After excellent results in phases 1 and 2, this news is not the best for Valneva’s anti-Covid-19 vaccine. The Saint-Herblain (Loire-Atlantique) based biotech has announced to launch an additional phase 3 trial for its vaccine candidate on August 12, 2021.
Although the laboratory does not specify the reasons for this new study, it indicates that its objective is to “generate safety and immunogenicity data” in people over 56. In short, a way to verify that the vaccine is safe for this age group. The trial will take place in New Zealand, with approximately 150 candidates. They will be vaccinated twice, 28 days apart.
Read more about Valneva and its vaccine candidate against Covid-19 and find the latest financial news with the Born2Invest mobile app.
Adapting to variants
A second cohort of 600 people “older than 12 years” will join the study for additional data. The goal: to compare data from “the vaccine candidate derived from a Covid-19 variant” to the original vaccine. The strain has yet to be confirmed, the laboratory said.
The results of this second cohort are very important for the biotech, as they would confirm that Valneva’s platform is adaptable to different variants if needed. “We are working on the variants of concern as part of our ongoing efforts to stay ahead of the virus,” said Juan Carlos Jaramillo, head of medical research, in a statement.
A competitive vaccine
If VLA2001 (the name of the vaccine) emerges victorious from these trials and Phase III, it has a strong chance of creating a strong competitive position alongside Pfizer-BioNTech and Moderna. Indeed, in addition to a vaccine platform that can be adapted to variants, this vaccine has the advantage of using another technology that has been validated and accepted for a long time: the inactivated and adjuvanted virus.
Its principle is simple. It consists in killing the virus before injecting it into the patient. The inactivated and therefore harmless virus will need adjuvants to trigger the immune reaction. Valneva’s adjuvant is produced by the American company Dynavax. The combination of the inactivated virus and the adjuvant allows the immune system to be trained. To date, Valneva is the only European player to develop a vaccine of this type.
This alternative technology would allow many countries to complete their “vaccine portfolio”. The United Kingdom has already signed an agreement with the group for the supply of 100 million doses if phase 3 is positive. On the European side, Valneva has broken off negotiations with the European Commission, preferring bilateral discussions on a country-by-country basis. The company still has to validate phase 3 and its complementary studies, which would allow the expected launch of the first French vaccine at the end of 2021 / the beginning of 2022.
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First published in L’USINENOUVELLE, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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