European Union drug regulators said Tuesday that they are ready to approve a new COVID-19 vaccine that targets the Omicron mutant within three to four months.
Emer Cooke, Executive Director of the European Medicines Agency (EMA), told the European Parliament that the EMA is being prepared if a pharmaceutical company needs to modify an existing COVID-19 vaccine to protect it from Omicron. ..
“If we need to change an existing vaccine, we may be able to get approval within 3-4 months,” Cooke said.
“Companies that adapt their prescriptions to include new sequences need to show that the production system works. Next, some clinical trials need to be done to confirm that it actually works. I have.”
In another statement, the EMA made it clear that reviews would begin when pharmaceutical companies determine that vaccine changes are needed and begin to work on them.
“We look forward to receiving a smaller (data) package that will reduce evaluation time,” said EMA, based on guidance from February on variant-specific vaccine upgrades.
The EMA guidance issued in February aimed to accelerate the approval process for pharmaceutical companies changing the COVID-19 vaccine against new variants.
Stephane Bancel, CEO of the pharmaceutical company Moderna, warning The existing vaccine may be less effective against the Omicron variant, as it was against the Delta variant, a comment that sent a shock wave to the financial markets on Tuesday.
“I think it’s going to be a material drop. I don’t know how much because I have to wait for the data. But all the scientists I talked to …” This is not good. It’s like “deaf”, “Bansel told the Financial Times.
As of Tuesday, 42 cases of Omicron variants have been identified in 10 of the 27 countries of the European Union, the EU’s public health agency. Said on Tuesday..
Cooke called on people to get the currently available approved vaccines and said they would continue to provide protection as new variants of Omicron become more prevalent.
Omicron has several mutations similar to the previous two variants (beta and gamma), making it less vulnerable to vaccines. In addition, Omicron has 26 unique mutations, many of which are in areas that appear to have been vulnerable to vaccine antibodies.
BioNTech SE Said on monday It is still unclear if the established COVID-19 vaccine needs to be remodeled, but research on vaccines targeting Omicron has begun.
Reuters contributed to this report.