New York, Jun. 17, (dpa/GNA) - The US Food and Drug Administration (FDA) has approved for emergency use the Covid-19 shot made by Pfizer/BioNTech as a three 3-microgram dose series for children between 6 months and 4 years of age, the companies said on Friday.
The emergency use authorization was based on data from a phase 2/3 randomized, controlled trial that included 4,526 children 6 months through 4 years of age, the companies stated.
During the trial, children received the third 3-micrograms dose at least two months after the second dose at a time when Omicron was the predominant variant of Covid-19.
Following the third dose in this age group, the vaccine was found to elicit a strong immune response, with a favourable safety profile similar to placebo.
The companies noted that they will begin shipping 3-micrograms paediatric doses as directed by the US government.
Eligible US residents will continue to receive the vaccine for free, consistent with the US government’s commitment to free access to Covid-19 vaccines.
The companies plan to submit requests for authorization of their Covid-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency (EMA) in early July.
The jab made my Pfizer/BioNTech is now authorized in the US for all individuals from the age of 6 months up.
GNA