Pfizer-BioNTech’s COVID-19 vaccine becomes the one to be approved by EU for children aged 12-15
The European Medicines Agency (EMA), the medicines regulator of the European Union (E.U.) has approved the Pfizer-BioNTech’s Coronavirus (COVID-19) jab for children aged between 12-15 years.
This is the first vaccine which has been approved for children in the bloc. Authorizing the vaccine, the EMA said that the vaccine was well tolerated in adolescents and there were no major concerns in terms of side effects.
The EMA said the children in the age group of 12-15 years require 2 doses of the vaccine, which has been branded as Comirnaty. The second dose of the vaccine must be administered after an interval of 3 weeks from the first dose. The E.U. has already approved the Pfizer-BioNTech’s vaccine for those aged 16 years and older.
Taking it to twitter, the EMA tweeted,
EMA’s human medicines committee #CHMP has today approved an application to extend the use of the Pfizer/BioNTech #COVID19vaccine (Comirnaty) to include children aged 12 to 15. #EMAPresser
— EU Medicines Agency (@EMA_News) May 28, 2021
It further tweeted, “
The recommended use of the Comirnaty #COVID19vaccine in children from 12 to 15 will be the same as it is in people aged 16 and above. It is administered as two injections in the muscles of the arm, at least 3 weeks apart. #EMAPresser
— EU Medicines Agency (@EMA_News) May 28, 2021
Speaking on the occasion, the Head of Health Threats and Vaccine Strategy at EMA – Marco Cavaleri said, “Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic.”
The EMA has left it to the Member States to decide if they want to vaccinate the children. Meanwhile, Germany has declared to vaccinate 12 years old children from June 7, 2021. Italy is also planning to follow the foot steps of Germany.
However, a member of Germany’s influential vaccine advisory committee Stiko – Professor Ruediger von Kries has said the vaccine might only be called in for children with particular health risks, citing a lack of data on long-term side effects.
Inoculating children and young people is considered a critical step towards reaching herd immunity. The data related to the trial of vaccine, released by Pfizer and BioNTech in March 2021 showed that the vaccine was 100% effective in adolescents aged 12 to 15 years.
Separately, the World Health Organization (WHO) has criticized the rich countries for moving to vaccinate their younger and less at-risk populations. The WHO believes that instead of vaccinating children, the vaccines should be donated to poor countries.
Apart from E.U., the United States (U.S.) and Canada have already approved the Pfizer-BioNTech’s jab for vaccinating children. Japan also joined them on Friday after it announced to vaccinate 12 years old children.
Other vaccine makers also are studying whether their shots can be given to children. Recently, Moderna has submitted a request to U.S. Food and Drug Administration (USFDA) for emergency use authorization in children of 12 years of age.
