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EU agency insists it has the 'most appropriate' vaccine regulation process after UK approves Pfizer jab

The UK formally approved the vaccine yesterday.

Image: DPA/PA Images

THE EUROPEAN MEDICINES Agency (EMA) has insisted it has the “most appropriate” method to approve a Covid-19 vaccine, following the UK’s announcement yesterday that it has approved a jab from Pfizer/BioNTech.

The EU regulator says it will hold a special meeting by 29 December at the latest to decide on whether to grant conditional approval for the vaccine.

However, ministers in the UK claimed Brexit had allowed them to adopt the jab ahead of their European neighbours by freeing it from the union’s rules.

Britain is still under EU drug marketing rules until 31 December, the end of a post-Brexit transition period, but has approved the vaccine under an emergency provision under European law.

“EMA considers that the conditional marketing authorisation is the most appropriate regulatory mechanism for use in the current pandemic emergency,” the agency said in a statement.

During public health emergencies, vaccine developers can ask the EMA for a conditional marketing authorisation to drastically speed up a process that normally takes years.

The EU watchdog said this involved a “controlled and robust framework” of studying data from lab studies and large clinical trials, before finally deciding whether to approve the vaccine.

“These are essential elements to ensure a high level of protection to citizens during the course of a mass vaccination campaign,” it said.

The EMA was located in London until last year, but moved to Amsterdam as part of Britain’s slow divorce from the European Union.

EU ministers earlier defended the EMA, with German Health Minister Jens Spahn saying: “The idea is not to be first, but to have a safe and efficient vaccine.”

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However, the UK’s medicines watchdog defended the country’s approval process. 

“Everybody can be confident that no corners whatsoever have been cut,” said Medicines and Healthcare products Regulatory Agency (MHRA) chief executive June Raine.

“The public deserve nothing less.”

© AFP 2020

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