115 Comments
Jun 16, 2023·edited Jun 16, 2023Liked by Katelyn Jetelina

Fantastic summary! And in regard to your statement that someone should help the FDA explain these findings to the public, that someone is definitely YOU! Maybe they would also want a simple 5 word feel-good statement for those in the public that don't have the time or inclination to digest a more complex answer, but for those of us who realize that Covid killed > one million Americans and want to do something about it, you are a lifesaver!

Expand full comment

Why will there need to be any discussion about WHO will get the vaccines? We are all at risk from COVID. This shouldn’t even be a conversation at Year 4 of this ongoing pandemic.

As a parent of young kids, I will be LIVID if the so-called public health apparatus decides to leave out our kids AGAIN.

Expand full comment
Jun 15, 2023·edited Jun 15, 2023

Absolutely there were humans who participated in the Covid vaccine clinical trials - I am a proud Phase 3 Pfizer participant! I would do it again in a minute - I met many wonderful fellow trial participants and was glad to contribute to the research. If someone tries to say no one was involved, just tell them your pal Jill sure was.

Expand full comment

Did I miss something?? No mention of protection for the immunocompromised, for whom the vaccines don't offer protection. The FDA should be prioritizing this group (est 3% of the pop) which is still the most vulnerable to poor outcomes from Covid.

Expand full comment

Query: should those of us who are over 70, currently due for another dose of the bivalent vaccine, and/or traveling abroad between now and early Fall get the old bivalent now—or wait for the new monovalent vaccine? Please advise. Thanks.

Expand full comment

Oof, I just had covid for the first time a couple weeks ago. Picked it up in NYC. Wasn’t terrible after the initial runny nose, sore throat, body aches (my knees really hurt) and fever. Paxlovid to the rescue. Had very mild rebound 2 days after the paxlovid with congestion, low grade fever and oddly leg muscle pain. I had been extra careful because I have diabetes and asthma.

Any news on new antivirals in the works? I know that the fear is that paxlovid may become infective. Paxlovid made me fee, better within hours of taking it.

Expand full comment

I don't understand the claim that the drop in vaccine effectiveness isn't really all that big because of some "immunity wall". What does that even mean? The only immunity I have from COVID is from vaccines.

Expand full comment

What is known about how effective a Novovax booster is compared to an mRNA booster (for someone who previously had mRNA boosters)? Thanks.

Expand full comment

Firstly, thank you. Additionally, I realize that not having discussed “who” will be eligible does not mean some will he excluded but as someone whose job it is to advocate for Vaccine uptake in children, waiting for late summer to release this is detrimental to acceptance. Success lies with families and this sows doubt in the necessity. This is absolutely what occurred when there was delay approving the bivalent booster. Bu the time it was approved, many willing parents had mentally moved on and it was no longer feeling urgent.

What a pity this will come so late.

I am looking forward to more information about administration data for same day flu and Covid vaccines too.

Thank you!

Expand full comment
Jun 15, 2023·edited Jun 16, 2023

Thank you for this excellent and timely summary. I am especially hopeful that Novavax will be able to manufacture a booster on time and at scale, and that FDA doesn't restrict access of Novavax for those of us who prefer it over mRNA.

Expand full comment
founding

Interesting article from Jeremy Faust on the meeting: https://open.substack.com/pub/insidemedicine/p/fda-moves-towards-monovalent-covid (For those who asked about benefits in younger populations, he has a good bit to say about that.)

Have to say, the booster landscape is getting more and more confusing. I would like to have a better understanding of the risks and benefits than I do so far, particularly on “imprinting” and on the pros and cons of mRNA v. Novovax.

On imprinting, BTW, Faust had this to say: “Second, dropping the Wuhan portion of the vaccine will decrease the immune imprinting that we’ve seen crop up, in which we accepted short-term protection in exchange for longterm higher rates of reinfection. (I discussed this on the PBS News Hour this spring).” This is the first I have heard of that trade off. Is anyone here familiar with what he means?

Expand full comment
founding

There are disturbing statistics about an extreme rise in excess deaths among working age people in 2021 and 2022. I would be very grateful if you would discuss. Some are attributing it to the vaccines. The rise is so huge (“blackswan like”) that I will not do another MRNA vaccine until I understand what these excess deaths mean. I have had 4 Modernas but now hear I have no protection against XBB. The risk/benefit calculationis starting to weigh to not getting more vaccines. I hope you can help explain.

Expand full comment

Thanks for the Cliff notes from today's FDA meeting on the fall vaccines. Like others, I hope that all can be eligible for the upcoming fall vaccine, just as with the flu vaccine. I'm 62, and feel that I could really benefit, but my layperson's understanding is that everyone could benefit from these vaccines. I look forward to learning more going forward. Thanks again!

Expand full comment

For those of us who had the bivalent vaccine last fall, should we get the available next bivalent now, or wait for the fall monovalent vaccine? Over 65 years, in good health.

Expand full comment
founding

This is an example of how confusing the booster situation can be for a layperson, even those of us who do our best to educate ourselves. This is an observation from the wonderful Eric Topol on a problem with the effectiveness of the bivalent, relating to a presentation in the FDA meeting: https://twitter.com/EricTopol/status/1669366459678752768

Expand full comment

Always a good read and informative.

Expand full comment