Brief Messages or Announcements – Page 43

FDA Advisory Committee Meetings on COVID-19 Vaccine EUA Amendments for Moderna, J&J Boosters and Heterologous Boosters, Pfizer Vaccine for Children

The FDA Advisory Committee will hold a meeting October 14-15 to discuss amendments to the Emergency Use Authorization (EUA) for Moderna and J&J COVID-19 boosters as well as heterologous boosting (mix and match). New data is available, including NIH preliminary results on the mix and match study.

The FDA also announced a meeting to discuss Pfizer COVID-19 vaccine for children age 5-11, which is scheduled for October 26, 2021.

Links to the livestream meetings details are in the press announcement (link above).

Meeting materials are posted here.

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.

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.

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.

FDA Advisory Meeting on Pfizer COVID-19 Vaccine Booster Announcement

The FDA announcement about the Advisory Committee meeting on the Pfizer COVID-19 vaccine booster for September 17, 2021 is here. The time will be 8:30 AM-3:45 PM ET (check your time zone provided on the FDA YouTube web page). Review materials (if available) will be posted at the FDA link provided in the announcement.

Comirnaty vs Comiranty Spelling Bee Issue Resolved

This is just an update on the Pfizer-BioNTech COVID-19 vaccine Comirnaty vs Comiranty spelling issue at UIHC, which has been resolved today. It took a few emails to get it fixed. I was beginning to think I was losing my mind and that I was the only who could see the mistake. Comirnaty had apparently been misspelled as Comiranty on several web pages for maybe a couple of weeks.

You can just look at the word Comirnaty and see how this could have happened. Looking at it in print makes me think there are two letter “m’s” in it. Transposing the two letters “a” and “n” looks easy to do. There are a few anagrams web sites that are picking up on the word Comirnaty. I kind of like “try anomic.” Can you really get “community,” “immunity,” and “mRNA” out of that agglomeration? Maybe. It’s a name game.

I could chalk this up to just me being a retired guy with too much time on his hands and nitpicking. On the other hand, there is that story about a typo ending World War II. In all fairness, there is some doubt about the accuracy of it. But it’s fascinating to think that the difference in spelling between cryptogamist (someone who studies algae) and cryptogramist (someone who studies codebreaking) might have made all the difference in the war’s outcome.

Comirnaty Misspelled by the Medical Community

This afternoon I just notified somebody at the University of Iowa Hospitals & Clinics (UIHC) that the Pfizer COVID-19 vaccine’s name is misspelled on several of their web pages. The new name for the vaccine is Comirnaty (pronounced koe-mir-na-tee). UIHC misspells it as “Comiranty.” And it has been that way for at least a week, probably since Pfizer publicly announced the name after the vaccine was fully licensed by the FDA. I found three instances of that although there could be more.

I found a news item that explains the name was deliberately chosen in order to remind us of the word “community” and the “mRNA” technology of the vaccine.

It actually reminded me of Foster Brooks whose comedy routine consisted of acting like he was drunk, slurring his speech in a parody of intoxication. The only way “Comirnaty” can make you think of “community” is if you’ve had a few too many.

On the other hand, “Comiranty” makes me think of the one Indiana Hoosier football player who was caught on camera with the word Indiana misspelled as “Indinia” on his jersey yesterday. By the way, Iowa beat Indinia 34-6 in the season opener. In all fairness, Indiana is not the only state that struggles with spelling.

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.”