New study to enrich thousands of children under 12 in dozens of sites in the United States, Finland, Poland and Spain.
Pfizer said it will begin testing its COVID-19 vaccine in a larger group of children under the age of 12 after selecting a lower dose of the vaccine at an early stage of the trial.
The study will enroll up to 4,500 children at more than 90 clinical sites in the United States, Finland, Poland and Spain, the pharmaceutical company said.
The vaccine made by Pfizer and its German partner BioNTech is already authorized for emergency use in anyone older than 12 years in the United States, Canada and the European Union. They receive the same dose as adults: 30 micrograms.
Registration for children ages five to 11 for the new study began this week. Based on the safety, tolerability, and immune response generated by 144 children in a phase I two-dose stroke study, Pfizer said it will test a dose of 10 micrograms in children between five and 11 years of age, and 3 micrograms for the age group from six months to five years.
A Pfizer spokesman said the company expects data to be five to 11 years old in September and would likely ask regulators for emergency use authorization later that month. Data for children ages two to five could come soon after, he said.
Pfizer expects to have data from the six-month to two-year age group sometime in October or November.
Nearly seven million adolescents have received at least one dose of the vaccine in the United States, according to the Centers for Disease Control and Prevention (CDC).
Inoculation of children and young people is considered a critical step in achieving “band immunity” and taming the COVID-19 pandemic.
However, scientists in the United States and elsewhere are studying the possibility of a link between heart inflammation and mRNA vaccines, particularly in young people. The Pfizer and Moderna Inc vaccines are affected by mRNA.
The Israeli Minister of Health said last week that he had found the small number of cases of myocarditis observed mainly in young people who received the Pfizer vaccine here were probably linked to their vaccination. The houses were generally light and did not last long.
Pfizer said he is aware of Israeli observations of myocarditis and that a causal link has not been established with his vaccine.
On Tuesday, the European Union’s drug regulator said it expects to give a verdict on the use of Moderna’s COVID-19 vaccine in children aged 12 to 17 next month, after at the request of the pharmacist.
The two-dose vaccine is already used in the EU for people over 18 in many countries. The company has also sought approval in Canada for use in adolescents and plans for a US application.
If approved, the Modern vaccine will become the second blow released for use in adolescents in the EU after the Pfizer and BioNTech vaccine had the green light last month.
A committee of the European Medicines Agency (EMA) will speed up the evaluation of data submitted with the application, the regulator said, adding that a delay will occur if the EMA requests any additional information.