THE EUROPEAN Medical Agency has approved use of the Covid-19 vaccine from US-based Novavax in people 18 years and older, making it the fifth coronavirus vaccine that can be used in the region.
The protein-based vaccine, of the kind used around the world to protect against many childhood illnesses, uses a more conventional technology.
"After a thorough evaluation, EMA’s human medicines committee concluded that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality," a statement said.
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.
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%.
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.
Nuvaxovid is given as two injections, usually into the muscle of the upper arm, 3 weeks apart.
Novavax and the EU reached a preliminary deal in December 2020 for the supply of the vaccine, but due to regulatory and production issues the final contract for up to 200 million doses was only signed in August.
The company said it would start shipping vaccines to the EU's 27 member states in January.
European Commissioner for Health and Food Safety Stella Kyriakides tweeted to say the approval of the vaccine "expands our portfolio of safe and effective vaccines, as vaccination and booster efforts continue to counteract the virus and its variants."
A decision on its use by the European Commission is to follow shortly.
Important #COVID19 vaccine news ▶️ the European Medicines Agency has recommended a conditional marketing authorisation for the #Novavax vaccine, based on a thorough safety and efficacy assessment.
👉@EU_Commission decision to follow. https://t.co/D0JSQOvlyg— Stella Kyriakides (@SKyriakidesEU) December 20, 2021
