Chris Asks For Update On Post Authorisation Conditions For Comirnaty Products
Christopher Chope Conservative, Christchurch
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.
Neil O'Brien The Parliamentary Under-Secretary for Health and Social Care
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.
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.
- ENDS -
To read the previous Written Question please CLICK HERE
- ENDS -
#88800
