EMA recommends Valneva’s Covid-19 vaccine for authorisation in EU

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Covid-19 Vaccine (inactivated, adjuvanted) Valneva for use in the primary vaccination of people from 18 to 50 years of age, the agency said on June 23.

Covid-19 Vaccine (inactivated, adjuvanted) Valneva contains inactivated (killed) whole particles of the original strain of SARS-CoV-2 that cannot cause disease, the EMA said.

It is the sixth vaccine recommended in the EU for protecting against Covid-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU member states during the pandemic, the agency said.

“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.”

The main study conducted with Valneva’s vaccine is an immunobridging trial.

Immunobridging trials compare the immune response induced by a new vaccine with that induced by an authorised comparator vaccine proven to be effective against the disease.

Results from the study, which involved nearly 3000 people aged 30 years and older, showed that the vaccine triggers the production of higher levels of antibodies against the original strain of SARS-CoV-2 than the comparator, Vaxzevria.

In addition, the proportion of people who produced a high level of antibodies was similar for both vaccines.

Additional data from this study also showed that the vaccine is as effective at triggering the production of antibodies in people aged between 18 and 29 as it is in people aged 30 years and older.

The CHMP concluded that Covid-19 Vaccine (inactivated, adjuvanted) Valneva is expected to be at least as effective as Vaxzevria at protecting against the disease.

Based on the data provided, it was not possible to draw any conclusion on the immunogenicity of Valneva’s vaccine (its ability to trigger the production of antibodies) in people above 50 years of age; therefore, the vaccine is currently recommended only for use in people between 18 and 50 years of age, the EMA said.

There are limited data on the immunogenicity of Covid-19 Vaccine (inactivated, adjuvanted) Valneva against variants of concern, including Omicron subvariants which are currently the dominant strains in many EU countries.

The side effects observed with Covid-19 Vaccine (inactivated, adjuvanted) Valneva in studies were usually mild and cleared within a couple of days after vaccination. The most common ones were tenderness or pain at the injection site, tiredness, headache, muscle pain and nausea (feeling sick) or vomiting.

The safety and effectiveness of the vaccine will continue to be monitored as the vaccine is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.

Based on the available evidence, the CHMP concluded that the benefits of Covid-19 Vaccine (inactivated, adjuvanted) Valneva outweigh its risks and recommended granting a standard marketing authorisation in the EU, the EMA said.

(Photo: Bulgaria’s Ministry of Health)

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