An advisory panel to the U.S. Food and Drug Administration (FDA) is scheduled to discuss a possible emergency approval of Biontech/Pfizer's Corona vaccine in children this Tuesday (between 2:30 and 11 p.m. CEST). While the recommendation for use in five- to 11-year-olds is not binding on the final decision, the FDA generally follows the experts' lead.The FDA's final decision could follow within hours or days of the advisors' recommendation. Subsequently, it must also be formally addressed by the CDC, the public health agency.
A vaccination campaign for the approximately 28 million affected children in the U.S. could begin as early as November, according to the White House. The government will deliver 15 million doses of vaccine to pediatricians, clinics and pharmacies within days of approval, it said.An advisory panel to the U.S. Food and Drug Administration (FDA) has voted in favor of emergency approval of Biontech/Pfizer's Corona vaccine for children ages five to 11. The panel's participants made the decision at a meeting Tuesday. The decision is not binding, but the FDA generally follows the experts' lead. A final FDA decision is expected later this week. Subsequently, the health authority CDC must also formally deal with it.
According to Biontech/Pfizer, a clinical trial showed that the vaccine was "well-tolerated" by children in this age group and produced a "strong immune response" one month after the second dose. Compared with adults and adolescents, the five- to 11-year-olds were given a significantly lower dose of the vaccine. They received the second necessary prick after 21 days. The study involved 2268 children in the age group.
For Germany, the question of evaluating the vaccine for children is still open, the chairman of the Standing Commission on Vaccination (Stiko), Thomas Mertens, told Deutsche Presse-Agentur. "We do not yet have a data basis for our evaluation and recommendation." First, he said, approval by the EMA is important, and the timing is still open.
"The Stiko has not yet seen and evaluated the data from the pivotal safety and efficacy study," Mertens said. But it is clear, he said, that such a study with fewer than 3,000 subjects cannot capture the risk of rare side effects.
The panel faces the same problem it did before recommending vaccination for 12- to 17-year-olds, Mertens said. "Children have a very low burden of disease from Sars-CoV-2, so it's a matter of very carefully balancing expected beneficial effects and conceivable adverse effects from vaccination." The Stiko will again conduct its own data analysis, he said.
For Mertens, the initial situation in the U.S. is not comparable to that here. "Children there are apparently much more likely to develop severe covid-19. This may be due to the healthcare system there and the higher proportion of children with risk factors, such as metabolic syndrome or poorly controlled diabetes."
Vaccination for 12- to 17-year-olds was originally recommended by the Stiko primarily for children with certain risk factors for severe courses. These include, for example, severe obesity or chronic lung disease. The general vaccination recommendation followed later, in mid-August. The health ministers of the federal and state governments had already agreed on a broader range of vaccinations for children aged twelve and older.
Could this happen again with younger children - first a vaccination offer from politicians and later a green light from the Stiko? "We hope that won't happen," explained Stiko member Martin Terhardt. "This is the only way to prevent renewed uncertainty and mistrust."
For vaccinations in this age group, he said, careful and well-coordinated preparation with good data and reliable statements is needed for both parents and vaccinating physicians.
Pediatricians warn against political pressure
For the Professional Association of Pediatricians and Adolescents, spokesman Jakob Maske expects EMA approval in mid-November at the earliest. "We will then wait for the Stiko recommendation." He said he initially expects a recommendation for chronically ill children, as with 12- to 17-year-olds, and possibly an "optional regulation" that would allow all other children to be vaccinated as well. "The difficulty is that so far there is a lack of empirical data from other countries."
According to the Berlin pediatrician, however, when considering the necessity of vaccination, it is also important to keep in mind that the highest proportion of so-called PIMS cases is observed in five- to 11-year-olds: Pediatric multisystem inflammatory syndrome rarely occurs overall as a result of Corona infection, but it does require hospital treatment.
Sars-CoV-2 is currently detected in Germany, particularly in children and adolescents. The seven-day incidence among 5- to 14-year-olds was reported by the Robert Koch Institute on Monday to be 203 and rising. Long-term consequences are also feared by some.Maske reported a lot of pressure from some parents to get their children vaccinated as soon as possible. He said there are doctors who specifically offer vaccinations in so-called "off-label use," meaning even without a license for the age group. This is not illegal, but ultimately a question of safety, Maske said. Overall, however, he assumes that the number of people vaccinated in this way is very small.It is to be hoped for the success of the childhood vaccination campaign that politicians do not put renewed public pressure on the Stiko, Maske said. "With 12- to 17-year-olds, this has caused a lot of confusion and cost us pediatricians a lot of convincing."