The Commission gave a conditional marketing authorisation (CMA) to the Novavax COVID vaccine, with 100 million doses expected in early 2022
The vaccine has been given approval, with 100 million doses expected for delivery to the EU in early 2022.
Stella Kyriakides, Commissioner for Health and Food Safety, said: “This is our first protein-based vaccine, which shows promising results against COVID-19. Vaccination and boosting to increase protection against COVID-19 is today more important than ever if we are to stem the wave of infections and counter the emergence and spread of new variants.”
In June, 2021, Novavax’s new COVID vaccine was found to have an efficacy of 93.2% against variants. At the time, that meant Delta, Alpha and Gamma – the three formerly most powerful variations of the virus. Now, the Novavax offering, known as Nuvaxovid, will have to handle Omicron too.
This vaccine is given three weeks apart.
The side effects of the new vaccine were usually mild or moderate and cleared within a couple of days after vaccination – with the most common ones being tenderness or pain at the injection site, tiredness, muscle pain, headache, a general feeling of being unwell, joint pain, and nausea or vomiting. This is relatively similar to existing mRNA vaccine side effects.
How does a protein vaccine work?
The Novavax vaccine, Nuvaxovid, works by teaching the body what the COVID spike protein looks like. A version of this spike protein is put into the body, not the one found in the virus, but a lab-manufactured edition of it.
The vaccine also has an ‘adjuvant’, which helps the immune system to have a stronger response to the virus.
The immune system is then able to recognise the spike protein on the virus when or if a person comes into contact with COVID-19. The virus can be stopped before it enters the cells of the body.
It is the first vaccine to be approved in the EU which works via protein, as opposed to the mRNA offerings of Pfizer or traditional vaccine tech of AstraZeneca.
“Welcome additional protection” says von der Leyen
Commission President, 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.”
The EU will be able to order an additional 100 million doses over the course of 2022 and 2023, on top of the expected 100 million doses in early 2022.
At the moment, Member States have ordered roughly 27 million doses of Novavax. They have the right to donate these to countries with low double-vaccination rates, but it is more likely that Novavax will be used as a booster.