Regulatory approval of Pfizer/BioNTech vaccine for COVID-19, MHRA (updated 3rd December 2021)

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine. 3 December 2021The Pfizer/BioNTech vaccine (Comirnaty) Conditional Marketing Authorisation has been renewed: changes to the SmPC – section 9 and section 10. 15 November 2021Updated sections of the Summary of Product Characteristics and Patient Information Leaflet for COVID-19 Vaccine Pfizer/BioNTech (Conditional Marketing Authorisation documents) to include information about receiving a 3rd/booster dose. Also to in clude two new reagents, Sodium Hydroxide and Hydrochloric Acid, which are used in small quantities during the preparation of one of the solutions used in the manufacturing process. The official International non-proprietary name ' tozinameran ' has also been added.
Source: Current Awareness Service for Health (CASH) - Category: Consumer Health News Source Type: news