European regulator to decide Dec. 29 on 1st virus vaccine
The European Medicines Agency will convene a meeting on Dec. 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 said Tuesday.
The agency also said Tuesday it could decide as early as Jan. 12 whether to approve a rival COVID-19 vaccine developed by Moderna Inc., said an AP report.
The German pharmaceutical company BioNTech and its U.S. partner Pfizer said earlier Tuesday 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 Oct. 6.
The move comes a day after rival Moderna said it was asking U.S. and European regulators to allow the use of its COVID-19 vaccine.
BioNTech said if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.T he companies said last month that clinical trials with 44,000 participants showed the vaccine is 95% effective. The efficacy rate in particularly vulnerable older age groups was more than 94%, they said.
In a statement, the EU medicines regulator said 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 said 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 Jan. 12.
BioNTech and Pfizer have already submitted a request for emergency approval with the U.S. Food and Drug Administration and the U.K. regulator MHRA, as well as rolling submissions in other countries including in Australia, Canada and Japan.
BioNTech said it stands ready to ship stockpiles of vaccines where they are needed when the Amsterdam-based agency or the FDA approve the vaccine.
The Commission, the EU’s executive arm, has secured deals allowing to purchase doses with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer and CureVac.