Read on Twitter
1/11
to discuss the journey of evidence on #COVID19vaccines & blood clots, focusing on:
What is pharmacovigilance?
Value of hypothesis generating Qs
What 
is often available in press releases & journalism pieces
to discuss the journey of evidence on #COVID19vaccines & blood clots, focusing on: What is pharmacovigilance? Value of hypothesis generating Qs What 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
efficacy & safety
of pharmaceuticals in a timely manner. https://www.who.int/publications/i/item/10665-42493
What is pharmacovigilance?
Pharmacovigilance ( @WHO) is a process involving review of reported Adverse Drug Reactions (ADRs) with goal of assuring
efficacy & safety of pharmaceuticals in a timely manner. https://www.who.int/publications/i/item/10665-42493
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's lifecycle.
(see link
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
@GovCanHealth carries out this process & reports on it to the public.
Just like with medications, vaccine safety & efficacy is followed throughout the product's lifecycle.
(see link
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
4/11
Pharmacovigilance matters.
This is how public health agencies assess & monitor risk vs benefit.
This is also how we figure out
like:
Prevalence of rare ADRs,
Risk factors,
Work with clinicians & scientists on risk mitigation & treatments of ADRs.
Pharmacovigilance matters.
This is how public health agencies assess & monitor risk vs benefit.
This is also how we figure out
like: Prevalence of rare ADRs, Risk factors, 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.
The assumption is not valid on its own without being tested.
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.
The assumption is not valid on its own without being tested.
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
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
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
fast because we are administering these 
to millions of people at a time.
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
fast because we are administering these to millions of people at a time.
8/11
B. Press releases & journalism pieces provide 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/
B. Press releases & journalism pieces provide
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/
9/11
C. As we gather more data through studies & pharmacovigilance reviews correlations either become stronger or weaker.
This is where we are right now
C. As we gather more data through studies & pharmacovigilance reviews correlations either become stronger or weaker.
This is where we are right now
10/11
So what now?
Public health agencies around the
are doing their best to assess risk vs benefit based on:
Population risk factors (circulation of virus, age group to be , alternative , etc...)
ADRs in similar demographics, own populations, etc..
So what now?
Public health agencies around the
are doing their best to assess risk vs benefit based on: Population risk factors (circulation of virus, age group to be , alternative , etc...) 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
. I hope this thread provides some context to the process that I feel is currently transpiring.
I'm happy to welcome respectful discussion & questions.
This process is complex & fragmentation of information can make it difficult to piece it all together in a clear
. I hope this thread provides some context to the process that I feel is currently transpiring. I'm happy to welcome respectful discussion & questions.
