A critical meeting took place yesterday at the FDA. The VRBPAC (external scientific committee to the FDA) discussed one central question: What is our vaccination plan for fall? There were a number of presentations from external agencies (CDC, WHO, disease modelers) and vaccine manufacturers.
It is one thing to roll out a booster for the public. But if we learned anything in the last two years, it is that it is another, more difficult task, to get the public to accept the shot. The WHO and the FDA must take shot reluctance into the equation and minimize the traction any counter propaganda the anti-science community comes up with. This project is part very high level bioscience and part lo-tech marketing.
side question - we know that as long as the covid vaccine effictiveness at preventing infection are too low to drive what people have traditionally considered 'immunity', a large part of the population will consider them unnecessary and uptake will lag (despite infection prevention still being in the 40% range based on admittedly out-of-date data like https://www.healthdata.org/covid/covid-19-vaccine-efficacy-summary, the public discourse describes it as effectively zero). We know that the original vaccines had infection prevention stats almost as good as severe disease prevention (>90%). Has there been data on whether any of the Omicron targeted vaccines get that effectiveness metric back up there?
Have there been any updates on non-spike related vaccines, e.g., the Walter Reed approach? Seems that the mutations, whether driven by vaccine natural selection or just the complexity of the spike, are mainly on the spike and not the core.
I'm confused by the two statements (quoted below), as they seem contradictory, but I must be misinterpreting ... will the fall vaccine likely include BA.4/5 or no?
1. "the WHO is recommending a fall monovalent or bivalent booster with the BA.1 formula instead of using a BA.4/5 formula. (I must say, I agree with WHO’s approach. We aren’t going to “win” a rat race with this virus.)" ----- vs ----- 2. "Looks like we are getting an Omicron vaccine in the fall. It will likely be a bivalent vaccine and probably with BA.4/5 formula."
Thank you Katelyn for such clear writing on a challengingly nuanced topic; love how you highlight the unknowns (and why they are unknown)! QUESTION: accuracy of home molecular tests and lab-performed PCR tests to detect BA.4/5. We occasionally use Lucira's home molecular test in certain situations (when we THINK it's worth the 70-75 bucks). Lucira says their test has high accuracy on all Omicron variants but wonder if it's reasonable their accuracy figures apply to all Omicron variants? Same Q for lab PCR? Here's what Lucira says: https://www.lucirahealth.com/technical-brief/? (posted June 7, 2022). Many thanks!
I watched some of the FDA hearings yesterday and had a question. A few times I heard the mRNA vaccines referred to as "gene therapy" and "not real vaccines." What is the scientific definition for "vaccine," and do the ones from Pfizer and Moderna fit this definition?
Any indication on whether there would need to be a minimum amount of time between booster rounds, e.g., if a person got a currently-available booster, how much time would need to elapse before they could get the (yet-to-be-released) omicron-targeted booster?
I’m confused about one point. There was a lot of discussion about which variant(s) to focus on in this fall’s booster, but it appears that the FDA simply voted to approve having a variant included. (That’s kind of like voting “yes” in a presidential election.) How is the decision made about which variants to include?
Why no mention of Novavax in your comments?? There are data to indicate that its efficacy does NOT fall off anywhere near as fast as with the mRNA vaccines.
Not quite clear to me if you favor a BA.1 (per WHO) or a BA.4/5. I am probably reading it incorrectly.
It is one thing to roll out a booster for the public. But if we learned anything in the last two years, it is that it is another, more difficult task, to get the public to accept the shot. The WHO and the FDA must take shot reluctance into the equation and minimize the traction any counter propaganda the anti-science community comes up with. This project is part very high level bioscience and part lo-tech marketing.
side question - we know that as long as the covid vaccine effictiveness at preventing infection are too low to drive what people have traditionally considered 'immunity', a large part of the population will consider them unnecessary and uptake will lag (despite infection prevention still being in the 40% range based on admittedly out-of-date data like https://www.healthdata.org/covid/covid-19-vaccine-efficacy-summary, the public discourse describes it as effectively zero). We know that the original vaccines had infection prevention stats almost as good as severe disease prevention (>90%). Has there been data on whether any of the Omicron targeted vaccines get that effectiveness metric back up there?
Have there been any updates on non-spike related vaccines, e.g., the Walter Reed approach? Seems that the mutations, whether driven by vaccine natural selection or just the complexity of the spike, are mainly on the spike and not the core.
I'm confused by the two statements (quoted below), as they seem contradictory, but I must be misinterpreting ... will the fall vaccine likely include BA.4/5 or no?
1. "the WHO is recommending a fall monovalent or bivalent booster with the BA.1 formula instead of using a BA.4/5 formula. (I must say, I agree with WHO’s approach. We aren’t going to “win” a rat race with this virus.)" ----- vs ----- 2. "Looks like we are getting an Omicron vaccine in the fall. It will likely be a bivalent vaccine and probably with BA.4/5 formula."
Thank you Katelyn for such clear writing on a challengingly nuanced topic; love how you highlight the unknowns (and why they are unknown)! QUESTION: accuracy of home molecular tests and lab-performed PCR tests to detect BA.4/5. We occasionally use Lucira's home molecular test in certain situations (when we THINK it's worth the 70-75 bucks). Lucira says their test has high accuracy on all Omicron variants but wonder if it's reasonable their accuracy figures apply to all Omicron variants? Same Q for lab PCR? Here's what Lucira says: https://www.lucirahealth.com/technical-brief/? (posted June 7, 2022). Many thanks!
I watched some of the FDA hearings yesterday and had a question. A few times I heard the mRNA vaccines referred to as "gene therapy" and "not real vaccines." What is the scientific definition for "vaccine," and do the ones from Pfizer and Moderna fit this definition?
For those that haven’t gotten our second booster yet, is the recommendation to wait for the Omicron booster or get what’s currently available? Thanks!
Any indication on whether there would need to be a minimum amount of time between booster rounds, e.g., if a person got a currently-available booster, how much time would need to elapse before they could get the (yet-to-be-released) omicron-targeted booster?
Thanks for this great information. Do we know why Offit voted no? Has he discussed it? I respect his opinion a lot.
I’m confused about one point. There was a lot of discussion about which variant(s) to focus on in this fall’s booster, but it appears that the FDA simply voted to approve having a variant included. (That’s kind of like voting “yes” in a presidential election.) How is the decision made about which variants to include?
Why no mention of Novavax in your comments?? There are data to indicate that its efficacy does NOT fall off anywhere near as fast as with the mRNA vaccines.
Do we know why Offit voted “no”?
So why did Dr. Offit vote no? What were his arguments to not include Omicron component in the fall booster vaccin?
I got my 2nd booster today. Do you think I can get another booster in 4 months? I'm a healthy 55 year old male.
So very helpful. Thank you so much. I so appreciate what you are doing!!!