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Vaccine maker Valneva has initiated an accelerated process in the United Kingdom for its vaccine. The Austro-French company believes approval is possible this year.
The Austrian-French vaccine manufacturer Valneva on Monday initiated a so-called rolling approval procedure (“rolling review”) in the UK for the approval of its Corona vaccine candidate VLA2001. If the initial data from the currently ongoing Phase III trial are positive, the company believes initial approval will be granted before the end of 2021, the company said. Valneva is pursuing a classical approach with its Covid-19 vaccine using inactivated viruses.
Valneva developed dead agent
This approach has been proven for many decades. In this approach, the entire killed virus is presented to the body. Thus, the immune system has to deal with all parts of the pathogen.
In the accelerated rolling review process, experts at a regulatory agency evaluate the data even before the series of trials is completed and an official marketing authorization application is submitted. In the case of the Valneva vaccine, this is the British Medicines and Healthcare products Regulatory Agency (MHRA). The company expects the first meaningful study results at the beginning of the fourth quarter.
Valneva site also in Vienna
VLA2001 is currently the only inactivated adjuvanted whole virus vaccine candidate against Covid-19 from Europe, the company says. Production of the Covid-19 vaccine will take place in Scotland and filling in Sweden. At the Vienna site, Valneva conducts research and development as well as quality assurance.
The company has been working with the U.K. government since September of last year. The deal includes an option for the UK to buy up to 190 million doses by 2025. Accordingly, 100 million doses have been ordered so far for 2021 and 2022.
Possible candidate for routine vaccinations
In addition to its potential to combat the current pandemic, VLA2001 is also seen as a candidate for later routine vaccination or to combat new variants. The vaccine could also be of interest as a booster vaccine, with a clinical trial currently underway in the United Kingdom.
— source: vienna.at/picture: pixabay.com
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