The European Union could approve two coronavirus vaccines being tested by Pfizer-BioNTech and by Moderna before the end of next month, EU Commission president Ursula von der Leyen said Thursday.
Von der Leyen said the European Medicines Agency could give “conditional marketing authorisation… as early as the second half of December if all proceeds now without any problem”.
Working together, US giant Pfizer and Germany’s BioNTech have developed a vaccine the firms say has had successful clinical trials and have sent data to the EMA.
US biotech company Moderna has said its experimental vaccine is 95 percent effective.
The Amsterdam-based EMA will have to study test results before recommending that Brussels gives its approval, but — speaking after talks with EU leaders — von der Leyen was cautiously optimistic.
The European Union has contracts to reserve hundreds of millions of doses of future vaccines with BioNTech, Purevac, AstraZeneca and Sanofi if they can be brought to market.
“And we continue negotiations with Moderna, and we are in talks with Novavax,” von der Leyen said, adding that all 27 EU leaders had voiced support for the EU buying program.
She stressed that in the case of US firms, the EMA was in daily contact with its American equivalent the FDA.
“And if all proceeds with no problems. EMA tells us that the conditional marketing authorisation for BioNTech and Moderna could happen as early as the second half of December 2020.”
Earlier in the day, BioNTech co-founder Ugur Sahin told AFP that the firm was hoping for quick approval.
– Shipments delayed? –
“We are working at full speed,” he said, confirming the companies plan to apply for emergency use authorisation of their jab in the US on Friday, while European regulators will receive another batch of data “next week”.
“There is a chance that we can receive approval from the US or Europe or both regions this year still,” said Sahin, who is also BioNTech’s chief executive.
“We may even start delivering the vaccine in December,” he added, “if everyone works together very closely.”
But, earlier this week, Moderna CEO Stephane Bancel warned that protracted negotiations with Brussels over a contract to reserve his vaccine could delay shipments.
“It is clear that with a delay this is not going to limit the total amount but it is going to slow down delivery,” he told AFP, in an interview.
Pfizer/BioNTech and Moderna have taken the lead in the global chase for a vaccine, after large-scale trial data this month showed their jabs were around 95 percent effective against Covid-19.
The twin breakthroughs have lifted hopes for an end to a pandemic that has infected more than 56 million people and caused more than 1.3 million deaths worldwide since the virus first emerged in China late last year.