On Monday 20 December, the European Commission granted a conditional market authorisation for Nuvaxovid (NVX-CoV2373), the Covid-19 vaccine developed by the US pharmaceutical company Novavax.
This market authorisation, approved by the EU27, was decided in accordance with the recommendations of the European Medicines Agency (EMA), which had been examining this protein-based vaccine for almost 11 months.
The agency confirmed that the data on Nuvaxovid, including from two phase 3 clinical trials, “were robust and met the EU criteria for efficacy, safety and quality”.
The two clinical trials involved 30,000 participants in the US and Mexico, and 15,000 participants in the UK. Their results, published in the New England Journal of Medicine (NEJM), revealed a vaccine efficacy of Nuvaxovid of approximately 90% against the original SARS-CoV-2 virus strain and the Alpha and Beta variants.
“There is currently little data on the efficacy of Nuvaxovid against other variants of concern, including Omicron”. the EMA said, noting that side effects (pain at the injection site, fatigue, headache, nausea) were “generally mild to moderate” and disappeared within two days of vaccination.
Initial doses expected to arrive in January
The vaccine will therefore be available to EU citizens over 18 years of age probably as early as next month.
An advance purchase agreement for 100 million doses of Nuvaxovid was concluded last summer between the European Commission and the manufacturer (see EUROPE 12774/7). The contract gives Member States the possibility to order an additional 100 million doses during the years 2022 and 2023.
“The initial doses are expected to arrive in Europe in January”, Novavax said in a statement on Monday. Some 27 million have so far been ordered by the EU27 for the first quarter of 2022, the Commission said.
New deliveries from Pfizer/BioNTech
In addition to these deliveries of Nuvaxovid, new deliveries of Comirnaty and Spikevax vaccines will be made.
The European Commission announced, on Sunday 19 December, that it had agreed with Pfizer/BioNTech to accelerate the delivery of its Covid-19 vaccine (Comirnaty) in the coming weeks: An additional 20 million doses are expected to reach the EU in the first quarter of 2022 (5 million in January, 5 million in February and 10 million in March).
The European institution and the EU27 also agreed to activate a first option for the purchase of 200 million new doses of Comirnaty - an option provided for in the third contract signed with the group.
“This order also covers vaccines adapted to the Omicron variant, should these vaccines become available”, the Commission said.
These various manoeuvres, it says, will bring the total number of shipments by Pfizer/BioNTech to 650 million doses in 2022, including 215 million in the first quarter. (Original version in French by Agathe Cherki)