EMA is listing unusual blood clots with low platelets as a side effect of the AstraZeneca Covid vaccine ema.europa.eu/en/news/astraz… 1/n
...90 cases: 62 with CVST & 24 with splanchnic vein thrombosis (that's abdominal). 18 of 90 people died. It was 90 out 25m, so less than 4 per million. An immune response is a plausible explanation for this, they conclude. 2/n
...MHRA's press conference is delayed, so no word yet there... 3/n
...The data they're discussing were up to March 22. As of April 4, it had risen to 169 cases of CVST and 53 of splanchnic thrombosis with low platelets. The rate is higher than expected. No definite cause established...4/n
..."No specific risk factors could be identified based on the current data." The committee could not conclude age or gender was a risk factor: most occurred in women below 60, but that could be because of the way the vaccine was used...5/n
...It usually occurred within 2 weeks of vaccination. There'll be a warning added to the product information for Europe. The benefits of course clearly outweigh this very rare risk...6/n 
...Over to the UK, where they're not concluding it's a side effect, but the BBC reports they're saying the link was getting firmer. In the UK by end of March, 79 people reported with the condition, of whom 19 died. ...7/n
...In the UK, people under 30 will be offered a different vaccine if it's available, because the risks of Covid-19 are so much lower for this age group. (The people who died were between 18 & 79 years of age.) ...8/n
...Back to the EMA press conference: all the cases reported there were after the first dose, but there haven't been many second doses in Europe yet...9/n
...They are hampered at the moment by the level of reporting they're getting: they don't have as much detail for each of the cases. Detailed studies will be done, however... 10/n
...Meanwhile over in the UK...BBC reports the deputy chief medical officer says it's time for a "course correction".... 11/n
...EMA is requiring a range of studies from AstraZeneca: mechanistic studies (laboratory studies on impact on clotting etc); going back to the trials they've done; & epidemiological studies.... 12/n
...The EMA is also funding 2 studies, from the universities of Erasmus & Utrecht, which will take a few months, looking at clotting disorders associated with Covid-19 & vaccinations...13/n
....EMA stressing that these are reporting rates, not incidence rates. At the moment, the rate in Germany, is 1 in 100,000 & that's their working assumption of incidence...14/n
...@kakape asked if treatment was now affecting the fatality rate: the answer - too soon to know if it's making a difference & the condition is very difficult to treat: no treatment recommendation is possible as yet, other than avoiding heparin...15/n
...Now they're discussing whether it's possible J&J could have the same problem: it's under close scrutiny, for all vaccines. At this stage, there have been a very small number of cases with similarities, but not the same condition & not apparently higher than expected...16/n
... Asked to clarify how sure they are that it is a possible side effect: the answer was, they consider it "strongly associated", & it's probably a causal association...17/n
...EMA asked why isn't Europe recommending restricting to a certain age the way the UK is: EMA said they don't believe there's enough evidence to make that recommendation in Europe, but that the vax is mostly used among older people in the EU...18/n
...Listed the data they have for other vaccines: they stressed the incidence is not higher-than-expected. What they know of, for CVST (presumably with low platelets comes next....19/n
...No elevated risk here:
-J&J, there have been 3 cases worldwide (4.5 million people have had this vaccine in Europe);
-BNT-Pfizer, 35 cases reported worldwide (54 million people have had the vax in Europe);
-Moderna, 5 cases reported worldwide (5 million uses in Europe)...20/n
-J&J, there have been 3 cases worldwide (4.5 million people have had this vaccine in Europe);
-BNT-Pfizer, 35 cases reported worldwide (54 million people have had the vax in Europe);
-Moderna, 5 cases reported worldwide (5 million uses in Europe)...20/n
...And the EMA press conference is over. Meanwhile over in the UK, the JCVI chair, according to BBC, said the decision to offer alternatives to younger people is "really out of the utmost caution" rather than "any serious safety concerns"..../21
Note: not clear if the 4.5m for J&J is for Europe, or is pretty much only the US data. TY @Brian_Orak @ZacharyBrenner
...PS: The EMA's 50-page report is now online: ema.europa.eu/en/documents/p…
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