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Kai Kupferschmidt Profile picture
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1 Dec, 4 tweets, 2 min read
Here we go. Moderna and Biontech/Pfizer have today submitted the data on their #covid19 vaccines to the EMA to request a conditional market authorisation. EMA spokesperson told me they think a decision could come “by the end of this year at the earliest”.
If data submitted on Biontech vaccine is robust enough, “EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 29 December at the latest”

ema.europa.eu/en/news/ema-re…
If data on Moderna vaccine is robust “EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 12 January at the latest”.

ema.europa.eu/en/news/ema-re…
I assume spokesperson was talking about Moderna vaccine since timeline for Biontech is faster according to press release.
Data on both vaccines were already being shared with EMA as part of a “rolling review” (Biontech started that earlier), one reason decision can come faster.

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Kai Kupferschmidt Profile picture
1 Dec
I don’t really remember how we marked the beginning of a new week in pre-pandemic times, but these days we celebrate “good news on vaccines” Mondays, followed by “not so good news on global #covid19" Tuesdays.
That’s to say: the WHO’s weekly sitrep is up. Quick thread
Big picture:

3,935,330 new cases and
69,916 new deaths
were reported to @WHO last week.
That means deaths have risen for a sixth week (+3%), but cases are down 4% from last week.

It is a huge amount of death and disease from one little pathogen. Image
@WHO Number of new #covid19 cases finally going down after two months of increases may sound great.
The problem is that the data includes the craziness of US Thanksgiving numbers.
US case number is basically the same as last week, when it should probably be a lot higher.
Read 7 tweets
Kai Kupferschmidt Profile picture
30 Nov
“Last week saw the first decline in newly-reported #covid19 cases globally since September, due to a decrease in cases in Europe”, says @DrTedros at @WHO presser. Says it’s "thanks to the effectiveness of difficult but necessary measures put in place in recent weeks”.
@DrTedros @WHO #covid19 cases are still increasing inmost other regions, says @drtedros and warns that gains can easily be lost, especially with the holiday season coming up. "This is no time for complacency."
@DrTedros @WHO "We all need to consider whose life we might be gambling with in the decisions we make”, says @DrTedros. “We all want to be together with the people we love during festive periods. But being with family and friends is not worth putting them or yourself at risk."
Read 22 tweets
Kai Kupferschmidt Profile picture
30 Nov
More stunning data out from Moderna’s vaccine trial today:

Of 196 #covid19 cases
185 were in placebo group
11 in vaccine group
- 94,1% efficacy

All 30 severe #covid19 cases were in placebo group
- so that’s, well, 100% for now

There was one #covid19 death in the placebo group
“Efficacy was consistent across age, race and ethnicity, and gender demographics”


The 196 #covid19 cases included:
33 in people 65+
42 in people "identifying as being from diverse communities”
Moderna says it will submit today for EUA at FDA and for conditional marketing authorisation at EMA.

FDA meeting to review safety and efficacy data likely on December 17.

Press release here (and yes, it’s another “vaccine news by press release Monday”):
investors.modernatx.com/news-releases/…
Read 8 tweets
Kai Kupferschmidt Profile picture
29 Nov
Interesting piece by @mattapuzzo and others at @nytimes looking at the list of seven demands Trump conveyed to @WHO before he announced withdrawal. No clear strategy apparent. “It was all about my country, my politics, my election”, says @LawrenceGostin. nytimes.com/2020/11/27/wor…
“The third item asked Dr. Tedros to say that countries were right to consider travel restrictions during the pandemic ... Dr. Tedros was wary of being drawn into the American presidential campaign, where travel restrictions were a rallying cry for the Trump campaign.”
“The American requests also called for the W.H.O. to pre-qualify coronavirus drugs and vaccines for use around the world once they were authorized by major regulators in the United States, Canada, Europe or Japan.”
Read 4 tweets
Kai Kupferschmidt Profile picture
27 Nov
“#Covid19 is an uneven pandemic”, says @DrTedros at @WHO press conference on #sarscov2. “70% of cases and deaths are in just four countries.”
(Number seems wrong to me, though general point is true of course. Will check.)
@DrTedros @WHO So, according to @WHO’s own numbers US, India, Brazil and Russia account for about 30 million cases, pretty exactly half the global total of now more than 60 million cases.
On deaths: about 660,000 are US, Brazil, India and Mexico, less than half the 1,4 million global deaths.
@DrTedros @WHO Many countries have shown #covid19 can be controlled with existing tools, says @DrTedros. "One of the things all these countries have in common is an emphasis on testing."
Read 24 tweets
Kai Kupferschmidt Profile picture
27 Nov
This (German) article by @hfeldwisch raises important questions about the Gangelt publication by @hendrikstreeck et al, that I've been wondering about. It argues that the study underestimates how deadly #sarscov2 is because not all the deaths were counted. medwatch.de/2020/11/26/die…
@hfeldwisch @hendrikstreeck I had wondered about this before because

1. We know that deaths lag cases and studies like this Princess Diamond one (eurosurveillance.org/content/10.280…) take that into account when calculating IFR
2. @hfeldwisch and others had warned before that the Gangelt study was not doing that
@hfeldwisch @hendrikstreeck The study was published in @NatureComms last week. Headline finding was an estimate for the infection fatality rate of #SARSCoV2 of 0,36%.
That was based on 7 deaths in the community of Gangelt compared to 1956 (estimated) infections.
nature.com/articles/s4146…
Read 12 tweets

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