The regulatory submission of Pfizer and BioNTech is based on data from the Phase 2/3 clinical study of their Comirnaty booster dose in children aged five to 11 years
The submission is based on Phase 2/3 study data. (Credit: Willfried Wende from Pixabay)
Pfizer and BioNTech have filed an application with the US Food and Drug Administration (FDA) seeking emergency use authorisation (EUA) for a 10µg booster dose of their Covid-19 vaccine in children aged five to 11 years.
Earlier this month, the companies unveiled positive safety, tolerability and immunogenicity results for the booster dose in this age group, from a Phase 2/3 clinical trial.
The data also showed that the third dose of Pfizer-BioNTech Covid-19 vaccine, marketed as Comirnaty, produced significant protection against the Omicron variant.
The regulatory submission of Pfizer and BioNTech is based on data from the Phase 2/3 clinical study of their Covid-19 vaccine booster dose in children aged five to 11 years.
In the Phase 2/3 study, the 10µg booster dose of Comirnaty vaccine has shown a strong immune response in children aged five to 11 years, with no new safety signals.
The two companies intend to submit the study data to the European Medicines Agency (EMA) and other regulatory agencies worldwide, for authorisation of Comirnaty booster dose.
In a separate development, Pfizer and Valneva have unveiled positive Phase 2 paediatric data for their Lyme disease vaccine candidate, VLA15.
In April 2020, Pfizer entered into a collaboration agreement with Valneva, a speciality vaccine company to jointly develop VLA15.
VLA15 is an investigational multivalent protein subunit vaccine currently under clinical development and is the only available vaccine candidate for Lyme disease.
The vaccine leverages an established mechanism of action that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease, said Pfizer.
Based on the positive study data, the two companies intend to continue the inclusion of paediatric participants in the planned Phase 3 trial.
The Phase 3 trial is designed to evaluate VLA15 in adults and paediatric patients aged five years and older, with plans to kick off in the third quarter of this year.
Valneva chief medical officer Juan Carlos Jaramillo said: “Lyme disease affects all age groups, but with their affinity for being active outdoors, the paediatric population is at the greatest risk of Lyme disease.
“These first paediatric results are therefore extremely important and support the inclusion of paediatric participants in our planned Phase 3 trial.
“In partnership with Pfizer, we are excited to further investigate our VLA15 vaccine candidate, which will hopefully help protect both adults and children against Lyme disease.”