The lack of FDA approval for mRNA COVID vaccines is preventing doctors like me from telling immunocompromised patients what we really think they should do with regards to a boosters.

I get asked every day.
Ditto with J&J single dose recipients. Especially elderly and immunocompromised living in high incidence areas.
With approval, doctors have liberty of recommending off label treatments. Under EUA we are all unsure what we can legally do and what we cannot.

At least a clarification on that question would help.
This type of guidance is helpful. wdam.com/2021/07/23/hea…

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More from @VincentRK

25 Jul
COVID vaccines are no doubt having a huge effect keeping deaths down. See below.

But there are warning signs which we cannot ignore.

Thread
1/
Warning sign #1

The continuous emergence of more serious, more transmissible variants, delta being a major one. mayoclinic.org/diseases-condi…
Warning sign #2

Waning protection in vaccinated individuals against infection over time. @JoshuaPCohen1 forbes.com/sites/joshuaco…
Read 6 tweets
23 Jul
No! I wouldn't blame the unvaccinated. I would blame the pundits and politicians spreading misinformation on TV and social media even though they themselves are likely vaccinated. google.com/amp/s/www.poli…
I would blame continued mixed messages. I would blame lack of approval of the vaccines which keep sending a message that somehow some mysterious thing is preventing FDA from concluding that the vaccines are safe and effective— that's the standard they are supposed to adjudicate.
Misinformation and mixed messaging are the culprits.
Read 5 tweets
22 Jul
The drop in cases and deaths occurred following start of vaccinations as been reversed in the UK by the delta variant.

Hospitalizations are on the rise in many states the US, and it appears almost all are unvaccinated. Deaths will like rise here as well. Please get vaccinated.
Each day brings news reports like this.

Maryland marylandmatters.org/2021/06/28/unv…
Read 8 tweets
21 Jul
We shouldn't make patients feel guilty that they are breaking the law to protect their health. Yet that's what we are doing

1) Medicare Modernization Act asks government to look the other way & use enforcement discretion to not prosecute patients importing drugs for personal use
2) Now similarly I'm seeing a lot of tweets where patients are made to feel they have to lie in order to get a COVID vaccine booster that their own doctors think they need because for example they are immunosuppressed and don't seem to have had an immune response.
The Medicare Modernization Act even went to the extent of saying that it should be made clear what is OK and what is not, so patients know whether they will run into trouble if they for example bought insulin from Canada.
Read 4 tweets
21 Jul
For months I have been advocating for CDC and FDA to issue guidance on second doses for the millions of people who got the single dose J&J vaccine.

Now we have more data. I urge them to act. The delta variant doesn't respect one dose. nytimes.com/2021/07/20/hea…
One dose of Pfizer and Astra Zeneca didn't cut it. There was nothing special about J&J that would have allowed it to be uniquely effective. We knew this months ago.

One dose is not enough. One dose is not = fully vaccinated.
Short term protection which is what was studied in the randomized trials was good. So was it after one dose of Astra Zeneca.

But immunology 101 is that a second exposure to same antigen allows more class switching and more effective and durable response.
Read 5 tweets
18 Jul
COVID vaccines work & keep severe disease & deaths down. But if England lifts restrictions tomorrow, amidst a serious rise in cases in the UK, it is inviting loss of life.

Why not wait till this spike goes down? Why do it now when you have barely 50% of people fully vaccinated? ImageImage
Deaths are going up, but not in the same magnitude as prior waves coz high % of elderly have been vaccinated.

You can see the rise in deaths better in log scale.

Does the decision mean willingness to accept 50 deaths a day? That is seriously not good. Image
Make some arbitrary decision and stick to it despite overwhelming evidence that the decision is a huge mistake is something we have seen over and over in this pandemic in many (but not all) countries.
Read 5 tweets

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