The FDA has said it investigated the blood clot/low platelets cases after J&J vaccine & found no causal association with the vaccine: they're continuing to investigate. abc.net.au/news/2021-04-1… Given the way the EMA's statement of formal investigation is being reported,...1/4
..I went back to EMA press conference to check my tweets. Peter Arlett from EMA said: (at ~40 mins) Since the trial "There have been 3 cases with the J&J vaccine of blood clots associated with low platelets which have some similarities to these cases...2/4
...that we’ve been describing today for AstraZeneca vaccine. However the numbers are extremely small compared to the 4.5 million patients vaccinees that have received the J&J vaccine worldwide.” (~51 mins) "…if you look at those reports of blood clots with thrombocytopenia...3/4
...for those other vaccines & then compare them to the background rates we would expect to see, they are not raised.”
So it's 1 in the original 1-dose trial, 3 post-marketing in the US. None reported from the 2-dose trial or from South Africa. Rate not higher-than-expected
4/4
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Preprint on Brazilian trial by @butantanoficial of Sinovac's CoronaVac, 2 weeks apart. Data for 9,823 people who had 2 doses, 12,396 after 1 dose.The P1 ("Brazilian") variant of concern was not circulating in the areas the trial ran...1/n papers.ssrn.com/sol3/papers.cf… HT @josegallucci
...14-day interval seems too close, & immunity may increase over time: they recommend 28 days. Their primary efficacy, unlike other vax trials, includes people who had previous SARS-CoV-2 infection. But this table provides the comparable number: 50.5% (CI 34-63)..2/n
...Their primary efficacy analysis was based on 85 vs 168 people with symptomatic Covid-19. Unfortunately, they don't provide detailed data on symptoms so can't try to see whether this was milder disease than other trials... 3/n
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. ema.europa.eu/en/documents/p…
...1/n
..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
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
...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
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...."