russell by Fotograaf Onbekend / Anefo. 1957. Nationaal Archief. Public Domain. Via Wikimedia.

ACIP Meeting on COVID-19 Vaccine Boosters: Day One

This was the first day of the Advisory Council on Immunization Practices (ACIP) on COVID-19 vaccine boosters. I was struck by how organized it was. I was also struck by the statement by one presenter that they’re still waiting for a final decision from the FDA on the issue. I thought they made that last Friday. The decision has not yet been posted, though and I think it has to be published on the FDA website before it’s gospel.

In fact, ACIP is wondering if tomorrow’s meeting should be postponed if the FDA decision has not been made by then. Tomorrow is when ACIP plans to vote on what they decide about the who and how of the booster shots. Would they really leave it up in the air like that?

The only thing I see about boosters on the FDA website after the September 17th meeting is a podcast on September 20th that FDA Commissioner, Dr. Janet Woodcock did on a show called “In the Bubble with Andy Slavitt.” I thought it was a good general introduction to the booster issue. The interview also included questions about Pfizer’s latest study of their COVID-19 vaccine in children, ages 5-11 years of age. I thought there were too many commercials. There was supposed to be another broadcast about boosters on the show today, but I was too busy watching the ACIP meeting. I’m pretty sure I’m getting most of what I need from that, but I might check out the Andy Slavitt show “Toolkit: Answering Your Booster Questions.”

I know one thing; I heard the best lecture about the basic immunology of the boosters this morning. See the slides from the presentation “Adaptive immunity and SARS-CoV-2” by Dr. Dr. Natalie Thornburg, PhD. I still have cold sweats every time I think of the first basic immunology lecture we got in medical school. That was ages ago. The poor lecturer at some point during her talk happened to look up at us and she abruptly stopped talking. She looked dismayed by what must have been the totally lost look on our faces. She was demoralized and there was this—pause. She looked like all the air was sucked out of her. I thought for a moment she was too demoralized to go on.

I don’t remember how I got through the immunology exam. I do know I still have flunking nightmares of being a student at some level of college or medical school. In the dream, I’m usually trying to find a lecture hall, riffling through a key set of notes and books, all of which are incredibly jumbled up. I’m always hopelessly late and I have this sense of despair about ever graduating.

But today’s presentations were brilliant, fascinating, and helped clarify at least some issues in the complexity, not the least of which is deciding what the main goal of the boosters should be. Should it be preventing severe disease, hospitalization, and death, or preventing infection altogether?

I learned that not only are nursing home residents at high risk for getting COVID-19 but that it’s actually the level of community transmission that drives infection rates in residents (see presentation “Modeling the potential impact of booster doses in nursing home residents” by Dr. R. Slayton). Which brings up the issue of transmissibility of the virus, which is very high. Would the boosters cut the transmissibility? It’s unclear.

The boosters seem to be very safe and effective for pregnant people, yet only about 30% of them get vaccinated—cut that percentage in half for African American women. See the lectures with the word “pregnancy” in the title.

Dr. Sara Oliver’s “Work Group Summary” was enlightening and disturbing. The safety and immunogenicity date are reassuring but limited. But getting more data takes more time. What are the next steps for the ACIP? They are awaiting regulatory action from the FDA. I get a sense that we need a lot more beyond Dr. Janet Woodcock’s word on that. As she said in the “In the Bubble” interview with Andy Slavitt— “We need to get this right.” I think that means they need to take whatever time it takes to do that.

Will ACIP meet tomorrow? Will they vote? Don’t ask me; I still have flunking nightmares.

CDC Advisory Committee on Immunization Practices Meeting This Week on COVID-19 Vaccine Boosters

The CDC Advisory Committee on Immunization Practices (ACIP) will meet this week, Sept 22 and Sept 23 to discuss COVID-19 vaccine boosters. The agenda is posted although slides are not and the topic headings do not so far indicate a clear plan to vote on any specific booster recommendations. Recall on the August 30, 2021 ACIP meeting, Dr. Sara Oliver alluded to the probability of a vote on boosters (slide 49) in the presentation, “Framework for booster doses of COVID-19 vaccines.”

The University of Iowa Hospitals & Clinics (UIHC) today announced what its plan would be for boosters after the ACIP committee makes its own recommendation for boosters. The Iowa Department of Public Health must also give its approval. It looks like the guidance would be for UIHC employees only for the time being. Since more information about the ACIP recommendations for boosters will be posted on The Loop, you can access that directly. I will also be posting a link in the main menu on my blog site for now.