1/11

https://abs.twimg.com/emoji/v2/... draggable="false" alt="🧵" title="Thread" aria-label="Emoji: Thread"> to discuss the journey of evidence on #COVID19vaccines & blood clots, focusing on:

https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern"> What is pharmacovigilance?
https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern"> Value of hypothesis generating Qs
https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern"> What https://abs.twimg.com/emoji/v2/... draggable="false" alt="ℹ️" title="Informationsquelle" aria-label="Emoji: Informationsquelle"> is often available in press releases & journalism pieces
2/11
What is pharmacovigilance?

Pharmacovigilance ( @WHO) is a process involving review of reported Adverse Drug Reactions (ADRs) with goal of assuring
https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern">efficacy & safety https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern">
of pharmaceuticals in a timely manner. https://www.who.int/publications/i/item/10665-42493">https://www.who.int/publicati...
3/11
@GovCanHealth carries out this process & reports on it to the public.

Just like with medications, vaccine safety & efficacy is followed throughout the product& #39;s lifecycle.

(see link https://abs.twimg.com/emoji/v2/... draggable="false" alt="👇" title="Rückhand Zeigefinger nach unten" aria-label="Emoji: Rückhand Zeigefinger nach unten"> more details)
https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-2-vaccine-safety/page-2-vaccine-safety.html">https://www.canada.ca/en/public...
4/11
Pharmacovigilance matters.

This is how public health agencies assess & monitor risk vs benefit.

This is also how we figure out https://abs.twimg.com/emoji/v2/... draggable="false" alt="🧩" title="Puzzle piece" aria-label="Emoji: Puzzle piece"> like:
https://abs.twimg.com/emoji/v2/... draggable="false" alt="📎" title="Büroklammer" aria-label="Emoji: Büroklammer">Prevalence of rare ADRs,
https://abs.twimg.com/emoji/v2/... draggable="false" alt="📎" title="Büroklammer" aria-label="Emoji: Büroklammer"> Risk factors,
https://abs.twimg.com/emoji/v2/... draggable="false" alt="📎" title="Büroklammer" aria-label="Emoji: Büroklammer"> Work with clinicians & scientists on risk mitigation & treatments of ADRs.
5/11
What is a hypothesis generating question?

When scientists & clinicians come across a trend (in the case of the #COVID19Vaccine rare incidences of clots) a hypothesis or assumption is created.

https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern">The assumption is not valid on its own without being tested. https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern">
6/11
How do we test a hypothesis?

This involves conducting a research study (which can help determine causation or strength of correlation). Once this is done, links associated with risk factors & other outcomes becomes stronger. https://online.stat.psu.edu/stat502/lesson/1/1.2">https://online.stat.psu.edu/stat502/l...
7/11
What are we seeing in press-releases & journalism pieces?

A. The speed of information being generated associated with ADRs in the real-world population is https://abs.twimg.com/emoji/v2/... draggable="false" alt="⚡️" title="Hochspannungszeichen" aria-label="Emoji: Hochspannungszeichen">fast because we are administering these https://abs.twimg.com/emoji/v2/... draggable="false" alt="💉" title="Spritze" aria-label="Emoji: Spritze"> to millions of people at a time.
8/11

B. Press releases & journalism pieces provide https://abs.twimg.com/emoji/v2/... draggable="false" alt="ℹ️" title="Informationsquelle" aria-label="Emoji: Informationsquelle"> based on "hypothesis generating" aspects of the research question.

To be clear, there have been some phenomenal pieces of journalism so far.

h/t to @hswapnil for sharing this with by @hildabast : https://www.theatlantic.com/health/archive/2021/03/astrazeneca-vaccine-blood-clot-issue-wont-go-away/618451/">https://www.theatlantic.com/health/ar...
9/11

C. As we gather more data through studies & pharmacovigilance reviews correlations either become stronger or weaker.

https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern">This is where we are right nowhttps://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern">
10/11

So what now?

Public health agencies around the https://abs.twimg.com/emoji/v2/... draggable="false" alt="🌏" title="Asien-Australien auf dem Globus" aria-label="Emoji: Asien-Australien auf dem Globus"> are doing their best to assess risk vs benefit based on:

https://abs.twimg.com/emoji/v2/... draggable="false" alt="📎" title="Büroklammer" aria-label="Emoji: Büroklammer"> Population risk factors (circulation of virus, age group to be https://abs.twimg.com/emoji/v2/... draggable="false" alt="💉" title="Spritze" aria-label="Emoji: Spritze">, alternative https://abs.twimg.com/emoji/v2/... draggable="false" alt="💉" title="Spritze" aria-label="Emoji: Spritze">, etc...)
https://abs.twimg.com/emoji/v2/... draggable="false" alt="📎" title="Büroklammer" aria-label="Emoji: Büroklammer"> ADRs in similar demographics, own populations, etc..
11/11

This process is complex & fragmentation of information can make it difficult to piece it all together in a clear https://abs.twimg.com/emoji/v2/... draggable="false" alt="🖼️" title="Bilderrahmen mit Bild" aria-label="Emoji: Bilderrahmen mit Bild">. I hope this thread provides some context to the process that https://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern">I feelhttps://abs.twimg.com/emoji/v2/... draggable="false" alt="⭐️" title="Mittelgroßer Stern" aria-label="Emoji: Mittelgroßer Stern"> is currently transpiring.

I& #39;m happy to welcome respectful discussion & questions.
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