The European Medicines Agency has approved the use of Pfizer’s coronavirus vaccine in adolescents aged 12 to 15

The European Medicines Agency (EMA) on Friday supported the Extension of the use of the Pfizer / BioNTech vaccine to adolescents aged 12 to 15 years, which makes it first preparation against COVID-19 with scientific support in the European Union for children under 16.

During a press conference, Marco cavalry, Head of vaccine strategy, confirmed this.pediatric indication»Agreed today at an extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP), which concluded that the vaccine is ‘safe’ and effective in children in this age group.

Pfizer and BioNTech tested their phase III coronavirus formula in 2,260 adolescents and assured that its effectiveness was 100% and with a “strong” immune response.

In tests, they add, the vaccine was “generally well tolerated“.

The vaccine, already approved in the EU since December for people over 16, will have the same application in children from 12 to 15 years old than that currently administered to adults: it will be given as two injections into the muscles of the upper arm, “three weeks” apart between the first and second dose.

On another side, the EMA ensured that it maintained its recommendation to inject a second dose of the AstraZeneca vaccine to those who received a first injection without experiencing any side effects from blood clotting as there is no evidence that the second injection increases the risk of developing thrombocytopenia compared to the first dose

The European regulator pointed out that some studies, which have yet to be analyzed by the EMA, provide evidence on the effectiveness of using a second dose of an mRNA vaccine, the result of which shows that “there is no problem from a safety point of view” and that this is “a really effective approach” from an immunological point of view.

May 10 the United States Food and Drug Administration (FDA), approved the use of the COVID-19 vaccine developed by Pfizer and BioNTech in adolescents between 12 and 15 years old.

The expansion of the eligible population “is an important step in the fight against the pandemic“Said the commissioner of the health agency of the North American country, Janet Woodcock.

“Today’s actions allow a younger population to be protected from COVID-19, which is not about to regain a sense of normalcy and end the pandemic. Parents and guardians can rest assured that the agency has conducted a rigorous and comprehensive review of all available information, as we have done with all of our emergency clearances for COVID-19 vaccines, ”he said. he adds.

In the press release, the health entity pointed out that from March 1, 2020 to April 30, 2021, the Centers for Disease Control and Prevention (CDC) were notified approximately 1.5 million cases of COVID-19 in people aged 11 to 17, only in the United States.

Children and adolescents generally have milder COVID-19 disease course than adults. The Pfizer-BioNTech COVID-19 vaccine will be given to this age group in a series of two doses, three weeks apart, the same dose and the same dosing schedule for people over 16 years of age.

The FDA has determined that Pfizer-BioNTech COVID-19 vaccine meets legal criteria and that the known and potential benefits of this vaccine in people 12 years of age and older outweigh known and potential risks, which supports use in this population.

KEEP READING: