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Valneva SE has a vaccine that could be more resistant to strains and thus have an advantage over other vaccines in a possible annual vaccination campaign against a disease that has already claimed three million lives. The first participant in the three-phase clinical trials of this vaccine will be vaccinated this week. If these tests are successful, the vaccine can be approved as early as the fall.
The vaccine developed by Valneva is the only potential inactivated candidate vaccine against COVID-19 currently in clinical trials in Europe. Inactivated vaccines, a centuries-old method used to develop flu and polio vaccines, take a sample of the killed virus and are used to stimulate an immune response without causing infection.
If all other COVID-19 vaccines developed in the region focus on the viral needle protein, this vaccine could protect the human body from the strains and become a perfect booster against the virus.
The company has already agreed with the United Kingdom (UK) 190 million dollars. supply of vaccine doses. Kate Binham, former head of the UK Vaccine Task Force, says the vaccine could be used as a winter booster for older adults if the vaccine is successful.
“Being able to access a broader antigen spectrum from a full virus vaccine is really important,” he says. “Viruses are mutated, so having a broader immune response to a complete vaccine can provide long-term protection.”
The importance of healthcare in the postwar world is enormous. And Valneva, who has 100 million. The listing of US dollar denominated securities on the Nasdaq Stock Exchange is scheduled for this year and the financial interest is huge. The value of the agreement with the United Kingdom is 1,400 million. ($ 1.7 billion), more than ten times its annual revenue last year.
But the road to success is not easy. Due to the more complex production associated with inactivated virus technology, the Valneva pathway has been consistently longer than other vaccines, meaning that its advanced stage clinical trials in the UK begin at a time when more than half the country has already been vaccinated.
As a result, this vaccine is not being tested against an artificial placebo but against AstraZeneca Plc. And the Oxford University vaccine and should show an equivalent or higher antibody response.
“No development or development is possible without risk,” said Thomas Lingelbach, CEO of the company, who has no idea what the impact of the regulators’ decision would be if the vaccine turned out to be even slightly less effective than AstraZeneca. “I’ll be open to you, I don’t even want to think about a scenario like that.”
This is not the first time that a 57-year-old man has taken a risk.
In the summer of 2012, when he ran the Austrian biotech company Intercell AG, Th. Lingelbach met Franck Grimaud, CEO of the French company Vivalis, in one of Vienna’s oldest restaurants. Both businesses were going through tough times at the time, and a London banker offered the two men a meeting and to discuss a possible merger.
At the end of dinner at the Ofenloch restaurant, the two decided that, by joining forces, they could become a major vaccine specialty company focused on developing disease vaccines with limited preventive or therapeutic treatment options.
“One night we put everything together, all our strengths and weaknesses, and we considered why it would be appropriate to join us,” said Grimaud, who is currently president and director of business development at Valneva. “And we did what we talked about in that meeting.”
When a pandemic struck last year, the company had two traveler-approved preventive vaccines in its portfolio, one for Japanese encephalitis and the other for cholera. Two more vaccines, against Lyme disease and the mosquito-borne Chikungunya virus, have reached the clinical trial phase. As soon as it became clear that COVID-19 would not go away anytime soon, Valneva executives saw an opportunity to benefit from the company’s expertise.
The development of information RNA (mRNA) and adenovirus-based vaccines by Pfizer Inc., Moderna Inc. and the University of Oxford has created a gap in the inactivated vaccine method. In April 2020, with most of Europe living in quarantine and the infection rate growing rapidly, the company began work on the vaccine using its Japanese encephalitis vaccine platform.
The main idea was to develop “a complement to other vaccines, taking into account subpopulations: immunosuppressed people, pregnant women, children or, as we see a growing trend, the fact that inactivated vaccines could serve as a maintenance vaccine,” he said. . the 55-year-old A. Grimaud.
The UK very quickly agreed to buy the vaccine and invested in a Valneva manufacturing plant in Scotland. Human clinical trials began in December last year and positive data was received in April, with no safety concerns of more than 90%. significant levels of antibodies detected by the participants.
Another possible agreement with the European Commission (EC), in preparation from the third quarter of 2020, was completed in April this year. Currently, the company is focused on bilateral negotiations with individual EU countries.
Th. Lingelbach, without revealing details, alludes to the problems that European officials face with the United Kingdom as a consequence of the order of priority, a factor that has repeated the deal with the British from the beginning. According to the EC spokesperson, the Commission understands Valneva’s position and is consulting with the Member States on what action to take. The company did not meet certain conditions for the deal, he said.
“Although a lot of effort has been made, we have not made progress,” said Th. Lingelbach. “We keep going, wheels and wheels.”
The company also consulted with Australia and Canada about possible orders.
Other inactivated vaccines against COVID-19 have been developed outside of Europe. The Chinese companies Sinovac Biotech Ltd. and Sinopharm also use this method. Although the Sinovac vaccine initially reported around 50% efficacy rates, below other vaccines and at the minimum threshold set by regulators, more detailed actual data suggest that the rate may be higher, and inactivated vaccines have been reported to of Sinopharm are more than 70 percent effective.
In an ideal world, the Valneva vaccine would be tested against another inactivated vaccine, Th. Lingelbach said, but since there is no such vaccine approved in the West, AstraZeneca is the best comparable option. Some adjustments had to be made to take into account the different dosing schedules and age restrictions when administering AstraZeneca in the UK.
Hoping that this COVID vaccine will become a regular maintenance vaccine that ensures a stable income, the company also expects its Lyme disease and Chikungunya virus vaccines to be available around 2025, leading the company to the next league.
Valneva has hired hundreds of workers and plans to go from producing around 3 million vaccines a year to more than 100 million. vaccinations as early as next year, if this COVID vaccine meets expectations.
“Not everything is the way it used to be,” Grimaud said. This project “makes us wake up every morning, but sometimes we don’t let ourselves sleep through the night.”
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