By Jack Denton
The European Union drug regulator’s decision whether to approve two of the leading COVID-19 vaccine candidates won’t come for about a month, putting the 27 member countries of the bloc behind the U.S. and U.K. in mobilizing for widespread vaccinations.
The European Medicines Agency said on Tuesday that its formal assessment of the vaccine from drugmaker Pfizer /zigman2/quotes/202877789/composite PFE +0.19% and its partner BioNTech /zigman2/quotes/222361179/delayed XE:22UA -0.69% would come by Dec. 29, while the assessment for biotech company Moderna’s /zigman2/quotes/205619834/composite MRNA -1.47% vaccine will happen by Jan. 12.
These due dates represent a delay from the EU’s initial timeline, according to a report from the Financial Times, which said the bloc was supposed to assess both vaccines on Dec. 22.
On Monday, Moderna asked the EU to approve its vaccine for emergency use, after it was found in clinical studies to be more than 94% effective in preventing illness from COVID-19.
A wait of four to six weeks for an assessment in the EU means that countries like France, Germany, and Italy, which will have to individually approve any vaccine after the EMA’s ruling, likely won’t begin vaccinations until the beginning of January, at the earliest.
In the U.K., regulators are set to approve the Pfizer-BioNTech vaccine within days, according to media reports, with deliveries set to begin hours after approval and the first vaccinations to happen as early as Dec. 7.
The U.K. regulator, the Medicines and Healthcare products Regulatory Agency, previously said on Nov. 23 that a decision on the vaccine would be made in the “shortest time possible.”
The U.K. has ordered 40 million doses of the Pfizer-BioNTech vaccine, which was found in trials to have 95% efficacy in preventing COVID-19 in people over 65 years old.
The government has also asked the MHRA to review the vaccine in development from drugmaker AstraZeneca /zigman2/quotes/203048482/delayed UK:AZN +1.66% and the University of Oxford, which was found to be 70% effective in late-stage trials in the U.K. and Brazil.
In the U.S., the Food and Drug Administration has said it will meet on Dec. 10 to discuss whether the Pfizer-BioNTech vaccine should be authorized for use.
Moderna’s appeal to EU regulators was mirrored in the U.S., where the U.S. biotech company has asked the FDA for emergency approval.