European regulators have pushed back formal safety assessments of the Pfizer/Biontech and Moderna vaccines, meaning vaccinations will not take place on the continent until next year.
The European Medicines Agency (EMA) today said it planned to decide on whether to approve the vaccine being developed by Pfizer and BioNTech by 29 December, meaning distribution will not start until 2021.
The EMA also said it does not plan on making a ruling on the Moderna vaccine until 12 January.
The news will come as a major blow to the EU’s hopes of a swift return to normality, placing the continent on the back foot in the race for a vaccine.
Both jabs were originally supposed to be assessed by the EMA on 22 December, while German officials said as recently as Sunday that the Pfizer vaccine could come as soon as mid-December.
The vaccines must be individually approved by each EU member state, which will come three to four days after the vaccines are approved by the EMA.
Pfizer and Biontech on Monday formally submitted their drug to the EMA for approval.
“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 Biontech co-founder Ugur Sahin.
Separately, the UK Medicines and Healthcare products Regulatory Agency could approve the Pfizer/Biontech vaccine as early as this week, making Britain the frontrunner in the global race for a full-scale vaccine rollout.
Meanwhile, the US Food and Drug Administration does not expect to make a decision on vaccine approvals until mid-December.
Last Friday, health secretary Matt Hancock asked regulators to begin to consider Astrazeneca’s vaccine for emergency approval, adding that the NHS was prepared to start vaccinating the public “by December”.
Speaking at the Downing Street press conference last night, Hancock said: “In the past fortnight we have made some really significant progress on vaccines and the NHS now stands ready to deploy a vaccine, should one be approved by the UK’s independent regulator.”
Nadhim Zahawi, the UK’s newly-appointed vaccine tsar, said yesterday that the NHS was “ready to go”.
“We’ve got to make sure that the regulator’s happy. And then we will begin almost immediately, because we’re ready from the NHS side,” Zahawi told the BBC.
The UK has spread its bets by ordering 357m doses of seven different vaccines.
Final results published yesterday from the trials of Moderna’s Covid-19 vaccine confirmed it has 94 per cent efficacy with no serious side effects, kickstarting the approval process with regulators around the world.
The UK has bought 7m doses of the vaccine, including a 5m dose agreement struck on the day Moderna announced its interim result of 94.5 per cent efficacy, and a further 2m last week.