Wednesday, 26 May 2021
The European Medicines Agency (EMA) will decide whether to authorise Pfizer/BioNTech’s coronavirus vaccine for 12- to 15-year-olds on Friday, the EU regulator said.
If approved, the vaccine would be the first one to get the green light from the EMA to be given to young people in the 27-nation European Union.
For the time being, its approval is limited to people over 16 years old.
The EMA says it will hold a press conference on Friday to share “the outcome of an extraordinary meeting of its Committee for Medicinal Products for Human Use (…) on the paediatric indications of the vaccine.”
The United States’ drug agency has already approved the Pfizer vaccine for 12-15 year olds.
The EMA’s executive director Emer Cooke announced in early May that the Amsterdam-based regulator would conduct an accelerated assessment of the data submitted by vaccine developers for approval when it comes to that age group.
The results of this were initially expected in June.
Cooke told European newspapers on 11 May that the EMA had received the data from Pfizer/BioNTech and that the agency (which was also waiting for “data from clinical trials and the study in Canada”) planned to “accelerate” its assessment.
In mid-May, however, director-general of the World Health Organisation (WHO) Tedros Adhanom Ghebreyesus called on countries to stop vaccinating children and adolescents, who are less vulnerable to the disease, against Covid-19.
Dr. Tedros said to instead donate those doses to the Covax system, which aims to redistribute coronavirus vaccines to poor countries.
That ethical issue is likely to be raised again (as it was when the Pfizer vaccine was approved for those over the age of 16), should the vaccine be approved for 12-15 year olds on Friday.
Meanwhile, Belgium announced it would stop administering the single-dose Johnson & Johnson coronavirus vaccine to people younger than 41 years old, following the death of a woman who was vaccinated with it.
The Brussels Time