Pfizer and BioNTech finalised their submission for vaccine approval to the European Medicines Agency on Monday
Pfizer and BioNTech finalised their submission for vaccine approval to the European Medicines Agency on Monday © BioNTech

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European regulators have pushed back formal assessments of the two most effective coronavirus vaccines, potentially delaying distribution of Pfizer/BioNTech and Moderna inoculations in EU countries to next year.

The European Medicines Agency said it planned to give an opinion on the Pfizer/BioNTech vaccine at a meeting on December 29. However, EU member states will still take several days to individually approve the regulator’s decision, meaning that distribution of the vaccine is unlikely until early January.

The regulator has also delayed assessing the rival Moderna vaccine until January 12. Both jabs were supposed to be assessed by the EMA on December 22, according to best-case scenario documents seen by the Financial Times.

Member state officials have been pressing the EMA to align itself with UK and US regulators. The UK Medicines and Healthcare products Regulatory Agency could approve the Pfizer/BioNTech vaccine as early as this week, while US regulators are due to rule this month on both the Moderna and Pfizer/BioNTech vaccines.

A panel of US experts will meet on December 10 to evaluate Pfizer’s application and a week later to discuss that made by Moderna. Their recommendations will then inform whether the Food and Drug Administration gives the green light.

If the US regulator does authorise one or both vaccines, the
developers say they are ready to start shipping within hours.
Public health experts say they still expect several million doses to
be available by the end of the year.

Pfizer and BioNTech on Monday finalised their submission to the EMA, which has been reviewing data from the companies’ large-scale clinical trial on a rolling basis since October.

“As a company located in the heart of Europe, [Monday’s] milestone is important to us as we continue to seek to enable a worldwide supply [of the vaccine],” said Ugur Sahin, co-founder and chief executive of BioNTech.

Having hinted a few days ago that Germany could start vaccinating people this month, Jens Spahn, health minister, damped those hopes on Tuesday, shifting the focus to 2021. “I assume that we can start vaccinating in January at the latest,” he said, in view of the current approval process.

The plan is for mobile teams to start giving people the inoculation in care homes and hospitals across Germany, he added. The broader population will get the shot only from the early summer. 

The AstraZeneca/Oxford jab would not be scrutinised before January, according to people briefed on the discussions.

The EMA said it would recommend granting a conditional marketing authorisation if it concluded “that the benefits of the vaccine outweigh its risks in protecting against Covid-19”.

“The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA member states within days.”

Additional reporting by Guy Chazan in Berlin and Kiran Stacey in Washington

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