October 27, 2021, 2:11 pm | Read time: 4 minutes
For children under twelve, no COVID-19 vaccine has been approved in European and many other countries so far. In the U.S., this could change now–data on the BioNTech/Pfizer vaccine has been reviewed there. And in Germany?
COVID-19 vaccinations for children under 12 could begin in the U.S. in early November, while in Germany, parents eager to vaccinate will have to wait significantly longer. This is according to Jakob Maske, spokesperson for the Professional Association of Pediatricians. He expects the EU Medicines Agency EMA to approve the BioNTech/Pfizer vaccine no earlier than mid-November. “We will then wait for the Stiko recommendation.”
In Germany, the question of evaluating the vaccine for five- to eleven-year-olds is still open, said Thomas Mertens, chairman of the Standing Committee on Vaccination (Stiko).
Experts Support Emergency Approval in the U.S.
An advisory panel of the U.S. Food and Drug Administration (FDA) has recommended emergency approval of the BioNTech/Pfizer COVID-19 vaccine for children between five and eleven years old. This decision was made during a meeting on Tuesday (October 26). The decision is not binding, but the FDA usually follows the experts’ advice. A final decision from the FDA is expected later this week. Subsequently, the Centers for Disease Control and Prevention (CDC) must also formally address it.
A vaccination campaign for the approximately 28 million affected children in the U.S. could then start as early as November. According to the White House, the government will deliver 15 million vaccine doses within days of approval. To pediatricians, clinics, and pharmacies. In Europe, the German company BioNTech and its U.S. partner Pfizer have also applied for approval of their COVID-19 vaccine for children in this age group.
Stiko Chairman Mertens: Wait for EMA Approval
“We do not yet have a data basis for our assessment and recommendation,” said Mertens. First, EMA approval is important. “Stiko has not yet seen or evaluated the data from the approval study on safety and efficacy.” However, it is clear that such a study with fewer than 3,000 participants cannot capture the risk of rare side effects.
The committee faces the same problem as before the vaccination recommendation for 12- to 17-year-olds, said Mertens. “Children have a very low disease burden from SARS-CoV-2. Therefore, it is important to carefully weigh the expected positive effects against the potential adverse effects of the vaccination.” Stiko will conduct its own data analysis again.
The situation in the U.S. is not comparable to that here, according to Mertens. “Children there apparently suffer severe COVID-19 more frequently. This may be due to the health care system there and the higher proportion of children with risk factors such as metabolic syndrome or poorly controlled diabetes.”
Also of interest: COVID-19 vaccination from age 12–what parents and children should know now
EMA Approves BioNTech Vaccine for Children Aged Five and Up
COVID-19 Vaccination for Children Ages 5 and Up: What Parents Should Know
Initial Recommendation for Chronically Ill Children Expected
Pediatricians’ spokesperson Maske expects, as with the 12- to 17-year-olds, an initial Stiko recommendation for chronically ill children and possibly a “can rule” that also allows vaccinations for all other children. “The difficulty is that there is a lack of empirical data from other countries.” Certain pre-existing conditions are considered risk factors for severe COVID-19.
There is significant pressure from some parents who want to vaccinate their children as soon as possible, reported Maske. Some doctors are offering vaccinations in so-called off-label use, meaning without approval for the age group. This is not illegal but ultimately a question of safety. Overall, Maske assumes that the number of children vaccinated in this way is very low.
COVID-19 Infections Increasing Among Children and Adolescents
It is hoped for the success of the vaccination campaign among children that politicians will not again publicly pressure Stiko, said Maske. “With the 12- to 17-year-olds, this caused a lot of confusion and required a lot of persuasion from us pediatricians.”
SARS-CoV-2 is currently being detected primarily among children and adolescents in Germany. The Robert Koch Institute (RKI) reported a seven-day incidence of 207.4 among 5- to 14-year-olds on Tuesday, with an upward trend. Across all age groups, the RKI reported 113 new infections per 100,000 inhabitants per week, compared to 75.1 a week ago.
With material from dpa