BREAKING: FDA approves Pfizer vaccine booster for people over 65 and those at risk of serious illness.

More here in a minute.

1/
First, you can listen to FDA Commissioner explain how she considered this decision on @inthebubblepod. 2/
What will happen next is Thursday the CDC advisory committee tomorrow will meet to make specific recommendations on how to implement this approval. Then Th or Friday, Dr Walensky will make a final decision.

They will do a few things. 3/
1-Who will qualify— likely health care workers, people with illnesses, and other risk factors— for people of any age. Anticipate a wide berth.
2- what proof if any will be required
3- can people with J&J and Moderna get a Pfizer boost? 4/
On that question, unless prohibited, any doctor should be able to prescribe a Pfizer shot for a Modernan or J&Jer as a backstop if they feel waiting the weeks until those are approved is too big a risk. 5/
I made the case here that the FDA would be justified in now or at some point reducing the age to 40 and above.

They didn’t. What they did do is create a hole a mile wide for people 6 months out to get vaccinated. 6/
Today on my podcast is a toolkit episode that explains how within a CVS or anywhere else you can get a booster, what they look for, and what they don’t if you want one.

The other guest also answers whether you should want one from a scientific perspective.
7/
Including the key mix-match questions for Pfiderna and J&Pf.

(I made that up. Clever)

I spent a bunch of time this week trying to anticipate all the booster questions so hopefully all those things help. 8/

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More from @ASlavitt

20 Sep
When the GOP cited “health freedom” to make opposition to pre-existing condition protections their mainstream view a decade ago, it became only a half a step away from today’s full scale embrace of anti-science, anti-health measures. 1/
“Health freedom” is one of those phrases someone cleverly arrives at because it sounds better than “full hospitals and portable morgues.” But its without a practical difference.

What exactly am I entitled to with my health freedom?

2/
It’s a big rallying cry for major candidates.

Scott Jensen in MN, Larry Elder in CA & JD Vance in OH are untalented even as politicians go.

So 10k likes from Russian bots and @Yolo304741 are all the encouragement they need to convince themselves they’re on the right track. 3/
Read 12 tweets
18 Sep
COVID Update: The very unclear story of boosters will become clear.

I will try to sort it out. And attempt to be clear myself! 1/
The evidence for a booster shot is obvious for people as they age or are at risk. The immune response was lower to begin with & after 6 months vs Delta that adds up to risk of hospitalization. 2/
Boosters dramatically increase antibody levels. And the safety profile of the boosters is also pristine. No real side effects.

It’s a no brainer for everyone with immune system issues or a little, ah, age on them. How much age? 65? 60? 50? 40? Will get back to that. 3/
Read 25 tweets
17 Sep
COVID Update: The FDA is meeting on boosters.

There are a lot of moving pieces. We are monitoring & the head of the FDA is coming on @inthebubblepod Monday.

Follow here if interested today for updates & explanation of what to expect. 1/
As background, the FDA meeting starts today and will hopefully end today.

The CDC will then meet to make recommendations on: age, time, mix-match recommendations, nursing homes, and more. I will address each of these.

It could be a full week before all that is ironed out. 2/
Let me start with where there is certainty & likelihood.

Americans over 65: the evidence says 3 things.
-Booster is safe
-Booster dramatically increases immune response, symptom reduction, hospitalization#
-Seniors have lower levels of immunity after 2nd dose

A no brainer. 3/
Read 22 tweets
15 Sep
COVID Update: There is an amazing array of efforts, some not very visible, to tackle COVID.

If you want to know how COVID plays out, the variables are here. But there’s the fatal flaw: us. 1/
I can try to classify many of the efforts to address COVID as now (high impact progress we are working on now), med term (things underway but not immediate), and long term (potential big game changers). 2/
The now items are critical to saving lives today & reducing the odds of future variants.

Number one on that list is to vaccinate the majority of the globe by the first quarter. 3/
Read 25 tweets
14 Sep
COVID Update: With requirements rolling across the country, I called a company that implemented vaccine requirements last month.

Here is the experience & lessons for the rest of us. 1/
Background first. The company is based in the Midwest with 6000 people.

The workforce has salaried, factory workers and service center workers.

Their starting point was 70% of the staff vaccinated.

The CEO announced that by 10/1 everyone needed to be vaccinated. 2/
The first reaction was a 10% reduction in their employee satisfaction surveys— the first reduction in the history of the company.

Some people were quite upset. So the CEO began to try to understand people’s reasons for being unvaccinated & their objections. 3/
Read 24 tweets
12 Sep
This chart is interesting.
What it says is that Delta is spreading within households (that’s what Secondary Attack Rate means) at the same level as peak flu season.
Note the increase over last September.

It implies at least 3 things we should try to understand better. 1/
First, kids are getting COVID at school and infecting family members.

Policies preventing schools from protecting kids are failing the entire family including seriously at risk adults. 2/
Second, household infections are going to grow over the Fall and early Winter without more layered interventions. 3/
Read 4 tweets

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