American pharmaceutical group Pfizer Inc. and its German partner BioNTech SE announced on Friday that they have transmitted to the European Medicines Agency (EMA) the medical data obtained from a clinical study that supports the use of their anti-COVID-19 vaccine in children in the age group 5-11 years, informs Reuters and AFP.
Although the COVID-19 vaccine developed by the Pfizer-BioNTech alliance is not currently approved for this age group, it has been approved for adolescents over the age of 12 in both the United States and the European Union.
The two companies asked the U.S. Food and Drug Administration (FDA) in early October to authorize this serum for children ages 5-11, and an FDA advisory committee will meet in November to examine those medical data.
Although children are less likely to develop severe forms of COVID-19, they can still transmit the SARS-CoV-2 virus to other people, including vulnerable populations, who are at higher medical risk.
The Pfizer-BioNTech vaccine has been shown to induce a strong immune response among children between the ages of five and 11 in a study of 2,268 participants, the two companies said on September 20.
On that occasion, the US-German alliance stated that its anti-COVID-19 vaccine was well tolerated by those children and induced a “robust” immune response, comparable to that seen among young people in the 16-25 age group. years, reports AFP.
About 28 million children between the ages of five and 11 will soon be able to access this vaccine, and the first inoculations could take place in a few weeks, after the data has been validated by health authorities.
In Europe, the two companies want to change the conditional marketing authorization, currently granted for people over 12 years old, according to Agerpres.ro.
The dosage of the Pfizer-BioNTech vaccine given to children in the 5-11 age group was adjusted to 10 micrograms per injection, lower than the 30 microgram dosage used in older patients.
In Israel, children in this age group who are at risk of developing serious complications from COVID-19 may already be vaccinated with Pfizer serum from August 1, under a “special authorization.”
The American company Moderna is also conducting clinical trials with its anti-COVID-19 vaccine, in which several thousand children participate. The results of these studies have not yet been announced.