EU medical authority releases Covid-19 vaccine for children

Dusseldorf The European Medicines Agency Ema has approved the Biontech vaccine for children. From now on, five to eleven year olds can be vaccinated against Covid-19 in Europe. 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.

Pediatricians welcomed Ema’s decision. “It’s good news that we now have a vaccine approved for children. This is especially true for families whose children need protection due to previous illnesses, “said Peter Dötsch, President of the German Society for Pediatric and Adolescent Medicine, the Handelsblatt.

The Federal Ministry of Health assumes that the children’s vaccine will be available in Germany around December 20th. One reason for the delay is the special production of the doses: they contain only a third of the amount of active ingredient that is administered to adolescents and adults aged twelve and over. Special filling systems must be used for this.

The first shipment will contain 2.4 million cans. Dötsch hopes that the Standing Vaccination Commission (Stiko) will recommend the drug for the risk group among children by December 20 at the latest. A general vaccination recommendation for five to eleven year olds will only be given much later.

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“It can be assumed that the Stiko will only give this when there is a sufficient database, for example from the USA, on the effect of the vaccines and the safety profile,” says Dötsch, who also heads the Clinic for Pediatric and Adolescent Medicine at the University Clinic in Cologne is.

How should parents behave?

Parents whose children do not suffer from a serious pre-existing illness should, in the view of doctors, wait and see. “I can only advise parents to use the Stiko recommendation as a guide,” says Dötsch. “The body brings together vaccination experts with decades of experience.”

The professional association of paediatricians is also advocating this. “It would not be advisable for politicians to recommend vaccination as long as there is no recommendation from the committee that advises politicians,” says its spokesman, Jakob Mark. Of course, the number of infections increased and with it the pressure to take all possible countermeasures.

But paediatricians oppose a broad vaccination of children solely for reasons of fighting pandemic. “In no case are we allowed to vaccinate children just for social reasons so that we can finally raise the general vaccination quota,” says the Cologne doctor Dötsch. “Children are not there to protect adults – it has to be the other way around.”

Then why should I have my child vaccinated?

Stiko will quickly recommend children who suffer from serious pre-existing conditions, such as a disability or diabetes. The recommendation could also apply to healthy children in whose close environment parents or siblings have serious illnesses.

Overall, the Stiko recommendation and the majority of paediatricians are based on a risk-benefit analysis. And that turns out differently when looking at children than when looking at adults.

Because the risk of severe Covid 19 disease is significantly lower in healthy children than in adults. So far, however, doctors have not been able to rule out any long-term health consequences or severe courses. The risk assessment also includes the consideration of vaccination and side effects.

On the other hand, there is the benefit. “The individual benefit of a vaccination must always be recognizable for the child”, says Dötsch and explains: “This lies in the protection against illness and against abstinence from social participation.” There will be quite a few parents who have their children vaccinated because they want to give them more security and enable a normal school and social life.

Are doctors allowed to vaccinate all children now?

The experts assume that parents will have their children vaccinated even without a recommendation from the Stiko. In principle, this is possible because the doctors are now officially allowed to do this after they have been approved by the Ema.

Ultimately, it is a decision of the parents. “If you are unsure, I advise you to talk to your pediatrician about the benefits and risks of a vaccination,” says Dötsch. The experts expect: In the end, most parents who do not fundamentally refuse a vaccination will probably wait for the general recommendation by Stiko at the beginning of 2022.

Because that would ultimately mean that the panel would estimate the benefit to be significantly higher than the risk on the basis of the available data. Stiko has already made it clear that it applies special standards to children. The panel also takes the position that the most important measure to overcome the pandemic must remain the vaccination of as many adults as possible.

How high are the health risks of a child vaccination?

There are two phases in this question. For approval and evaluation by Ema, only the data from the phase 3 study by Biontech and Pfizer on the effect and safety profile are decisive.

The two companies tested the drug with a significantly lower dose of active ingredient on 2,268 children between the ages of eleven and five in different countries. They put the protective effect against Covid 19 disease at 91 percent.

Experts evaluated the data in the “New England Journal of Medicine”. According to her, no serious vaccine-related side effects were observed, only the symptoms that also occur in adolescents and adults. They are mild and temporary: fever, pain at the puncture, fatigue or headache are part of it. The vaccination is safe and effective, is the conclusion.

In the opinion of the authors, the only three more severe damage in the observation period had no connection with the vaccination – in one case it was a broken arm. Heart muscle inflammation, as it occasionally occurred after a broad vaccination of over twelve-year-olds, was not found.

These are the experiences from this very small study group. However, the Stiko bases its recommendations primarily on the data collected in the first practical phase of use. They will come from countries like the US and Israel that have started vaccinating in all age groups.

Where are children already vaccinated?

In the United States, nearly three million children between the ages of five and eleven have received the Biontech vaccine since the beginning of November. The Americans vaccinate low-threshold, which in practice means: The syringes are administered in schools, pharmacies, drug stores or in drive-in stations.

Serious side effects associated with the vaccination have not yet been observed in children in the USA. From the US health authority CDC, more precise data on this should not be available until the beginning of December. US doctors assume that the situation will be similar to that of twelve to 17-year-olds who have been vaccinated in the US since the summer.

There were only very rare cases of serious side effects in the six months after the start of the vaccination. Heart muscle inflammation was found mainly in young men, but according to the CDC this subsided after medical treatment and did not leave any consequences.

This side effect also occurred more frequently with the vaccine from Moderna, which is why the German Stiko only recommends vaccination with the agent from Biontech / Pfizer for under 30-year-olds. For the time being, children under the age of eleven will only get this vaccine in Germany.

In addition to the experience from the USA, the data from Israel should also be important for a Stiko recommendation on widespread child vaccination. The country began vaccinating five to eleven year olds on Tuesday. Thousands of vaccination appointments with the responsible health insurance companies have already been booked. Prime Minister Naftali Bennett accompanied his nine-year-old son David to the vaccination on Tuesday.

More: Pros and cons – is it correct to introduce compulsory corona vaccination in Germany now?

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