Friday, May 28, 2021
Mild side effects
Biontech safely protects children from Covid-19
In Germany, a possible corona vaccination for children is causing heated debates. In the USA and Canada, people over the age of 12 are already vaccinated with the Biontech vaccine. The data that are crucial for approval look promising.
The Biontech vaccine also safely protects children between the ages of 12 and 15 from Covid-19 disease. This has now been shown by published data which were already the basis for the emergency approval of the vaccine in the USA in this age group and which are also available to the European Medicines Agency (EMA) for approval testing. In the study, there were no Covid-19 cases in more than 1000 vaccinated children and adolescents, in the roughly equal, unvaccinated control group there were 16.
After the vaccination there were mostly only slight vaccination reactions such as tiredness or headaches, the scientists write in the “New England Journal of Medicine”. The positive results also justify tests on younger children or other groups that are particularly worthy of protection, such as pregnant women, they emphasize.
Children and adolescents are generally less ill than adults, but there are also severe cases among them, especially among children with previous illnesses, writes Robert Frenck’s team from the Cincinnati Children’s Hospital (Ohio). They also played an essential role in the spread of the virus, and their vaccination was essential for achieving herd immunity. Finally, safe vaccines are also important for this age group so that education and social development are not further hampered.
Better immune response than adults
The researchers had evaluated data from a total of 2260 children between 12 and 15 years of age. They had received two doses of the vaccine (1131 children) or placebo injections (1129 children) with saline solution 21 days apart. For seven days after each injection, the test subjects noted any vaccination reactions. Adverse effects were recorded up to six months after the second injection.
According to the researchers, the effectiveness of a double vaccination was 100 percent, since there was no Covid-19 case in the study group compared to the placebo group. Apart from that, laboratory tests also showed that the vaccination produced a stable immune response, it was even better than in the group of adolescents and young adults between 16 and 25 years of age.
As in other age groups, the vaccine reactions when they occurred were mild to moderate. The participants complained of pain at the injection site, fatigue, headache and fever – more frequently after the second dose than after the first. The symptoms usually disappeared within a few days. There were no serious adverse effects such as thrombosis or anaphylactic shock.
EMA could give the green light soon
The US drug agency FDA extended the emergency approval for the vaccine Comirnaty from the German manufacturer Biontech and its US partner Pfizer to children and adolescents aged 12 to 15 years. A corresponding application has been submitted to the European approval authority at the end of April. The EMA will probably decide on this Friday, approval is considered likely. Once EMA approval is granted, the modified conditional approval will be valid in all 27 EU member states.
There are debates in Germany about vaccinating children and adolescents. The Standing Vaccination Commission (STIKO) had indicated that, despite the likely EMA approval of the vaccine, it did not want to give a general vaccination recommendation for all children, but rather only for previously ill children. The data on possible side effects is still too thin. Medical professionals expressed similar concerns. Federal Minister of Health Jens Spahn had previously emphasized that, after EMA approval, he wanted to offer vaccinations to the first children from the age of 12 before the start of the summer holidays.