Science

Three Questions About the Announcement of “Positive” Results from the Valneva Vaccine Candidate

A new Covid-19 vaccine soon on the market? The French-Austrian laboratory Valneva communicated on Monday about the progress of its phase 3 trials for its candidate vaccine. Referring to the “initial positive” results, the company announced that “the trial met its two main endpoints.”

The vaccine developed by Valneva works with a so-called “inactivated virus” technology, more traditional than messenger RNA, and which is used in particular for influenza vaccines every year. The treatment works with infectious agents of the virus that are rendered harmless and capable of triggering the response of an individual’s immune system. It is the only vaccine developed in Europe that uses this technique.

By requiring two doses, “it should only require a standard cold chain,” said the company, which ranges from 2 to 8 degrees Celsius. “This is a much more traditional approach to vaccine manufacturing than the vaccines that have been rolled out so far in the UK, Europe and the US, and these results suggest that this vaccine candidate is in the works. play an important role in fighting the pandemic, “said Adam Finn, the trial’s principal investigator and professor of pediatrics at the University of Bristol, quoted in the company statement.

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Regarding its efficacy and safety, the results of the phase 1 and 2 trials, launched last December, are encouraging. In 90% of the participants, or 153 adults between the ages of 18 and 55, high levels of antibodies were observed. So far, the independent data monitoring committee has not raised any particular concerns. For phase 3, the trials were conducted in 4,012 adult participants, recruited from the UK: the candidate vaccine was “generally well tolerated”, the company states. What it adds: “The VLA2001 tolerance profile [le nom du vaccin Valneva, ndlr] it was statistically significantly more favorable compared to the other vaccine used in the trial. ”

  • Why is this Valneva ad important?

The announcement comes less than a month after the British government terminated a major contract for 100 million doses. With little explanation, the UK then used a clause in the contract to terminate it. British health authorities had “not approved the Valneva vaccine at the time,” according to a spokesman for the prime minister, Boris Johnson. This decision had precipitated the fall of the biotech title on the stock market, registering a decline of almost 40% shortly after the announcement of the United Kingdom. A blow for the company, which had already suffered the refusal of the European Union to authorize its vaccine in April.

On Monday, Valneva’s share rose 36.83% to 16.45 euros. A positive sign for this Franco-Austrian biotech based in Saint-Herblain, on the outskirts of Nantes (Loire-Atlantique), and employing around 600 people in six countries. “These are very satisfactory results, which come to reassure investors after the bad news last month,” said Pierre Michaud, portfolio manager at Monocle AM. After the fiasco of the French giant Sanofi in its race for the Covid-19 vaccine, Valneva’s encouraging results thus relaunch a French company in the global race for the vaccine.

  • What is the next step ?

After these “positive” results from the phase 3 trials, the vaccine must be registered with the competent health authorities. A procedure that the company wishes to initiate “as soon as possible”, declared Thomas Lingelbach, CEO of Valneva. Therefore, the laboratory indicates to have “initiated the gradual submission of the initial authorization request file to the British health agency (MHRA)”. A similar application to the European Medicines Agency (EMA) is also being prepared, the company says.

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In France, the government expects to commercialize this vaccine by the end of 2021. “The challenge is to put its vaccine on the market before the end of the year”, declared the Minister of Industry Agnès Pannier-Runacher, on Europe 1, September 21.

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Albert Moukheiber is a doctor of neuroscience and a clinical psychologist.  The author of Your Brain is playing tricks on you (Ediciones Allary).By Albert Moukheiber

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"Many industrial or other projects desired by the State run up against rigidities and rules, laws and regulations."Nicolas bouzou

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Robin Rivaton, essayist, member of the scientific council and evaluator of the Foundation for political innovation (Fondapol).By Robin Rivaton

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David Baverez is an investor, based in Hong Kong since 2011. He is the author of "China-Europe: the great turning point" (Le Passeur Editeur, 2021).By David Baverez

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