EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age.
Article continues below
Nuvaxovid is the fifth vaccine recommended in the EU for preventing COVID-19. It is a protein-based vaccine and, together with the already authorised vaccines, will support vaccination campaigns in EU Member States during a crucial phase of the pandemic.
After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.
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. ■
An upper level high pressure system is expected to continue aiding well above average and potentially dangerous temperatures throughout the West into the first full weekend of September.