FDA VRBPAC Meeting on Covid Vaccine for Fall of 2024

The voting question for today’s FDA VRBPAC Meeting on the Covid Vaccine strain for this fall is:

“For the 2024-2025 Formula of COVID-19 vaccines in the U.S., does the
committee recommend a monovalent JN.1-lineage vaccine composition?
Please vote “Yes” or “No” or “Abstain.”

The FDA Selection of the 2024-2025 Formula for COVID-19 vaccines briefing document has a thorough review on the issue.

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.

FDA VRBPAC Meeting on Covid Vaccines Postponed

The May FDA VRBPAC meeting on Covid vaccines, originally scheduled for this month has been rescheduled to June 5, 2024, 8:30 AM-4:30 PM EST.

Reminder: FDA Advisory Committee to Meet in May 2024 to Discuss Updating Covid-19 Vaccine:

Just a reminder: the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on May 16, 2024 to make recommendations on Covid-19 strain selections for the fall vaccine of 2024-2025.

FDA Advisory Committee to Meet in May 2024 to Discuss Updating Covid-19 Vaccine

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on May 16, 2024 to make recommendations on Covid-19 strain selections for the fall vaccine of 2024-2025.

CDC ACIP Meeting on Covid 19 Vaccine Additional Dose

The CDC ACIP meeting on February 28, 2024 on the proposal of a Spring booster of the Covid 19 vaccine was interesting and confusing. Initially right after the morning presentations, we were a little confused about whether the committee was targeting only those who got the vaccine booster last fall or everybody. That didn’t make much sense given the concern about low overall uptake of the vaccine.

The presenters also mentioned that getting the Spring Covid booster would be part of a shared clinical decision-making discussion with your doctor, similar to that recommended for the RSV vaccine. That was bewildering because we think that’s part of the reason some people might skip the RSV vaccine, given the news reports last year pointing out you had to have a prescription from a medical provider in some states to get it.

I was pretty interested in learning more about T-cell immunity given the concern about waning which of immunity from vaccines over a few months, which I think was based on neutralizing antibodies from B cells. I thought the CDC web site link to an article about the T-cell immune response suggested that cell mediated immune responses might mean that our immunity might not be waning that quickly. However, one of the presentations, “Evidence to Recommendation” showed a slide indicating that your T-cell immunity gets weaker with age (ref. de Candia P, Prattichizzo F, Garavelli S, Matarese G. T Cells: Warriors of SARS-CoV-2 Infection. Trends Immunol. 2021 Jan;42(1):18-30. doi: 10.1016/j.it.2020.11.002. Epub 2020 Nov 13. PMID: 33277181; PMCID: PMC7664351.)

I’ve read other articles, one of them on the CDC website, which says you may have more durable immunity provided by T-cells, but if I read it carefully, the authors hedge and say that T-cell adaptive immunity may not be as strong when you’re older. (Moss, P. The T cell immune response against SARS-CoV-2. Nat Immunol 23, 186–193 (2022). https://doi.org/10.1038/s41590-021-01122-w).

Later in the afternoon, the committee voted that those who are 65 years old and older should get the spring dose. There was no further discussion of limiting it to only those who got the Covid vaccine in the fall of 2023. There was also no discussion of the shared clinical decision-making detail. The committee upvoted the resolution with a majority.

And yet, the voting question did say: ACIP recommends that persons greater than or equal to 65 years of age “should” (which was changed from “may”) receive an additional dose of 2023-2024 Formula COVID-19 vaccine. The “additional dose” means in addition to the vaccine (monovalent XBB.1.5) given last fall. That’s a relatively select group, when you take the subset of those who are 65 and older.

However, the slides in the “Evidence to Recommendation” had recommended there should be shared clinical decision-making, meaning that you should discuss getting the vaccine with your doctor. However, according to the STAT NEWS article summary of this meeting, substituting the word “should” for “may” would make the conversation with a doctor unnecessary.

Finally, there was no discussion at all of changing the 5-day isolation precaution for those testing positive for Covid-19. If the committee were planning to drop that, as many news agencies recently reported, I would think they’d have discussed it at length at the meeting.

The CDC Director will have to sign off on the additional Covid-19 shot before it’s official.

2/29/2024 Update: CDC Director endorsed the additional dose yesterday.

Thoughts on Upcoming CDC ACIP Meeting

Sena and I are talking about the upcoming CDC meeting on February 28th-29th next week. The agenda looks like they’ll be talking about an “additional dose” of the Covid-19 vaccine.

Given the extent of vaccine fatigue going on, I tried to find a layperson-friendly article on the web about vaccine immunity with details about how long it lasts.

There’s review article from 2022 that helps a little bit. The author says that boosting every few months may not be practical as a long-term strategy. It leads to vaccine fatigue in the population. We all know how low the Covid-19 vaccine uptake has been. The author says that boosters should be offered annually or even less often. There is more to immunity than neutralizing antibodies.

The suggestion of some experts is to offer Covid-19 boosters to whoever wants it. I feel like I’m getting mixed and circular messages when I read that my immunity is “waning,” and I need another one. We’ve gotten every Covid-19 shot since the vaccine campaign began. Experts even differ on whether to call Covid-19 a “seasonal” respiratory virus. That would suggest you could get one shot annually during the respiratory virus season-like the flu shot. Obviously, it’s not that simple if the CDC recommends another Covid-19 vaccine this spring.

And the CDC respiratory virus channel snapshot from February 16, 2024 is a little concerning. A couple of days ago there was a news report that schools in Forest City, Iowa would have to move to remote learning because of outbreaks of influenza, strep throat, and even stomach flu. According to the CDC, respiratory virus activity levels are high all over Iowa, which surprised me this late in the season.

CDC ACIP Meeting February 28-29, 2024 to Discuss Covid-19 and Other Vaccines

There are news stories about a pending CDC-ACIP meeting (February 28-29, 2024) which might include information about a CDC recommendation to possibly add a 3rd additional Covid-19 vaccine booster this spring.

The Covid-19 vaccine portion of the meeting is scheduled for February 28, 2024 at 8:30 AM EST. There will be a vote at 1:55 PM EST that day.

Interestingly, also on the agenda is a discussion about the RSV vaccine on February 29, 2024 at 8:30 AM EST. We wonder whether the committee will talk about the current requirement for a shared clinical-decision making discussion with a physician for getting the RSV vaccine.

New Large Covid-19 Vaccine Study Shows Association with Rare Side Effects Which Other Smaller Studies Have Found

I’ve seen a couple of news stories about the CDC supported large study across many countries which essentially shows that Covid-19 vaccines can be associated with rare side effects. The stories might tend to raise anxiety about the vaccines’ overall safety, which has been repeatedly proven in other studies.

The study is published in the journal Vaccine and the conclusions are consistent with smaller studies showing the Covid-19 vaccines safety although they do have rare side effects.

One of the news stories contacted an expert, Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center, who confirmed that.

Unfortunately, there are over 1200 comments (and counting) containing alarmist and misleading information about the vaccines.

CDC May Change the 5 Day Covid-19 Isolation Guidelines

I see many news headlines reporting that the CDC may be planning to drop the 5 day Covid-19 isolation guidelines. For now I’m taking that as a rumor until the CDC website says something official about it.

Word on the street is that we may know more in April.