The European Union’s drug watchdog on Friday approved the Pfizer / Biotech coronavirus job for children aged 12 to 15, the first vaccine to be given to children in the block.
The Amsterdam-based European Medicines Agency said the vaccine was “well tolerated” in adolescents and there were no “major concerns” about side effects.
The move will provide further impetus to Europe’s immunization program, and Germany says it will begin providing jobs to children over the age of 12 next month.
The United States and Canada have granted Pfizer rights to adolescents.
“In anticipation, the EMA’s Human Medicine Committee today approved the use of vaccines from Pfizer / Biotech over a 12- to 1-year period,” Marco Cavalleri, EMA’s head of vaccination strategy, told a news conference.
Until now, shots made by US pharmaceutical company Pfizer and German research firm Biotech have only been authorized by the EU for people over the age of 16.
EU Health Commissioner Stella Kiriakids hailed it as “one step closer to ending the epidemic”, but said there were still options on whether to treat their children.
“Apart from the government’s decision, it is ultimately a decision to be made by the parents of their parents,” she said on Twitter.
As EU countries seek to expand their vaccine coverage, EMA chief Emer Cook said the regulator has quickly tracked the approval that was initially expected in June.
Watchdog made sure it took the necessary steps to ensure it was safe.
Tests showed that the Pfizer vaccine was “highly preventable” for Kovid-1 in children, EMA Cavalleri said.
In one trial, none of the 1,000 children who received the vaccine developed Covid-1, compared to 1 in 98 children who received placebo injections.
“From a safety standpoint, this vaccine was tolerated and the side effects of this age group are very similar to what we have seen in young adults and do not raise major concerns at this time,” Cavalleri said.
The EMA confirmed that it was looking at “extremely rare” cases of heartburn in people under the age of 0 who were given the Pfizer vaccine.
“Currently there is no indication that these cases are due to vaccination and the EMA is closely monitoring the matter,” it said in a statement.
U.S. officials have also reported fewer heart attacks in Pfizer and Moderna, some young people using the same messenger RNA technology.
The EMA said it was “working closely” with its US counterparts.
Ugur Sahin, CEO and co-founder of Biotech, welcomed Friday’s decision as “another important milestone in our collective effort to expand the vaccination program to as many people as possible.”
Pfizer CEO Albert Boula said providing the vaccine to teens would “help reopen schools and return to normal daily life.”
Pfizer’s approval for adolescents marked the beginning of a gun for Germany to vaccinate children over the age of 12, Chancellor Angela Merkel announced Thursday.
But Merkel stressed that vaccinations would not be mandatory and would not affect whether children could go to school or go on vacation.
Austria’s immunization committee announced late Friday that it would follow suit.
Moderna said he expects EU and US officials to seek authorization in early June. Tests have shown that it is “highly effective” in adolescents.
(Except for the headline, this story is not edited by NDTV staff and is published from a syndicated feed.)