Since the first marketing authorisations for the COVID vaccines (Pfizer/BioNTech’s Cominraty®and Moderna’s vaccine) were granted in December 2020 and early January 2021, much has been said about the approval process for these products.
In his presentation, Jordi Faus has set out the basic applicable principles to the process of approval of vaccines in accordance with European rules. The differences between compassionate use, use of medicines in emergency situations, and conditional marketing authorisations have been explained. With regard to the latter, it has been highlighted that European pharmaceutical law has foreseen this figure since 2006, that more than 30 conditional authorisations have been granted since then; and that only two of them have been cancelled (cancellations for commercial reasons, not related to their safety or effectiveness).
Jordi Faus has also explained the requirements and conditions applicable to this type of authorization and highlighted the effort made by the competent administrations in terms of information and transparency. The importance of keeping commercial agreements on the supply of vaccines confidential in order to favour the negotiating capacity of national health systems and therefore protect public interests has also been mentioned.
The presentation concluded by highlighting that authorisations for these products are commonly subject to variations that are also evaluated by regulatory authorities (such as the amendment of the Comirnaty® Technical data sheet to provide the administration of 6 doses in each vial); and encouraging caution in addressing second and third generation issues that will undoubtedly appear in the near future.