Saturday, October 23, 2021

The European Union’s drug regulator approved the Pfizer vaccine for children 12 to 15 years old.


The European Medicines Agency approved on Friday the use of the Pfizer-BioNTech coronavirus vaccine for children aged 12 to 15, in what the drug regulator called “an important step forward in the fight against the pandemic” in a statement.

The U.S. Food and Drug Administration authorized the vaccine for that age group earlier this month after clinical trials showed it was safe.

The E.M.A.’s opinion will now be sent to the European Commission, the bloc’s administrative arm, for final approval, which it is expected to do swiftly. It will then be up to the national governments of the member countries to decide if and when to inoculate children, the regulator said.

Anticipating the vaccine’s approval, Germany announced on Thursday that it would open appointments to children in that age range starting June 7. Italy will start vaccinating people who are 16 and older next month, the commissioner in charge of vaccinations announced on Friday.

The European Union had a slow start to its vaccination campaign, with shortages of doses delaying the rollout in many member countries. The bloc’s efforts have gained pace in recent weeks, and now appear to be on track to get at least one dose to 70 percent of its adult population by the end of June.

The Pfizer vaccine has already been authorized in the bloc for those who are 16 and older. The doses for children will be the same as for adults, with two shots administered three weeks apart.

In Italy, all regions will broaden eligibility to those 16 and older starting June 3, Francesco Paolo Figliuolo, the army general in charge of Italy’s vaccination effort, told reporters on Friday.

General Figliuolo said that the country will make 20 million more doses available next month. He acknowledged that the amount isn’t enough to fully vaccinate Italy’s population of about 60 million, “but if we think about two or three months ago, we couldn’t have imagined it even in the rosiest predictions.”

For much of the year, Italy, which was severely hit by the pandemic in early 2020, has vaccinated only the elderly and the most vulnerable residents, both because of the scarcity of doses and for a number of logistical reasons. The country opened vaccinations to those 40 and older only in the last few weeks, with the exception being health care workers and teachers.

Public concern has grown about people starting to move around more, especially as summer approaches, while younger Italians have yet to receive their first shots. But not all regions have taken the same approach to vaccination: In Lazio, where Rome is situated, for example, the governor opened eligibility to all students about to take the test to receive their high school diplomas.

Italy’s Medicine Agency is also expected to authorize the use of the Pfizer-BioNTech vaccine for children 12 to 15 years old next Monday, a spokeswoman said, paving the way for students to return to in-person learning in September.

According to a database maintained by the Italian government, more than 19 percent of Italians are fully vaccinated, and 37 percent of the population have received a first dose, in line with the European average.

In the statement on the Pfizer vaccine for children 12 to 15, the E.M.A. said it would continue to track very rare cases of heart inflammation reported after vaccination, mostly in people younger than 30. The agency said the vaccine’s benefits outweighed the risks, and it remained unclear whether there was any possible link between the inflammation and vaccination.



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