(ANSA) - BRUSSELS, SEPTEMBER 06 - The European Medicines Agency (Ema) has begun to evaluate an application for the use of a booster dose of the Comirnaty vaccine (Pfizer-BioNTech) to be administered six months after the second dose to age 16 or older.
"The booster doses are given to vaccinated people (ie people who have completed the primary vaccination) to restore protection after it has decreased", explains the same Ema. The assessment will be made on the basis of the data submitted by the pharmaceutical company and the outcome is expected "within the next few weeks, unless additional information is required".
Among the information provided by Pfizer-BioNTech to the EMA's Committee for Human Medicines (CHMP) are also the results of an ongoing clinical study in which approximately three hundred adults with healthy immune systems have received a direct dose about six months after the second. dose. (HANDLE).