Under 12-year-olds cannot be vaccinated against the coronavirus yet. A study by Pfizer and Biontech now shows that their vaccine is safe and effective in five to eleven year olds. However, approval is still pending.
Biontech and Pfizer want to apply for approval of their corona vaccine for children aged five to eleven as soon as possible. The vaccine has proven to be safe and effective in studies, announced the two pharmaceutical companies on Monday in Mainz after evaluating the first results of the approval study for the Comirnaty vaccine for children under twelve.
In the study, five to eleven year old children were vaccinated twice with an interval of three weeks – but the dose was only a third of what people aged twelve and over were vaccinated. According to the information, a total of 4500 children between the ages of six and eleven take part in the study, the data presented on the five to eleven year olds go back to 2268 participants. Over 90 clinics in the USA, Finland, Poland and Spain are involved.
Approval should be applied for
According to the company, the vaccine was “safe, well tolerated and showed robust neutralizing antibody responses”. The antibodies formed after the corona vaccination therefore have a good protective effect. The antibody responses in the children are comparable to those from a previous study with 16 to 25 year olds who received three times the dose. Possible side effects are also comparable.
“We are pleased that we can present the data for this group of school-age children to the regulatory authorities before the start of winter,” said Biontech co-founder Ugur Sahin. Pfizer boss Albert Bourla sees the study data as a “solid basis” for the approval of the vaccine also for younger people. This is also urgent in view of the spread of the delta variant and the associated considerable risk for children.
Biontech and Pfizer are expected to apply to the FDA for emergency approval for the vaccine in the United States. The data should also be submitted as quickly as possible to the European approval authority EMA and other approval authorities around the world.
The vaccine manufacturers are also expecting the results of the approval study for children under five years of age this year. These children receive an even lower dose than five to eleven year olds.
