FDA VRBPAC Meeting to Discuss Covid-19 Vaccines

The FDA VRBPAC meeting to discuss Covid–19 vaccines is scheduled for May 22, 2025, 8:30 a.m. – 4:30 p.m. ET. The committee will meet in open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.  

I couldn’t see any specifics about the forthcoming meeting. I assume there will be updates.

Procrastinate on Getting the Covid Vaccine?

This post is sort of my thinking out loud about whether or not I should get the Covid vaccine ahead of this summer that was approved last year as being appropriate to get twice a year by the CDC—once in the fall along with the flu shot and once to protect against the Covid summer surge that some experts argue has been happening every summer since the pandemic onset.

The trouble is that the dominant subvariant is no longer the JN.1 or KP.3.11. The currently dominant circulating bug is LP.8.1 according to the CDC Nowcast chart.

And what confuses me is that one expert still recommends getting the September 2023 updated vaccine, but recommends getting the “bivalent booster.”

And a recent article from the University of Minnesota Center for Infectious Disease Research and Policy (CIDRAP) says that a preprint study (not yet peer-reviewed) says the current Covid vaccine was only 53% effective against hospitalization and 39% medically attended Covid-19. Most patients got the vaccine targeting the XBB.1.5 variant. I think that’s related somehow to the KP.2 variant. I have a vague memory of hearing about the XBB.1.5 during the CDC meeting in September 2023.

I’m a retired psychiatrist, not a retired virologist. The information available to the public seems confusing to me and I imagine I’m not the only one so affected.

The CDC is recommending the 2024-2025 Covid-19 vaccines, which target the JN.1 variant, which is now 0% of circulating variants on the list. But I’m not sure whether the current vaccines would be as protective against the different variants now dominant.

The CDC April indicators show downward trends for test positivity, ER visits, hospitalizations, and deaths.

On the other hand, an August 2024 article from Johns Hopkins warns that Covid-19 rates have consistently risen in July-August risen since 2020. The author says that it’s still unclear whether Covid-19 will continue to have dual seasonality. Other factors that affect this in addition to the emergence of more transmissible variants are human behavior, such as staying in air-conditioned spaces more and traveling.

My big question is should an old guy get the 2024-2025 Covid-19 vaccine or just wait and see, especially in light of the difficult political situation with HHS sounding like it might require new, placebo-controlled trials of some vaccines before “tweaking” them to target more current variants—which could take several months.

But it doesn’t look like there’s a plan to tweak the 2024-2025 Covid-19 vaccine in any case. I’m probably worrying too much, but I’m on the fence. I’m already too good at procrastinating.

CDC Meeting Results in Recommending a 2nd Covid-19 Vaccine Dose for Those 65yr and Older and for the Immunocompromised

I missed the October CDC meeting which resulted in a decision to recommend a 2nd dose of the Covid-19 vaccine for those 65 years and older and for the immunocompromised.

The Evidence to Recommendations (EtR) slides by Roper indicated Covid-19 circulates year round, peaking in late summer and winter.

The recommendation that those in the above-named populations should get 2 doses of Covid-19 vaccine spaced 6 months apart seems based on reasonable considerations.

It looks like the vaccine would be the same as the one previously recommended for this year.

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 Weekly Snapshot Shows Respiratory Virus Activity High

As of January 5, 2024, CDC is reporting that respiratory illness is increasing across the country. The levels are generally high in almost all regions.

“Activity Levels Update:

  • The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated or increasing across most areas of the country. This week, 39 jurisdictions experienced high or very high activity.
  • Nationally, emergency department visits due to influenza and COVID-19 are elevated in all age groups and increasing in all but school-aged children. Recent, holiday-related school closures and associated changes in healthcare seeking behavior may be impacting trends in influenza- and COVID-19-related visits among school-aged children. RSV-related emergency department visits decreased slightly nationally.
  • Nationally, COVID-19 wastewater viral activity levels and test percent positivity—indicators for infection levels—are higher than the same time last year (currently estimated as being 27% higher and 17% higher, respectively). However, indicators for illness requiring medical attention are lower, including emergency department rates being 21% lower than the same time last year.”

New Dominant Covid-19 Variant EG.5

There is a new dominant Covid-19 variant called EG.5. It’s also called Eris. It’s descended from the XBB strains. It’s in the Omicron family and there is no indication it causes more severe disease and would be susceptible to current vaccines.

Selected Highlights of CDC ACIP Meeting on Covid-19 Vaccines

Today I’m highlighting a few items of interest to older adults from the summary slide set on Covid-19 vaccines presented on June 23, 2023 at the CDC ACIP meeting last week. Information for other age groups are included in the slide set.

Covid-19 continues to be a major health threat for the population, especially older adults and the immunocompromised. Vaccines are still the most effective intervention. However, the bivalent vaccine uptake was very low; most people didn’t get it.

A new Covid-19 monovalent vaccine with an XBB.1.5 composition, is expected to be available this fall.

In the fall, the vaccine manufacturers will switch to the commercial marketplace. In order to continue making Covid-19 vaccines available to the uninsured, there is a Bridge Access Program for Covid-19 Vaccines and Treatments” which is described at the HHS website.

Covid-19 Variants in the News

Sena alerted me to a CBS news item with the headline “CDC tracking new Covid variant EU.1.1.” The story seemed a bit misleading because the FDA just announced approval of vaccines for XBB.1.5. beginning in the fall.

I checked the CDC Data Tracker for variants and noticed XBB.1.5 is still the most common Covid-19 subvariant in the U.S.

While the EU.1.1 is on the list of subvariants tracked, it’s pretty far down the line and is much less common than the news headline seems to suggest. And it’s not clear the new vaccine for XBB.1.5 wouldn’t protect against EU.1.1 as well.