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Valneva doses: pending approval in the EU
Photo: Henrik Montgomery / TT / IMAGO
After a long wait, biotech company Valneva can expect its Covid-19 vaccine to be approved in the European Union.
The European Medicines Agency Ema gave the go-ahead for the drug on Thursday.
The responsible committee of the Ema recommended the vaccine for use as a first vaccination in people aged 18 to 50 years.
The final decision rests with the European Commission, but its approval is considered a formality.
In the European Union it would be the sixth approved Covid 19 vaccine and a so-called dead vaccine.
The vaccine contains the inactivated Sars-CoV-2 virus and two enhancers.
According to the current definition, inactivated vaccines consist of either inactivated pathogens or pathogen components.
As Ema reports, the approval is essentially based on a study in which the Valneva preparation VLA2001 was compared with the vaccine from Astrazenca (Vaxzevria).
Almost 3,000 participants aged 30 and over received either two doses of Valneva or Vaxzevria.
Antibody levels against the original Sars-CoV-2 variant were later measured.
According to Ema, those vaccinated with the Valneva drug had higher levels of antibodies.
The vaccine was also tested in the study in 18- to 29-year-olds, where it stimulated antibody production to a similar extent.
Only recommended up to the age of 50
Because Ema believes that there is too little data for people over 50, it initially only recommends approval for the 18 to 50 age group.
There is only very limited data on how the vaccine works against new variants, such as Omikron, writes the Ema.
According to the agency, the side effects observed in the study were usually mild and subsided within a few days.
The most frequently reported were pain at the injection site, fatigue, headache and muscle pain, nausea and vomiting.
As with all newly developed vaccines, the safety of the vaccine must
continue to be examined, since the studies required for approval cannot make any reliable statements about possible very rare side effects.
Valneva recently questioned the future of its inactivated vaccine after the European Commission announced it might terminate the pre-purchase agreement due to delays in the approval process.
wbr/rtr