Sa latest assessment, sinabi ng EMA experts na ang mga naiulat na kombinayson ng blood clot at low blood platelet ay bihira at walang mga risk factors.
"This case clearly demonstrates one of the challenges posed by large scale vaccination campaigns when millions of people receive these vaccines, very rare events can occur that were not identified during the clinical trials. The role of pharmacovigilance, the monitoring of these side effect, is to help us to rapidly detect and analyse these risks. This case also shows us that our pharmacovigilance system is working, these very rare and unusual events have been picked up, identified, analysed and have allowed us to come to science-based recommendations to allow the safe and effective use of this vaccine," ani E-M-A Executive Director Emer Cooke.
Highlights
- Kadalasan sa mga kaso ay iniulat sa mga babaeng 60 pababa
- Inamin din ng Safety committee chair ng EMA na si Sabine Straus, na hindi pa natutukoy ang dahilan ng clotting at kasalukuyan pang sinasagawa ang mga imbestigasyon
- Marami ng mga bansa sa Europe ang pansamantalang sinuspende ang roll out ng nasabing bakuna
