logo
Plus   Neg
Share
Email

EMA Receives CMA Application For BioNTech/Pfizer And Moderna COVID-19 Vaccines

European Medicines Agency said in a statement that it has received applications for conditional marketing authorization or CMA from BioNTech/Pfizer and Moderna for their Covid-19 vaccines.

The Agency also said its human medicines committee or CHMP has scheduled extraordinary meetings to conclude the evaluation.

The EMA said if there is enough data, CHMP will complete its assessment of the BioNTech/Pfizer vaccine by December 29, and the Moderna vaccine by January 12.

Pfizer and BioNTech, on November 20, submitted a request to the U.S. FDA for Emergency Use Authorization for their mRNA-based COVID-19 vaccine candidate, BNT162b2. Their request is scheduled to be reviewed by the FDA's Vaccines and Related Biological Products Advisory Committee on December 10.

BNT162b2 has demonstrated an efficacy of 95 percent in preventing COVID-19 in a phase III study.

In addition to the submissions to EMA, FDA, and U.K. MHRA, Pfizer and BioNTech have also initiated additional rolling submissions in various countries including Australia, Canada, and Japan. The companies also plan to submit applications to other regulatory agencies around the world.

Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses of BNT162b2 in 2020 and up to 1.3 billion doses by the end of 2021.

Among the peers, Moderna, on Monday, submitted a request to the FDA for Emergency Use Authorization of its COVID-19 vaccine candidate mRNA-1273, and also filed an application for CMA with the European Medicines Agency. In a phase III study, the vaccine candidate has demonstrated the efficacy of 94.5 percent in preventing COVID-19.

For comments and feedback contact: editorial@rttnews.com

Health News

Follow RTT