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
...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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More from @hildabast

8 Apr
Digging into the detailed EMA report on the AZ vaccine investigation. (The committee vote for their decision was 31 out of 32.) They discuss several hypotheses that have been proposed for the phenomenon, if it's triggered by the vaccine.
..1st was one from researchers in Germany/Austria, based on studying several of the people: that it's similar to heparin-induced thrombocytopenia ("HITT-like"), & related to Platelet Factor 4. assets.researchsquare.com/files/rs-36235… (preprint)...2/n
...EMA conclusion: there are similarities, so still needs to be investigated. But there are differences too: eg HITT doesn't cause a condition that occurred here (DIC). So they called this unproven...3/n
Read 10 tweets
22 Mar
Oh this is great news! 🥳

Oxford-AstraZeneca vaccine: 79% efficacy & possibly increasing over time

Press release for interim efficacy results from the US trial for 32,449 people, randomized 2:1 to placebo (140 events - symptomatic Covid-19)... 1/n

... Typo in previous tweet: 141 events. (No confidence intervals provided.)

...Vaccine efficacy was consistent across ethnicity & age, include older. It was 80% for people aged 65 & older.

No breakdown of events by vaccine & placebo...3/n
Read 8 tweets
22 Mar
Distracted by the other EMA thing, I'm only just catching up with the 218-page EMA assessment report for the J&J vaccine ema.europa.eu/en/documents/a…

For background, my summary from the 62-page FDA report is here absolutelymaybe.plos.org/2021/03/16/com…

Tweeting about what's new or different...1/n
...As usual, in-depth look at quality of manufacturing. "No raw materials of human or animal origin are used" in the final production. The cell line used to optimise production of the vaccine vector is PER.C6, which has already been studied for safety...2/n
...Current batches manufactured mostly in Leiden & emerging in Baltimore: they've shown consistency in the European manufacture - EMA wants them to follow-up with data showing the Baltimore production is comparable (this is all standard) ...3/n
Read 19 tweets
21 Mar
Out of the several different major vaccination strategies internationally, the UAE's is one of the most unusual. There are 4 vaxes available (Sinopharm Beijing, BNT-Pfizer, Sputnik V, Oxford-AstraZeneca), & free vaccination now open to everyone 16+ khaleejtimes.com/coronavirus-pa… ...1/n
... When you apply for an appointment, you choose the vaccine you want.... "Press 1 for Sinopharm...."

(Here from when there were 3 vaccines) khaleejtimes.com/coronavirus-pa… ...2/3
...Over 56% of the population has had at least 1 dose; over 72% of seniors & people with chronic diseases. As of now, open to everyone.


JHU's tracker says 23% of the population is fully vaccinated coronavirus.jhu.edu/vaccines/inter… 3/3
Read 4 tweets
11 Mar
The Danish Health Authority has suspended use of the Oxford-AstraZeneca Covid vaccine for 14 days as a precaution while an investigation into serious adverse events proceeds...1/n sst.dk/da/Nyheder/202… HT @iamPWK
...There is no confirmation that the vaccine caused any of the serious adverse events (SAEs) under investigation: this is a precaution, while the investigation proceeds. The SAEs are related to blood clots in Austria & Denmark ...2/n
...There were 2 thrombosis-related (blood clot) SAEs in Austria & the first investigation was whether it was related to a specific batch of vaccine. The EMA (Euro drug regulator) determined that there wasn't a problem with the batch...3/n
Read 5 tweets
10 Mar
Data & Safety Monitoring Board for phase 3 trial of Sinopharm's vaccines in Peru - about 12,000 people, 2 vaccines vs placebo - has recommended discontinuation of the Wuhan vaccine arm for inadequate efficacy (*not* the Beijing vax in use globally) ...1/n cayetano.edu.pe/cayetano/es/no…
...The university running the trial have sought the permission of the drug regulator to unblind participants & offer the volunteers in the Wuhan & placebo arms vaccination with the Beijing vaccine which did meet efficacy criteria (results aren't ready for release though)...2/n
...Sinopharm recently issued a press release saying the Wuhan vaccine efficacy rate was 75%. They applied to NMPA (China's drug regulator for authorization). NMPA authorized it on Feb 27 ...3/4 english.nmpa.gov.cn/2021-02/27/c_5…
Read 4 tweets

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