Biotech company Valneva can expect approval of its Covid-19 vaccine in the European Union after a long wait. The European Medicines Agency (EMA) gave the green light for the French-Austrian company’s vaccine on Thursday. The relevant committee recommended the vaccine for use as a primary vaccination in people aged 18 to 50 years. The final decision rests with the European Commission, whose approval is considered a formality.
In the European Union, it would be the sixth approved Covid 19 vaccine and the first so-called dead vaccine. The vaccine contains the inactivated SARS-CoV-2 virus and two enhancers. The mRNA vaccines from Biontech/Pfizer and Moderna, the two vector vaccines from AstraZeneca and Johnson & Johnson(J&J) and the protein-based vaccine from Novavax are already on the market.
Valneva recently questioned the future of its inactivated vaccine after the European Commission announced it might terminate the vaccine’s pre-purchase agreement due to delays in the approval process.
Valneva’s Covid vaccine VLA2001 is the only candidate whole-virus (“killed”) vaccine developed in Europe. Valneva follows an approach that has been tried and tested for many decades. All of the dead virus is presented to the body. Thus, the immune system has to deal with all parts of the pathogen. Production takes place in Scotland and Sweden, but according to the company, most of the development work was done via Vienna. VLA2001 has already been approved in Great Britain and Bahrain and since May 13 also in the United Arab Emirates.
The stock market traders also reacted immediately to the EMA’s approval recommendation for Valneva: the shares of the Austrian-French biotechnology group jumped in price by 21 percent on Thursday afternoon on the Euronext after a previous suspension of trading.
Meanwhile, the EMA has also recommended releasing Novavax’s vaccine from as young as 12 years old. The vaccine (Nuvaxovid) is also given to adolescents in two doses, about three weeks apart. According to the studies, it has an infection protection of about 80 percent. However, how strong it is in the very contagious omicron variant is unclear.
According to the EMA, a series of tests with around 2,200 12- to 17-year-olds showed that the vaccine was just as effective as in people aged 18 to 25. Side effects are mild in most cases: These include headaches and muscle pain, nausea and pain at the injection site. However, fever occurs more frequently in adolescents than in adults. But this only lasts a few days at most. The compound contains tiny particles of a lab-made version of the SARS-CoV-2 spike protein. They should ensure that the body itself stimulates the production of antibodies and T cells against the virus.