The European Medicines Agency (EMA) assured yesterday Tuesday at . agency that, “due to progress in the evaluation” of the use of the Pfizer in children between the ages of 12 and 15, it hopes to complete the review of all available data from clinical trials in this age group “before the end of this month.”
A source from the European regulator stressed that “originally, the EMA aimed to issue an opinion in June“, But the Committee for Medicinal Products for Human Use (CHMP) now intends to” accelerate the timetable with a view to completing the review before the end of this month. “
The last word to administer this vaccine in this population will be the decision of the EU member states
In a joint interview with the German economic outlet Handlesblatt and the news agency ., the executive director of the EMA, Emer Cooke, anticipates that the European regulator will receive data from a similar review in Canada “and this could accelerate our assessment.” Thus, it clarifies that the last word to administer this vaccine in this population will be the decision of the member states of the European Union.
On May 3, the EMA began to evaluate the request of the pharmaceutical companies Pfizer and BioNTech to include minors between 12 and 15 years of age in the vaccination with their preparation against covid-19, an option authorized yesterday in the United States by the Food and Drug Administration (FDA).