EU agency could approve vaccines in late December, early January

The European Medicines Agency will convene a meeting on December 29 to decide if there is enough data about the safety and efficacy of the COVID-19 vaccine developed by Pfizer and BioNTech for it to be approved, the regulator says.

The agency also says it could decide as early as January 12 whether to approve a rival COVID-19 vaccine developed by Moderna Inc.

The German pharmaceutical company BioNTech and its US partner Pfizer said earlier that they had asked the regulator for speeded-up, conditional approval of their coronavirus vaccine, concluding the rolling review process they initiated with the agency on October 6.

The move comes a day after rival Moderna said it was asking US and European regulators to allow the use of its COVID-19 vaccine.

BioNTech says if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.

In a statement, the EU medicines regulator says it had already begun a “rolling review” of the Moderna vaccine based on laboratory data previously submitted by the company and would now assess data on how well that vaccine triggers an immune response and whether it is safe enough for broad use across Europe.

The agency says that “if the data are robust enough to conclude on quality, safety and effectiveness,” then it could approve the Moderna vaccine at a meeting scheduled for January 12.

— AP