Chris Seeks Information On Coronavirus Clinical Trials
Christopher Chope Conservative, Christchurch
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 73786 on Coronavirus: Vaccination, which covid-19 booster vaccines have been subject to clinical trials; when did these trials (a) start and (b) finish; and whether the results of those trials were (i) scrutinised and (ii) approved.
Neil O'Brien The Parliamentary Under-Secretary for Health and Social Care
All approved COVID-19 booster vaccines have been trialled and assessed to ensure efficacy and safety for the public. Booster doses help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19. For the UK Autumn booster campaign, the Medicines and Healthcare products Regulatory Agency (MHRA) advises people to come forward for their booster vaccination when invited to do so.
There are 2 Phase 1/2/3 studies with Comirnaty:
- C4591001: Phase 1/2/3 study in younger than 12 years old: started initially in May 2020. Due to finish in December 2023
- C4591007: Phase 1/2/3 study in children (6 month to 12 years old): started initially early 2021. Due to finish in December 2024.
Both of these trials include booster studies. The adult study includes multiple booster studies, the first started in April 2021, some more recent data in Feb 2022. All the sub-studies will finish on the same date (Dec 2023).
The children booster study (5-12 year olds) started in January 2022. It will finish at the same date as the whole study (December 2024).
All studies have been evaluated and discussed at MHRA’s Expert Working Group and Commission for Human Medicines.
- ENDS -
To read the previous Written Question please CLICK HERE
#83516
