EU criticises ‘hasty’ UK approval of Covid-19 vaccine

The move to grant emergency authorisation to the Pfizer/BioNTech vaccine has been seen by many as a political coup for UK Prime Minister Boris Johnson, who has led his country out of the EU and faced criticism for his handling of the pandemic.

The decision was made under an ultra-fast, emergency approval process, which allowed the British drugs regulator to temporarily authorise the vaccine only 10 days after it began examining data from large-scale trials.

In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.

The agency said on Tuesday it would decide by Dec. 29 whether to provisionally authorise the vaccine from U.S. drugmaker Pfizer Inc and its German partner BioNTech.

A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.

Pfizer UK Country Manager Ben Osborn said, “We have provided complete data packages, the unblinded data, to both regulators. I think what you’re seeing is just the difference in the underlying process and timelines, as opposed to any difference in data submission.”

June Raine, the head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), said, “The way in which the MHRA has worked is equivalent to all international standards.

“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” she added.

The EMA started a rolling review of preliminary data from Pfizer trials on Oct. 6, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data.

The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA.

“The idea is not to be first but to have a safe and effective vaccine,” Germany’s Health Minister Jens Spahn told a news conference.

Asked about the emergency procedure used by Britain, he said EU countries had opted for a more thorough procedure to boost confidence in vaccines.

“If you evaluate only the partial data as they are doing they also take a minimum of risk,” the EMA’s former head Guido Rasi told an Italian radio.

“Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first,” he added.

EU lawmakers were even more explicit in their criticism of Britain’s move.

“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.

“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU Parliament.

Under EU rules, the Pfizer vaccine must be authorised by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use.

Britain is still subject to EU rules until it fully leaves the bloc at the end of the year.

“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the Parliament.

“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”

REUTERS