Pfizer Inc (PFE.N) said Tuesday it would begin testing its COVID-19 vaccine on a larger group of children under the age of 12 after a lower dose of the shot was selected at an earlier stage in the study.
The study will include up to 4,500 children at more than 90 clinical centers in the United States, Finland, Poland and Spain, the company said.
Based on the safety, tolerability, and immune response generated by 144 children in a Phase I study of the two-dose shot, Pfizer said it was a dose of 10 micrograms in children between 5 and 11 years of age and 3 micrograms for those Age group from 6 months to 5.
A Pfizer spokesman said the company is expecting data from 5-11 year olds in September and will likely ask regulators for emergency clearance later this month. Data for children ages 2 to 5 could come in soon after, he said.
Pfizer expects to have data on the 6 months to 2 year age group sometime in October or November.
The vaccine – manufactured by Pfizer and its German partner BioNTech SA – is approved in Europe, the USA and Canada for use in children aged 12 and over. You will be given the same dose as adults: 30 micrograms.
According to the U.S. Centers for Disease Control and Prevention, nearly 7 million teenagers in the United States have received at least one dose of the vaccine.
Vaccinating children and adolescents is seen as a crucial step in achieving “herd immunity” and taming the COVID-19 pandemic.
Still, scientists in the United States and elsewhere are investigating the possibility of a link between heart inflammation and mRNA vaccines, particularly in young men. Both Pfizer and Moderna Inc. (MRNA.O) Vaccines are mRNA shots.
The Israeli Ministry of Health said last week it had determined that the low number of myocarditis cases seen mainly in young men receiving the Pfizer vaccine there was likely related to their vaccination. The cases were generally mild and did not last long.
Pfizer said he is aware of Israeli observations of myocarditis and that no causal link has been established with his vaccine.
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