8th Jun 2023

EU agency: 'Omicron vaccine' approval to take 3-4 months

  • Emer Cooke, executive director of the European Medicines Agency, urged those Europeans that are eligible to get booster Covid-19 shots (Photo: European Parliament)
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The chief of the EU medicines regulator has said the bloc could approve vaccines adapted to cover the new Omicron variant of the Covid-19 virus within three to four months, if needed.

Fears have been growing over whether current vaccines are effective against the emerging variant which has sparked fresh restrictive measures around Europe.

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"Were there a need to change the existing vaccines, we could be in a position to have those approved within three to four months," the European Medicines Agency's executive director, Emer Cooke, told MEPs on Tuesday (30 November).

"We know that viruses mutate, and we are prepared," Cooke said in the health committee.

However, Cooke added, a lot of the work will have to be done by companies, before regulators can prepare a stamp of approval.

"That is work the companies will do: adapting their formulations to include the new sequencing, will have to show that the production system works, do some clinical trail to prove that it actually works in practice, and change manufacturing accordingly," she said.

She echoed earlier statements by drugmakers that it would take around two weeks to know if the current Covid-19 vaccines would be able to target Omicron.

In February 2020 the EMA has put in place a system for companies to fast-track adaptation to vaccines.

Boosting boosters

Cooke also argued that fears around Omicron not being targeted by current vaccines should not dissuade people from getting the jab.

"It is very important that we continue to give the message that the current vaccines provide protection, and we need to ensure that those eligible get booster doses," she said.

Cooke said with the new variant boosters have become even more important.

She said that in her native Ireland, where the vaccination rate is 83 percent of the adult population, there have been 15 deaths per one million population in the last 14 days. In countries where the vaccination rate is lower than 50 percent, there had been over 250 deaths per one million.

The EU currently has authorised four different Covid-19 vaccines and four more are under review. Cooke said Novavax's vaccine could be authorised "within weeks".

The agency also plans to put out recommendations on the 'mix-and-match' booster strategies, "by the end of the week", she said, adding that studies show mixing vaccines is effective.

Cooke also shed some light on the human toll that EMA staff - who recently relocated from London to Amsterdam after Brexit - have been going through.

She warned there is an "increasing number of staff long-term sick leave", and is concerned with the health of her staff. "We definitely need help," Cooke said, adding that EMA "can't rest for a while".

44 cases

Meanwhile, the European Centre for Disease Prevention and Control (ECDC) said on Tuesday there are 44 confirmed cases of Omicron infections in 11 EU countries - Austria, Belgium, the Czech, Denmark, France (Reunion), Germany, Italy, the Netherlands, Portugal, Spain and Sweden.

The agency said the "majority of confirmed cases have a history of travel to African countries".

"All cases for which there is information available on severity were either asymptomatic or had mild symptoms," the ECDC said, adding that "so far, no severe cases or deaths have been reported among these cases".

The Dutch health authority on Tuesday said it had found the Omicron variant in two local cases almost two weeks before scientist in South Africa issued a warning about the new variant on 24 November.

The RIVM health institute said it found Omicron in samples dating from 19 and 23 November.

The Wall Street Journal has reported that the CEO of the vaccine-maker BioNTech, Ugur Sahin said the variant could lead to more infections but vaccinated people likely remain protected from severe disease.

However, another the CEO of another drug producer, Moderna's Stéphane Bancel, warned that existing vaccines were unlikely to be as effective against the Omicron variant, according to Reuters.

Both companies - BioNtech partnering with Pfizer - have said they had started work to redesign current vaccines to fit Omicron mutations.

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