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.

More COVID-19 Vaccine Booster Sausages This Week?

I saw a nice summary by Stat News of last Friday’s FDA Advisory Committee meeting on Pfizer’s COVID-19 vaccine booster. They indicate the Advisory Committee on Immunization Practices (ACIP) are meeting this coming Wednesday and Thursday to fine-tune the FDA recommendations, which was a messy affair. I have been checking the ACIP web site frequently but so far, I’ve not seen any agenda or slide sets for September 22 and 23. Is that a signal that watching their meeting will be even more like watching sausages being made?

Just as an aside on the quote attributed to Otto Von Bismarck I mentioned in my post on Friday—it’s probably apocryphal.

Laws are like sausages; better not to see them being made.”

Otto Von Bismarck or maybe John Godfrey Saxe

I glanced around the web and ran across several articles which cast doubt on whether the big sausage duel ever took place. It’s kind of a shame because it had the medical science angle. Supposedly the scientist Rudolf Virchow who was studying the parasite responsible for causing trichinosis had responded to Bismarck’s challenge to a duel by proposing they each eat one of two sausages as weapons. Bismarck and Virchow would choose a sausage to eat, one of which was loaded with trichinella or one that was not. They couldn’t tell by looking at the sausages which was which. I first learned about this duel on the Travel Channel show (episode entitled “Sausage Duel”), which I think set the context as nasty factories churning out Trichinella laden sausages because of horrifyingly unsanitary practices. The show cast Virchow and Bismarck as opponents over that issue specifically. Bismarck conceded and that led to the factories cleaning up their act. Scientists triumph over politicians!

That probably never happened, according to more than one writer. So maybe I should choose another quote. One by a lawyer statesman might be a partial fit:

If Columbus had an advisory committee, he would probably still be at the dock.

Arthur Joseph Goldberg

Another that I like just because I’m a Dave Barry fan:

“If you had to identify, in one word, the reason why the human race has not achieved, and will never achieve, its full potential, that word would be ‘meeting.’”—Dave Barry.

If you had to identify, in one word, the reason why the human race has not achieved, and will never achieve, its full potential, that word would be “meeting”.

Dave Barry

Some sources on the web say Barry’s quote was in one of his many books I used to own: Dave Barry Turns 50. It’s in a list: “25 Things I Have Learned in 50 Years.” I didn’t check with Barry’s web site to verify the quote. You can find some of them on line. Many of those items are on the order of booger jokes, of which I happen to be a fan. This quote also happens to be highlighted on the website called mycommittee, which ironically advertises committee management software which promises to make them more productive. The home page shows a sample software document entitled “Decisions regarding response to Covid-19.”

Hmm. Maybe the advisory committees could use this.

ADDENDUM: Whoa! ACIP just posted this Wednesday’s draft agenda. More materials will surely follow.

Watching Sausages, Laws, and FDA Advisory Committee Decisions Being Made

Sena and I watched the FDA Advisory Committee live streamed meeting yesterday on whether or not Pfizer’s COVID-19 vaccine booster should be given full licensure. You know, there’s a much-discussed question about who actually made the following quote:

“Laws are like sausages; better not to see them being made.”—often attributed to Otto Von Bismarck although it’s been attributed to others.

You can view the arguments about who said it at this link. The point is I think it should also apply to FDA meeting decisions. Our overall impression is that it was a messy process. We watched the entire daylong proceeding. The bottom line was that the committee revised the original question and reframed the approval from full licensure to Emergency Use Authorization (EUA):

The FDA approved the EUA for the booster based on the “totality” of the available evidence instead of just the originally specified Clinical Trial C4591001 (because of the small number of subjects including only a dozen in the older age group; the data from Israel was also fair game) and restricted the population to those age 65 and older (instead of the original 16 years and older). They further specified further that the booster should target those at increased risk for severe disease—which is to be understood to include health care professionals and others at risk for high occupational exposure.

One of the voting members disclosed candidly that his wife had already received a booster shot at a pharmacy well in advance of the meeting (technically off-label) and that he planned to do the same—after they unanimously approved the booster after the question was reframed. Sena and I both thought this was an extraordinary statement coming from an FDA advisory committee member.

The original question was voted down with only 2 of 18 members voting in favor. Dr. Stanley Perlman of The University of Iowa voted no on the original question and voted yes on the revised question. For many days now, the news has been reporting that a large number of people have been getting a booster shot despite the lack of FDA approval.

Dr. Arnold “Arnie” Conto M.D., the Acting Chair of the committee, after being asked to read the original question, slipped by indicating the age as “16 months” instead of “16 years.” He was instrumental in holding the committee members to staying on time for each phase of the meeting.

Dr. Conto: “Do the safety and effectiveness data from clinical trial C4591001 support approval of a Comirnaty booster dose administered at least 6 months after completion of the primary series for use in individuals 16 months of age and older?”

“I see someone has his hand raised. Do you have a question?”

Dr. X: Lips clearly moving but no sound.

Moderator: “Please unmute your mike” (Everyone was guilty of this oversight repeatedly throughout the day. One participant actually started speaking audibly and then leaned over and switched off his mike, possibly not to break the trend).

Dr. X: “Oh my, sorry about that. Arnie, we’re not sure on that part about “16 months and older.”

Dr. Monto: Oh yeah, I meant “at least 16 days and younger.”

Dr. X: Lips moving but no sound.

Moderator: “Unmute, please!”

