Valneva gives an update on the approval: When will the first real inactivated vaccine come to Germany?

Created: 04/23/2022, 04:50

By: Markus Hofstetter

Valneva's corona vaccine has received its first approval in Bahrain.

© Pavlo Gonchar/Imago

The vaccination campaign is faltering, despite Novavax.

Valneva's VLA2001 could be a turning point.

It is the only dead vaccine against Corona.

When will it be approved in the EU?

Update from March 12, 3:41 p.m .:

Valneva expects its corona vaccine to be approved by the EU in April.

The Franco-Austrian company expects the VLA2001 vaccine to immunize adults aged 18 to 55 to receive “conditional market approval” next month.

Valneva announced this on Friday (March 11).

Deliveries to European countries should then begin in the second quarter of 2022.

In October 2021, Valneva announced “positive” initial results from the phase 3 clinical trial of the vaccine.

In December, the European Medicines Agency (EMA) then initiated an accelerated approval process.

The EU Commission has already concluded a supply contract with Valneva

.

According to the company, the agreement provides for the delivery of up to 60 million corona vaccine doses in two years, 24.3 million of them in 2022.

Valneva approval in Germany: when will the inactivated corona vaccine reach us?

First report from March 8th:

Saint-Herblain - Valneva's corona vaccine recently received the first approval worldwide.

The French biotechnology company announced March 1 that VLA2001 had received an emergency permit in Bahrain.

The vaccine is scheduled to be delivered at the end of March.

According to Valneva, two doses are necessary for comprehensive protection against the corona virus*.

Valneva Corona vaccine: EU signs contract for up to 60 million doses

According to its own information, the European Medicines Agency (EMA)* started an examination of the study results for VLA2001 for the EU at the beginning of December 2021.

At the end of February, Valneva received an initial assessment from the authorities, including some questions.

The manufacturer is confident that it will be able to answer these questions satisfactorily by the end of the first quarter so that approval can be granted.

The first VLA2001 deliveries should therefore take place early in the second quarter of 2022.

Back in November 2021, Valneva and the EU signed a deal to supply up to 60 million cans*, of which just over 24 million could leave the factories later this year.

It is not yet known how many doses of this are planned in the event of approval for Germany.

Valneva Corona vaccine: VLA2001 only Covid-19 vaccine with inactivated whole viruses

What makes the Velneva product special?

VLA2001 is a vaccine containing inactivated whole viruses.

According to the manufacturer, this is a traditional process that has been tried and tested for decades.

VLA2001 is the only such vaccine being tested in clinical trials within the EU.

Nevertheless, Thomas Lingelbach, CEO of the company, does not call VLA2001 an inactivated vaccine: "Instead of inactivated vaccines, we should rather speak of inactivated whole virus vaccines." Because according to Lingelbach, other vaccines basically also contained dead components.

Valneva designates VLA2001 as a vaccine intended for the active immunization of at-risk populations to prevent transmission and symptomatic infection with Covid-19 during the pandemic.

However, it has the potential to also serve as a booster vaccination, “since it has been shown that repeated booster vaccinations with inactivated whole virus vaccines work well.” However, VLA2001 has not yet been approved for this purpose.

Corona vaccine from Valneva: VLA2001 triggers the body's own alarm system

How does VLA2001 work?

With the vaccine, the immune system independently builds up protection against the corona virus.

So-called adjuvants are added to this, which, according to the Federal Ministry of Education and Research (BMBF), can significantly increase immunization.

These "trigger the body's own 'alarm system' and thus fool the immune system into believing that pathogens have penetrated the body to a considerable extent".

The immune system reacts to the alarm with increased activity, including the proliferation of antibody-forming cells.

Valneva Corona Vaccine: High Efficacy Compared to Astrazeneca

Valneva determined its effectiveness in a comparative study with the vector vaccine from Astrazeneca*.

VLA2001 scored

a defensive reaction in 95 percent of all participants.

The concentration of the antibodies is even superior to that of the Astrazeneca vaccine.

A central question is whether VLA2001 protects people from the disease just as well as the previous Covid-19 vaccines*.

According to experts, this has not been proven.

“The Valneva vaccine was compared to the Astrazeneca vaccine.

The protective effect of the vector vaccine Astrazeneca is certainly lower than that of the mRNA vaccines," says Professor Christian Bogdan, member of the Standing Vaccination Committee (Stiko), in the

.

According to Valneva, VLA2001 also offers protection against the omicron variant.

In January, the company reported that three doses are highly effective against this corona variant.

Accordingly, 100 percent of the 30 tested serum samples showed neutralizing antibodies against the delta variant and 87 percent against the omicron variant.

Corona vaccine from Valneva: fewer side effects according to the study

According to the Valneva study, tolerability is also better than with Astrazeneca.

With VLA2001, there would be fewer reactions at the injection site and fewer systemic reactions in the body, such as fatigue.

Again, Bogdan disagrees.

Rare side effects* could not be ruled out with this study.

“Approximately 2000 people received the Valneva vaccine in the study.

On this basis, I cannot make any reliable statement about side effects that occur less frequently than 1 in 100. That is not statistically possible.”

Corona vaccine from Valneva: company boss advises against waiting for VLA2001

Anyone who is skeptical about the current corona vaccines should not wait for the availability of VLA2001.

They are "waiting for something that we definitely know less about than any other Covid-19 vaccine that has been in clinical use since the middle of last year," Bogan said in the

.

Personally, he doesn't believe in giving up vaccination now in order to wait for another type of Covid 19 vaccine.

The vaccines that are currently available are very safe and effective, particularly in protecting against serious illness, hospitalization and death.

In December 2021, Valneva boss Lingelbach made a similar statement to the news magazine

: “I don’t advise anyone to wait for our vaccine.

That would be ethically unacceptable.” He is currently recommending vaccines from other manufacturers to relatives and acquaintances.