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During the recent wave of the coronavirus pandemic, particularly the most contagious crucial delta variant, COVID-19 is most often diagnosed in children. Vaccination of members of this age group is considered an essential tool to continue contact lessons and to manage the pandemic.
“This data was shared with the FDA for an initial evaluation,” the companies said in a statement.
“A formal application should be made in the coming weeks for the emergency use of COVID-19 in children aged five to less than 12 years,” the companies added. According to them, the corresponding application is also intended to be submitted to the European Medicines Agency (EMA) and other services.
A week ago, Pfizer and BioNTech announced that clinical trials in several countries had shown the vaccine to be safe for use in children and stimulated a strong immune response to pandemic coronavirus antibodies, preventing the infection from entering cells.
In the trials, children 5 to 11 years old received two 10-microgram doses of the vaccine. Older people receive 30 micrograms.
The second injection was given three weeks after the first.
The FDA has previously stated that it will complete its evaluation “in weeks rather than months” after receiving all formal application materials.
In the United States, the Pfizer vaccine was fully and officially approved in August, so it is already possible to vaccinate the youngest children in the country if your doctor recommends it. However, the US authorities have warned not to do so until all the safety data is available.
Pfizer and BioNTech are also testing their vaccine in children ages six months to two years and two to five years.
Preliminary data on the effects on children in these age groups may be available as early as the “fourth quarter” of this year.
A total of 4.5 thousand patients participated in clinical trials in the United States, Finland, Poland and Spain. children from 6 months of age. up to 11 years.
