BioNTech CEO Ugur Sahin said the ongoing studies are “very encouraging” and that “children are very well protected by the vaccine.”
A woman along with a girl walks past a graffiti depicting a coronavirus in Mumbai, India. Photo credit: AP Photo / Rafiq Maqbool
Pfizer / BioNTech said on Friday that they have asked European regulators to approve their COVID-19 vaccine for 12-15 year olds, which is a crucial step towards livestock integrity. The companies have already made a similar request to the U.S. authorities earlier this month. Their vaccine is currently only approved for use in people over 16 years of age. In a joint statement, Pfizer and BioNTech said they had sent a request with the Amsterdam-based European Medicines Agency (EMA) to extend the use of their jaw to “young people aged 12-15.”
Ugur Sahin, founder and CEO of German BioNTech, said on Thursday that the jacket could be available to those age groups from June if EU approval is granted.
The change is based on the results of a phase 3 study that the vaccine provided “robust antibody responses” and that it was 100% effective in controlling the disease in 12-15 year olds.
“The vaccine was also generally well tolerated,” the statement added.
In an interview with Der Spiegel weekly, Sahin said he expects regulators to evaluate the data for four or six weeks.
Once approved, the green light would be valid in all 27 Member States of the European Union.
Pfizer and BioNTech added that they also intend to seek authorization “with other regulators worldwide.”
No coronavirus vaccines are currently approved for use in children.
Although children and adolescents are not more likely to develop severe Covid disease, they make up a large portion of the population and their inoculation is considered key to ending the pandemic.
The opportunity to make older children mock before the start of the next school year would also ease the burden on parents who practice home schooling while remaining at work.
“It’s very important to let the kids go back to normal school and let them meet with family and friends,” Sahin told Spiegel.
BioNTech and Pfizer are also competing to get their kicks approved for younger children from six months onwards.
“In July, the first results for five 12-year-olds may be available, and for younger children in September,” Sahin said.
The ongoing studies so far are “very encouraging,” Sahin said, suggesting that “children are very well protected by the vaccine.”
The BioNTech / Pfizer shot is based on mRNA technology and was the first COVID-19 jab will be adopted in the west late last year.