Filenews 20 December 2021
The EMA recommended conditional marketing authorisation for the vaccine against Covid-19 of the company Novavax, Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 disease in people aged 18 years and older.
Nuvaxovid is the fifth vaccine recommended in the EU to prevent COVID-19. It is a protein-based vaccine that, together with the already licensed vaccines, will support vaccination campaigns in EU Member States during a critical phase of the pandemic.
After a thorough evaluation, the EMA's Committee for Medicinal Products for Human Use (CHMP) unanimously concluded that the data on the vaccine were robust and met EU criteria in terms of efficacy, safety and quality.
Results from two main clinical trials showed that Nuvaxovid was effective in preventing COVID-19 disease in people aged 18 years and older. More than 45,000 people participated in the studies. In the first study, about two-thirds of the participants received the vaccine and the rest received a placebo (a dummy injection). In the second study, participants were divided equally between the group of participants receiving the Nuvaxovid vaccine and the group of participants receiving placebo. Participants did not know if they had been given nuvaxovid vaccine or placebo.
The first study, conducted in Mexico and the United States, showed a decrease in the number of cases of developing symptomatic COVID-19 disease in people who received the Nuvaxovid vaccine (14 cases of 17,312 people) after 7 days after the second dose, compared to people who received the placebo (63 out of 8,140 people). This means that in this study the vaccine had an efficacy of 90.4%.
The second study conducted in the UK also showed a similar decrease in the number of cases of developing symptomatic COVID-19 disease in people who received the Nuvaxovid vaccine (10 cases out of 7,020 people) compared to people who received placebo (96 out of 7,019 people). In this study, the effectiveness of the vaccine was 89.7%.
Overall, the results of the two studies show that the effectiveness of the Nuvaxovid vaccine corresponds to about 90%. The original strain of SARS-CoV-2 and some variants of concern such as the Alpha variant and the Beta variant were the most common ionic strains released when studies were ongoing. At this stage there is limited data on the effectiveness of Nuvaxovid against other variants of concern, including the Omicron variant.
Side effects seen with Nuvaxovid in the studies were usually mild or moderate with remission within a few days after vaccination. The most common side effects were tenderness or pain at the injection site, fatigue, muscle pain, headache, general feeling unwell, joint pain and nausea or vomiting.
The safety and efficacy of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system as well as additional studies by the company and the European authorities.
Where to find more information
The product information for Nuvaxovid contains information for healthcare professionals, a package leaflet for the public and details of the conditions for authorisation of the vaccine.
The evaluation report detailing the EMA's assessment of Nuvaxovid and the full risk management plan will be made public shortly. The clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency's clinical trials website in due course.
More information is available in a review of the vaccine in a common language, including a description of the benefits and risks of the vaccine and why the EMA recommended its authorisation in the EU.
How Nuvaxovid works
Nuvaxovid works by preparing the body to defend itself against COVID-19 infection. The vaccine contains a laboratory version of a protein found on the surface of the SARS-CoV-2 virus (spike protein), . It also contains an "adjuvant", a substance that helps to enhance immune responses to the vaccine.
When a person receives the vaccine, their immune system will recognize the protein as foreign and produce natural defences — antibodies and T cells — against it. If, later, the vaccinated person comes into contact with the SARS-CoV-2 virus, his immune system will recognize the spike protein in the virus and will be ready for attack. Antibodies and cells of the immune system can protect against COVID-19 by killing the virus through synergy, preventing it from entering the body's cells and destroying infected cells.
Nuvaxovid is given as two injections, usually into the muscle of the upper arm, over a period of 3 weeks.
Conditional marketing authorisation
The European Commission will now speed up the decision-making process on the conditional marketing authorisation for Nuvaxovid, allowing this vaccine to be included in the vaccination programmes developed across the EU.
Conditional marketing authorisation (CMA) is used as a fast-track authorisation procedure to speed up the approval of treatments and vaccines during public health emergencies in the EU. CMAs allow the licensing of drugs that meet an unfulfilled medical need on the basis of less comprehensive data than is usually required. This is the case if the benefit of the immediate availability of a medicine or vaccine to patients outweighs the risks they suffer given the unavailability of all data in a timely manner.
A CMA guarantees that the approved medicine or vaccine meets the eu's strict standards of efficacy, safety and quality and is produced in approved, certified facilities according to high pharmaceutical standards for large-scale production.
Once the CMA has been administered, companies must provide further data from current or new studies within predetermined deadlines to confirm that the benefits continue to outweigh the risks.
Monitoring the safety of Nuvaxovid
According to the EU's safety monitoring plan for COVID-19 vaccines, the Nuvaxovid vaccine will be closely monitored and subject to various activities specific to COVID-19 vaccines. Although a large number of people have received COVID-19 vaccines in clinical trials, some side effects can only occur when millions of people are vaccinated.
Companies are required to provide monthly safety reports in addition to the regular updates required by law and to conduct studies to monitor the safety and efficacy of vaccines as they are used by the public. In addition, independent studies of COVID-19 vaccines coordinated by eu authorities will provide more information on the long-term safety and benefit of the vaccine to the general population.
These measures will allow regulators to quickly assess data derived from a range of different sources and take any necessary regulatory action to protect public health.
Evaluation of Nuvaxovid
During Nuvaxovid's assessment, the CHMP had the support of the EMA Safety Committee (PRAC), which assessed Nuvaxovid's risk management plan, as well as the COVID-19 EMA task force (COVID-ETF), a team that brings together experts from across the network of European regulators to facilitate swift and coordinated action on medicines and vaccines against COVID-19.
