Vaccine manufacturer Novavax is in the process of having conditional marketing authorisation reviewed by European authorities for its protein-based coronavirus vaccine that it is calling Nuvaxovid.
The European Medicines Agency (EMA) has started evaluating the company’s application and has said that the process is being fast-tracked because Novavax had already supplied information on its vaccine technology as a part of a rolling review process.
Conditional marketing authorisation is authorisation that is granted to a medication based on less data that would normally be required for approval on the basis that the benefits from a medication or therapy outweigh any risks.
A protein-based vaccine such as Nuvaxovid is one that has particles of protein that are like the spike protein found on the surface of the coronavirus and it contains a substance known as an ‘adjuvant’ that helps stimulate the immune system’s response to the vaccine.
“The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine,” the EMA said.
Data that has already been provided to the European medicines regulatory body includes material from laboratory studies, information on the quality of the vaccine and the manner of production as well as details of the efficacy of the vaccine that are available from clinical studies in adults.
“If EMA concludes that the benefits of Nuvaxovid outweigh its risks in protecting against COVID‑19, it will recommend granting a conditional marketing authorisation,” the EMA statement said.
“The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days.”
Stanley Erck, Novavax’s president and chief executive officer, said the EMA announcement represents a further step in the process to getting the vaccine out to market.
“Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program,” Erck said.