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.

New Large Covid-19 Vaccine Study Shows Association with Rare Side Effects Which Other Smaller Studies Have Found

I’ve seen a couple of news stories about the CDC supported large study across many countries which essentially shows that Covid-19 vaccines can be associated with rare side effects. The stories might tend to raise anxiety about the vaccines’ overall safety, which has been repeatedly proven in other studies.

The study is published in the journal Vaccine and the conclusions are consistent with smaller studies showing the Covid-19 vaccines safety although they do have rare side effects.

One of the news stories contacted an expert, Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center, who confirmed that.

Unfortunately, there are over 1200 comments (and counting) containing alarmist and misleading information about the vaccines.

What’s Up with Seasonal Vaccines This Fall?

I just read an interesting article in JAMA on this fall’s Covid-19 vaccine. Most of it is from the FDA meeting in June (Rubin R. This Fall’s COVID-19 Vaccines Will Target Omicron XBB Subvariants, but Who Needs Them Remains to Be Seen. JAMA. Published online July 05, 2023. doi:10.1001/jama.2023.10053).

One expert was quoted, indicating that there will be “…an elaborate discussion” at the CDC ACIP meeting about who should get the new monovalent XBB.1.5 vaccine. I don’t see that the meeting is scheduled yet.

There are some other interesting quotes to pass along:

“Back in March and the first half of April, XBB.1.5 represented more than 80% of circulating SARS-CoV-2 in the US, according to CDC estimates. Its dominance began to slip in late April, and as of late June, XBB.1.5 represented little more than a quarter of circulating SARS-CoV-2 variants. By then, though, XBB.1.5 and 9 other XBB subvariants together accounted for a total of 96% of circulating SARS-CoV-2 in the US. Fortunately, members of the XBB family of subvariants are antigenically similar to each other, so a vaccine against XBB.1.5 should protect against the rest of them as well, the WHO committee noted.”

“By the third quarter of 2022, an estimated 96.4% of approximately 143 000 blood donors in a nationwide, longitudinal cohort had SARS-CoV-2 antibodies from previous infection or vaccination or both, according to an analysis published in June in Morbidity and Mortality Weekly Report.

Or, as Sawyer told JAMA, “[t]he whole US has had this virus in one form or another.”

Because of the high prevalence of SARS-CoV-2 antibodies in the population, Paul Offit, MD, in an interview predicted “a focused recommendation by the CDC” regarding who should receive the XBB.1.5 vaccine.”

“Offit said he expects that the CDC will recommend the new monovalent XBB.1.5 vaccine for groups at the greatest risk for severe disease, reflected in continuing hospitalizations for COVID-19. Those groups likely would include people who are 75 years or older, people with severely compromised immune systems, and pregnant people, Offit said.”

“At least for people 60 years or older, the fall vaccine situation will be more complicated than it was a year earlier, Schaffner noted. That’s because at its regular monthly meeting in June, ACIP voted to recommend that this age group have the option of being vaccinated against respiratory syncytial virus (RSV) after consulting with their physician or pharmacist.”

That would mean that there would be 3 vaccines coming in the fall: RSV, Covid-19, and influenza. Sena and I have been doubtful about why a conversation with a physician would be necessary for the RSV vaccine. We don’t know whether that means you couldn’t get it without a physician’s order. There are also questions about coadministration of the RSV and Covid-19 vaccines.

Because the time is coming soon for seasonal vaccines, we’re hoping the questions will be answered soon.

FDA Meeting June 15, 2023 on Strain Selection for Periodic Covid-19 Vaccine

The FDA Vaccines and Related Biological Products Advisory Committee will meet June 15, 2023 from 8:30 a.m.-5:00 p.m. ET “to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024.”

CDC Advisory Committee Meeting November 2nd on Pfizer Covid-19 Vaccine for Children Ages 5-11

The Advisory Committee on Immunization Practices (ACIP) have scheduled a meeting for November 2, 2021 from 10 AM-5 PM, ET to discuss the Covid-19 vaccine for children ages 5-11.

This follows the FDA authorization for the vaccine in this age group, which was announced today on their web site.

COVID Conspiracy Theories

A few days ago, I read the news story about COVID-19 antivaxx vigilantes interfering with the medical care of patients hospitalized with COVID-19. The writer interviewed Dr. Wes Ely, MD, MPH. He’s an intensive care unit (ICU) specialist at Vanderbilt University.

I first corresponded with Dr. Ely by email about 10 years ago when I wrote a blog called “The Practical Psychosomaticist.” I sort of poked fun of him in one of my posts about the chapter on psychiatrists and delirium in one of his books, Delirium in Critical Care, which he co-authored with another intensivist, Dr. Valerie Page, and published in 2011.

I can’t really tell the anecdote the way I usually told it to residents and medical students because of copyright rules but the antipsychotic drug haloperidol is mentioned. I made fun of the very short section “Psychiatrists and Delirium” in Chapter 9 (“Treatment of delirium in critical care”). It’s only a couple of paragraphs long and comically gives short shrift to the psychiatrist’s role in managing delirium. That’s ironic because I have always thought the general hospital psychiatric consultant’s role was very limited in that setting.

Maybe you should buy that book and, while you’re at it, buy the other one he recently published this month, Every Deep-Drawn Breath. My wife just ordered it on Amazon. It’s reasonably priced but in order to qualify for free shipping, she had to buy something else. It turned out to be Whift Toilet Scents Drops by LUXE Bidet, Lemon Peel (travel size, not that we’re traveling anywhere in this pandemic). Be sure to get the Lemon Peel.

