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To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 November to Question 88800 on Coronavirus: Vaccination, if he will place in the Library a copy of the clinical data that has been submitted in relation to condition 7 in the table.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 November to Question 88800 on Coronavirus: Vaccination, if he will place in the Library a copy of the clinical data that has been submitted in relation to condition 7 in the table.
A copy of the table and documents that gives the clinical data which was submitted in relation to condition 7 will be deposited in the Libraries of both Houses.
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...
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 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.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he will make an assessment of the compatibility of the conditional marketing authorisation (CMA) for the Comirnaty vaccine with the requirement that such authorisations...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he will make an assessment of the compatibility of the conditional marketing authorisation (CMA) for the Comirnaty vaccine with the requirement that such authorisations...
The post-authorisation conditions relating to any Conditional Marketing Authorisations (CMA) are only removed from the licence once these conditions have been met and a full Marketing Authorisation (MA) could then be considered. Where clinical studies are continuing, companies will update to the regulatory authorities through post-authorisation measures.
As there are no further specific obligations, the status changed from CMA to MA for the following Comirnaty products on 9 November 2022:
- Comirnaty 30 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0002);
- Comirnaty 30 micrograms/dose Dispersion for Injection (PLGB 53632/0004); and
- Comirnaty 10 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0006).
To ask the Secretary of State for Health and Social Care, when the NHS was made aware of the findings disclosed in July 2021 by the US Food and Drugs Administration of a potential increase in four types of serious adverse events in elderly people who had had the Pfizer...
To ask the Secretary of State for Health and Social Care, when the NHS was made aware of the findings disclosed in July 2021 by the US Food and Drugs Administration of a potential increase in four types of serious adverse events in elderly people who had had the Pfizer...
Following its initial findings in June 2021, the FDA issued a subsequent statement confirming that after detailed analysis, these events were not found to occur more frequently in the elderly people who received the Pfizer COVID-19 vaccine.
To ask the Secretary of State for Health and Social Care, whether there is a deadline by which the Medicines and Healthcare products Regulatory Agency is required to convert the Conditional Marketing Authorisation for the Pfizer Covid-19 vaccine for use in adults into a Full Marketing Authorisation; and whether there...
To ask the Secretary of State for Health and Social Care, whether there is a deadline by which the Medicines and Healthcare products Regulatory Agency is required to convert the Conditional Marketing Authorisation for the Pfizer Covid-19 vaccine for use in adults into a Full Marketing Authorisation; and whether there...
In general, the Conditional Marketing Authorisation (CMA) is valid for one year, where the Medicines and Healthcare products Regulatory Agency will evaluate whether the company has addressed the post-authorisation measures and CMA commitments. If this has been sufficiently addressed, the CMA can be converted to a full Marketing Authorisation (MA).
Where commitments need to be addressed, the CMA may be extended for further year before the conversion to a full MA can take place. It is not expected that there will be any major implications for patients from a change in the status of the Comirnaty vaccine’s authorisation.