European regulators have pushed back formal assessments of the Pfizer/BioNTech and Moderna vaccines, delaying distribution of the jabs in EU countries to next year.
The European Medicines Agency said it plans to give an opinion on the Pfizer/BioNTech vaccine at a meeting on December 29, making distribution in member states, which will individually rubber stamp the Amsterdam-based regulator’s decision, unlikely until early January.
Member-state approval would come three to four days after the vaccine is approved by the EMA.
The regulator has pushed back the assessment of the rival Moderna vaccine to January 12. Both jabs were originally supposed to be assessed by the EMA on December 22, according to best-case scenario documents seen by the Financial Times.
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 Mainz-based BioNTech.
German officials were saying as recently as Sunday that distribution of the vaccine — which initial data found to be more than 95 per cent effective in thwarting Covid-19 — could come as early as the middle of December.
The AstraZeneca/Oxford jab would not be scrutinised before January, according to people briefed on the discussions.
Member state officials have been pressuring 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 the US Food and Drug Administration is expected to make a decision on vaccine approvals in mid-December.
The EMA said that 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.”