Getting a TON of questions about AZ vaccine safety, so a few points as you watch news unfold the next days:
- There are no clear answers yet. Getting them will take time.
- There is a lot of bad info and speculation out there. Think long and hard about what sources you trust.
- Information flow takes time. So some dissonance now between different assessments may disappear when all have the same data on which to base their assessments. For now data from national authorities like that provided by PEI is most likely to be up-to-date.
- People are making extremely difficult decisions with a lot of uncertainty between two risky/bad outcomes.
If you think it is obvious what has to be done, at least consider that maybe you do not have all the information. Or maybe you have not thought all that hard about it.
- Responsible sources/journalists will concentrate on trying to explain what is known and more importantly what the questions are and what scientists/regulatory agencies are doing to try and answer them. They will not pretend to have all the answers.
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EMA press conference on AstraZeneca safety signal is scheduled for 16.00 for now.
Just to give you an idea of what I will be looking out for, here are a few questions I would love to have answers to (and I don’t expect we can answer all of them already):
- Is there a significantly elevated number of people with the described clinical picture (widespread blood clotting, low platelet count, cerebral venous thrombosis) amongst vaccinees?
- Are there other things that unite them?
- Is there a common diagnosis? HUS, DIC, something?
- Is the age and gender distribution amongst cases unusual or in line with who was given the vaccine?
- Are most or all of the cases linked to a specific manufacturing plant?
- Any data on what treatments may have worked or not worked in these patients?
A lot to say about AZ vaccine pause in Europe, but I will try to stick to a two key questions in this thread (more later): 1. What are the symptoms that have led to the pause? 2. Is there a plausible mechanism for the vaccine causing them?
1. There has been a lot of general talk about blood clots and deep vein thrombosis, but the picture described to @GretchenVogel1 and me by doctors and regulatory agencies is a much more complicated one and based on at least 13 previously healthy individuals from 5 countries.
@GretchenVogel1 Main characteristics seem to be:
- widespread blood clots
- few platelets (thrombocytopenia)
- internal bleeding
- cerebral venous thrombosis
As @steinarma told us: “It’s a very special picture”.
“I'm not here to give you the outcome of any scientific review”, says EMA director Emer Cooke at start of press conference on AstraZeneca vaccine safety. "I'm here to explain the steps in the process, what we're doing, and when you can expect us to come to a conclusion."
“This is not unexpected”, says Emer Cooke. “When you vaccinate millions of people, it's inevitable that you have rare or serious incidences of illnesses that occur after vaccination”. Role of EMA is to evaluate whether there is a causal effect or it is coincidence, she says.
Experts will meet Thursday "to come to a conclusion on the full information that has been gathered and to advise us as to whether there are any further actions that need to be taken”, says Cooke. “We will inform the public of the outcome immediately after this meeting."
“More countries have suspended the use of AstraZeneca vaccines as a precautionary measure, after reports of blood clots in people who had received the vaccine from two batches produced in Europe”, says @DrTedros at @WHO presser on #covid19.
@DrTedros@WHO "This does not necessarily mean these events are linked to vaccination”, says @drtedros. "WHO’s Advisory Committee on Vaccine Safety has been reviewing the available data, is in close contact with the @EMA_News and will meet tomorrow."
@DrTedros@WHO@EMA_News “But the greatest threat that most countries face now is lack of access to #COVID19 vaccines”, says @drtedros. "Almost every day, I receive calls from senior political leaders around the world, asking when their country will receive their vaccines through COVAX."
Lab-confirmed infections this time last year: 119,820
This year: 449
You read that right
@rki_de There is also a sentinel program in which doctors send in samples from patients with respiratory disease symptoms to the national reference laboratory.
Number of samples with influenza viruses this time last year: >600
This year: 0
@rki_de The situation in Germany mirrors that in countries across the world. Here is the excellent @HelenBranswell with the view from the US:
Some stunning and very worrying #Ebola science out today, suggesting the ongoing outbreak in Guinea is not due to fresh spillover from nature, but the virus has persisted in humans since the devastating epidemic in 2013-2016.
Three groups of researchers posted sequencing data from #Ebola patients in the Guinea outbreak on virological.org today. Two groups each have sequences from four patients, the other from two. It’s unclear how much overlap there is (I suspect a lot) virological.org/c/ebolavirus/g…
Looking at the virus sequences, all three groups reached the same conclusion: The outbreak was caused by the Makona strain of Ebola Zaire, the same strain that caused the devastating outbreak in West Africa that started in 2013.