The European Commission has granted conditional marketing authorisation for US biotech firm Novavax’s COVID-19 vaccine, Nuvaxovid, on Monday (20 December) following the European Medicines Agency (EMA) recommendation.
The President of the European Commission, Ursula von der Leyen, tweeted: “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”.
Results from two main clinical trials are promising for Novavax’s vaccine when fighting the original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta. Rates of 90% efficiency at preventing COVID-19 in people over 18 years of age were found in both studies.
But with the new variants, such as Omicron, its efficiency is unknown. The EMA’s press release states that “there is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron”.
Nuvaxovid is given as two injections, three weeks apart. Side effects reported in the studies were usually mild or moderate and cleared within a couple of days. Tenderness or pain at the injection site, tiredness, and muscle pain were among those most commonly reported.
The first protein-based vaccine in the EU
Health Commissioner Stella Kyriakides said that “this is our first protein-based vaccine, which shows promising results against COVID-19”.
This is a “much more traditional” vaccine platform, as Adam Finn of the European Technical Advisory Group of Experts on Immunisation (ETAGE) and chair of paediatrics at the University of Bristol, told EURACTIV.
“It’s a very well-established technology now. It’s been around for about 30 years. The most prominent example of this technique is the hepatitis B vaccine,” said Finn.
Protein-based vaccines have an advantage – they can be transported at higher temperatures than mRNA vaccines, reducing their cost while increasing accessibility.
Nuvaxovid works by preparing the body to defend itself against COVID-19. The vaccine contains a version of a protein found on the virus’s surface, which has been produced in the laboratory. When a person is given the vaccine, their immune system identifies the protein as foreign and builds natural defences against it.
Once the vaccinated person comes into contact with SARS-CoV-2, the immune system recognises the spike protein in the virus and is prepared to defend the organism.
The downside is that protein-based vaccines might be less adaptable, and it could take slightly longer to adjust them to new variants if needed, said Finn.
Finn said that in comparison, mRNA and adenoviral vector vaccines “reformulated slightly quicker, all you need is the genetic sequence to start doing that”.
Camilla Foged, professor at the University of Copenhagen, told EURACTIV in an interview that it will take longer to adapt protein-based vaccines to new various virus strains, “because you have to express a new protein”.
The Novavax vaccine will now be included in the Commission’s secured portfolio of vaccines produced in Europe. Other already-signed contracts include AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac, Moderna, and Valneva.
With conditional market authorisation, Novavax can deliver up to 100 million of their COVID-19 vaccines to the EU starting in the first quarter of 2022. The contract allows member states to purchase an additional 100 million doses throughout 2022 and 2023.
The first doses are expected to arrive in the first months of 2022, and for this first quarter, Member States have ordered around 27 million doses.
[Edited by Alice Taylor]