The European Medicines Agency (EMA) has cleared the way for two vaccines from Biontech/Pfizer and Moderna, each of which can be administered from the age of six months. The approval of the EU Commission is still pending, but after a positive EMA vote it is considered a formality.
The vaccines with the trade names Comirnaty and Spikevax were already approved for adults, adolescents and children aged five and six years and older, but in different doses depending on age. The new vaccines for the very little ones now contain even lower doses, and the vaccine from Biontech/Pfizer is also produced in a different solution. While two syringes are enough for the Moderna vaccine for infants and small children, Biontech/Pfizer needs three.
According to the EMA experts, the available data on the vaccines have shown that even babies and young children would be well protected against Covid-19 at a very low dose and also against infection in the first few weeks after vaccination. After a vaccination, fatigue, loss of appetite, skin rash or pain at the injection site may occur. However, these side effects are usually very mild and only last a few days. EMA experts will continue to monitor and assess the safety and efficacy of both vaccines.
The results are worse than those for vaccinations for older children and adults.
Parts of the study data for the vaccine from Moderna have now been published in the journal New England Journal of Medicine released. As part of the work, 3,040 children between the ages of two and five years and 1,762 children between the ages of 6 and 23 months were vaccinated twice with 25 micrograms of Spikevax. 1008 children between 2 and 5 years and 593 between 6 and 23 months received only a sham vaccination without active substance. However, the protection against contracting Covid-19 (i.e. actually developing symptoms beyond the mere infection) was limited. It was 37 percent among 2- to 5-year-olds and 51 percent among younger children.
The relative protection was calculated from the following absolute numbers: In the older children’s group, there were 119 cases of Covid-19 among the 2594 vaccinated (4.6 percent) and 61 cases among the 858 placebo vaccinated (7.1 percent). Of the 1,511 younger children in the study, 51 had symptoms of Covid-19 (3.4 percent) despite being vaccinated; among the 513 children who only received the placebo shots, there were 34 (6.6 percent). Mathematically, among older children, a little more than every third case (37 percent) and among younger children every second case (51 percent) of Covid-19 was prevented by the vaccination.
The results are therefore significantly worse than those of earlier studies on vaccinations for older children and adults. The Moderna researchers justify this by saying that the omicron variant of the coronavirus was already circulating at the time of their new study, but the vaccine, like the vaccine for young children from Biontech/Pfizer, was still being developed against the original coronavirus from Wuhan.
Many of the children at risk have long since been vaccinated.
It is still unclear whether the Standing Vaccination Commission (Stiko) will even recommend vaccination for small children against Covid-19 against this background. “We are still advising, we will probably decide in November whether we will make a recommendation,” says pediatrician Martin Terhardt, a member of Stiko. There is a lot to consider: the risk of small children being infected with the Sars-CoV-2 coronavirus is extremely high; the risk that they will then become more seriously ill is rather low. Only extremely rarely do small children become seriously ill with Covid-19, according to Terhardt, the serious inflammatory syndrome PIMS, which almost 1000 children in Germany have developed since the beginning of the pandemic in the course of a Covid-19 disease, has become much rarer with Omikron than with previous variants . “Although there have also been some deaths from Covid-19,” says Tehardt, but without exception children with previous illnesses, such as those of the nervous system, heart or lungs, were affected.
“Children like this have been offered vaccinations for a long time, even if there hasn’t been any approval for small children yet,” says Terhardt. You will then receive a low dose of the already approved children’s vaccines. Many of the children at risk have therefore long since been vaccinated. However, it is easier for parents and paediatricians to get and administer this vaccination if there is now official approval.
On the other hand, it is rather questionable whether the need in families with healthy children is great: even for older children between five and eleven years of age, the desire for a Covid 19 vaccination is low. Only 22.3 percent of this age group in Germany have been vaccinated once, 19.9 percent twice. The majority of children in Germany have also been through the infection at least once for a long time, so that many parents do not see the need for vaccination at first.