The EMA is recommending a marketing authorisation for COVID-19 Valneva vaccine (inactivated, immune-enhanced vaccine) for use in the primary vaccination schedule in people aged 18 to 50 years.
COVID-19 Valneva (inactivated, immune-enhanced) vaccine contains inactivated (killed) whole particles of the original SARS-CoV-2 strain that cannot cause disease. It is the sixth vaccine recommended in the EU to protect against COVID-19 and, together with the already licensed vaccines, will support vaccination campaigns in EU Member States during 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 reliable and met EU criteria for efficacy, safety and quality.
The main study conducted with Valneva's vaccine is an immunografting trial. Immunografting trials compare the immune response elicited by a new vaccine to that elicited by a licensed comparator vaccine that has been shown to be effective against the disease.
The results of the study, which enrolled about 3,000 people aged 30 years and older, showed that the vaccine triggers the production of higher levels of antibodies against the original SARS-CoV-2 strain than the comparison vaccine, Vaxzevria. In addition, the proportion of subjects who produced a high level of antibodies was comparable for the two vaccines.
Additional data from this study also showed that the vaccine is equally effective in triggering antibody production in subjects aged 18 to 29 years as in subjects aged 30 years and older.
Therefore, the CHMP concluded that the COVID-19 Valneva vaccine (inactivated, immune-enhanced) is expected to be at least as effective as Vaxzevria in protecting against the disease. On the basis of the data submitted, no conclusion could be drawn on the immunogenicity of Valneva vaccine (its ability to induce the production of antibodies) in persons over 50 years of age. Therefore, the vaccine is currently only recommended for use in persons aged 18 to 50 years.
There are limited data on the immunogenicity of the COVID-19 Valneva vaccine (inactivated, immune-enhanced) against variants of concern, including the Omicron sub-variants that are currently the predominant strains in many EU countries.
Adverse reactions observed with COVID-19 Valneva (inactivated, immune-enhanced) vaccine in the studies were usually mild and resolved within two days after vaccination. The most common were tenderness or pain at the injection site, fatigue, headache, muscle pain and nausea (feeling sick) or vomiting.
The safety and efficacy of the vaccine will continue to be monitored as the vaccine is used throughout the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.
Based on the available data, the CHMP concluded that the benefits of COVID-19 Valneva vaccine (inactivated, immune-enhanced) outweigh the risks associated with it and recommended that a standard marketing authorisation be granted in the EU.
Standard marketing authorisation
The vaccine dossier includes the results of an immunografting trial. Although placebo-controlled efficacy trials have so far been the standard for the licensing of COVID-19 vaccines, the EMA considers that at this point in the pandemic, a well-justified and appropriately designed immunografting study is sufficient for the licensing of future COVID-19 vaccines. This is because there are now EU licensed vaccines against COVID-19 that have been shown to be safe and effective and can be used for comparison in studies. In addition, at present, it would be difficult to recruit enough people who have not been vaccinated or previously exposed to the virus to conduct large clinical efficacy trials.
The European Commission will now expedite the decision making process on the standard marketing authorisation for Valneva (inactivated, immune-enhanced COVID-19 vaccine), allowing for the inclusion of this vaccine in the vaccination programmes that have been developed across the EU.
A standard marketing authorisation is considered appropriate for this vaccine as the immunografting study met its objectives and the data submitted are considered adequate.
Where to find more information
The product information for COVID-19 Valneva vaccine (inactivated, immunoenhanced) contains information for healthcare professionals, a package leaflet for the public and details on the licensing of the vaccine.
The assessment report with details of the EMA assessment of COVID-19 (inactivated, immune-enhanced) Valneva vaccine 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 data website in due course.
More information is available in a plain language summary of the vaccine, including a description of the benefits and risks of the vaccine and the reasons why the EMA recommended its authorisation in the EU.
How the COVID-19 (inactivated, immune-enhanced) vaccine Valneva works
The COVID-19 vaccine Valneva (inactivated, immune-enhanced) works by preparing the body to defend itself against COVID-19 disease. The vaccine contains inactivated (killed) whole particles of the original SARS-CoV-2 strain that cannot cause the disease. It also contains two "immune enhancers", substances that help boost immune responses to the vaccine.
When a person is given the vaccine, their immune system recognises the inactivated virus as foreign and produces antibodies against it. If the vaccinated person later comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend against it.
The COVID-19 Valneva vaccine (inactivated, immune-enhanced) is administered in two injections, usually in the upper arm muscle, with a 28-day interval between doses.
Safety monitoring of COVID-19 (inactivated, immune-enhanced) Valneva vaccine
According to the EU safety monitoring plan for COVID-19 vaccines, COVID-19 Valneva vaccine (inactivated, immune-enhanced) will be closely monitored and will be subject to several activities specific to COVID-19 vaccines. Although a large number of individuals have received COVID-19 vaccines in clinical trials, certain adverse reactions may only occur after millions of individuals have been vaccinated.
In addition to the regular updates required by law, the company is required to submit monthly safety reports. In addition, independent studies on COVID-19 vaccines coordinated by the EU authorities will provide more information on the long-term safety and benefits of the vaccine in the general population.
(AF)
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