Status: 26.08.2022 18:07
BioNTech and Pfizer have submitted their BA based on Omicron variants. 4 and BA.5 tailored corona vaccine in the EU. The vaccine is to be used as a booster from the age of 12.
The Mainz-based vaccine manufacturer BioNTech and its US partner Pfizer have applied for approval in the European Union of a corona vaccine tailored to the currently predominant omicron variants. The companies announced that a corresponding application for a booster dose for people aged twelve and over had been submitted in full to the EU medicines regulator EMA.
Vaccine against archetype and current subtypes
It is about a vaccine that should work against the original form of the corona virus and the currently dominant variants BA.4 and BA.5. According to the company, half of the vaccine candidate consists of the previous vaccine Comirnaty and the other half of a messenger molecule (mRNA) that is tailored to the spike protein of the subtypes. Except for this addition, all other components of the vaccine are unchanged.
Pre-clinical data showed that booster vaccination with the BA.4/5 matched agent elicited a “strong neutralizing antibody response” against these subtypes, as well as against subtypes BA.1/2 and the original wild-type strain.
EMA wants to decide at the beginning of September
In July, the two manufacturers applied for approval for the vaccine adapted to Omikron-BA.1. Both adapted vaccines could be available in the EU if approved in September, BioNTech said. The EMA recently announced that the responsible committee wants to decide on the applications from BioNTech/Pfizer and the US company Moderna for approval of their adapted vaccines on September 1st.