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The EEA has indicated that it will hold a special meeting no later than December 29 to decide whether to grant a conditional marketing authorization for the vaccine being developed by BioNTech and Pfizer.
However, UK ministers in the former European Union said that Brexit had allowed them to approve the vaccine earlier than their European neighbors, as the British were no longer bound by the rules of the 27-nation bloc.
Until December 31, when the post-Brexit transition period expires, the UK still has EU rules on drug marketing, but the country has approved the vaccine under a provision of European law for emergencies.
“The EVA is of the opinion that a conditional marketing authorization (CMA) is the most appropriate control mechanism … in the context of the current pandemic,” the EVA said in an email to AFP.
In the event of a public health emergency, vaccine developers can apply to the EEA for a conditional marketing authorization to significantly speed up the process, which generally takes several years.
The EVA said this included a “vigorous, controlled” study of laboratory tests and data from large-scale clinical trials before making a final decision on whether to approve the vaccine.
“These are essential elements to ensure a high level of protection for citizens during the mass vaccination campaign,” said the EU Agency for Medicines.
The EVA was based in London until last year, but moved to Amsterdam when Britain withdrew from the EU.
EU ministers defended the EEA. German Health Minister Jens Spahn previously said: “The idea is not to be the first, but to have a safe and effective vaccine.”
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