Thread by @maxonwifi

ACIP day 1 here we go

Dr. Keipp Talbot advised there could be some tech difficulties citing layoffs to communications staff.

Two new members: Karyn Lyons and Jane Zucker

mpox vaccine recommendations were updated to comply with the president's executive order on gender. The two recs side by side (old vs new).

Dr. Jamie Loehr is clear: there're not enough data on resource use right now to support updating recommendations for mpox vax use in teens. Dr. Brooks notes that it appears to be a broad recommendation for a relatively uncommon infection.

Tracy Beth Høeg is FDA's representative. She just hopped in. Recently announced as a special assistant to the FDA commissioner. She says "it's very challenging" to say benefits outweigh the harms because of the low number of shots given so far.

if you were on the first livestream link, there's a new one: youtube.com/live/dNCVr9AvF…

Flu vaccine-related votes were removed from the new agenda this week, but Dr. Loehr presented that a "vote concerning updates to the 2025-26 ACIP influenza statement is expected at the June 2025 ACIP meeting."

flu vaccine effectiveness by age and flu type via california dept of public health. The vast majority of cases were type A.

AstraZeneca has been presenting on its planned launch of FluMist, an intranasal vaccine that can be either self-administered (shipped directly to people) or administered by a HCP. This is set to launch ahead of the upcoming flu season.

Covid-19 vaccine presentations have begun. After the introduction, Moderna will discuss its next-gen vaccine, mRNA-1283. Recall the company disclosed in February that its BLA was accepted and the FDA PDUFA date is May 31. This will be a good marker for how mRNA apps fare.

a VRBPAC meeting is still anticipated in the spring to decide Covid-19 strains. An earlier VRBPAC meeting to decide flu strains was canceled.

Moderna's next-generation candidate, which is a 1/5th of the dose of Spikevax, largely outperformed the approved vaccine in a comparative study assessing safety, immunogenicity and relative VE.

There was one fatal event in the Spikevax group, a sudden death in a 77-year-old woman with a history of cardiovascular disease within 1 week of vaccination. Investigator deemed the event unrelated to Spikevax and most likely attributed to underlying cardiovascular disease.

Covid-19 fell from the 8th leading cause of death among kids in 2022 to the 12th leading cause of death among kids in 2023. For adults, Covid-19 fell from 4th to 10th from 2022 to 2023.

Interesting survey results from 1,141 parents of kids 0-17. They are much more likely to get their kids a flu vaccine to prevent a respiratory illness than the Covid vaccine.

Tracy Beth Høeg when asked about Novavax's application: there will be an update coming out publicly very soon.

ACIP is considering reducing the number of recommended HPV vaccine doses, but any changes aren't likely to include immunocompromised people. ACIP currently recommends three doses for that population.

KEN SHE trial results are quite profound and seemingly support a one-dose vaccination series. 98% vaccine efficacy for HPV 16/18. one dose demonstrated significant durability

expectation is for ACIP to vote on two questions at the June ACIP meeting regarding HPV vaccine recommendations: one about whether a single dose is sufficient for some people and another about the recommended age range for vaccination.

Merck announced in March 2024 that it would launch a study testing a single-dose of Gardasil. It expected to begin enrolling patients in Q4 2024. It hasn't, and the company is still talking to FDA and EMA about trial design.

"Regulatory feedback anticipated in 2Q2025"

new CMV vaccine workgroup acknowledges that because Moderna's Phase 3 trial is testing efficacy in seronegative, non-pregnant women, than implementation could be hard. Because women would theoretically need serological testing before vaccination. Hypothetical convo for now.

"There's no reason why we have healthy children dying of measles in the US." - ACIP chair as this measles presentation gets underway

Another CDC team is deploying to Texas to assist with the measles outbreak this week.

"We do believe that there's quite a large amount of cases that are not reported and under reported," presenter Dr. David Sugerman.

"We are scraping to find the resources and personnel needed to provide support to Texas and other jurisdictions," - Sugerman.

Day 1:

- fin -