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26 Oct, 10 tweets, 5 min read
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.
4. @matthewherper has been posted some really interesting updates to our #VRBPAC live blog, with helpful data-interpreting illustrations. Check back often. statnews.com/2021/10/26/pfi…
5. Not clear why #VRBPAC isn't enforcing the time limit on speakers.
6. Hearing some ... lack of enthusiasm for Covid vaccine for all 5-11 yos among some #VRBPAC members.
I don't think it will prevent most from voting for it, but not sure it will be unanimous.
7. A point several #VRBPAC members have stressed is the need to be able to keep kids in in-person schooling. The cost of the long period of disrupted education is weighing on minds here.
8. Just a reminder that @matthewherper & I are live blogging this #VRBPAC meeting. Our takes here: statnews.com/2021/10/26/pfi…
8. The #VRBPAC vote passes.
Based on the totality of scientific evidence available, do the benefits of the Pfizer- BioNTech Covid-19 vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11 years of age?
Yes: 17
No:
Abstain: 1
9. Our first crack at explaining the outcome of the #VRBPAC meeting is here. We'll be updating this. statnews.com/2021/10/26/fda…

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More from @HelenBranswell

Helen Branswell Profile picture
26 Oct
1. A short #flu interlude:
@ECDC_EU released a statement today on flu in Europe warning of a potentially severe season looming for the elderly. It doesn't appear to be based on a ton, though flu activity seems to be higher than normal fo this time of year in Croatia.
2. @ECDC_EU's claim this might be a severe season for the elderly is based on the fact that most of the flu seen in the EU is H3N2, which is hard on seniors. This could be a bad year; no doubt about it. But this feels like not a ton of data on which to predict what's to come.
3. It also is timed to the launch of the @ECDC_EU's #flu awareness campaign. So there's that. ecdc.europa.eu/en/news-events…
Read 7 tweets
Helen Branswell Profile picture
21 Oct
1. The #ACIP meeting on #Covid boosters is about to begin. Day long meeting. It will be interesting to see if they try to put some guard rails up around a pick-your-own-adventure booster process that @US_FDA seems to have green lit.
I will try to live tweet, but no promises.
2. If you want to listen to the meeting, here's the link: video.ibm.com/channel/VWBXKB…
3. CDC Director Rochelle Walensky, who overruled #ACIP the last time the committee met on #Covid vaccines, is addressing the committee now. No mention of having overruled ACIP.
Read 55 tweets
Helen Branswell Profile picture
15 Oct
1. Gonna sneak in a little #flu info here. New global data from @WHO covering the period to the end of Sept. shows flu activity remains very low around the world. Where flu is detected, influenza B (Victoria) viruses seem to be the dominant viruses spreading.
2. Of nearly 250,000 respiratory specimens tested for flu around the world in the 2 weeks ending Sept. 26, only 2,022 were positive. That's a 0.8% positivity rate.
#Flu will return & when it does, we could pay dearly for its hiatus. But not clear when the return will occur.
3. I'll add more to this thread after 11 a.m., when @CDC posts its weekly #flu report, FluView.
Here's a link to the @WHO flu report. who.int/teams/global-i…
Read 9 tweets
Helen Branswell Profile picture
14 Oct
1. #Ebola news: The new outbreak near Beni in the northeastern part of DRC is a flare up of the 2018-2020 North Kivu outbreak, genetic sequencing by Congo's @inrb_kinshasa has confirmed, @SoceFallBirima told me. This outbreak is not a new spillover from nature.
Thread.
2. The first confirmed case in this new outbreak was a 3 yo boy who died on Oct. 6. Comparison of the genetic sequence of virus from this boy showed it most closely compared to viruses sequenced in July 2019.
This is the 2nd flare up in North Kivu from the 2018-20 outbreak.
3. The 1st flare up in North Kivu happened earlier this year. This new flare up is not linked to the Feb. cluster of cases, comparison of the sequences shows.
@SoceFallBirima says an investigation is underway to figure out how this flare up ignited & if there are more cases.
Read 4 tweets
Helen Branswell Profile picture
13 Oct
1. The preprint from the @NIH mix-&-match #Covid vaccine trial is out. Interesting though not surprising findings. It is too bad the study was conducted using a full dose of Moderna's vaccine, given the fact the company's booster is a half dose. medrxiv.org/content/10.110…
2. The fact that the study used 2x as much vaccine in the Moderna arm than Moderna is proposing to give people with its booster shot means the Moderna findings have to be taken with a big grain of salt. It's a huge shame.
3. The study found all boosters did what the name implied — they boosted antibody levels. But mRNA boosters did it more than the J&J vaccine did.
Caveat: These findings are based on antibodies in blood not vaccine effectiveness trials. Don't know how long the boost will last.
Read 4 tweets
Helen Branswell Profile picture
1 Oct
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!
fda.gov/news-events/pr…
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

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