The Food and Drug Administration (FDA) have announced it won’t make a decision on whether to authorise a COVID-19 vaccine for children younger than 5 until data on a third dose becomes available.
The vaccine trial that commenced on 20th January, was designed to test the safety and efficacy of a lower dose of vaccine and was reported to include 3,900 children between the ages of 6 months and 4 years.
To understand if two doses would provide sufficient protection in children younger than 5, Pfizer and BioNTech have been testing two 3-microgram doses, a small fraction of the adult dose. Smaller doses are expected to trigger an equivalent immune response in children, indicating strong protection.
With the study advancing at a rapid pace, Pfizer and BioNTech will opt to wait for the three-dose data suggesting it may provide a higher level of protection in this age group.
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The Washington Post: Coronavirus vaccine for young children further delayed as FDA reverses course, says it will wait for data on three doses