|
 The study will enroll up to 4,500 children at more than 90 clinical
sites in the United States, Finland, Poland and Spain, the company
said.
Based on safety, tolerability and the immune response generated by
144 children in a phase I study of the two-dose shot, Pfizer said it
will test a dose of 10 micrograms in children between 5 and 11 years
of age, and 3 micrograms for the age group of 6 months to 5.
A Pfizer spokesperson said the company expects data from 5- to
11-year-olds in September and would likely ask regulators for
emergency use authorization later that month. Data for children 2 to
5 years old could arrive soon after that, he said.
Pfizer expects to have data from the 6-month to 2-year-old age group
sometime in October or November.
The vaccine - made by Pfizer and German partner BioNTech SA - has
been authorized for use in children as young as 12 in Europe, the
United States and Canada. They receive the same dose as adults: 30
micrograms.
Nearly 7 million teens have received at least one dose of the
vaccine in the United States, according to the U.S. Centers for
Disease Control and Prevention.
[to top of second column] |
 Inoculating children and young
people is considered a critical step toward
reaching "herd immunity" and taming the COVID-19
pandemic. Still, scientists in
the United States and elsewhere are studying the possibility of a
link between heart inflammation and mRNA vaccines, particularly in
young men. Both Pfizer and Moderna Inc's vaccines are mRNA shots.
Israel's Health Ministry said last week it had found the small
number of myocarditis cases observed mainly in young men who
received the Pfizer vaccine there were probably linked to their
vaccination. The cases were generally mild and did not last long.
Pfizer has said it is aware of the Israeli observations of
myocarditis and that no causal link to its vaccine has been
established.
(Reporting by Ankur Banerjee in Bengaluru and Michael Erman in New
York; Editing by Arun Koyyur, Will Dunham and Mark Heinrich)
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