Christophe wrote:MA still provisional
Clearly you are not reading the documents.
No the marketing authorization is final but there is continuous monitoring by independent laboratories
A Phase IV is then carried out after the marketing of the vaccine. Indeed, there are systems to monitor the safety and effectiveness of all vaccines. The data collected is used to adjust policies for the use of vaccines in order to optimize their impact. They also allow the vaccine to be tracked safely throughout its use. It is thus a question of verifying whether very rare, but serious adverse effects occur in the millions of people vaccinated.
Vaccines are required to meet excessively strict standards of pharmaceutical quality, efficacy and safety, especially since the general public is extremely concerned about their possible disadvantages. National and international health authorities are responsible for verifying that vaccines meet these criteria.
Sciensano's Vaccines and Blood Products Quality Department provides independent quality control of vaccine batches before they are marketed in Belgium and Europe. This independent control is carried out after the controls carried out by the pharmaceutical companies.
Sciensano is part of the European Network of Official Medicines Control Laboratories (OMCL). The European Directorate for the Quality of Medicines and Healthcare coordinates this network, which tests all batches of vaccines destined for Europe. Independent testing of each batch of vaccines ensures their quality and compliance with product specifications. When a batch of vaccines is tested by one of the laboratories in the network, the certificate issued is recognized by all the countries of the European Union. The batches of vaccines distributed by manufacturers in Belgium are therefore tested and approved either by Sciensano or by another laboratory in the European network.
ext, ext...