If authorised, the Pfizer-BioNTech Covid-19 vaccine would be the first Covid-19 vaccine available for paediatric populations aged below five years
Pfizer and BioNTech initiate rolling submission. (Credit: x3 from Pixabay.)
Pfizer and BioNTech have initiated a rolling submission to expand the emergency use authorisation (EUA) of their Covid-19 Vaccine to include children aged six months to four years.
The move follows the companies’ EUA submission with the US Food and Drug Administration (FDA) for their vaccine in children aged below five years.
The submission seeks authorisation of the first two 3µg doses of their planned three-dose primary series in this age group and is expected to complete in a few days.
Pfizer and BioNTech intend to submit the data on a third dose, which is expected in a few months, to support a potential expansion of the EUA.
In October last year, the vaccine was authorised in the US for use in children aged between five and 11 years. A booster dose was recently authorised in people aged 12 to 15 years.
Pfizer chairman and chief executive officer Albert Bourla said: “As hospitalizations of children under five due to Covid-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through four years of age to achieve high levels of protection against current and potential future variants.
“If two doses are authorised, parents will have the opportunity to begin a Covid-19 vaccination series for their children while awaiting potential authorisation of a third dose.”
According to Pfizer, more than 10.6 million children have tested positive for Covid-19 in the US, since the start of the pandemic.
In addition, the reported Covid-19 cases and related hospitalisation among children has significantly increased with the surge of the Omicron variant.
If authorised, Pfizer-BioNTech Covid-19 Vaccine would be the first vaccine to help protect children aged below five years, along with potential future emerging variants of concern.
The submission was based on data from the Phase 1/2/3 trial, which evaluated the safety, tolerability, immunogenicity, and efficacy of the first two doses of the vaccine in children.
Pfizer and BioNTech said that they will share the data with the European Medicines Agency and other regulatory agencies worldwide.
BioNTech CEO and co-founder Ugur Sahin said: “Our vaccine has already demonstrated a favourable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from five years old.
“If authorised, we are very excited about the prospect of offering parents the opportunity to help protect their children six months through four years of age from Covid-19 and the potentially severe consequences of infection.”