Austria boss of Valneva sees “foot in the door” for more time-consuming development: Inactivated vaccine “VLA2001” could be approved in the second half of 2021.
In the race for Covid-19 vaccines, the biotech company Valneva, which has a large research site in Vienna, chose a special route. Behind the candidate name “VLA2001” is a vaccine that contains inactivated viruses. Valneva Austria boss Thomas Lingelbach told the APA that it was “deliberately chosen” that the classic approach would not be there for the first approvals. The long-term potential is still there.
Inactivated vaccines confront the body with viruses that have been rendered harmless. As a result, the body’s own defense system deals with the pathogen and develops the necessary protective immune response. This approach has been tried and tested for many decades. The French-Austrian vaccine company Valneva planned and carried out the clinical development of its candidate with inactivated coronaviruses in Vienna, as well as organized production and quality management. More than 200 of the approximately 600 international employees work in the federal capital.
After the start of the pandemic in March, the decision was made to take a different approach, Lingelbach said. Of the more than 150 vaccine projects worldwide, this is the only project in the EU and the USA in which the virus is administered as a whole in an inactivated state. “We knew from the start that we would be later with this approach because it would take longer to develop,” and the start-up of large-scale production also took longer than with some of the vaccines with novel approaches that are already at the door.
Higher security through killed viruses
The tried and tested technology can guarantee a high level of security. Since the body is presented with the entire killed virus, the immune system has to deal with all parts of the pathogen, which, after a booster vaccination, leads to a longer-lasting immunization of five to ten years, Lingelbach was convinced. In addition, it is to be expected that “special target groups” such as smaller children, people with compromised immune systems or pregnant women can be vaccinated without hesitation. These advantages could then come to the fore in the second wave of vaccines. In Austria, up to 20 percent of the population are seen as potential recipients of the vaccine.
A first clinical trial (phase I-II) in 150 healthy adults will start in the next two to three weeks in Great Britain, where the company also has production facilities. The results should be there in April 2021, when a large phase II-III study will start with over 3,000 participants to provide the necessary proof of safety. Approval could take place in the second half of 2021.
Great study in the UK
The major study will also take place in Great Britain, among others, where the company has signed a partnership with the government worth around 1.4 billion euros over 190 million vaccine doses. “The British government is taking on a significant risk investment”, which is a great advantage for a medium-sized pharmaceutical company, said the Valneva Austria boss. The first 60 million cans have to be delivered by the end of the next few years. Production takes place in Scotland and Sweden.
Talks are currently being held with the EU Commission, which handles purchasing for all member states centrally, for agreements on delivery towards the end of 2021 and beginning of 2022. Thanks to the strong location in Austria, you have “one step in the door”. Lingelbach was convinced that the Covid 19 problem will not be over with the first wave of vaccinations of the well-known “Frontrunner” vaccines: “We see our vaccine as complementary to it.”
Production possible in emerging countries
Since the vaccine is expected to have a long shelf life and standard cold chain storage at temperatures between two and eight degrees Celsius is sufficient, it is suitable for long-term programs. One currently reckons with a price of around eight euros per dose. For inactivated vaccines, for example, there are also many production capacities in emerging countries. Here the vaccine could perhaps also be produced locally in the future and used relatively easily.
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