EU’s drug regulator: ‘We know that viruses mutate, and we’re prepared’

The head of the EU’s drug regulator struck a reassuring tone following reports that the newest coronavirus variant, named Omicron, had spread to many countries.

“We know that viruses mutate, and we’re prepared,” said Emer Cooke, the executive director of the European Medicines Agency, said in testimony to the European Parliament’s health committee Tuesday.

FCooke said that regulations have already been in place since February allowing vaccine makers to fast-track the approval process if modified coronavirus vaccines are needed.

In any case, a careful assessment was needed to say whether a modified vaccine was actually required for the new variant, specified Cooke. The large number of mutations found in the Omicron variant — particularly in the crucial spike protein — have raised concerns that it might be able to bypass immunity granted by existing vaccines.

“We have contingency plans in place,” said Cooke, who added that the agency was working with other regulators, as well as with the World Health Organization and the European Centre for Disease Prevention and Control, to prepare for any worst-case scenarios.

The EMA head added that compared to last winter the bloc was in a much better situation, with “more tools” in place.

She detailed how vaccines were working — pointing to her home country of Ireland where 93 percent of the adult population was immunized. COVID-19 deaths per million in Ireland stood at 15, versus the 250 per million registered in two unnamed EU countries with vaccination rates below 50 percent.

Meanwhile, authorization of the Novavax vaccine could happen in a “matter of weeks,” said Cooke, adding that the regulator was working on a strategy for mix-and-match boosters that will be published soon, possibly by the end of the week.

Cooke also said that the EMA was working with member countries to provide them advice on emergency use of the new antiviral pills developed by Merck and by Pfizer ahead of EU-level marketing authorization.



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