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.