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British-Swedish producer AstraZeneca has applied for conditional EU authorization of its COVID-19 vaccine, European Commission President Ursula von der Leyen said on Tuesday.
This would be the third vaccine to get the green light in the bloc, following approval of the vaccines produced by BioNTech/Pfizer and Moderna. It has already been approved for emergency use in Britain.
The announcement comes amid criticism of too-slow vaccine roll-outs across the bloc of nearly 450 million people, with either not enough jabs available or EU countries not administering the doses they have.
“Good news! AstraZeneca has applied to [the European Medicines Agency, EMA] to have its vaccine authorised in the EU,” von der Leyen tweeted.
“EMA will assess the vaccine’s safety and efficacy,” she says. “Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.” According to the EMA, an opinion on the conditional authorization could follow on January 29, provided that the data are sufficiently robust and complete.
Conditional market authorization is a fast-track procedure for emergencies that means that companies have to continue to provide additional data from ongoing studies within specific deadlines.
If the EMA issues a positive opinion, the European Commission still has to give its own approval - but this is largely seen a formality.
European Commissioner for Health Stella Kyriakides welcomed Tuesday’s announcement as a step forward in the EU’s efforts “to secure more safe and effective vaccines.” “An accelerated assessment of quality, safety and efficacy will follow,” she said.
The Oxford-developed vaccine can be stored at higher temperatures and is cheaper than the BioNTech/Pfizer and Moderna ones, but has a lower efficacy rate.
Once approved, it could be distributed across the bloc on a short notice: For both Moderna and BioNTech/Pfizer, it was a matter of days after they received the commission’s go-ahead.
Also on Tuesday, the commission concluded exploratory talks, which build the basis for a contract to be concluded at a later stage, with biotech company Valneva for 30 million doses, plus a potential additional 30 million doses.
In a debate with the European Parliament, the commission’s director-general for health and food safety Sandra Gallina said she expected sufficient vaccines to be available by April.
The parliament, meanwhile, criticized an alleged lack of transparency of the commission’s vaccine strategy, including negotiations with companies and specifics on delivery schedules.
But Gallina rejected the allegations, shifting the blame to companies.
“I hope that the companies will agree, little by little, to show all the contracts,” she said. “As commission, we have no problem with transparency.” The commission announced on Monday that parliamentarians could have access to the contract concluded with pharmaceutical company CureVac in a designated reading room.
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13/01/2021
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