ALERTING @EMA_News and #physicians:
Integrity issues in #EUdravigilance appear to be systemic, not limited to C-19 vaccines (as reported in 2022).
Most disturbing is that other drugs are affected too.
We present #Synagis (#RSV virus) for #infants < 2yr, as an example.
1/n
Integrity issues in #EUdravigilance appear to be systemic, not limited to C-19 vaccines (as reported in 2022).
Most disturbing is that other drugs are affected too.
We present #Synagis (#RSV virus) for #infants < 2yr, as an example.
1/n
We extracted serious cases for infants on 19-Dec-22 and compared against our download of 30-Apr-22.
We found that in 44% of all #serious cases the age-group was removed.
As a consequence, the safety profile for #Synagis has been #compromised.
2/n
We found that in 44% of all #serious cases the age-group was removed.
As a consequence, the safety profile for #Synagis has been #compromised.
2/n
Graph showing nr of #serious reports, observed from the two downloads:
Contrary to the deletion of C-19 vaccine cases we reported earlier,
here we find other types of intervention that compromise a drug’s safety profile,
notably for infants.
Details below >>
3/n
Contrary to the deletion of C-19 vaccine cases we reported earlier,
here we find other types of intervention that compromise a drug’s safety profile,
notably for infants.
Details below >>
3/n
In the graph, we now add the Age Group.
Notice how in 44% of all serious cases, the Age Group has been set to Unspecified.
Cases without the age of a patient properly specified, are not included in Safety Monitoring.
4/n
Notice how in 44% of all serious cases, the Age Group has been set to Unspecified.
Cases without the age of a patient properly specified, are not included in Safety Monitoring.
4/n
The deletion of the Age field, causes two phenomena:
1. Less case reports are available for Safety Analysis;
2. Drop in Inclination for the Dec-19 download
Severely impacting Disproportionality Analysis and hampering the ability to generate important Safety Signals.
5/n
1. Less case reports are available for Safety Analysis;
2. Drop in Inclination for the Dec-19 download
Severely impacting Disproportionality Analysis and hampering the ability to generate important Safety Signals.
5/n
This example with #Synagis clearly underlines that EMA’s #EUdravigilance database is likely to be compromised across all drugs and vaccines,
Perhaps not by EMA itself, but due to a lack of effective controls at its Stakeholders, for which EMA is legally responsible.
6/n
Perhaps not by EMA itself, but due to a lack of effective controls at its Stakeholders, for which EMA is legally responsible.
6/n
Earlier findings we reported (1)
7/n
https://twitter.com/waukema/status/1571797099808804865?s=20&t=2AG33EH9Rwp0z1FIaz--Sw
7/n
Earlier findings we reported (2)
8/n
https://twitter.com/waukema/status/1563886753186021377?s=20&t=2AG33EH9Rwp0z1FIaz--Sw
8/n
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