Discover and read the best of Twitter Threads about #VRBPAC

Most recents (24)

ICYMI: Despite the 4 ‘NO’ votes and concern of premature birth, #VRBPAC went full steam ahead to recommend Pfizer’s new #RSV vaccine for pregnant women to passively immunize their babies.

Watch the Full Meeting w/ Liveblog by Dr. @NassMeryl:……
@NassMeryl Dr. Bernstein, one of the 4 “NO” votes, made an astute comparison to the failed rotavirus vaccine which was pulled from the market in 1999 due to an increased risk of intussusception (serious intestinal blockage) in babies:

“I don’t want another rotavirus vaccine where……
@NassMeryl Instead, he proposed a new, experimental plan to give ALL BABIES monoclonal antibodies on their first day of life.

“Although it’s investigational or still being studied … nirsevimab at birth for all healthy infants I think really will potentially be a game changer against RSV……
Read 7 tweets
My comments to @US_FDA's VRBPAC committee today:

Dear Committee,

I address you as an admin of a tinnitus adverse event support forum.
My only conflict is the unlikely copay reimbursement in the two thousand dollar range from CICP if I were to influence recognition, and later file a claim.
With that, my comments, as a triple, but unfortunately not quadruple dosed individual, are not being made to dissuade vaccination, but have the goal of further improving frequency and outcomes for an unlikely event.
Read 20 tweets
1. #ACIP, @CDCgov's vaccine advisory panel, meets today to study the data on Novavax's Covid vaccine and will vote on whether to recommend its use.
I'll be live tweeting the meeting.
If you want to watch the meeting yourself, it's viewable here:…
2. Several members of #ACIP appear not to be attending today's meeting. Perhaps they'll join later but I think there are at least 4 of the 15 voting members not present.
3. Make that 3 missing members. I think.
Read 37 tweets
"On June 28, the #FDA decided that henceforth THEY will choose the variants for reformulated #COVID19 shots and NO clinical trials will be conducted to evaluate #safety. Because $cience." (… ) #SARSCoV2 #VaccineSideEffects #EarlyTreatmentWorks
Via #FDA's #VRBPAC meeting, also linked in the piece ⬆️. ( ) #COVID19 #SARSCoV2 #VaccineSideEffects #EarlyTreatmentWorks
Read 7 tweets
Live blog of #VRBPAC meeting by @HelenBranswell and @matthewherper

First interesting info is that VE for BA2 hospitalization ("what we should care about" since we gave up on stopping disease) is at best 71% after 3 doses. Far worse than the 95% that we had to original strain Image
@HelenBranswell @matthewherper Live blog link, thx to Helen and Matthew for condensing the important points:…
And in the biggest shocker of any VRBPAC I've seen, Novavax showed up. We're used to them not being invited to the party.

And not only did they show up, they actually presented new data on Omicron including BA1 BA2 and BA5.

And it was very impressive data too

h/t @doctorvasan Image
Read 22 tweets
Rückblick Teil 4
zum Meeting des #VRBPAC, das die @US_FDA bei der Zulassung der Impfstoffe berät.
Wir teilen den Rückblick auf mehrere Threads auf. Wer sich die kompletten 7.5h im Original anschauen möchte, kann das hier

- Moderna FDA Stellungnahme-
Die FDA hat im Anschluss an die Modernapräsentation eine Stellungnahme abgeben

Bild 1: um was geht es?
Bild 2: wann/wie wurden die Daten erfasst
Details zum Studiendesign (Bild 1-3) und Studienziel (Bild 4)
Read 15 tweets
Rückblick Teil 3
zum gestrigen Meeting des #VRBPAC, das die @US_FDA bei der Zulassung der Impfstoffe berät.
Wir teilen den Rückblick auf mehrere Threads auf. Wer sich die kompletten 7.5h im Original anschauen möchte, kann das hier

Teil zwei ...
Findet ihr hier

Es ging los mit Moderna. Was wird beantragt?
Hier die Details zur Moderna Impfung:
Read 29 tweets
Rückblick Teil 2
zum gestrigen Meeting des #VRBPAC, das die @US_FDA bei der Zulassung der Impfstoffe berät.
Wir teilen den Rückblick auf mehrere Threads auf. Wer sich die kompletten 7.5h im Original anschauen möchte, kann das hier

Teil eins ...
Teil eins unseres Rückblicks findet ihr hier:

Im zweiten Teil geht es um die Ausgangslage im Bezug auf die Impfstoffe und um die Anträge
an sich. Es wird lang. Aber dranbleiben lohnt. Der Prozess ist sehr klar und auch für Laien verständlich.
Los geht's:
Was beantragt Moderna?

⏩2fache Impfung mit je 25mcg mit 4 Wochen Abstand ⏪

Achtung: die Daten zu einer möglich notwendigen Boosterimpfung wurden nicht evaluiert. Später wurde diese Thematik angesprochen, wir werden das noch aufgreifen.
Read 5 tweets
Rückblick zum gestrigen Meeting des #VRBPAC, das die @US_FDA bei der Zulassung der Impfstoff berät.
Wir teilen den Rückblick auf mehrere Threads auf. Wer sich die kompletten 7.5h im Original anschauen möchte, kann das hier
Um was ging es?
Empfehlung zur Zulassung von COVID-19 Impfstoffen in den USA für Kinder ab 6 Monaten.

