Breaking. FDA Guidance document on J & J vaccine efficacy. Overall efficacy 67%. Efficacy to prevent severe COVID 77%.
Severe COVID efficacy analysis.
Efficacy maintained in older patients.
Link to FDA guidance document. fda.gov/media/146217/d…
COVID related hospitalizations with J& J vaccine (sponsor provided additional information). 90-100% efficacy. @ASlavitt fda.gov/media/146218/d…
Link to additional data on variants and hospitalizations provided by sponsor. fda.gov/media/146218/d…
Vaccine efficacy analysis by country. fda.gov/media/146219/d…

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More from @VincentRK

26 Feb
In randomized trials with 6 different COVID vaccines involving ~175000 persons:

0 hospitalizations for COVID in persons who received the recommended schedule of vaccine.

That is ZERO.
Astra Zeneca Oxford
Pfizer
Moderna
Novovax
Sputnik V
J & J
Source: I read each FDA guidance document for Pfizer, Moderna, and J & J. The @TheLancet papers for Astra Zeneca (most recent) and Sputnik V. And press release for Novovax interim analysis.
Read 4 tweets
25 Feb
If you had any doubts about the efficacy of vaccines: Marked reduction in deaths in vaccinated persons in nursing homes than in overall US population. #VaccinesSaveLives @nytimes @mathisonian @smervosh @danielle_ivory Image
If you don't believe this, and the data from randomized trials and other real world data we already have, then your aren't gonna believe.
This is why I'm confident that vaccines will get us back to normalcy.

This is why I don't this March will be terrible.

This is why I think we can be near normal by summer as proportion of people who have been vaccinated and those with prior COVID inches close to herd immunity
Read 7 tweets
25 Feb
Mutants or not this is what's happening. Update. #COVID

What we can control: Vaccines
What we can't control: Mutants
(Except through Vaccines). ImageImage
Same story in Israel where more than half the country has received at least 1 dose of vaccine. And real world data show marked protection from vaccines. ImageImage
This is pretty good sustained reduction since my earlier tweet from over 2 weeks ago.
Read 4 tweets
24 Feb
COVID Deaths. ft.com/content/a2901c…
You can hardly see India on here now.

While relaxations on masks & lockdowns led to increased deaths in Europe & USA, we don't see this in India even though I think similar relaxations occurred. Next month is critical.
There is worry about new cases increasing in Maharashtra. Hope this is controlled with some changes to policy and by expanding vaccinations quickly.
Deaths may lag behind the rise in cases and that's why I think we will need another month to assess the severity of the recent increase in cases over the last 10 days. news.google.com/articles/CAIiE…
Read 4 tweets
23 Feb
Never ever interpret clinical trial data in medicine in isolation. It is always best interpreted in context of biologic plausibility and pre test probability.
Pre test probability is affected by how much we know, especially results of other similar studies.

Not everyone puts in the effort to learn what's out there to calculate the best pre test probability.
Similarly not everyone may have studied enough to understand the underlying biology.
Read 6 tweets
23 Feb
In addition to virulence, SARS CoV-2 had the perfect trifecta:

1. High rate of asymptomatic infections
2. Highly contagious
3. Surprised immune system

Variants may retain most features. But after vaccination they will NOT be new to immune system.

That's why we will win.
I do worry about variants. And read up a lot on them. But I also recognize that the only realistic weapon we have against the emergence and proliferation of COVID variants is to vaccinate as many people as possible m, globally, with whatever approved vaccine is available.
Focus focus focus on what is in our control. And act on that.
Read 4 tweets

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