Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 November 2022 to Question 88800 on Coronavirus: Vaccination, for what reason the marketing authorisation holder did not submit the six month safety follow-up data in subjects aged between five and 11 years old from study C4591007 by July 2022 as required by condition nine; and whether an extension was granted following a request by the marketing authorisation holder.

Prior to the planned submission date, Pfizer-BioNTech advised the Medicines and Healthcare products Regulatory Agency (MHRA) that there had been delays in obtaining the data for the report and requested an extension. The MHRA assessed any potential risk to public health and considered the significant post-marketing safety data already available from the use of the Comirnaty vaccine in children, which did not indicate any new safety concerns in this age group. An extension was agreed and the MHRA continues to monitor the safety of Comirnaty in children and adults through its surveillance strategy and will act promptly to protect public health, should any new safety concerns arise.