In the email Dr. Ely sent to me and many others about the book, he said, “Every penny I receive through sales of this book is being donated into a fund created to help COVID and other ICU survivors and family members lead the fullest lives possible after critical illness. This isn’t purely a COVID book, but stories of COVID and Long COVID are woven throughout. I have also shared instances of social justice issues that pervade our medical system, issues that you and I encounter daily in caring for our community members who are most vulnerable.”

Anyway, the Anti-Vaxx vigilantes have played a big role in filling up the Vanderbilt ICU and many others by posting conspiracy theories about the COVID-19 vaccines on social media, which for some reason are hard to control. They persuade patients and their families that doctors are trying to kill them with the treatments that are safe and effective. Instead, they recommend ineffective and potentially harmful interventions such as Ivermectin, inhaling hydrogen peroxide, and gargling iodine.

There are different opinions about conspiracy theories and those who believe in them. Some psychiatrists say that conspiracy theories are not always delusional. One psychiatrist wrote a short piece in Current Psychiatry, Joseph Pierre, MD, “Conspiracy theory or delusion? 3 questions to tell them apart.”  Current Psychiatry. 2021 September;20(9):44,60 | doi:10.12788/cp.0170:

What is the evidence for the belief? Can you find explanations for it or is it bizarre and idiosyncratic?

Is the belief self-referential? In other words, is it all about the believer?

Is there overlap? There can be elements of both.

The gist of this is that the more self-referential the conspiracy theory, the more like it is to be delusional.

Another article which expands on this idea is on Medscape: Ronald Pies and Joseph Pierre, “Believing in Conspiracy Theories is Not Delusional”—Medscape-Feb 04, 2021. According to them, delusions are fixed, false beliefs (something all psychiatrists learn early in residency) and usually self-referential. Conspiracy theories are frequently, but not necessarily, false, usually not self-referential, and based on evidence one can find in the world—often the internet. Conspiracy theories have blossomed during the COVID-19 pandemic. One of them is that it’s a government hoax. An important difference between the current pandemic and the flu pandemic of 1918 is the world wide web which makes it easier for many people to share the conspiracy theories.

Pies and Pierre describe a composite vignette of someone who has a conspiracy theory featuring many false beliefs about the COVID-19 vaccines ability to change one’s DNA, thinks that research results about the vaccines are faked, mistrusts experts, has no substance abuse or psychiatric history and no mental status exam abnormalities. He exhibits exposure to misinformation, biased information processing, and mistrusts authorities.

They would say he has no well-defined psychiatric illness and antipsychotic treatment (such as haloperidol) would not be helpful. However, similar to the approach with frankly delusional patients, they would argue against trying to talk the person out of his false beliefs. Instead, if the person can be engaged at all, the focus should be on trying to establish trust and respect, clarifying differences in the information sources available, and allowing time for the person to process the information. It would be more helpful to avoid confrontation and arguments, instead pointing out inconsistencies in the information the person has and contrasting it with facts. Countering misinformation with accurate information could be helpful.

There are two major routes to anti-vaccination beliefs of the severity under discussion here. One is the problem of conspiracy theories out there. The other is the florid delirium that can happen to patients admitted to ICUs with severe COVID-19 disease. The former may not be a classifiable mental illness per se, but the latter definitely is.

Haloperidol is not the main solution for either problem.

Jab Who?

I just read a news item saying that the Blank Park Zoo in Des Moines, Iowa is administering COVID-19 vaccine to the animals there. I wondered how that would go, especially with large animals. I figured the zoo staff would be using dart guns. Talk about vaccine hesitance.

Then I saw a YouTube showing animals at the Louisville Zoo in Kentucky getting their shots. Apparently, they can get sick from COVID-19 infection. There were a few disparaging comments from viewers. Would 70 zoos vaccinate their animals if it weren’t safe and effective?

The animals didn’t seem to mind it. In fact, they were probably more cooperative than some humans. Of course, they got treats. But we give gift cards, beer, lottery prizes, turkey-flavored candy corn—which don’t really work. About 25% of Iowans don’t plan to get the vaccine according to a Des Moines Register news story.

Will the animals get boosters?

Featured image credit: Jim & Sena Amos at Henry Vilas Zoo in Madison, WI in 2009.

Update on COVID-19 Vaccine Boosters

The messaging on COVID-19 boosters is being clarified by the CDC and the FDA in separate announcements, posted September 1, 2021.

The CDC update is here. The FDA announcement is here. The FDA plans to hold a virtual meeting about the issue September 17, 2021 from 8:30 AM to 3:45 PM EST and it will be livestreamed on the agency’s YouTube channel. Background material will be made available to the public two days before the meeting.

“Those who are tardy do not get fruit cup.”

Advisory Committee On Immunization Practices Meeting On Boosters Today

Judging from the slides in Dr. Sarah Oliver’s presentation, “Framework for booster doses of COVID-19 vaccines” in the ACIP meeting this afternoon, there is limited data to support COVID-19 vaccine boosters for the general population at this time. The target populations for boosters would be the residents of Long Term Care Facilities (LTCF), health professionals, and those over 65 and 75 years of age, although the goal of ensuring that as many unvaccinated individuals get vaccinated should be actively pursued. There will continue to be further meetings to discuss the role of boosters.