FDA provides EUA for Pfizer-BioNTech’s Covid-19 vaccine in children

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine for children aged 5 to 11 years.

The 10-µg vaccine doses are intended to be given twice  for this age group. The two doses are to be administered with 21 days apart.

This is claimed to be the first authorisation for Covid-19 vaccicoronane shot for children of this age group in the US.

Pfizer chairman and CEO Albert Bourla said: “This is a day so many parents, eager to protect their young children from this virus, have been waiting for.

“Over 6 million children in the U.S. have been diagnosed with Covid-19 since the start of this pandemic, and a high number of young people continue to be infected every week.

“With this FDA authorisation, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”

The FDA approval is based on data obtained from a randomised, controlled Phase II/III trial which saw participation of 4,500 subjects aged 5 to 11 years.

This trial showed that the vaccine had 90.7% vaccine efficacy rate in subjects, from one week right after receiving their second dose.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) also reviewed results of this trial.

As per the study’s Data Monitoring Committee review, no serious safety concerns related to this vaccine have been found.

BioNTech CEO and co-founder Ugur Sahin said: “Emergency use authorization is supported by clinical data showing a favourable safety profile and high vaccine efficacy in children, underlining its potential to address a current public health need.

“As children 5 through 11 get reacclimated to the new school year, both in and out of the classroom, our goal is to help keep them safe and protected and get them back to normalcy.”

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will recommend its usage to children aged 5 to 11 years.

The companies have also submitted applications to other regulators including the European Medicines Agency for the authorisation of their Covid-19 vaccine for this age group.