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Emergency authorisation for Pfizer/BioNTech vaccine expanded in the US

Data from a study involving 12 to 15 year olds has also been submitted to the EMA for potential approval

The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for Pfizer/BioNTech’s COVID-19 vaccine to include adolescents aged 12 to 15.

The new approval makes Pfizer/BioNTech’s COVID-19 vaccine the first to be authorised in the US for individuals in this age group.

Following the FDA’s decision to expand the EUA for the vaccine, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will convene to discuss the recommendations for use of the jab in this age group.

“[The] expansion of our EUA represents a significant step forward in helping the US government broaden its vaccination programme and help protect adolescents before the start of the next school year,” said Albert Bourla, chairman and chief executive officer of Pfizer.

“We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world,” he added.

The amended EUA is based on data from a phase 3 trial evaluating the vaccine in adolescents aged 12 to 15, both with or without prior evidence of SARS-CoV-2 infection.

In this age group, the vaccine demonstrated 100% efficacy and also produced robust antibody responses, which exceeded those recorded earlier in vaccinated participants aged 16 to 25.

The vaccine was also well tolerated, with side effects in this study found to be ‘generally consistent’ with those seen in participants aged 16 to 25.

Pfizer and BioNTech have also submitted the data from this trial to a number of additional global regulators, including the European Medicines Agency (EMA).

The companies have another study currently ongoing that is evaluating their COVID-19 vaccine in children aged six months to 11 years.

They expect to have definitive readouts from this study and, depending on the data generated, submit data for an EUA or variation to a conditional marketing authorisation for two cohorts – children aged two to five and aged five to 11 – in September.

In addition, Pfizer and BioNTech are hoping for a trial readout and submission for the cohort including children aged six months to two years in the fourth quarter of 2021.

Article by
Lucy Parsons

11th May 2021

From: Regulatory



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