To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 16 November 2022 to Question 83513, which post-authorisation conditions relating to the conditional marketing authorisations of the Comirnaty products specified have been met; and if he will place in the Library a copy of the Marketing Authorisation together with the evidence that the conditions had been met.
This answer is the replacement for a previous holding answer.
Answered on
22 November 2022
The Commission on Human Medicines considered that, based on the large body of clinical data now available on these vaccines from clinical trials and real-world experience, the safety profile and efficacy of the products are now considered comprehensively characterised and meet the requirements for conversion to a full Marketing Authorisation and that the remaining conditions could therefore be downgraded to Risk Management Plan or Post-Authorisation Measures. On 9 November, the Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection line extension application was also licensed and has a full Marketing Authorisation.
The following table shows the cumulative conditions during the Conditional Marketing Authorisations.
Description | Due date |
1. In order to complete the characterisation of the active substance and finished product, the Marketing Authorisation Holder (MAH) should provide additional data. | July 2021 Interim reports: 31 March 2021 |
2. In order to ensure consistent product quality, the MAH should provide additional information to enhance the control strategy, including the active substance and finished product specifications. | July 2021. Interim reports: March 2021 |
3. In order to confirm the consistency of the finished product manufacturing process, the MAH should provide additional validation data. | March 2021 |
4. In order to confirm the purity profile and ensure comprehensive quality control and batch-to-batch consistency throughout the lifecycle of the finished product, the MAH should provide additional information about the synthetic process and control strategy for the excipient ALC-0315. | July 2021 Interim reports: January 2021, April 2021 |
5. In order to confirm the purity profile and ensure comprehensive quality control and batch-to-batch consistency throughout the lifecycle of the finished product, the MAH should provide additional information about the synthetic process and control strategy for the excipient ALC-0159. | July 2021 Interim reports: January 2021, April 2021 |
6. In order to confirm the efficacy and safety of Comirnaty, the MAH should submit the final Clinical Study Report for the randomized, placebo-controlled, observer-blind study C4591001. | December 2023 |
7. In order to confirm the safety of Comirnaty in individuals aged 12 to 15 years of age, the MAH should submit six-month safety follow-up data in subjects aged 12 to 15 years from study C4591001. | October 2021 |
8. In order to confirm the efficacy and safety of Comirnaty, the MAH should submit the final Clinical Study Report for the randomized, placebo-controlled, observer-blind study C4591007. | July 2024 |
9. In order to confirm the safety of Comirnaty in individuals aged 5-11 years of age, the MAH should submit 6-month safety follow-up data in subjects aged 5-11 years from study C4591007. | July 2022 |
By the conversion of the Conditional Marketing Authorisations to full Marketing Authorisations, these conditions were all met with the exception of ‘6’ and ‘8’, which were converted to Risk Management Plan measures. Condition ‘9’ was converted to a Post-Authorisation Measure with an extension until 31 December 2022 to submit the data.