Thread by @waukema

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.

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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.

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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 >>

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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.

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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.

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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.

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Earlier findings we reported (1)



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Earlier findings we reported (2)



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