In Europa ist für die Zulassung die @EMA_News zuständig. Deren nächstes Meeting findet nächste Woche statt. Die #u5Impfung steht nicht auf der Agenda

Das nächste Meeting der @EMA_News wird am 18.-21. Juli stattfinden.
Eine Agenda dazu ist uns noch nicht bekannt.
Auf dieser Sitzung wird die Zulassung hoffentlich diskutiert. Danach geht es durch mehrere Gremien. Dann folgt evtl. die europäische Zulassung.
Read 14 tweets
At #VRBPAC today I made note of 2 interesting back-to-back comments made by panelists in regard to Moderna's proposed #vaccine in 6 month-5 yr olds.
I'll let Dr Meissner & Dr Portnoy speak for themselves.
I hope media captures nuances.
From 6:11:48-6:17:40 ImageImage
There are also comments like this one, parapharased (typos and all) by Dr Gans.
I'm not saying it's easy to extract the entirety of these full adcomm days, but I also feel like I see a bit of oversimplification, esp. if it doesn't follow an easy narrative.
At my old gig for 9 yrs I watched 100's of advisory committees. For most of those yrs I transcribed every single voting comment. It's a hard habit to break, I think because seeing comments in writing, in full, made me appreciate how nuanced even a one-sided/unanimous vote can be.
Read 3 tweets
Ni @US_FDA ni personne pourra prétendre ne pas avoir su à temps:
▶️58 bébés moins de 3 ans injectés ont souffert d'effets indésirables mettant en jeu leur pronostic vital possiblement jusqu'au décès: les données VAERS présentées ici👇le révèlent…
▶️Alors que la #FDA affirme dans son document que l'efficacité du vaccin chez les nourrissons est de 80,4%, ce document révèle que cette allégation est basée sur seulement 10 cas COVID-19 identifiés dans l'essai parmi 1415 participants: 7 du groupe placebo/3 du groupe "vaccin"! Image
▶️Dans la plupart des cas signalés pour ces tout-petits, il s'agit d'atteintes multisystémiques (saignement menaçant le pronostic vital, choc anaphylactique, syndrome anticholinergique, encéphalite, hypoglycémie et syndrome des neuroleptiques)
Maintenant, vous tous @US_FDA savez!
Read 8 tweets
FDA #VRBPAC meeting on Novavax is today. We'll see soon enough but the single voting question looks like a softball, simply whether benefits outweigh risks. Since there's benefit similar to RNA with lower risks, should be an easy yes. Image
Wouldn't be surprised if there were a few myocarditis cases here, but there could be ascertainment bias, and the rate is already much lower than RNA, so the benefit/risk ratio is better. Novavax stated that the rate is 0.007% vs 0.005%, barely different…
Meaning barely different between 0.007% vaxxed vs 0.005% placebo. This appears similar to the risk with Pfizer (HR = 1.34x vs unvaccinated, mixed population) and lower than Moderna (HR = 3.9x). People still get to choose between these per their preference.…
Read 10 tweets
1. #VRBPAC is meeting today to review Novavax's submission for an EUA for its Covid vaccine. Often @matthewherper & I live blog VRBPAC meetings but not today. I'll try to live tweet.
Gonna be an interesting day.
If you want to watch the meeting:…
2. #VRBPAC is going through roll call now. There's a big committee today — 23 (22 voting members, 1 non-voting). There's fully a dozen temporary members sitting on this panel. Tons of expertise here. A number of former VRBPAC members.
3. #VRBPAC is being asked whether Novavax's #Covid vaccine should be given an EUA. This is for their primary series (2 doses, given 3 weeks apart); they aren't asking for an EUA for use of their vaccine as a booster. It's based on the Wuhan (aka original) strain.
Read 43 tweets
Woah, looks like a few key #VRBPAC members who've been participating in past FDA AdCom meetings for COVID vaccines had terms that ended yesterday: Kurilla, Meissner, & Offit. These are standouts. There may be more members, but I haven't had a chance to compare all w/ ended terms.
However, I believe that they can be brought in to serve as temporary members. The panel makeup will be interesting to follow. Here's the current standing #VRBPAC roster:…
Monto (the prior VRBPAC Chair) isn't on the standing roster page anymore. I wonder when his term expired?
Read 4 tweets
1. #ACIP is meeting this afternoon to discuss the recently @US_FDA authorization of Covid boosters for youths aged 12 to 15. I'll be live tweeting. The agenda is here… and the meeting can be monitored here:…
2. Slide presentations for today's #ACIP meeting can be found here, though most of them aren't yet up:…
3. At present there are 13 of the 15 #ACIP voting members in attendance. Chair Grace Lee says others may join later. This meeting was set up at short notice and members have had to scramble — as they have multiple times through the pandemic — to clear time for this meeting.
Read 40 tweets
I disagree with the implication that that the panelists would jump right in with those points. And truthfully, if he felt they should have prevented approval, he should have voted that way. 1/
1- What would longer follow-up have achieved? Since the vast majority of vaccine adverse effects occur quickly in the first month after vaccination, it isn't a safety issue. Those children are still enrolled and we'll learn more from them. Waiting 6+ mos would delay vaccines. 2/
2- Yes, children have less severe infection than adults. They also die from COVID. As mentioned during #VRBPAC , 30% of the kids who have died from COVID had no medical issues. And if you think this should be restricted to high-risk kids (I don't), ACIP will consider. 3/
Read 11 tweets
1. @US_FDA's Peter Marks opens the meeting acknowledging how heated the public debate on authorizing this vaccine for young children is. #VRBPAC members were hit with an organized campaign from anti-vaxers over the weekend. @DrPaulOffit told me he was getting an email a minute.
2. Acting #VRBPAC chair Arnold Monto, who is generally quick to cut off speakers when he wants to move the agenda onward, says lots of time has been allotted for today's meeting.
3. #VRBPAC is taking a short lunch break, till 1 pm ET. Then there's a 60 minute public comment period. Speakers are drawn by lottery, but I'd be very surprised if this isn't a very heated hour of comment.
Read 10 tweets
b/c i apparently seem to like doing this a little too much, i'm going to be livetweeting this whole summit below!

