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The European Union’s drug regulator stated that teenagers are “well-tolerated” by the vaccine and have no “significant concerns” about side effects.
The European Union drug regulator has approved the Pfizer-BioNTech coronavirus vaccine for children aged 12 to 15. This is the first vaccine in the European Union to give children the green light.
The Amsterdam-based European Medicines Agency said on Friday that the vaccine was “well-tolerated” in adolescents and there were no “major problems” in terms of side effects.
Marco Cavaleri, Head of Health Threats and Vaccine Strategy at EMA, said: “Expanding the protection of safe and effective vaccines among this young population is an important step in the fight against this epidemic.”
The United States and Canada have authorized Pfizer for use in young people.
EMA stated that the 12-15 year old age group needs two doses of the vaccine called Comirnaty. The interval between vaccination should be at least three weeks, the same as adults.
It added that it is now up to the various EU countries to decide whether and when to provide vaccines to young people.
Germany on Thursday formulated a plan to provide vaccination to 12-year-old children from June 7th, awaiting EMA’s ruling. Italy also stated that it is preparing to expand its activities to over 12 years old.
Vaccination of children and young people is considered a key step in achieving “herd immunity” and controlling the pandemic. Japan joined these countries on Friday and approved Comirnaty for 12-year-old children.
Young people are much less likely to develop serious illnesses, and many have no symptoms, which allows them to spread COVID-19 to others unknowingly.
Pfizer and BioNTech released trial data in March, showing that their vaccine provided 100% protection from infectious diseases in trials conducted on 2,260 12 to 15-year-old teenagers. And the tolerance is also very good.
Cavaleri said that so far, the shorter duration of safety monitoring in trials in the 12-15 year-old age group is not a problem compared to older cohorts.
When asked about the side effects, he said at a press conference: “Based on the experience of many other vaccines we have collected over the years, … what we have seen in young people is also seen in young people. He added that as the future vaccinators become younger, surveillance will be strengthened.
However, others have expressed caution, such as a member of Stiko, the influential German vaccine advisory committee. Pediatrics professor Ruediger von Kries said the vaccine may only be suitable for children with specific health risks, citing the lack of data on long-term side effects.
At the briefing, EMA also stated that reports of cases of myocardial inflammation following Comirnaty vaccination need not be concerned, as they continue to occur at a rate that normally affects the general population.
Other vaccine manufacturers are also studying whether their vaccines are safe and effective for children. Earlier this week, Moderna Inc stated that its lens can effectively protect children under the age of 12; it stated that it will submit an emergency use authorization request to the U.S. Food and Drug Administration next month.
But the World Health Organization criticized rich countries for taking action to vaccinate their young and lower-risk populations, saying that the extremely limited amount of COVID-19 vaccine should be shared with poor countries so that they can also protect their health workers and those who are most vulnerable. people.
WHO Director-General Tan Desai said earlier this month: “I understand why some countries want to vaccinate their children and adolescents, but now I urge them to reconsider and donate vaccines to COVAX instead,” he said. It is an initiative to distribute vaccines supported by the United Nations. Provide vaccines to low-income countries.
Of the more than 1 billion COVID-19 injections managed globally, less than 2% went to poor countries.
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