This is an “off-label use”, ie the use of a drug outside of the approval. Because the corona vaccination for younger children is still in the trial phase, but is increasingly discussed among parents of healthy children.
The use of a drug outside of its approved indication is generally not prohibited. The vaccinating doctor has an increased duty of care and a special duty to provide information to the patient. Some doctors, who also vaccinate younger people against Covid-19, are in favor of vaccinating only children with certain pre-existing diseases at the moment. The Innsbruck virologist Dorothee von Laer recently said that regarding “children at risk” one should definitely consider it.
“So far notable complications”
The interest among local legal guardians in the off-label use of the Covid vaccination – currently only the vaccine from Biontech / Pfizer, which has been used for children and adolescents from the age of twelve since early summer, before infections due to the start of school and autumn, but also from previous ones, is considered positive reports on the ongoing series of studies with younger children. “In the last few days there were also some inquiries and discussions in the BMSGPK,” said the Ministry of Health about the APA.
There have been no significant complications with information from the authorities: Currently, the BASG (Federal Office for Health Safety) has received two reports of suspected side effects after vaccination of children under the age of twelve. “These were local reactions (pain at the vaccination site or in an extremity). In both cases, the authorization holder was reported directly, so no other information is available,” it said.
Pfizer expects approval in September
“Since there is no approval or recommendation (for use by people under twelve years of age, note), the responsibility for vaccinating doctors and the legal representation of the vaccinated people”, the ministry stated in principle at the request of the APA. The National Vaccination Board (NIG) “advises against vaccinating children under the age of twelve before it is approved or recommended”.
Pfizer expects to be able to apply for approval for five to eleven year olds in September and a short time later for children between six months and five years. “First, approval must be available, then, based on the available data on benefit-risk and a synopsis of the epidemiological situation and burden of disease in children, the vaccination panel will discuss how exactly the recommendation makes sense from a medical point of view. Safety is the top priority here”, so the local health department on how to proceed. With regard to the time horizon, they did not want to anticipate anything: “We are still expecting approval in 2021, but ultimately this depends on the data submitted and the authority.”
“From my point of view, it should actually be recommended for all children, simply because of the current figures,” said Markus Zeitlinger, the board of directors of the University Clinic for Clinical Pharmacology at the Medical University of Vienna, in the Ö1-Journal. In the meantime, the five to 14 year olds are now the main group alongside the 15 to 24 year olds among new infections in Austria, and the start of school is “not even priced in”. He would therefore “definitely recommend vaccinating all children of this age as soon as the vaccine is approved and as soon as we have seen the data, because no one from Biontech / Pfizer has that yet,” he emphasized.