Question to the Department of Health and Social Care:

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 will be any implications for patients from a change in the status of the authorisation.

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.