I haven't had a chance to start listening yet, but if FDA is saying this then it's a good step forward.

I don't have time yet to talk about why this discussion should have been had a month ago before the current EUA expansion to 12-15 yos
For those who want to know more about side effects, FDA slides are up and there will be good data reported on myocarditis risks. I will follow along and try to post here.

fda.gov/advisory-commi…
ACIP has scheduled a meeting for June 18, 2001 to update data and discuss risk/benefit with myocarditis.

They have not found signals compared to other vaccinations, but observed>expected after dose 2
I will be tweeting more on this as they present data, so mute me if you'd like. Data from select sites that monitor vaccine safety. No overall signal for myocarditis (but not limited to 2nd dose or younger)

Data do not include 2nd doses in 12-15year olds, since that too recent.
The CDC is now presenting the key data on myocarditis. Time to listen if interested.
Just a reminder that anyone (literally - anyone) can enter an adverse event in VAERS. Generally it's not a good idea to just focus on numbers from VAERS without critical thinking.
In all of these cases the median time to symptom onset is very short - days after vaccine.

predominately male, but not exclusively

Also important that this is data through May 31, so does not include any 2nd dose information from adolescents 12-15 year olds.
key slide, after 2nd dose of vaccination.

Observed exceeding expected known background rate for myocarditis for these preliminary reports - not all will be true cases tho.

Of 528 reports, over half are in <24 yo.

We need these data for 12-15 year olds - not available yet.
I included this before, but again. This is comparing to other vaccinated people.

No statistical signals for any prespecified outcomes. BUT this is not age stratified - includes all ages and he stresses limited vaccine doses given so far in 12-15 year olds.
But there is evidence of dose effect - if the myocarditis were just background, why is it so much more common after dose 2? Good question walid.

This is ages 16-39 year old rates. Still no data for 12-15 year olds.
Just to make my point clear - which I said at time as well - this discussion, these data, should have been part of the discussion PRIOR to the EUA to 12-15 year olds, not 1 month later.

The SAME data would have been seen, even if not as updated.
Dr. Meissner, a leading national expert in pediatric vaccinations.

Asking about TTS in J&J vaccine in younger women vs. rate of myocarditis in young kids. CDC responds ~1 in 100k but won't put a firm number on latter but sounds like will at ACIP meeting next week.
Meissner is making point that myocarditis likely should be included in informed consent. Sounds like more discussion next week at ACIP.

I have to sign off but look forward to more discussion later today.

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More from @walidgellad

10 Jun
One day i'd like to write about how I think downplaying the possibility of an adverse event for a vaccine in order to not scare the public ends up scaring the segment of the public that you most need to convince to take the vaccine.

They already worry something is being hidden
Think TTS with astra zeneca or J&J.

First response from all officials was "there's no link between vaccine and side effect." I don't think it's helpful to say things like that, when you have no idea if it's true.

E.g. here is UK saying no prob in March

bbc.com/news/uk-563975…
here is a few weeks later.

Same thing happened with J&J and TTS, and it seems likely for myocarditis and mRNA.

Instead, acknowledge some concern. Don't just reflexively brush things off. You lost trust.

cnbc.com/2021/04/07/eu-…
Read 6 tweets
9 Jun
Had the acting FDA commissioner said anything about the aducanunab approval?

FDAs actions were unprecedented and need to be addressed.
Aducanumab approval is of monumental significance for FDA and American healthcare.

The acting commissioner's account is tweeting about standards of identify for yogurt.

It's clear Dr. Woodcock is not creating these tweets, but I'm disappointed in the silence on this issue from the acting commissioner.

If someone has seen a statement from the commissioner on the use of accelerated approval in this way for aducanumab, please let me know.
Read 5 tweets
12 Apr
Regeneron’s Covid mAb as a prophylactic injection: Reduced risk of symptomatic infection by 81%

Amazing. This is subcutaneous, not IV.

Prophylaxis in healthy people who are exposed to covid.

This would totally change how we deal with covid.

endpts.com/regenerons-cov…
Lilly has also shown that mABs prophylaxis works, although not with subcutaneous yet.

One consideration: mABS receipt is one of the few contraindications to covid vaccine. However, mABS, unlike vaccines, work immediately. Think Michigan.

statnews.com/2021/01/21/eli…
Since we are also considering an EUA for vaccines to extend to younger children....

Note that Regeneron is studying these prophylactic antibodies in young kids and adolescents...
and as treatment for covid in kids.

clinicaltrials.gov/ct2/show/NCT04…
Read 4 tweets
11 Apr
This issue deserves more discussion:

is an EUA justified, or necessary, for the COVID vaccine in children given the current understanding of COVID risk to children and fact that adult vaccination will greatly reduce that risk (as in Israel).
The issue of whether EUA is justified is totally separate from the ethical issue Vinay brought up previously about vaccinating children in US while millions of adults around world die from COVID without vaccine.

Don’t have the answer. Would like to see more debate.
Appreciate the responses here.

Remember, I’m not questioning vaccination for children here. I’m questioning EUA as the mechanism.

EUA allows for less data on safety and efficacy when there are no treatments and the disease is serious and life threatening.
Read 4 tweets
9 Apr
When Covid cases go up, hospitalizations go up.
When hospitalizations go up, people die.

Michigan's deaths plotted below. We have not vaccinated enough people to think that case counts don't matter any more.

covidactnow.org/us/michigan-mi… Image
We know what happens in the next few weeks. Case counts are still going up - that means hospitalizations will continue to rise, as will deaths.

Deaths will not go up as much, but they will go up.

We've seen this again and again. Image
I started tweeting about Michigan a month ago.
It was clear what was happening. Sorry to all those in Michigan who have to deal with it.
Read 4 tweets
29 Mar
I'm already interrupting my twitter break because what is happening in Michigan is preventable suffering.

Covid ER visits (grey bars) reaching peak levels. Hospitalizations almost triple what they were a month ago, ICU patients doubled.

All predictable. Cases matter still.
For weeks i've been tweeting about Michigan and I need to tweet or i'll just yell at my desk.

All anyone could do was gush over the vaccine numbers, while a tragedy was unfolding in front of us.
All anyone can do is gush over vaccine number, while today, we still haven't fully administered the first shipment of one-shot J&J vaccines that were delivered A MONTH AGO.

Where is the push to do better?

Read 10 tweets

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