A total of 10 200 doses of the Valneva vaccine against Covid-19 have been delivered to Bulgaria and by the end of the week, will be available at the regional health inspectorates, the Health Ministry said on October 31.
According to the European Medicines Agency (EMA), which in June 2022 recommended it for a conditional marketing authorisation in the EU, Valneva contains inactivated (killed) whole particles of the original strain of SARS-CoV-2 that cannot cause disease.
It was the sixth vaccine recommended in the EU for protecting against Covid-19.
The vaccine is administered for primary immunisation in people aged 18 to 50 years, and the schedule of vaccine administration is two doses, with an interval between doses of 28 days.
People wanting to receive the Valneva vaccine should contact their regional health inspectorates, the Health Ministry said.
The EMA, announcing its recommendation in June, said that 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 EMA’s human medicines committee 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.
The EMA said at the time that there was 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 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 EMA said.
(Photo: EC Audiovisual Service/Savo Prelevic)
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