looks to be an absolutely *phenomenal* set of talks.
oh gods this is happening at the same time as #VRBPAC? lol oops. (not really of any interest to me but i imagine at least a few people would want to see both).
okay, here we go! opening comments from co-chairs Hilde Cheroutre & Li-Fan Lu right now.
Read 127 tweets
1. If you're a fan of #VRBPAC — and seriously, who isn't a fan of VRBPAC? — October is going to be a banner month.
3 upcoming meetings. More boosters! Mix-&-match! #Covid vaccine for kids!…
2. @US_FDA announced this afternoon it will convene its vaccines advisory committee, #VRBPAC, on Oct. 14 & 15 to discuss booster shots for both the Moderna (Oct. 14) & J&J (Oct. 15) vaccines.
That will be especially welcome news for J&J recipients, I think.
3. As a bonus, the Oct. 15 meeting will include discussion of data from the NIH's mix-&-match study, where they've been looking at whether boosting with a different vaccine works as well or better, aka a heterologous boost. This is critical info for the best use of Covid vaccines
Read 4 tweets
1. Good morning. #ACIP is meeting today and tomorrow. Today, at least, I will be live tweeting.
@US_FDA has not yet indicated what it is going to do with Pfizer's application for a booster license. So it's really completely up in the air at this point how this turns out.
2. You'll recall FDA's advisory committee, #VRBPAC, voted that there wasn't enough data to approve the Pfizer application to give a booster to everyone 16 & older. VRBPAC did agree there was enough data to authorize boosters for people 65 & older & people at high risk.
3. But as I mentioned, FDA hasn't indicated what it's going to do. It is not bound to follow #VRBPAC's advice, but it will cause a real stir if it does not. If it doesn't follow VRBPAC's advice, it may set up a situation where a second advisory committee #ACIP disagrees with FDA.
Read 46 tweets
There's another #WarpSpeed briefing today at 11:30amET…

While officials declare victory with #COVID19 #vaccines, keep in mind nearly 318,000 Americans have lost their lives -- lives lost Trump & Azar refuse to acknowledge.

Reminder: 318,000 Americans have died of #COVID19.

Alex Azar refuses to acknowledge that at his briefings.…

#COVID19 #vaccines $MRNA $PFE $BNTX
Read 25 tweets
Couple of notes on the Moderna VRBPAC FDA briefing document. A thread 1/
#VRBPAC #COVID19Vaccine…
This is just beautiful. Note that the 2nd dose was given at day 28, and curves diverge around day 14. Early protection. 2/
They also give details about the ~2000 subjects who received only one dose. VE 14 days after the 1st dose was 92% (wide CI though) and 80.2% overall. 3/
Read 11 tweets
Just out in @JAMAcurrent: The Ethics of Continuing Placebo in SARS-CoV-2 Vaccine Trials w/ @mlipsitch and #FrankMiller

A thread with updates on recent developments 1/n…
After @pfizer @BioNTech_Group vaccine was granted @US_FDA #EUA last week, one question on everyone’s mind is: when should vaccine be offered to participants in placebo group? 2/n
We argue: Given limited vaccine supply for at least several months, only those participants on placebo who would be eligible for vaccination outside the trial should be offered vaccine for now 3/n
Read 10 tweets
WELL I'm going to have to dig into this. Reminder that vaccine development is not straightforward, despite the super-exciting day we are having watching #VRBPAC

Australian COVID vaccine terminated due to HIV ‘false positives’…
"The UQ vaccine candidate uses a protein and adjuvant platform, containing the COVID-19 spike protein and a "molecular clamp". A small component is derived from.... HIV, that is not able to infect people or replicate."

Any details out there?
Read 4 tweets

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