Tuesday, June 15

The EMA approves the use of the Pfizer vaccine in children under 16 years of age


A health worker preparing one of the doses of the Pzifer vaccine.

A health worker preparing one of the doses of the Pzifer vaccine.
Eduardo Parra – Europa Press

The Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has granted the conditional marketing authorization to the vaccine from Pfizer and BioNTech against Covid-19 for children from 12 to 15 years old, Until now it was authorized for more than 16 years.

At a press conference, the head of Strategy for Vaccines and Biological Threats for Health, Marco Cavaleri, has assessed the data that support its approval. “It was already for young people from 16 years of age onwards and now we have data that shows that the vaccine is safe also in the ages of 12 to 15 years and that is what allows the scientific community to conclude this decision today, “he explains.

However, as explained the decision to use it will depend on each of the countries of the European Union yes to use it in this population. “Member States will have to decide whether and when to use it to protect a safe and effective vaccine for the younger population; It is an important step in the fight against grief, “he explained.

The vaccine will follow the same administration guidelines as for adults, which means that two doses are required and must be given at least three weeks apart. The decision was made based on a trial where they have seen similar or even better results than what they are seeing in young adults.

Side effects

“The data really shows that the vaccine is highly protective in this population to prevent disease from a safety perspective. It was well tolerated and the desired effect in this age group was very similar to that seen in young adults, “he explained. However, he recalled that the EMA continuously monitors the safety and effectiveness of this vaccine in both children and adults.

Because a higher production of this serum is expected to be necessary, Cavaleri has pointed out that the EMA is working to authorize the expansion of manufacturing capacity and also whenever possible to increase flexibility in the storage conditions of the vaccine as this is to the benefit of the vaccination campaign in the European models.

They have also reported that the PRAC safety committee of the EMA is currently evaluating very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) that occurred after vaccination with Comirnaty, mainly in people under 30 years of age. There is currently no indication that these cases are due to the vaccine and the EMA is closely monitoring this problem.

Clinical trial in 2,260 children

The effects of ‘Comirnaty’ in children were investigated in 2,260 children aged 12 to 15 years. This study was carried out in accordance with Comirnaty’s Pediatric Investigation Plan (PIP), which was agreed upon by the EMA Pediatric Committee. the trial showed that the immune response to Comirnaty in this group was comparable to the immune response in the 16-25 year age group (measured by the level of antibodies against SARS-CoV-2).

Efficacy was estimated in about 2,000 children aged 12-15 years who did not show signs of previous infection. They received either the vaccine or a placebo (a dummy injection), without knowing which one they were given. Of the 1,005 children who received the vaccine, none developed Covid-19 compared to 16 children of the 978 who received the sham injection. This means that, in this study, lThe vaccine was 100% effective in preventing Covid-19 (although the real rate could be between 75% and 100%).

However, due to the limited number of children included in the study, the trial could not have detected rare side effects. The most common side effects in children 12 to 15 years old are similar to those in people 16 years of age and older. 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 of vaccination.


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