Vaccines – Vaccine maker Valneva plans to expand

Vaccines - Vaccine maker Valneva plans to expand

The woman behind the glass is guaranteed to breathe virus-free air. A respirator hood over his head protects him from the Sars-CoV-2 pathogen, which has claimed nearly 3.9 million lives since the outbreak of the pandemic a year and a half ago. You may only enter a Level 3 high-security laboratory with a protective suit, disposable gloves and rubber boots. The special filters ensure that no virus is released. Only a team of about 20 employees has access. You are in the middle of Vienna researching a vaccine against the coronavirus.

The woman carefully opens a refrigerator and takes out a container with red liquid. “It contains a nutrient medium for the virus,” says Michael Mohlen, vice president of technical development, Walneva Austria. About 10 crore viruses are stored in this laboratory. Viruses have to be “fed” with the nutrient medium day and night. Even on weekends.

104 Covid-19 Vaccines Are Loud World Health Organization WHO Vaccine candidate from Valneva is currently in clinical development including VLA2001. It is fundamentally different from previous mRNA and vector vaccines. Because the Franco-Austrian company relies on one of the oldest vaccine technologies: the dead vaccine. It contains inactivated whole Sars-CoV-2 virus particles and two so-called helpers, potentiators that enhance the immune response.

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Phase III studies in the UK have been underway since early June. The 4,000 study participants will receive either a vaccine from Valneva or a previously approved vaccine from AstraZeneca. “This is a comparative study. It means we show effectiveness indirectly,” says Thomas Lingelbach, CEO of Valneva. They want to be at least as good or better as the British-Swedish competitor’s vaccines. It is expected that the first data from the study will be available in September. It should be approved in Great Britain and the EU this year.

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The European Medicines Agency (EMA) has approved four vaccines so far. Billions of cans have already been vaccinated. Valneva is a few months behind other manufacturers. Lingelbach doesn’t see a problem with that. “Our vaccine is complementary. It can be used as a booster for children and people with immunodeficiencies.” Another target group is people who do not want to be vaccinated or who are skeptical about new mRNA vaccines. A dead vaccine may be an option for them. In addition, the side effect profile of dead vaccines is known.

Valneva plans to manufacture more than 150 million cans annually. “We cannot produce in large quantities as mRNA manufacturers,” says Wallneva’s CEO.

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Valneva began production of its vaccine in the first quarter. As production of the Covid-19 vaccine increased in many countries, the demand for special tubes and plastic bags exploded. There are only four to five manufacturers of these products worldwide. Preference was given to companies with mRNA vaccine. “We had a production deficit of more than 40 percent,” says Lingelbach.

Valneva produces the main active ingredient in Scotland, and bottling takes place in Sweden. To increase capacity, a new plant is being built at the Scottish location in Livingston for 100 million euros. Valneva bears one-third of the cost and the British government two-thirds. It has been funding vaccine development since September 2020 and will in return secure up to 190 million doses with a total value of 1.4 billion euros – if vaccine development is successful. “The British government invests in risk,” Lingelbach says.

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There were also talks with the European Union to buy the vaccine. However, they stopped in the spring. Valneva and the EU Commission could not come to an agreement. The pharmaceutical company then decided to negotiate bilaterally with EU countries. Austria announced that it would buy 1.2 million cans from Valneva.

Now, however, the negotiation process with the European Union is again gaining momentum. “We are at a very advanced stage with the EU regarding deliveries for 2022 and 2023,” Lingelbach says. How much dosage is involved has been a matter of conversation since then.

In Vienna, where the overall development is planned, implemented and controlled, the final product release testing also takes place. Of the more than 650 employees, 200 work at the Vallneva site in Vienna-Landstrasse.

There could be more soon. CEO Lingelbach plans to expand. “We have very little vaccine capacity in Europe. We are looking at doing something in Austria,” he says. Various locations in France, Sweden and Austria are currently being evaluated. For the “Wiener Zeitung,” says Lingelbach, “we have to expand the capabilities.” They work with contract manufacturers for a short time, but Lingelbach wants to do as much production in-house as possible. “Austria is definitely at the top of the list,” he says. A decision is yet to be made.

Economics Minister Margaret Schrambock (ÖVP) wants to give more support to the local pharmaceutical space and network it with each other. “We want to promote clinical studies further,” she says when visiting the Valneva laboratory. The funds are to be distributed through the EU programme.

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Valneva expects sales of 80 to 105 million euros this year. Sales with the vaccine VLA2001 have not yet been taken into account.

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