European agency approves Covid vaccine for children aged 5 to 11 years

The European Medicines Agency (EMA) approved on Thursday (25) Pfizer’s vaccine against Covid-19 for children between the ages of 5 and 11, a decision that will help accelerate the fight against the virus at a time when the pandemic advances in Europe.

The EMA announced that an expert panel “recommended broadening the indication of the Comirnaty vaccine to include children between 5 and 11 years old,” the agency said, citing the brand name of the immunizer.

The messenger RNA vaccine had already been authorized in adolescents aged 12 years and over in the 27 countries of the European Union (EU).

Outside Europe, Pfizer’s immunizing agent has already been approved for children aged 5 to 11 in countries such as the United States, Israel and Canada.

Children in this age group will receive a third of the dose given to older people, in two doses three weeks apart, explained the European agency.

The vaccine showed 90.7% efficacy in a trial with 2,000 children in this age group.

Side effects were classified as “mild to moderate”. They may last a few days and present as pain located in the area of ​​inoculation, fatigue, headache and/or muscle pain, or a cold.

Thus, the EMA “concluded that the benefits of Comirnaty in children ages 5 to 11 outweigh the risks, particularly among those with comorbidities that can increase their risk of contracting a severe form of covid-19,” according to the statement.

The EMA has authorized four vaccines against covid for the general population: those from Pfizer and Moderna, with messenger RNA, and those from AstraZeneca and Johnson & Johnson, which use the technique of “non-replicating viral vector” based on adenovirus.

Although final approval depends on the European Commission, it usually follows the EMA’s recommendations and an EU source told Reuters the decision was likely to come on Friday.

“Today’s recommendation (…) is clear that the BioNTech-Pfizer vaccine is safe and effective for young children and may offer additional protection,” said EU Health Commissioner Stella Kyriakides on Twitter.

Countries will not be able to start rolling out vaccines among younger children until next month. The first shipment of the low-dose children’s version will be delivered on Dec. 20, said a spokeswoman for BioNTech.

The EU joins a growing number of countries that have approved vaccines for children aged 5-11 and younger.

Tens of millions of children in this age group will be eligible for the vaccine in the EU. Germany will receive 2.4 million doses with the first shipment, enough to inoculate approximately half of the country’s children aged between 5 and 11, said a spokeswoman for BioNTech.

For pediatric injections, the US regulator authorized a new version of the vaccine, which uses a new buffer solution and allows them to be stored in refrigerators for up to ten weeks.