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

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The top of the EU’s drug regulator struck a reassuring tone following stories that the most recent coronavirus variant, named Omicron, had spread to many nations.

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

Cooke stated that laws have already been in place since February permitting vaccine makers to fast-track the approval process if modified coronavirus vaccines are wanted.

In any case, a careful assessment was wanted to say whether or not a modified vaccine was truly required for the new variant, specified Cooke. The massive number of mutations discovered in the Omicron variant — notably within the essential spike protein — have raised concerns that it'd be capable of bypass immunity granted by present vaccines.

“We now have contingency plans in place,” stated Cooke, who added that the agency was working with other regulators, in addition to with the World Health Organization and the European Centre for Disease Prevention and Control, to organize for any worst-case situations.

The EMA head added that compared to final winter the bloc was in a a lot better state of affairs, with “extra tools” in place.

She detailed how vaccines have been working — pointing to her house nation of Eire where 93 % of the adult inhabitants was immunized. COVID-19 deaths per million in Ireland stood at 15, versus the 250 per million registered in two unnamed EU nations with vaccination charges under 50 %.

Meanwhile, authorization of the Novavax vaccine might occur in a “matter of weeks,” stated Cooke, adding that the regulator was engaged on a technique for mix-and-match boosters that can be revealed soon, probably by the top of the week.

Cooke additionally stated that the EMA was working with member nations to offer them advice on emergency use of the brand new antiviral tablets developed by MSD and by Pfizer ahead of EU-level advertising authorization.

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