An advisory board of the US Food and Drug Administration (FDA) has spoken out in favour of emergency approval of Biontech/Pfizer's Comirnaty corona vaccine for children between the ages of five and eleven. This was decided by the participants of the committee at a meeting on Tuesday evening. The decision is not binding, but the FDA usually follows the experts. A final decision by the FDA is expected later this week. Subsequently, the health authority CDC must formally deal with it.
According to the White House, a vaccination campaign for the approximately 28 million children affected in the USA could start in November. The government will deliver 15 million cans of vaccine to pediatricians, clinics and pharmacies within a few days after admission.
According to BioNTech, a clinical trial showed that the vaccine was "well tolerated" for children in this age group and produced a "strong immune response" one month after the second dose. Compared to adults and adolescents, the five- to eleven-year-olds were given a significantly lower dose of the vaccine. They received the second necessary spades after 21 days. The study involved 2268 children in the age group.
Is the Comirnaty vaccine licensed for use on kids in Europe as well?
The German company Biontech and its US partner Pfizer also applied for an approval of their Corona vaccine for children in this age group in Europe. The spokesman for the professional association of pediatricians, Jakob Maske, expects this at the earliest in mid-November. "We will then wait for the STIKO recommendation." For Germany, the question of the evaluation of the vaccine for five to eleven-year-olds is still open, said the chairman of the constant vaccination commission (STIKO), Thomas Mertens. First of all, admission by the EMA is important. "The STIKO has not yet seen and evaluated the data from the approval study on security and effectiveness," says Mertens. However, it is clear that such a study with less than 3000 subjects cannot grasp the risk of rare side effects.
For the STIKO, the same problem arises as before the vaccination recommendation for the 12- to 17-year-olds, explains Mertens further. "Children have a very low burden of disease from Sars-CoV-2. It is therefore important to weigh up the expected positive effects and conceivable undesirable effects of vaccination very carefully." STIKO will again carry out its own data analysis.
Sars-CoV-2 is currently detected in Germany, especially in children and adolescents. The Robert Koch Institute reported the seven-day incidence among 5- to 14-year-olds at 207.4 on Tuesday, and the trend is rising. Across all age groups, the RKI reported 113 new infections per 100,000 inhabitants per week, compared to 75.1 a week ago.
