Health

enhanced post-marketing surveillance of vaccines

Written by Steven mark

In addition to the pharmacovigilance required of pharmaceutical companies, independent monitoring is activated as soon as they enter the market and without time limit.

The European Medicines Agency (EMA) centralizes application files for vaccines against Covid-19.
The European Medicines Agency (EMA) centralizes application files for vaccines against Covid-19. Hannah Mckay / REUTERS

To obtain marketing authorization (MA) for a vaccine, the manufacturing pharmaceutical company must submit to health authorities the results of phase 3 clinical trials proving their effectiveness and concluding that there is a favorable risk-benefit balance. But the monitoring of the health impact of the users of these new products does not stop there. The very large-scale distribution of the vaccine in the population is always accompanied by the establishment of a phase 4 of pharmacovigilance. “With several thousand participants selected, phase 3 only makes it possible to identify the most frequent side effects, explains the Pr Agnès Sommet, head of the pharmacology department at Toulouse University Hospital. In phase 4, the very large number of people vaccinated in real life shows rarer, sometimes serious, events. We also try to answer questions about specific sub-populations. ”

In the case of Covid-19 vaccines, this is the EMA,

This article is for subscribers only. You have 81% left at
discover.

Subscribe: 1 € the first month

Can be canceled at any time

About the author

Steven mark

Leave a Comment