Brussels (Brussels Morning) The European Commission has authorised its fifth COVID-19 vaccine – Nuvaxovid developed by the US biotech company Novavax. In a statement issued on Monday, the EC said that its authorisation is based on an assessment by the European Medicines Agency (EMA)’s and is supported by EU member states.
EC President Ursula von der Leyen noted “at a time where the Omicron variant is rapidly spreading, and where we need to step up vaccination and the administration of boosters, I am particularly pleased with today’s authorisation of the Novavax vaccine.” She welcomed “the fifth safe and effective vaccine of our vaccine portfolio”, which, she noted, offers “additional protection to the European citizen against the pandemic.” She hoped that the latest authorisation would persuade those who have not been vaccinated against COVID-19 to take action and do so.
Stella Kyriakidou, the European Commissioner for Health and Food Safety, reiterated that the vaccine is “safe and effective”, pointing out that it is the first protein-based vaccine that the EC approved. She asserted that vaccination is necessary to stop the spread of coronavirus, emphasising that the newly approved shots are safe and effective. Kyriakidou said her message to EU citizens was simple: “vaccinate, vaccinate, vaccinate.”
According to the EC’s deal with Novavax, the company will deliver up to 100 million of the new shots to the EU in the first quarter of next year. The agreement allows for the possibility of increasing the figure to 200 million shots up to the end of 2023. To date and overall, the EU, with its 450 million or so citizens, has ordered more than 3.6 billion COVID-19 shots.
Novavax first applied for approval of its vaccine in November. The EMA was able to approve it quickly because of having reviewed some of the data earlier as part of its rolling review process. After receiving the EC’s conditional marketing authorisation (CMA), manufacturers must provide additional data to confirm that the benefits of their products outweigh any risks that they might carry. CMA underpins the EU’s approach to mass vaccination push, having been put in place for public health emergencies. Unlike regular market authorisation, CMA is based on incomplete data, which is why manufacturers are required to provide additional evidence following initial approval.
