BioNTech seek approval for COVID-19 vaccine in children aged 5-11
pharmafile | September 13, 2021 | News story | Sales and Marketing | COVID-19, FDA, Vaccine, children
Children between 5 and 11 years old are to be targeted by BioNTech as the company seeks approval for younger populations. The FDA have released a statement outlining their need to “follow the science” when approving the jab for children.
With almost 44 million people in the UK double vaccinated, Pfizer-BioNTech have announced that they will be applying for authorisation in paediatric populations.
Currently, only children ages 12 years and up are authorised to receive the Pfizer-BioNTech vaccine in the UK. Their COVID-19 vaccine COMIRNATY® has been given full FDA approval for those 16 years and older, but BioNTech have confirmed they are trialling on an even lower age bracket.
“In the coming weeks we will present the results of our study on the five to eleven-year-olds worldwide to the authorities and apply for approval of the vaccine for this age group, including here in Europe,” BioNTech Chief Physician Özlem Türeci told German news site Der Spiegel.
The FDA released a statement from Janet Woodcock, MD, Acting Commissioner of Food and Drugs and Peter Marks, MD, PhD, Director – Center for Biologics Evaluation and Research (CBER), regarding their requests to comment on the vaccination of young children: “It’s important that the public recognise that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population.
“Parents need to remember that the vaccine doses that are currently being studied in younger children are not necessarily the same vaccine doses that were authorized for individuals 12 years and older or approved for individuals 16 years of age and older – there are different dosing regimens being investigated.
“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible. We have to let the science and data guide us.”
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
