Reminder: FDA VRBPAC Meeting June 5, 2024 on Covid Vaccines for Fall 2024

There will be an FDA VRBPAC meeting on June 5, 2024, 8:30 a.m.-4:30 p.m. ET to discuss Covid vaccines for this fall.

CDC ACIP Meeting Today on Covid-19 Vaccines

Today is the scheduled meeting for the CDC Advisory Committee on Immunization Practices (ACIP). It meets from 10 AM-4 PM EDT. The final agenda is here.

The presentation slides are at this link.

I also want to recommend the recent article on the new Covid vaccine published in Scientific American on September 1, 2023, entitled “When Will the Next COVID Vaccine Be Available, and Who Should Get It?

I think it’s a nice, balanced article which avoids extreme opinions and sticks to the scientific facts.

FDA Authorizes Updated mRNA Covid-19 Vaccines

Today, the FDA approved and authorized the updated mRNA Covid-19 vaccines, specifically for the monovalent XBB.1.5 variant.

See the announcement on the FDA website for full details. The CDC ACIP will meet to discuss clinically-based recommendations for the use of these vaccines tomorrow.

What is the Answer to Automated Answering Machine Recordings?

I’ve been calling local pharmacies in an effort to schedule getting the updated Covid-19 vaccine updated bivalent booster and the flu shot as well. I imagine I’m not the only one encountering the frustrating automated answering machines.

It’s confusing to find out that if I answer the question about how many Covid-19 vaccine shots I’ve gotten (which is 4, including the two initial doses and two boosters), the machine politely sort of congratulates me (“you’re good to go!) and then hangs up. That contrasts with the web-based organization message in large font against a bright red background which assures me that I can schedule a time to get both vaccines—if I set up an on-line account (which always makes me suspicious). It turns out that the old “continue as a guest” alternative puts my personal information at risk. I’m unable to get a live person on the line.

I found a few tactics on the web for bypassing these recordings, but I’m pretty sure they don’t work. Some of them have been around for over 15 years, like pressing zero once or even repeatedly. That can result in the recording automatically hanging up on you.

There are other suggestions for pressing various special characters on your smartphone, which some people swear by.

Speaking of swearing, I even found one suggestion for swearing repeatedly into the phone to get past the automated answering machine. I’m pretty sure that doesn’t work.

I think I’ll just sit tight and wait a while. There’s no rush. But I wish there were some polite and effective way to get a live person on the line when you get the automated answering machine from hell:

Drugs-R-Us Pharmacy: Hello, what would you like to do today? You can say, “vaccine,” “alien abductions,” or “triple fat burger with soggy fries and a cola.”

Customer: Vaccine.

Drugs-R-Us: Thank you! Would you like to do: schedule a new, review a scheduled time, cancel an appointment, or talk about the weather?

Customer: Schedule a new.

Drugs-R-Us: What vaccine would you like to schedule?

Customer: Updated Covid-19 booster.

Drugs-R-Us: Got it! And would you like any other vaccines?

Customer: Flu shot.

Drugs-R-Us: I see; I’ll make a note of that. You can ask the pharmacist at your visit for another vaccine, which would be administered as an intra-ocular injection in the eye of your choice. Now, a booster. I’ll need some more information, including your birthdate, phone number, number of previous vaccinations, distinguishing marks, social security number, all bank account numbers, record of previous arrests, and the name of your first-born child, if any. First, how many vaccines have you received?

Customer: Four.

Drugs-R-Us: You rock! You have all the vaccines you need and that means it’s Beer O’clock for you, dude. Is there anything else?

Customer: But I want the updated Covid-19 booster! Can’t you understand that it’s new and your company says it’s available now?

Drugs-R-Us: Good-bye (click).

Maybe I’ll have better luck next week.

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.

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.

Try to Keep Up with the COVID-19 News (Good Luck)

Things are happening fast all around the country and in Iowa when it comes to news about the COVID-19 vaccine boosters and mask mandates.

It looks like the Iowa ban on mask mandates for public schools will be on temporary hold by a Federal restraining order for now according to a news item from the Daily Iowan. A mask mandate is being planned by the Iowa City Community School District.

The watchword on COVID-19 vaccine boosters is “wait and see” according to a few scientists. Some of them are saying there is not enough data yet to support the need for boosters. I hope the link to this full text Lancet works. If it doesn’t work, try this link to see the article at ScienceDirect.

Central Iowa clinics as well as the University of Iowa Hospitals & Clinics (UIHC) seem ready to start boosting (Pfizer only for now) as soon as next week. UIHC has a notice on the Loop about it (they also mention the Federal vaccine mandate which could apply to them). Story County is just waiting for the word “go” from the Iowa Department of Public Health (IDPH). Everybody seems confident that the FDA will green light boosters this Friday after the Advisory Committee meeting.

There must be some kind of hot line between the IDPH and the FDA–and the CDC Advisory Committee on Immunization Practices (ACIP) as well because I thought they had to weigh in on the issue too. It seemed like ACIP had made their opinion pretty clear; they didn’t think it was necessary at the August 30, 2021 meeting that boosters were necessary for the general public. They did think boosters for the residents of Long Term Care Facilities, health care professionals, and the elderly could be warranted.

The CDC has updated information about boosters. Basically the ball goes to the FDA and the ACIP. The CDC has also posted more recent articles on their website that tend to support the continued efficacy of the current vaccines:

Scobie HM, Johnson AG, Suthar AB, et al. Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021. MMWR Morb Mortal Wkly Rep. ePub: 10 September 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7037e1external icon.

Grannis SJ, Rowley EA, Ong TC, et al. Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19–Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance — Nine States, June–August 2021. MMWR Morb Mortal Wkly Rep. ePub: 10 September 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7037e2external icon.

Bajema KL, Dahl RM, Prill MM, et al. Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalization — Five Veterans Affairs Medical Centers, United States, February 1–August 6, 2021. MMWR Morb Mortal Wkly Rep. ePub: 10 September 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7037e3external icon.

The situation is changing rapidly. I’ve read that the ACIP might hold a meeting on boosters on Saturday after the FDA this Friday. So far I don’t see it on the ACIP schedule. The one on September 29, 2021 is not about COVID-19 vaccine boosters.

CDC Publishes Data Prompting the Mask Guideline change

Today the CDC posted the data supporting the change in the mask guidelines for the fully vaccinated. It’s in the July 30, 2021 Morbidity and Mortality Weekly Report (MMWR) describing the outbreak of several hundred new cases of the Delta variant COVID-19 infection in Barnstable County, Massachusetts following July 4th events. Those who were fully vaccinated shed virus as much as the unvaccinated.

Organizers of the Iowa State Fair and those planning to attend, take note.

Brown CM, Vostok J, Johnson H, et al. Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021. MMWR Morb Mortal Wkly Rep. ePub: 30 July 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7031e2external icon.