The EMA recommended the conditional marketing authorisation for Novavax's Covid-19 vaccine, Nuvaxovid (also known as NVX-CoV2373) for the prevention of COVID-19 in people aged 18 years and older.
Nuvaxovid is the fifth vaccine recommended in the EU for the prevention of COVID-19. It is a protein-based vaccine which, 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 for 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. A total of more than 45,000 people were enrolled in the studies. In the first study, about two-thirds of the participants received the vaccine and the rest received a placebo (placebo injection). In the second study, participants were equally divided between the group of participants who received the Nuvaxovid vaccine and the group of participants who received placebo. Participants did not know whether they had been given the Nuvaxovid vaccine or placebo.
The first study, conducted in Mexico and the United States, showed a rate of 90.4% reduction in the number of cases of COVID-19 symptomatic disease in people who received the Nuvaxovid vaccine (14 of 17,312 cases) 7 days after the second dose, compared to people who received placebo (63 of 8,140 cases). This means that in this study the vaccine had an efficacy of 90.4%.13]
The second study conducted in the UK also showed a similar reduction in the number of cases of COVID-19 symptomatic 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 efficacy of the vaccine was 89.7%. Overall, the results of the two studies show that the efficacy of the Nuvaxovid vaccine is approximately 90%. The original SARS-CoV-2 strain and some variants of concern such as the Alpha variant and Beta variant were the most common viral strains circulating when the studies were ongoing. At this stage there are limited data on the efficacy of Nuvaxovid against other variants of concern, including the Omicron variant.
Where to find more information
The product information for Nuvaxovid contains information for healthcare professionals, an instruction sheet for the public and details of the licensing conditions for the vaccine.The assessment report detailing the EMA's assessment of Nuvaxovid and the full risk management plan will be published shortly. The clinical trial data submitted by the company in the marketing authorisation application will be published on the Agency's clinical trials website in due course.More information is available in a plain language overview of the vaccine, including a description of the benefits and risks of the vaccine and why the EMA recommended its licensing 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 immune booster, a substance that helps boost immune responses to the vaccine.When a person receives the vaccine, their immune system will recognise 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, their immune system will recognize the spike protein in the virus and be ready to attack. The immune system's antibodies and cells can protect against COVID-19 disease 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 in the upper arm muscle, over a 3-week period.Conditional marketing authorisation
The European Commission will now speed up the process of deciding on the conditional marketing authorisation for Nuvaxovid, allowing this vaccine to be included in 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 for the authorisation of medicines that meet an unmet medical need on the basis of less comprehensive data than is normally required. This occurs if the benefit of immediate availability of a medicine or vaccine to patients outweighs the risks involved given the untimely availability of all data. A CMA guarantees that the authorised medicine or vaccine meets strict EU standards for efficacy, safety and quality and is produced in approved, certified facilities in accordance with high pharmaceutical standards for large-scale production. Once a CMA is granted, companies must provide further data to the EU. Although large numbers of people have received COVID-19 vaccines in clinical trials, some adverse reactions may only occur when millions of people are vaccinated.Companies are required to provide monthly safety reports in addition to regular updates required by law and to conduct studies to monitor the safety and effectiveness of the vaccines as they are used by the public. In addition, independent COVID-19 vaccine studies 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 from a range of different sources and take any necessary regulatory action to protect public health.
Evaluation of Nuvaxovid
In evaluating Nuvaxovid, the CHMP had the support of the EMA Safety Committee (PRAC), which evaluated the Nuvaxovid risk management plan, as well as the COVID-19 EMA task force (COVID-ETF), a group that brings together experts from across the network of European regulatory authorities to facilitate rapid and coordinated action on COVID-19 medicines and vaccines.
Cyprus Times
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