Nov 30 Reuters - The EU drug regulator said on Tuesday it could approve vaccines adapted to target the Omicron variant of the coronaviruses within three to four months, but existing shots would continue to provide protection.
According to the European Parliament, the European Medicines Agency EMA executive director Emer Cooke said it was not known if drugmakers would need to tweak their vaccines to protect against Omicron, but the European Medicines Agency preparing for that possibility.
She said that if we change the existing vaccines, we could be in a position to have those approved within three to four months.
Companies that adapt their formulations to include the new sequencing will have to show that the production system works and they will have to do some clinical trials to prove that this actually works in practice. The CEO of the drugmaker Moderna MRNA.O warned that existing vaccines are unlikely to be as effective against the Omicron variant first detected in southern Africa, as they have been against the Delta version. Cooke said that even if the new variant becomes more widespread, the vaccines we have will continue to provide protection.
The EMA issued new guidance to speed up the approval process for drugmakers that modify their COVID- 19 vaccines to protect against new variants in February. nL 4 N 2 KV 4 RC Omicron shares several key mutations with two previous variants, Beta and Gamma, which made them less vulnerable to vaccines. Omicron has 26 unique mutations, many of which are targeted by vaccine antibodies.