The EU drug regulator on Thursday approved Pfizer-BioNTech’s COVID-19 vaccine for children ages five to 11, paving the way for the first vaccination as Europe struggles with a surge in the disease.
The Pfizer-BioNTech (PFE.N)(22UAy.DE) vaccine, which has been approved for use in the European Union for teens ages 12 to 17 since May, will be administered in two 10-microgram doses three weeks apart as an injection into the upper arm, the European Medicines Agency (EMA) recommended, Reuters reported.
The approval comes as Europe has once again become the epicenter of a pandemic that accounts for about half of the cases and deaths.
Company officials said their vaccine, called Comirnaty, showed 90.7 percent efficacy against the coronavirus in clinical trials in children ages 5 to 11. An adult dose of the vaccine contains 30 micrograms.
“The benefits of Comirnaty in children aged 5 to 11 years outweigh the risks, especially in those with diseases that increase the risk of severe COVID-19,” the EMA said.
Although final approval of the drug is up to the European Commission, it generally follows the EMA’s recommendations.
“Today’s recommendation clearly shows that the BioNTech-Pfizer vaccine is safe and effective for young children and can provide them with additional protection,” EU Health Commissioner Stella Kyriakides said on Twitter.
Countries won’t be able to begin administering the vaccine to young children until next month. The first low-dose pediatric version will be delivered Dec. 20, a BioNTech spokeswoman said Thursday.
The EU joins a growing number of countries, including the U.S., Canada, Israel, China and Saudi Arabia, that have authorized vaccines for children ages 5-11 and younger.
Tens of millions of children in this age group will be eligible for vaccination in the EU. Germany will receive 2.4 million doses with the first batch, enough to vaccinate about half of the country’s children ages 5-11, a BioNTech spokeswoman said.
For pediatric vaccinations, the U.S. regulator has approved a new version of the vaccine, which uses a new formulation and allows it to be stored in refrigerators for up to 10 weeks.
A rise in cases in Europe has prompted new unpopular travel restrictions.
Slovakia began a two-week travel restriction Thursday, following the example of neighboring Austria, and the governments of France and Portugal are considering additional restrictions.
Health experts are pushing for more use of revaccinations to avoid overburdening hospitals with waning immunity from earlier vaccinations.