"I want to start by stating that our safety committee the pharmacovigilance risk assessment committee of the European Medicines Agency has confirmed that the benefits of the AstraZeneca vaccine in preventing #COVID19 overall outweigh the risks of side effects”, says Emer Cooke.
“The PRAC, after a very in depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine”, says Cooke.
“Based on the current available evidence, specific risk factors such as age, gender, or previous medical history of clotting disorders have not been able to be confirmed as the rare events are seen in all ages, and in men and women”, says Cooke.
“Any national decision on the optimal use in vaccination campaigns will also take into account the pandemic situation in any individual country, and other factors such as hospitalization and availability of vaccines”, says Cooke.
PRAC did an in-depth analysis of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database, 18 of which were fatal, says Sabine Straus.
"As of April 4, 2021, the new drug safety database had received a total of 169 cases of CVST and 53 of splenic vein thrombosis. And at that moment 34 million people were vaccinated in the European Economic Area, and the UK”, says Straus.
“Our conclusion is that these clotting disorders are very rare side effects of the vaccine”, says Straus. "The currently available data did not allow us to identify a definite cause for these complications."
“Plausible explanations have been put forward, including an immune response that leads to a condition that seems similar to an atypical heparin induced thrombocytopenia”, says Straus.
“No specific risk factors could be identified based on the current data. The committee can therefore not recommend any specific measures to reduce the risk”, says Straus.
“We have seen that it predominantly affects women”, ays Cooke. But "some of that could be explained by the way that the vaccine is being used in the European Union and the European Economic Area”.
"The frequency is difficult to assess”, says Straus, but also mentions" approximately one in 100,000, or even a little bit higher”. Says based on this national vaccination authorities “can make up their minds on how they would like to vaccinate with which kind of vaccine".
Q: Does benefit also outweigh risks if you look only at women below 60 years of age?
Straus: "At the moment, that's something that's very difficult to answer … part of our further research and further investigation concerning this vaccine, but we do know that risk is very low."
Situation will keep evolving as more information becomes available, as groups being vaccinated change etc, says Emer Cooke. “So we can expect that there will be new information and new recommendations as time goes on."
“PRAC will be imposing on AstraZeneca, the manufacturer of the vaccine, a number of studies to ensure that we get robust data to further evaluate this safety issue”, says Arlett:
1. mechanistic studies in the lab to understand interaction with clotting systems
2. look at existing data foreclosed clinical trials for any further information on possible risk factors
3. ongoing clinical trials should collect data to further help clarify issue
“We are not relying just on the company”, says Arlett. EMA supporting studies to be conducted by two large consortia, led by unniversities in Rotterdam and Utrecht. "We would anticipate results starting to come in from those over the next couple of months."
I asked about 1/100,000 vs. 1/250,000
Reported rate "varies very much with how good the reporting system in a member state is and how good cases are being identified”, says Straus. “In Germany, a lot of work has been done and I think there is a reporting rate of 1 in 100,000."
“We know that in the UK the reporting rate is much lower, so that can have many many causes, but for the moment I think it's safe to assume that the reporting rate is around one in 100,000”, says Straus.
*splanchnic vein thrombosis

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More from @kakape

9 Apr
“Out of 220 countries and economies, 194 have now started vaccination and 26 have not”, says @DrTedros at #covid19 @WHO presser. “Of those, seven have received vaccines and could start, and a further five countries should receive their vaccines in the coming days."
@DrTedros @WHO (Tomorrow is day 100 of the year and @WHO had called on vaccinations against #covid19 to begin in all countries within the first 100 days of the year.)
@DrTedros @WHO The remaining 14 countries have not yet begun #Covid19 vaccination for a range of reasons, says @DrTedros. "Some have not requested vaccines through COVAX, some are not yet ready, and some plan to start in the coming weeks and months."
Read 16 tweets
6 Apr
15 Monate lang habe ich jetzt intensiv über diese Pandemie berichtet.
Ich habe mich in die Arbeit gestürzt, weil genau das hier mein Job ist. Aber auch weil es die Chance war etwas zu tun, sich nicht so nutzlos zu fühlen.
Ich habe mit Forscherinnen und Ärzten gesprochen, Artikel geschrieben, getwittert, einen Podcast gestartet, habe Panels moderiert, Pressekonferenzen gelauscht und Interviews gegeben.
Ich war häufig frustriert, gestresst, manchmal traurig.
Aber in dieser ganzen Zeit habe ich das schiere Ausmaß des Leids, das dieses winzige Virus verursacht hat, ziemlich erfolgreich von mir ferngehalten.
Drei. Millionen. Tote. Wie beginnt man das zu begreifen?
Read 11 tweets
2 Apr
My colleagues and I have decided to spend a few episodes of our @pandemiapodcast talking about the search for an HIV vaccine and parallels and differences with #covid19.
First episode (in German) here, a few thoughts (in English) to come:

@pandemiapodcast It’s worth noting that we are coming up on 40 years since the first report appeared on what would turn into the devastating AIDS pandemic. On 5 June 1981, @CDCMMWR reported on 5 young men in Los Angeles with a rare pneumonia caused by a fungus, 2 had died

@pandemiapodcast @CDCMMWR One month later, there were 26 similar cases reported in @CDCMMWR (cssh.northeastern.edu/pandemic-teach…).
As Tony Fauci told us:
"At that point, it dawned upon me, we have a really serious problem. And this is very likely a new disease, likely a virus."
Read 10 tweets
31 Mar
“Our position has not changed”, says @EMA_News head Emer Cooke about AZ vaccine. “According to the current scientific knowledge, there is no evidence that would support restricting the use of this vaccine in any population."
@EMA_News I asked about numbers for Europe:
62 cases of cerebral venous thromboses so far, says Cooke with 9,2 million people vaccinated with AZ.
"If we look at the age-adjusted exposure, we calculate a risk of one per 100,000 in the under 60s."
@EMA_News CVST is much more common in women in general and about 2/3 of AZ vaccinees in Europe were women, says Peter Arlett. "this is why it is at this stage, difficult to disentangle the fact that there has been a preponderance of reports of this very rare potential side effect in women"
Read 8 tweets
29 Mar
Preprint suggesting a HIT-like mechanism for rare thromboses in some AZ vaccinees is out now.
Important for scientists to discuss the data.
For everyone else, not used to reading case reports: This sounds scary, but remember that this is very very rare.
ResearchSquare also posted this editorial note with it:
And story from @GretchenVogel1 and me that tries to put this in context as much as we can right now is here:

Read 5 tweets
28 Mar
Just a reminder that this pandemic, far from being over, is gathering steam once again globally with cases going up across the world.
Yes, vaccines are starting to help. Half a billion doses have been given. But we are a LONG way from vaccinating ourselves out of this problem.
While vaccines are being rolled out, we need to keep using the tools from the last year: #physicaldistancing, test, trace, isolate, etc.
Fatigue and new variants are making the job harder, immunity from vaccines is slowly making it easier.
We have to hold on.
In the meantime deaths keep rising.
At the current pace we will reach 3 million deaths in early May. If the trend continues we will reach that sad milestone in April already.
Vaccinating those most at risk around the globe equitably would do a lot to keep that number lower.
Read 4 tweets

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