Clinical trials for children's Covid-19 vaccine approved in Poland
Poland is one of the countries approved by the Office for Registration of Medicinal Products to hold clinical trials of a vaccine for children six months to 12 years of age, said a health ministry spokesman on Friday.
Waldemar Andrusiewicz told a press conference that at the moment Poland was bound by the Summary of Product Characteristics, which stipulates how medicines are used and is also mandatory in the EU, in the matter of vaccinations for people from the age of 16.
He added that, however, modifications would probably be made to the document "since Pfizer will request a change in accordance with the latest research data which shows that vaccination is safe and effective in the 12-16 age group."
"The company will probably soon apply for a change, in the Summary of Product Characteristics in the EU, to the European Medicines Agency," he stated. "At that time," he said, "if revisions are made… we'll be able to talk and think about vaccinating young people from the age of 12 in Poland."
The health ministry spokesman also noted that Poland was one of four countries in which Pfizer-BioNTtech, in the near future, will conduct research on the possibility of vaccinations from the age of 6 months.
He added that Poland is now one of the countries which the Office for Registration of Medicinal Products approved for clinical trials of a vaccine for children aged six months to 12 years of age.