In conclusion, the observed safety profile is considered favourable. Longer term safety data is awaited
from the ongoing clinical trials.
There are very limited data on the use of the vaccine in immunocompromised individuals and on use in pregnancy and breastfeeding. No data was generated with mRNA-1273 when administered concomitantly with other vaccines.
The CHMP considers the following measures necessary to address the missing safety data in the
context of a conditional MA:
The final clinical study report will be submitted no later than December 2022 and is subject to a specific obligation laid down in the MA. This will provide long-term data.