The Human Medicines Committee (CHMP) of the EMA (the European Medicines Agency) has launched an evaluation that starts the rapid process of approval from a new VACID vaccine, VLA2001, developed by Valneva, a French biotechnology company.
The decision is based on the preliminary results of laboratory studies and the first phase 3 clinical trials in adults.
This research suggests that the vaccine triggers the production of antibodies that are directed to SARS-COV-2 to a degree that exceeds the values of some of vaccines in use and can help protect against disease.
It is injected into two doses with 4 weeks of difference. The novelty is that VLA2001 is based on inactivated virus technology and is the only one of its type developed in Europe.
The vaccine contains the same SARS-COV-2 inactivated (dead) that can no longer cause the disease. VLA2001 also contains two 'adjuvants', substances that help strengthen the immune response to the vaccine.
When a person receives the vaccine, its immune system identifies the virus inactivated as strange and produces antibodies against it. It is a technology used for most flu vaccines and many vaccines administered in childhood with well-established levels of safety and efficiency and, for this reason, could satisfy the demand for some people who do not see with good eyes based vaccines In the new Messenger RNA technology, especially anti vaccines.
The Phase 3 study recruited a total of 4,012 participants from 18 years or more on 26 study sites in the United Kingdom.
It was based on a control group that did not receive a placebo, but the AstraZeneca vaccine (because with a growing number of authorized vaccines, the randomized placebo assays would not have been "ethical").
On October 18, Valneva announced the results: compared to VaxzeVria, VLA2001 produced 40% higher levels of antibodies that neutralized the Coronavirus.
It also produced fewer side effects. The participants of 30 years or more reported significantly from fewer adverse events up to seven days after vaccination.
The study was not published. The continuous review of data by EMA will continue until sufficient evidence is available for a formal marketing authorization request.
The French company announced on November 23 that it had signed an anticipated purchase agreement (APA) with the European Commission to provide up to 60 million doses of its candidate vaccine for two years.
The EU Commission stressed that the Agreement also provides for the possibility that the vaccine is adapted to new variants of viral strains.
It could also be used for reinforcements, since it has been shown that vaccines with inactivated viruses are very effective in stimulating the immune response when administered after the complete vaccination cycle.Date Of Update: 08 December 2021, 11:45