The EU Could Approve a Vaccine against Omicron in 3-4 Months
The European drug regulator announced on Tuesday that it would approve vaccines adapted to Covid's new version, Omicron, within three to four months if necessary, but existing drugs would continue to provide protection, Reuters reported.
Speaking to the European Parliament, European Medicines Agency (EMA) Executive Director Emery Cook said it was not known whether drug manufacturers would have to change their vaccines to protect against Omicron, but the EMA was preparing for that possibility.
"If there was a need to change existing vaccines, we could be able to approve them within three to four months," she said. "Companies that adapt their wording to include the new sequence (...) will then have to show that the production system works, then they will have to do some clinical trials to find that it actually works in practice.“
The EMA clarified in a separate statement that the review will begin when drug manufacturers decide they need to change the vaccine and start working on it. "We expect to receive smaller packages (data) that will reduce the evaluation time," said the EMA, based on the guidelines in force since February for each update of a variant-specific vaccine.
Forty-two cases of the Covid-19 Omicron variant have been confirmed in 10 European Union countries, the head of the EU's public health agency said on Tuesday. But Cook has tried to reaffirm repeated calls for people to be vaccinated with approved products currently available. "Even if the new version becomes more widespread, the vaccines we have will continue to provide protection," Cook said.
Reiterating previous remarks by vaccine maker BioNTech, Cook said laboratory tests should show over the next two weeks whether the blood of vaccinated people has enough antibodies to neutralize the new variant.
In February, the EMA issued new guidelines to speed up the approval process for drug manufacturers modifying their Covid-19 vaccines to protect against new variants. Omicron shares several key mutations with two previous variants, Beta and Gamma, that make them less vulnerable to vaccines. In addition, Omicron has 26 unique mutations.
BioNTech SE, which is partnering with Pfizer, said that on Monday it has begun work on a version of its established vaccine for Covid-19 that is adapted to Omicron, although it is not yet clear if it is needed. Rival Moderna has also said it is working on redesigning its Covid-19 vaccine for future booster vaccines.
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