COVID-19 Vaccine Nuvaxovid is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission.
Nuvaxovid is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. Nuvaxovid contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein), which has been produced in the laboratory.
How is Nuvaxovid used?
Nuvaxovid is given as two injections, usually into the muscle of the upper arm, 3 weeks apart.
How does Nuvaxovid work?
Nuvaxovid works by preparing the body to defend itself against COVID-19. It contains a version of the spike protein that has been produced in the laboratory. It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.
When a person is given the vaccine, their immune system will identify the protein in the vaccine as foreign and produce natural defences — antibodies and T cells — against it.
If, later on, the vaccinated person comes into contact with SARS-CoV-2 virus, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.
What benefits of Nuvaxovid have been shown in studies?
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 placebo (a 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.