Dr. X: “Oops, sorry! OK, Arnie. Does anyone know whether we’re supposed to vote on the time machine today, or will that be for the Advisory Committee on Immunization Practices?”

Christopher Lloyd: “I got that covered! Dang, I mislaid the keys to the DeLorean.”

We listened to those making short presentations at the open public hearing. They were each given about 3 minutes to make their statements. Some were in favor of the vaccine booster, others were not. Safety concerns were prominent, especially for giving vaccine boosters to children.

In fact, the committee seemed very ready to change the focus of the booster to place less specific emphasis on children. We imagine that’s part of the reason why the age range was adjusted away from specifying those 16 years and older (although they’ve probably been getting the primary series, even before the August approval of the Pfizer vaccine). One of the committee members asked, after the change of the age from “16 years” to “65 years” (but also specifying those at “high risk for severe disease”) whether that still meant a 16-year-old could get the booster. The answer was “yes.”

That made sense since children can have medical illnesses that increase their risk of serious complications from COVID-19 infection. But some committee members wondered about the 65 years of age cutoff, probably because they were not 65 years old. This and other speculations about how to specify the vulnerable population led to scrambling to get the meeting over because this was a question which the ACIP could clarify—and because it was getting very close to the end of the day.

We still don’t know when the ACIP is going to meet about the booster. They’ve added something for September 22 and 23, but I don’t find an agenda for it yet. Maybe they’ll have sausages for lunch.

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.

The Monsters

Sena and I got our annual flu shots last week, and I also got a pneumonia vaccine. We’ve been fully vaccinated against COVID-19 since earlier in the year. Now we’re waiting for the word on whether we’ll need COVID-19 vaccine boosters. We’ll probably know more about that by the end of the week after the FDA Advisory Committee meeting on the matter.

We’re part of the vaccinated, which is increasingly distinguished from the unvaccinated in various ways. The controversy about the unvaccinated almost amounts to them being discriminated against, according to some news headlines. The COVID-19 pandemic is now being called a pandemic of the unvaccinated, although some are able to resist the trend by seeing through it and realize we’re all in this together.

It reminds me of an old Cold War era episode of The Twilight Zone, “The Monsters Are Due on Maple Street,” which originally aired in 1960. The gist is that aliens seeking to conquer earthlings create paranoia and violent conflict amongst neighbors on a quiet cul-de-sac simply by manipulating the electrical power to cars and other devices. At first, the electrical malfunctions are only puzzling until a boy named Tommy tells everyone that the trouble is being perpetrated by aliens who are indistinguishable from humans, a notion he got from a comic book.

And after that, everyone on the street begins accusing each other of being malevolent aliens disguised as humans, often on the basis of interpreting benign behaviors like insomnia or tinkering with a ham radio as evidence for dangerous plots. One character even shoots his neighbor dead, believing he’s a dangerous alien.

There was a 2003 remake of this in which the government, instead of aliens, is doing the manipulating. No doubt both of these will be re-broadcast as part of Twilight Zone marathons next month as part of the usual October Halloween TV program lineup.

Sena thought of another Twilight Zone show, “The Shelter,” first broadcast in 1961, which also might fit the current pandemic context. A doctor builds a bomb shelter to protect just him and his family in case of a disaster. The unthinkable happens with UFOs being sighted and the friends and neighbors who threw a party for him all want to beg, bargain, or threaten their way into the doctor’s bomb shelter because they didn’t build their own. He refuses to allow them in. The neighbors turn on each other, showing the worst selfishness, hatred, and racism. They finally break into the doctor’s shelter with a battering ram (which, of course, negates the safety it might have provided)—only to find out in that moment that the UFOs were just satellites. They had become monsters and could not see how it happened.

Depending on what news media outlet you prefer to read, the vaccinated or the unvaccinated will be cast as bad guys or good guys. As the rhetoric heats up based on divisions between political parties, religious groups, scientists, races, and nations, the antipathy has fostered escalating tensions over whether vaccine and mask mandates should or should not prevail. The unvaccinated have their own battering ram—fake vaccination passports, which negate the safety assurance. The unvaccinated can’t get in to see their doctors in person, poison themselves with unproven medicines, or accuse the government of trying to poison them with vaccines. The wealthy vaccinated buy their booster shots at the expense of those who can’t afford them and before the medical experts can approve their safety and necessity. People are resorting to violence.

I always had a little trouble with the title of the Twilight Zone episode, “The Monsters Are Due on Maple Street.” The monsters are not just due—we have arrived. Why is it so hard for me to recall an episode showing exactly how to recover our humanity?

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.

Pelican on the Lake

Sena and I went for a walk on the Terry Trueblood Trail yesterday. We saw a huge apple tree on the trail. We’ve never noticed it before. The boughs were bent and broken from the load of apples. There were a lot of buzzing insects, maybe some annual cicadas among them.

We saw a lone American White Pelican on the lake, the first one we’ve ever seen.  There were no other birds on the water. In fact, we didn’t notice other birds other than the pelican. All but one of the tree swallow nest boxes had been removed. Nothing peeked out from it.

The pelican just bobbed about on the lake. They migrate in autumn to Central and South Americas. They’re often seen in large groups, but this one was alone. They get pretty big, about 5 feet tall, and can have a 9-foot wingspan.

Pelicans are often connected to symbolic meanings including nurturing, humility, charity, healing, wisdom, and sacrifice.

Where were all the other pelicans?

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.