With the inactivated vaccine from Valneva, the EU medicines authority approved the sixth vaccine against the corona virus in the EU on Thursday.
Amsterdam – On Thursday (June 23), the European Medicines Agency EMA cleared the way for the sixth coronavirus vaccine in the European Union: the inactivated vaccine from the French-Austrian pharmaceutical company Valneva received a recommendation for people between 18 and 50 years of age. However, a deal with the European Commission almost fell through.
Coronavirus: why the Valneva vaccine almost never made it to market
Thomas Lingelbach, the head of Valneva, only had doubts about two weeks ago as to whether the pre-purchase agreement with the European Commission would last. Due to a delay in approval, the European Commission wanted to renegotiate the terms, but the Franco-Austrian group was unable to reduce the number of cans. Because the reduced quantities would not be sufficient “to ensure the sustainability of Valneva’s COVID-19 vaccine program,” said a press release. Valneva is the only medium-sized company in the Covid vaccine market, Lingelbach said in an interview Business Insider to consider.
On Thursday there was movement in the case, when the EMA gave the green light to the manufacturer’s inactivated vaccine. Now only the European Commission has to agree – but this is considered a formality. The EU Commission has already ordered 60 million doses. So far, five vaccines against Covid-19 have been approved in the EU: Biontech, Astrazeneca, Moderna, Johnson & Johnson and Novavax.
Corona vaccine Valneva uses similar technology as classic flu vaccines
The EMA had been reviewing all data from studies and trials on the vaccine, officially named VLA2001, since December. Valneva’s vaccine was approved in the UK in April. The preparation is given in two doses and is intended to help the body protect itself against infection with the virus. It is a so-called dead vaccine that contains inactive, i.e. dead, parts of the virus. People cannot become infected or become ill in this way, but the administration of the vaccine stimulates the formation of antibodies. The Valneva preparation thus uses a technology similar to that of classic flu vaccines.
After an in-depth review, EMA experts decided that the data on the vaccine was robust and met EU criteria on efficacy, safety and quality. However, there is currently too little data on the effect in people over 50 years of age. For this reason, the European Medicines Agency initially recommended VLA2001 only for people between 18 and 50 years of age. The extent to which Valneva’s vaccine is effective against the omicron variant was initially unclear due to the data available. The EMA describes the side effects as mild and short-term. These include pain at the injection site, fatigue, headache and muscle pain, and nausea. The agent can be stored at normal refrigerator temperatures, which means less logistical effort and is also an interesting alternative for poorer countries (AFP/dpa/bme).
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