EMA approves Pfizer vaccine on 12-15 year-olds

The Hague, May 28 (EFE).- The European Medicines Agency recommended Friday the use of Pfizer/BioNTech Covid-19 vaccines in adolescents aged 12-15 years.

The EMA scientific committee’s advice will be sent to the European Commission, which will issue the final approval.

The European agency also maintained it is safe to administer a second AstraZeneca vaccine dose to those who have received a first jab with no major side effects, arguing there is no evidence that the second dose increases the risk of blood clots.

The Pfizer vaccine will be the first jab to be scientifically backed by the EMA for use in under-16 year-olds in the European Union.

“It will be up to the individual member states to decide if and when to use these vaccines in adolescents in the future,” said Marco Cavaleri, head of vaccines strategy.

The observed side effects in adolescents are similar to those detected in young adults and are no cause for concern, he said.

The safety and effectiveness of the vaccine will continue to be monitored through different studies conducted by companies and European authorities, he announced.

“Extending the protection of a safe and effective vaccine in the younger populations is an important step forward in the fight against this pandemic,” said Cavaleri.

Pfizer and BioNTech announced their vaccine had a 100% efficiency and prompted solid immunologic responses in 2,260 teenagers who participated in a clinical trial.

Cavaleri said there is no need at the moment to administer a third dose of the Covid-19 vaccines, but the EMA will continue to collect evidence in the coming months to come up with a clear proposition.

He also announced the EMA is working to authorize the expansion of manufacturing capacity and increase flexibility in the storage conditions of the vaccines.


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