EMA green light for Covid vaccine for children

The European Medicines Agency (EMA) has given the go-ahead for the use of BioNTech / Pfizer’s corona vaccine in children aged five to eleven. The responsible EMA committee recommended an extension of the approval on Thursday. The final decision has yet to be made by the European Commission. But this is a matter of form. So far there has not been a corona vaccine that is approved in the EU for children under the age of twelve.

Children aged five and over should only receive a third of the adult dose of the BioNTech / Pfizer vaccine and two doses every three weeks. The EMA emphasized that studies have shown that the vaccine is safe and effective. So far, no serious side effects have been found, at most mild reactions such as fever, pain at the injection site, fatigue or headache. The experts had checked studies by the manufacturers since October.

If the approval is also fixed in the EU, there will soon be a corresponding recommendation from the National Vaccination Committee (NIG) in Austria, probably in the next few days. The Austrian Ministry of Health expects that the first children’s vaccine against Corona will be available across the EU towards the end of 2021. The first cans should be able to be delivered to all EU member states on December 20th, reports from Germany.

Children rarely get Covid-19. But, say the EMA experts, they too can get seriously ill. The benefits of vaccination should therefore be rated higher than possible risks.

In Israel and the USA, BioNTech / Pfizer’s own vaccine is already available for children from the age of five. In Austria there are so far only so-called off-label vaccinations for children under twelve. The dose for adults is divided into thirds and this part is given to children. Interested parents have to look for a doctor who will vaccinate their offspring. In the future, the vaccine specially developed for children will be administered, which simplifies the dosage.

Vienna already took on a pioneering role in off-label vaccination in November. The Austrian capital created the possibility that kids from the age of five can be immunized against corona – with just one third of the dose for adults. From November 15th, the first children could be immunized in the Austria Center Vienna, the first appointments were quickly booked out.

According to figures published on Wednesday, the Vienna vaccination center has so far vaccinated a total of 9,167 children under twelve. Most of them – 7,486 or 81.7 percent – came from Vienna. 1,612 or 17.6 percent came from other federal states, with Lower Austria accounting for the largest proportion with 1,396 or 15.2 percent, according to the office of City Councilor for Health Peter Hacker (SPÖ). On Tuesday alone, 1,165 children were vaccinated in Vienna, 976 (83.7 percent) live in the federal capital. After the first week of vaccination was such a great success, more appointments were made for that week. From Monday 2 p.m. to Wednesday 1 p.m., 8,898 new appointments were booked.

In Upper Austria and Tyrol, too, the opportunity was given in advance to vaccinate children “off label” before the EMA decision. After the green light from the European Medicines Agency, the offers in the countries should be expanded. In Lower Austria, too, over 300 injections for five to eleven year olds were planned for Thursday, “another 10,000 appointments have already been booked,” informed the LHStv. Stephan Pernkopf (ÖVP). In addition, 4,396 children in the state had previously been vaccinated “off label”. Corona injections for five to eleven year olds are available from paediatricians and family doctors, in the St. Pölten, Wiener Neustadt and Tulln vaccination centers and, shortly, in Wieselburg (Scheibbs district), Mistelbach and Laxenburg (Mödling district).

In Styria and Vorarlberg, the health authorities are already in the starting blocks. Dates for vaccinating children have already been reserved. In Salzburg, Burgenland and Carinthia, people wanted to wait for the EMA decision before opening appointments for children.

On Thursday evening, the green light was given in Salzburg for the corona vaccination for children from the age of five. The registration with the Salzburg paediatricians for the vaccination for five to eleven year olds is now starting, informed the state correspondence. This age group comprises a total of around 38,000 children. “We have made preparations so that the first vaccinations can be administered quickly,” said health officer LHStv. Christian Stöckl (ÖVP).

In Salzburg, vaccination with the BioNTech / Pfizer vaccine is primarily administered by paediatricians, but also by general practitioners. A special vaccination route for children will also be set up in the Salzburg Marionette Theater, and preparations are in full swing. The registration option on www.salzburg-impft.at will be activated in the course of tomorrow, Friday. The Kinderimpfstraße is expected to go into operation at the beginning of next week. There are also other exciting special vaccination campaigns in planning, it said. Among ten to eleven year olds in Salzburg, the seven-day incidence of currently almost 6,000 is very high.

“The data show that the vaccination is effective and safe for children between the ages of five and eleven,” said Health Minister Wolfgang Mückstein (Greens) on Twitter and announced that further information would be available at a press conference at 4 p.m. together with the members of the NIG give. “Really good news comes from the EMA today,” said Federal Chancellor Alexander Schallenberg (ÖVP). “Another important step in increasing vaccination coverage as the only exit ticket from the pandemic.”

“More and more children are also suffering from Corona and unfortunately we see severe progression among them. Therefore, this decision by the EMA is to be welcomed and another important framework condition so that we can also protect the children in this pandemic,” said Family Minister Susanne Raab (ÖVP) . “I assume that the National Vaccination Committee in Austria will quickly make a corresponding recommendation for the children’s vaccine.”

The deputy NEOS club chairman Gerald Loacker demanded that Austria then quickly develop and implement a comprehensive and low-threshold advisory service: “The federal government overslept and screwed up a lot when it came to vaccination education for adults, these mistakes must not also happen with possible child vaccinations,” he warned . “The information about the possible vaccination with children must be included in all information letters. Parents and children who have not yet been vaccinated should be given advice and counseling, in which a joint vaccination is offered after the information has been given.”

A second vaccine for children could follow soon. The EMA experts are currently examining an application from the US manufacturer Moderna.

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