Valneva: French company now announces delivery date for Europe – ahead of EMA approval.
In a booster study from December 2021* there was not as much positive to report as echo24.de* reported in detail. An omicron study has now been published on Valneva*. The manufacturer’s results once again bring decisive values to the effectiveness of the vaccine.
The French biotechnology company releases preliminary values from a laboratory study on Valneva vs Omicron on Wednesday, December 19. The inactivated vaccine* already showed good results* against Corona in study phase III. The manufacturer explained the new tests on its website: “Sera from 30 participants in the phase 1/2 study VLA2001-201 were used in a pseudovirus assay to determine the neutralization of the ancestral SARS-CoV-2 virus and the delta – and analyze Omicron variants.”
Valneva: The results of the Omicron study
The results give the experts hope for an adequate vaccine against the omicron. According to current results, Valneva is highly effective against this corona variant. The study explains: “All 30 samples (100%) had neutralizing antibodies against Ancestral virus and the Delta variant, and 26 samples (87%) had neutralizing antibodies against the Omicron variant. The average reduction in neutralization compared to parent virus was 2.7-fold for Delta and 16.7-fold for Omicron.”
Juan Carlos Jaramillo, MD, Valneva’s Chief Medical Officer, said optimistically in the statement, “We are extremely pleased with these results, which confirm the potential for broad-spectrum protection of our inactivated, adjuvanted, whole-virus vaccine and its ability to target variants of concern currently circulating to fight.”
Omicron study with Valneva: Three vaccine doses neutralize the virus
So, with this Omicron study by the French biotechnology company, it shows that three doses of Valneva vaccine could neutralize the Omicron variant. Juan Carlos Jaramillo: “These results complement previous findings from our phase 3 Cov-Compare study, which showed that two doses of VLA2001 administered as a primary series induce superior neutralizing antibody levels and a broad T-cell response .”
Valneva awaiting approval: Omicron study can help
Valneva is still awaiting approval in Europe. The European Medicines Agency (EMA) continues to examine the vaccine in the rolling review process*. The latest data is also forwarded to the relevant authorities in order to achieve rapid approval.
rolling review process
The Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Drugs, describes the rolling review process as follows:
The process serves to accelerate the path to COVID-19 vaccine approval by starting the evaluation of data packages from the non-clinical and clinical development of a vaccine candidate 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.
The French company also provided information about a fixed delivery date for Valneva in Europe. It says: “The delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the EMA.” * echo24.de is an offer from IPPEN.MEDIA.
List of rubrics: © dpa/ Artur Widak