Pfizer and its German pharmaceutical partner BioNTech announced they are submitting a request to the U.S. Food and Drug Administration (FDA) to authorize extra-low doses of their COVID-19 vaccine for children 6 months through 4 years of age.
The FDA had urged Pfizer-BioNTech to apply for the Emergency Use Authorization (EUA) earlier than the companies had planned.
If the FDA grants the authorization, it would be the first COVID-19 vaccine for the age group in the United States. A decision is expected as soon as by the end of February.
The intended dosage of the jab for this age group is one-tenth of that given to adults (30 µg), and one-third of that given to children aged 5–11 (10 µg).
If the three-dose study is successful, the companies will seek FDA emergency authorization for a third dose for children aged 6 months to under 5 years old in the first half of 2022, Pfizer-BioNTech announced.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose," Albert Bourla, the CEO of Pfizer, said in a statement.
“These proteins often cause permanent damage in children’s critical organs, including their brain and nervous system, their heart and blood vessels, including blood clots, their reproductive system, and this vaccine can trigger fundamental changes to their immune system," he said.
The federal government has a countermeasures program that can compensate eligible persons who suffer serious injury from approved vaccines. But the burden of proof has proven a challenging process.