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Valneva's inactivated COVID-19 vaccine candidate VLA2001 has been preliminarily evaluated by the European Committee for Medicinal Products for Human Use (CHMP)
.
Following the company's response, the European Medicines Agency (EMA) will provide an approval timeline
COVID-19 Management
Valneva expects to receive a positive recommendation from the CHMP for conditional approval of VLA2001 (primary immunization in adults 18 to 55 years of age) by the end of the first quarter of 2022
.
Following conditional approval, the company expects to ship to European countries early in the second quarter of this year
immunity
A randomized phase III trial comparing the vaccine candidates VLA2001 and AZD12221 showed that compared with AZD1222, patients in the VLA2001 arm had higher levels of neutralizing antibody titers and were generally well tolerated (significantly better than AZD1222)
.
VLA2001 is able to induce broad T cell responses against S, M and N proteins
A randomized phase III trial comparing the vaccine candidates VLA2001 and AZD12221 showed that compared with AZD1222, patients in the VLA2001 arm had higher levels of neutralizing antibody titers and were generally well tolerated (significantly better than AZD1222)
Thomas Lingelbach, CEO of Valneva, said: "We are satisfied with the initial assessment by CHMP and look forward to providing our response as soon as possible.
VLA2001 is the only inactivated COVID-19 vaccine in clinical development in Europe"
.
The vaccine is designed to actively immunize at-risk groups to prevent symptomatic infection with
COVID-19 .
It consists of SARS-CoV-2 inactivated whole virus particles with high S protein density combined with two adjuvants (alum and CpG 1018)
infection prevention
This combination has demonstrated high antibody levels in numerous preclinical experiments
.
It is expected to meet standard cold chain requirements (2 to 8 degrees Celsius) for easier distribution
Inactivated vaccines are made by inactivating or killing a disease-carrying virus or bacterium (or a very similar virus or bacterium) with chemicals, heat, or radiation
.
This approach uses technology that has been shown to work in humans to produce vaccines at a reasonable scale
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