NewsThat's what Valneva boss says about massive deviations in...

That's what Valneva boss says about massive deviations in two booster studies

Valneva comes up with different data for booster studies. CEO Lingelbach certainly sees a problem in the implementation.

Another vaccine, Valenva, is currently awaiting approval from the European Medicines Agency (EMA). In general, the vaccine from France is considered an inactivated vaccine. This makes it one of the hopes for vaccine skeptics. As * reported, Valneva boss Thomas Lingelbach of all people now classifies this categorization as wrong*. And the previous tests also raise questions. Although previous test series have yielded good data, there were extreme deviations in two booster studies. Lingelbach commented on this in an interview.

A booster study was published in mid-December 2021*, in which seven vaccines were examined with Astrazeneca, Biontech/Pfizer, Johnson & Johnson, Moderna, Novavax, Valneva and CureVac. The results were published in the oldest and most renowned medical journal The Lancet , among others.

Two booster studies of Valneva: different results

It was “a phase 2, multi-centre, randomized, controlled trial of third dose booster vaccination against COVID-19” . For the required values, the reactogenicity and immunogenicity of the seven vaccines listed were evaluated as the third dose after dual vaccination with AstraZeneca or Biontech. In data collected, Valneva was the worst performing inactivated whole virus vaccine with its booster effect.

reactogenicity and immunogenicity

Reactogenicity is defined as the ability to elicit reactions. It is about the expected vaccination reactions. Immunogenicity is the ability of an antigen to trigger an immune response (immunization, sensitization).

A little later, however, a message from the French biotechnology company followed, according to which positive data from the study phase III* could be added. In addition to Valneva, the manufacturer added an extended booster study to Omikron* in January.

Valneva boss sees problem with those responsible for the booster study

But why is it that the inactivated whole virus vaccine Valneva has such different results in the booster effect? In an interview with the news magazine Stern , the company’s CEO Thomas Lingelbach commented on the extreme deviations.

The Valenva boss sees a problem in those responsible for the booster study. Lingelbach: “The study was carried out by the British government and not by a classic clinical sponsor, which is why the study results are not suitable for applying for approval.” If you “want to have the label for a so-called heterologous booster,” he explains he says, you have to “generate your own data set as a company”.

Thomas Lingelbach: “With the study, the British government wanted to develop a vaccination strategy for the booster vaccination in older age groups for the winter of 2021/22.”

Different results for Valneva: study design not optimal

The CEO also explains the clear differences in the two booster studies on Valneva by the existing test structure: “The study setting was suboptimal for our vaccine in many respects.” Accordingly, the participants in the first study were on average 73.5 Year old. They were boosted about three months after the primary vaccination. Not the best period for Lingelbach: “A point in time when the booster did not make sense immunologically because the antibody levels were still very high.”

As the Valneva boss explains, their own study paid close attention to two essential things: “We have shown that participants who were given our vaccine and then boosted after six to eight months had a higher anti-level afterwards. “

Valenva booster study ongoing: Evaluation of tests with AstraZeneca

For the French biotechnology company, the development phases continue. The vaccine is still in the rolling review process of the EMA*. Data is therefore repeatedly supplied subsequently for approval. And that’s why the booster studies continue. Lingelbach: “In a second step, we are testing the immune reactions in people who have been primed with the active ingredient from AstraZeneca and then received the booster from Valneva. We are just generating this data record.”

rolling review

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, describes the rolling review process as follows: The process serves to speed up the process of COVID-19 vaccine approval by evaluating data packages from the non-clinical and clinical development of a vaccine candidate is already started before all the data required for a marketing authorization application has been collected. The formal application for approval can be made as soon as all the necessary data is available. Despite the acceleration, the requirements for quality, safety and effectiveness of the drugs concerned remain high.

In addition, a third step is to follow: The investigations are to be expanded again for the inactivated whole virus vaccine. Thomas Lingelbach explained to Stern that the test series would also be “carried out with mRNA-vaccinated or recovered people”. * is an offer from IPPEN.MEDIA.

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