The European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine Nuvaxovid, developed by Novavax, the fifth COVID-19 vaccine authorised in the EU.
This is reported on the DW website.
This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.
The Commission signed the contract with Novavax on 4 August 2021. With the conditional market authorisation, Novavax will be able to deliver up to 100 million of their COVID-19 vaccine to the EU starting in the first quarter of 2022.
The contract allows Member States to purchase an additional 100 million doses over the course of 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.
This will add to the total amount of 2.4 billion of the vaccine by BioNTech/Pfizer, 460 million doses of the vaccine by Moderna, 400 million by AstraZeneca as well as 400 million doses by Janssen.
Results from two main clinical trials found that Nuvaxovid was effective at preventing COVID-19 in people from 18 years of age. The studies involved over 45,000 people in total. In the first study, around two thirds of participants received the vaccine and the others were given a placebo (dummy) injection; in the other study, participants were equally split between Nuvaxovid and placebo. People did not know if they had been given Nuvaxovid or placebo.
The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic COVID-19 cases from 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared with people given placebo (63 out of 8,140 people). This means that the vaccine had a 90.4% efficacy in this study.
The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic COVID-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared with people given placebo (96 out of 7,019 people); in this study, the vaccine efficacy was 89.7%.
Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.
The side effects observed with Nuvaxovid in the studies were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were tenderness or pain at the injection site, tiredness, muscle pain, headache, a general feeling of being unwell, joint pain, and nausea or vomiting.
The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.