COVID-19: EU approves vaccine for 12 to 15 Years
The EU’s drug watchdog approved the Pfizer/BioNTech COVID-19 jab for 12 to 15-year-olds, the first vaccine to get the green light for children.
The EMA’s head of vaccine strategy, Marco Cavaleri said, the EMA’s Committee for Human Medicines has approved the use of the vaccine from Pfizer/BioNTech in adolescents from 12 to 15 years.
“Trials showed the Pfizer vaccine was highly preventative for COVID-19 in children.”
None of the 1,005 children who received the vaccine in a trial developed COVID-19 compared to 16 children out of the 978 who received a placebo injection.
“From a safety perspective, the vaccine was well tolerated and the side effects in this age group were very much similar to what we have seen in young adults and not raising major concerns at this point in time,” Cavaleri said.
The vaccine was well tolerated in adolescents and there were no major concerns in terms of side effects, the Amsterdam-based European Medicines Agency said.
The move will be a further boost for Europe’s vaccination programme, with Germany saying it will start giving the jab to children over the age of 12 from next month.
EU Health Commissioner, Stella Kyriakides said, “It is one step closer to ending the pandemic but said people would still have the choice about whether their children should get the jab.
“Beyond the decisions of governments, this is ultimately a decision to be made by parents for their children,” she added.
The EMA confirmed it was looking into very rare cases of heart inflammation in people aged under 30 who had been given the Pfizer vaccine.