Valnevy’s CEO explains why the dead-vaccine deal with the EU is in danger of collapsing


Valneva

The vaccine manufacturer Valneva has announced that it may have to terminate its contract with the European Commission to sell the entire viral vaccine.

Due to delays in vaccine approval, the Commission wants to drastically reduce shipments – which is out of the question for Valneva, CEO Thomas Lingelbach explained in an exclusive interview with Business Insider.

“We have already produced multiple doses of vaccines and face investment costs of more than EUR 100 million to further develop our vaccination program,” says the managing director. According to Business Insider, the amounts requested by the EU do not cover the costs.

Anyone who has not yet been vaccinated against the coronavirus can count on approval of an alternative to mRNA vaccines such as those from Biontech or Moderna. Even though the technology has proven safe, there are people who would prefer to wait for conventional vaccination. Such an alternative could be a vaccine from the French-Austrian company Valneva. Now, however, this plan is shaky.

On Friday evening, the company released a press release announcing that it was terminating an agreement with the EU to pre-sell the vaccine. Due to the delayed approval of the vaccine, the European Commission wants to adjust the purchase agreement and buy significantly fewer doses of the vaccine from the company. According to Business Insider, the quantities are to be reduced so that the costs are not even covered.

In an exclusive interview with Business Insider, Thomas Lingelbach, CEO of Valneva, explains the background of the announcement – and why he still hopes to get a deal.

Business Insider: Mr. Lingelbach, in your last press release, you threatened to terminate your pre-sale agreement with the European Commission. Why?

Tomasz Lingelbach: What to understand in this context: We are not a big pharmaceutical company like Pfizer. Valneva is the only mid-level company in the Covid vaccine market. We had an agreement with the European Commission that we would sell 24 million doses this year, with the option of further vaccinations next year.

We have already produced multiple doses of vaccines and we have over 100 million euros in capital investment ahead of us to further develop our vaccination program. As approval of our vaccine has been postponed by two months, the European Commission now wants to buy much less vaccine.

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BI: As far as we know, twelve million cans should go to Germany alone, now the EU wants it to be around a million.

Of course, I can’t say anything about the details, but there is enormity.

BI: You already mentioned that approval of the Valneva vaccine by the European Vaccine Commission was delayed by two months. This delay allowed the EU to adjust the purchase agreement in the first place. What are the reasons for the delay?

Lingelbach: We have submitted the exact same regulatory request to two regulators: the UK regulator and the European regulator. Our vaccine was approved in the UK on April 14, but it wasn’t enough for Europeans.

In March, we received a list of questions from the EMA, to which we quickly answered and sent. We were then expecting approval in April 2022. However, the EMA only reacted after eight weeks and presented another list of questions which we also answered. As a result, approval was postponed by two months to June 2022.

BI: In Germany, almost 76 percent of the total population has already been vaccinated. Do we need another vaccine at all?

LingelbachA: I understand countries have enough vaccines, but our vaccination has the key difference that it is a conventional whole virus vaccine. This type of vaccination has also been used for years in other vaccines, for example in vaccination against rabies.

Our market research shows that with our vaccinations, we can increase vaccination coverage by another one to two percent. Our conventional vaccine would also target those skeptical about mRNA vaccination. I think it would be a mistake not to get this option.

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BI: What are the benefits of your vaccine because the unit?

Lingelbach: In addition to providing an alternative for those who do not wish to be vaccinated with an mRNA vaccine, it can also help those who are already vaccinated. Various studies have shown that people who have been vaccinated and recovered have significantly higher protection against corona re-infection than those who have only been vaccinated.

Our vaccine is a so-called inactivated vaccine, which contains a complete, inactivated coronavirus. This means that the body simulates the infection without actually being infected. We expect the first results on compatibility with other vaccines this fall, so that our vaccine could possibly act as a booster for people who have already been vaccinated with mRNA.

Another advantage is the long and easy storage life. The cans can now be stored for 12 months, we plan to extend this even further. Inactivated vaccines can usually be stored in the refrigerator for up to 36 months.

BI: The incidence is now much lower than in fall or winter. Do you expect it to stay that way?

Lingelbach: I think there is another significant corona wave ahead of us. This is evident in the pace at which variants develop – another epidemic, in my opinion, cannot be prevented.

It should also be emphasized that we cannot prevent people from becoming infected even with vaccinations. However, vaccine protection reduces the risk of severe, life-threatening courses. Personally, I think this is our main goal. So we hope that we will nevertheless receive a significant mandate from the European Commission to continue supporting public health in Europe.

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