The European Commission granted approval to Novava under the brand name ‘Nuvaxovid’
The European Commission today, i.e., Tuesday, December 21, 2021, granted a Conditional Marketing Authorisation (CMA) to Novavax’s Coronavirus (COVId-19) vaccine, which will be sold under the brand, ‘Nuvaxovid’.
This is the 5th COVID-19 vaccine to be approved by European Medicines Agency (EMA), the medicine regulator of European Union (E.U.). The CMA was given after a thorough assessment of the safety, effectiveness and quality of the vaccine.
The vaccine has an efficacy of about 90%. There is limited data on its efficacy against the South Africa found Omicron variant. This is the first protein-based vaccine, which shows promising results against COVID-19. The European Commission signed the contract with Novavax on August 4, 2021.
Speaking on the occasion, the President of the European Commission – Ursula von der Leyen, said, “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. This is the fifth safe and effective vaccine of our vaccine portfolio, offering welcome additional protection to the European citizen against the pandemic. May this authorisation offer a strong encouragement to everyone who has not yet been vaccinated or boosted, that now is the time to do so.”
Taking it to twitter, Ursula tweeted,
We have now authorised the @Novavax vaccine.
— Ursula von der Leyen (@vonderleyen) December 20, 2021
With 5 approved vaccines, the EU has a varied portfolio, based both on novel technologies, such as mRNA, and classic ones, like Novavax, which is protein-based.
Vaccination, and boosters, are our best protection against COVID19.
Novavax will be delivering up to 100 million doses from the first quarter of 2022. Member States can purchase an additional 100 million doses over the course of 2022 and 2023. The first doses are expected to arrive in January 2022, For the first quarter of 2022, the Member States have ordered 27 million doses.
The European Commission has verified that all necessary elements such as scientific justifications, product information, educational material to healthcare professionals, labelling, obligations to marketing authorisation holders, conditions for use, etc. are clear and sound.
Prior to this, the E.U. has ordered 2.4 billion of the vaccine by BioNTech – Pfizer, 460 million doses of Moderna, 400 million doses of AstraZeneca and 400 million doses of Janssen.
Separately, the World Health Organization (WHO) has issued an emergency use listing to Novavax’s vaccine made by the Serum Institute of India (SII), the world’s biggest vaccine maker, paving the way for its use in low- and middle-income countries where rollout has been much slower than in Europe.
