National
Pfizer to test its coronavirus vaccine in children under 12 in Spain
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The laboratory will begin clinical trials with 4,500 children in four countries in the coming days
The Pfizer / BioNtech consortium has announced that in the coming days it will begin clinical trials of its coronavirus vaccine in 4,500 children under twelve years of age.
In May, it obtained the approval of the main world regulators - including the European Medicines Agency - for the use of its formula in adolescents between 12 and 15 years of age.
The initial trial in this younger age group, which the consortium wants to expand, involved only 144 minors to determine the dose that should be administered. Now, in this extensive phase of the study, some 4,500 children from 90 clinical centres in Spain, the United States, Finland and Poland will participate.
The Pfizer researchers' idea is to test a 10-microgramme dose in children between the ages of five and 11 years and a three-microgramme dose for the six-month to five-year-old age group, compared to the 30 microgrammes for those over 12.
The pharmaceutical company hopes to have the results of the trials in the five to eleven-year-old age group this September and will then immediately request the provisional authorisation from the regulators for this group. The company does not expect to have the trial results of the other age groups until October or November.
On 28 May, the EMA approved the use of the Pfizer / BioNTech vaccine for anyone over the age of twelve and Spain’s Ministry of Health hopes to start the vaccination of adolescents in late August or early September, at the start of the school year with the Pfizer formula.
If the vaccine is authorised for children under 12 years of age – some 5.3 million children in Spain would fall into this group.
