EMA nod for use of Pfizer-BioNTech Covid-19 jab in 12- to 15-year-olds
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the European Commission approve the use of the Pfizer-BioNTech vaccine against Covid-19 in adolescents aged from 12 to 15 years, the agency’s Dr Marco Cavaleri told a news conference on May 28.
Cavaleri said that the data showed that the vaccine was safe in this age group. He issued a reminder that previously, the EC had authorised the use of the vaccine on people over the age of 16.
The recommendation had been transmitted to the European Commission which will give final approval, while it will be up to individual EU countries to decide if and when to administer the vaccine in the 12- to 15-year-old age group.
The committee has recommended that the vaccine be used in the same way as for people over 16, two doses with an interval of three weeks between the two.
The conclusion was reached after clinical trials involving 2000 adolescents in the age group, Cavaleri said.
The immune response was similar or even better than in young adults, he said.
None of those in the clinical trials who received the Pfizer-BioNTech vaccine got Covid-19, while in the control group, who received a placebo, 16 got the illness.
Cavaleri said that from a safety perspective, the vaccine was well tolerated. The side-effects did not raise major concerns, he said.
The most common side effects in children aged 12 to 15 are similar to those in people aged 16 and above. They include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever. These effects are usually mild or moderate and improve within a few days from the vaccination.
The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns across the member states, through the EU pharmacovigilance system and ongoing and additional studies by the company and by European authorities, the EMA said.
(Photo: EC Audiovisual Service)
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