European regulator begins assessment of Novavax’s coronavirus vaccine

The European Medicines Agency has received an application for conditional marketing authorization for the coronavirus vaccine developed by Novavax, the EU regulator announced today.

The shot is the first protein-based vaccine to be assessed by the EMA. The regulator said that it could come to a decision “within weeks” because it had already started a rolling review of the clinical data backing the vaccine in February this year.

Novavax submitted its authorization request in October to the U.K.’s regulator, the Medicines and Healthcare products Regulatory Agency. And, earlier this month, Indonesia became the first country to approve the vaccine.

Protein-based vaccines can be stored in a normal fridge, making them an alternative to more expensive shots that require ultra-cold chain storage and distribution. But the U.S. company has reportedly faced manufacturing difficulties, which have hampered its broader efforts to scale up production.

Source: Politico