Vaccine ‘well tolerated’ in adolescents and there were no ‘major concerns’ over side effects, EU drug watchdog says.
The European Union’s drug watchdog has approved the Pfizer-BioNTech coronavirus jab for 12 to 15-year-olds, the first vaccine to get the green light for children in the bloc.
The vaccine was “well tolerated” in adolescents and there were no “major concerns” in terms of side effects, the Amsterdam-based European Medicines Agency said on Friday.
“Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic,” Marco Cavaleri, head of health threats and vaccine strategy at the EMA, said.
The United States and Canada have already authorised Pfizer for adolescents.
The EMA said two doses of the vaccine, branded as Comirnaty, were required in the 12-15 age group and should be administered with an interval of at least three weeks, the same as for adults.
It is now up to individual EU states to decide if and when to offer the vaccine to teenagers, it added.
Germany on Thursday laid out plans to offer shots to 12-year-olds from June 7, pending the EMA’s verdict. Italy has also said it is preparing to extend its campaign to over 12s.
Inoculating children and young people is considered a critical step towards reaching “herd immunity” and taming the pandemic, and Japan on Friday joined the countries with a go-ahead for Comirnaty in 12-year-olds.
Young people have been much less likely to suffer severe disease, with many experiencing no symptoms, allowing them to unwittingly transmit COVID-19 to others.
Pfizer and BioNTech in March unveiled trial data showing their vaccine offered 100 percent protection against the infectious disease in a trial with 2,260 adolescents aged 12 to 15. It was also well tolerated.
The shorter duration of safety monitoring in trials so far in the 12-15 age group compared with older cohorts was not a concern, Cavaleri said.
“Based on the experience that we’ve gathered with many other vaccines throughout the years is that … what we see with young adults is also seen in adolescents,” he told a news briefing, when asked about side effects. He added that monitoring would intensify as vaccine recipients become younger in future.
Others have voiced caution, however, such as a member of Germany’s influential vaccine advisory committee Stiko. Paediatrics professor Ruediger von Kries has said the vaccine might only be called for in children with particular health risks, citing a lack of data on long-term side effects.
At the briefing, EMA also said that reports of cases of an inflammation of heart muscles following vaccination with Comirnaty were no cause for concern as they continued to happen at a rate that typically affected the general population.
Other vaccine makers also are studying whether their shots are safe and effective in children. Earlier this week, Moderna Inc said its shot strongly protects children as young as 12; it said it would submit a request for emergency use authorisation to the US Food and Drug Administration next month.
But the World Health Organization has criticised rich countries for moving to vaccinate their younger and less at-risk populations, saying that the extremely limited number of COVID-19 vaccines should instead be shared with poor countries so they, too, can protect their health workers and those most vulnerable.
“I understand why some countries want to vaccinate their children and adolescents, but right now I urge them to reconsider and to instead donate vaccines to COVAX,” WHO chief Tedros Adhanom Ghebreyesus said earlier this month, referring to the UN-backed initiative to distribute vaccines to lower-income countries.
Of the more than 1 billion COVID-19 shots administered globally, fewer than 2 percent have gone to poor countries.