Filenews 8 June 2021
U.S. pharmaceutical company Pfizer Inc announced today that it will begin clinical trials of its vaccine for Covid-19 in a larger group of children under the age of 12, after it had chosen to use a lower dose of the vaccine at an earlier stage of the clinical trial.
Up to 4,500 children will take part in the study at more than 90 clinics in the US, Finland, Poland and Spain, the company said.
Based on the safety, tolerance and immune response developed by 144 children in the phase 1 clinical trial of the didosic vaccine, Pfizer said it would proceed with the trial of administering a dose of 10 micrograms to children between 5 to 11 years of age and 3 micrograms for the age group of 6 months to 5 years.
The vaccine - manufactured by Pfizer and German biotech company BioNTech - has been approved for use in children as young as 12 in Europe, the US and Canada. Children receive the same dose as adults: 30 micrograms.
Nearly 7 million adolescents have received at least one dose of this vaccine in the U.S., according to the U.S. Centres for Disease Control and Prevention.
Vaccination of children and young people is seen as a crucial step on the road to achieving herd immunity and eradicating the Covid-19 pandemic.
However, scientists in the US and elsewhere are studying the possibility of a link between the occurrence of myocarditis after the administration of mRNA technology vaccines, particularly in young people. Both Pfizer and Moderna Inc. vaccines are mRNA technology.
Israel's Health Ministry announced last week that it had identified a small number of cases of inflammation in the heart muscle in Pfizer-inoculated formulation for Covid-19, mainly in young men, a condition that may be linked to the vaccine. The incidents were generally mild and of short duration.
Pfizer stressed that it was aware of Israeli myocarditis registrations and that no causal link to the vaccine has been established.
RES- ICM
