The European Medicines Agency (EMA ) today announced the beginning of the evaluation of the Pfizer-BioNTech vaccine against covid-19 for children between 5 and 11 years old. Comirnaty, the Pfizer-BioNTech vaccine, has currently been authorized by the European Commission to be injected in people over 12 years of age since last May.
The EMA Committee for Medicinal Products for Human Use will review “the results of an ongoing clinical study with children 5 to 11 years of age to decide whether it is recommended to extend its use,” the regulatory body said in a statement.
The EMA expects to communicate the conclusions of its assessment within two months “unless additional information is needed,” he said. Subsequently, the recommendation will be sent to Brussels for the European Commission to evaluate authorizing its marketing in the EU.
The Pfizer-BioNTech vaccine was the first approved in the European Union for people over 18 years old, on December 21, 2020, and its use was extended to adolescents from 12 years old on May 28.
If approved by the regulatory body, Comirnaty would be the first licensed vaccine for children aged 5 and over in the EU.
The EMA Committee for Medicinal Products for Human Use (CHMP) has approved two new manufacturing sites for the production of the COVID-19 vaccine from BioNTech and Pfizer. One of the centers, located in Monza (Italy), is managed by Patheon Italia. The other, located in Anagni, also in Italy, is managed by Catalent Anagni. Both centers will manufacture the finished product. These centers will produce up to 85 million additional doses to supply the EU in 2021.
The CHMP has approved a ready-to-use formulation of the BioNTech and Pfizer COVID-19 vaccine that does not require dilution prior to administration. It will be available in a pack size of 10 vials (60 doses) and can be stored at 2-8 ° C for up to 10 weeks. The current concentrated formulation requires dilution before administration, is available in a pack size of 195 vials (1,170 doses) and can be stored at 2-8 ° C for up to one month).
“These differences will provide better storage, transportation and logistics options for the distribution and administration of the vaccine. The new formulation will be available in a gradual rollout that will begin in early 2022,” the EMA explained in a statement.