The European Medicines Agency, EMA, decided on Thursday to approve the Biontech / Pfizer vaccine for children aged five and over. What’s the schedule?
Update from November 25, 12:51 p.m .: The EMA has given the green light for the approval of the corona vaccine from the manufacturer Pfizer / Biontech for children aged five and over in Europe. The EMA announced on Thursday in Amsterdam. It will be the first corona vaccine to be approved in the EU for children under the age of twelve.
For children between the ages of five and eleven, the dose of Comirnaty des Biontech / Pfizer vaccine will be lower than for people aged 12 and over, the EMA announced on Twitter. As in the older age groups, the EMA recommends two vaccinations every three weeks.
The benefits of Comirnaty in children aged five to eleven outweigh the risks, especially in those with medical conditions that increase the risk of developing severe Covid-19 disease. The EMA refers to the results of a main study with almost 2,000 children (see also below). The children received either the vaccine or a placebo. Of the 1,305 children vaccinated, three developed Covid-19. In the placebo group, 16 of 663 children fell ill. The vaccine in the study would be 90.7 percent effective in preventing symptomatic corona infection. The safety and effectiveness of the vaccine in children and adults will continue to be closely monitored, the EMA said.
Probably still Thursday: EMA wants to decide on the approval of Biontech for children from the age of five
First report from November 25, 2021
Amsterdam – When can children in Germany be vaccinated against the coronavirus? In view of the extreme Corona * situation, many parents are waiting for a green light from the European Medicines Agency (EMA). This could change now.
Corona vaccine for children aged five and over
The EMA wants to make a decision on Thursday (November 25) on the approval of the corona vaccine from the manufacturer Pfizer / Biontech for children from the age of five. The responsible experts have examined the data on the risks and effectiveness of the vaccine in five to eleven year olds for a good two months and now want to complete the assessment. Incidentally, the application was submitted on October 15th.
Where are Covid vaccinations for children available?
In the USA, more than two million children between the ages of five and eleven have been vaccinated against Corona. In Israel, too, children can already be vaccinated with the Biontech / Pfizer vaccine. In Austria, five to eleven year olds can already receive the corona vaccination “off-label”. Parents have to find a doctor who will vaccinate their offspring against corona. Vienna rushes ahead. Last week, a vaccination line for children between the ages of five and eleven was set up in a vaccination center. With this so-called “off-label use”, parents must decide whether to vaccinate their children at their own risk and individually. A liability of the vaccinating physicians is excluded with the “off label” use.
When will the corona vaccination for children aged five and over come in Germany?
So far, the corona vaccine Comirnaty from Biontech / Pfizer has been approved for children and adolescents from the age of twelve in Europe. If the EMA gives the green light, the EU Commission has to give its official approval. But that is a matter of form. This would pave the way for child vaccinations in Germany. However, patience is again required.
In this country, many doctors may be waiting for a vaccination recommendation from the Standing Vaccination Commission (Stiko). Because only when the recommendation from Stiko is available will the federal government assume the costs and liability for the Covid-19 vaccination. The Standing Vaccination Commission (Stiko) wants to make its recommendation on corona vaccination for children from five to eleven years before the end of the year. Stiko boss Thomas Mertens explained in the Schwäbische Zeitung that the children in this age group have to weigh up the benefits and possible “residual risks”.
In a registration study by the company Biontech / Pfizer, no serious vaccine reactions or side effects were documented, said Mertens (see below). After a relatively short observation period, the effectiveness of the vaccine in the children was also roughly the same as that in the adults. However, the figures from the current studies are not sufficient to rule out rare side effects. You have to include the results of previous studies and application data. You are preparing the decision on a recommendation, said Mertens, as reported by the dpa news agency.
Is there already a corona vaccine for children in Germany?
In Germany, according to Federal Health Minister Jens Spahn (CDU), 2.4 million doses of the Biontech / Pfizer vaccine would not be available for children until December 20.
Bavaria is preparing to vaccinate children from the age of five together with the medical profession and the vaccination centers. Bavaria’s Minister of Health, Klaus Holetschek, pointed this out in Berlin on Wednesday evening. “We are here in close consultation with the professional association of paediatricians, who will support us in this,” said the CSU minister. He thinks it is “a positive and important development if the vaccine could also be used for children under the age of 12 in the future.”
What are the advantages of vaccinating children aged five and over?
Vaccination with the mRNA vaccine for children between five and eleven years of age is well tolerated, immunogenic and effective , according to a study relevant to approval, published in the specialist magazine “New England Journal of Medicine”. A protective effect against clinical Covid-19 diseases can also be proven, reports the Ärzteblatt online. A vaccination protects children from a – albeit rare – severe course or long-term consequences of Covid disease.
Side effects after a corona vaccination with Biontech
According to the study, the most common side effects of a corona vaccination with Biontech were pain at the vaccination site. At 81 centers in the United States, Spain, Finland and Poland, 2,285 children were given two doses of vaccine or placebo 21 days apart.
- Pain at the injection site in 71 to 74 percent of vaccinated children.
- Redness at the vaccination site 15 to 19 percent
- Swelling at the vaccination site 10 to 15 percent
- Fever at 3 to 7 percent
- Chills 5 to 10 percent
- Swelling of the lymph nodes 0.9 percent
- Four children had rashes on their arms, torso, face and body. They were mild and appeared about seven days after vaccination.
Not a single case of multisystemic inflammatory syndrome (MIS-C) has been reported that has only occurred after infection. Neither inflammation of the heart muscle (myocarditis) nor inflammation of the pericardium (pericarditis) were observed. However, given the small number of participants, that was to be expected, writes the Ärzteblatt . Myocarditis and pericarditis are considered rare vaccination complications. (ml / dpa) * Merkur.de is an offer from IPPEN.MEDIA