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The British Medicines Agency in London MHRA (Pharmaceuticals and Healthcare Regulatory Agency) was the first company in the world to approve the VLA2001 vaccine from the French manufacturer Valeneva, which contains inactivated viruses similar to the annual flu vaccine. Approval from the European Union (EU) is expected soon.
VLA2001 was developed by the French biotechnology company Valneva in Saint-Herbine. It contains SARS-CoV-2, which is multiplied in Vero cells and then inactivated with beta-propiolactone. The policy has proven itself in influenza vaccines and new polio vaccines.
Coronaviruses made in China such as Sinovac or PPIPP-Corvi and Sinoformin WIPP are also inactivated viruses. The group also includes Turkovak from Turkey, Kovivak from Russia, Kazakh from Kazakhstan and Kovacin from India. None of these vaccines are approved in the EU or the UK. This may be due to a lack of performance rather than a lack of interest from manufacturers.
The results of the Phase 3 study are the basis for gaining approval in the UK and soon in the EU compare cov-. The study was conducted at 26 locations in the UK. He first compared the immunogenicity of the VLA2001 and AstraZeneca vaccine AZD1222 in 4,012 adults. By day 43 the primary endpoints are neutralizing antibodies (GMT) and increased seroconversion and tolerance.
In terms of performance, the VLA2001 vector-based vaccine outperformed the AZD1222. The GMT of participants aged 30 and over was 803.5 and 576.6, which is significantly higher after administration of AZD1222. Seroconversion was achieved in more than 95% of the participants in both groups.
VLA2001 also exhibited a good T cell response. In an estimate examining the release of interferon gamma after exposure of viral components, 74.3% of cells responded to spike protein, 45.9% to nucleoprotein, and 20.3% to membrane protein. In the absence of the last two proteins from AZD1222 (and all other approved vaccines), VLA2001 may trigger a broader immune response.
It is difficult to determine from the study results whether it is beneficial for those who have been vaccinated. The study showed the same number of COVID-19 cases after vaccination in both vaccines, according to the manufacturer. However, this is a research end point and its information value is low. The October press release said that although the study was conducted during the Delta wave, there were no serious cases of COVID-19. Overall, the delta variant led to more severe diseases than the current Omigran variant.
According to the manufacturer, the tolerance of VLA2001 was good. Participants 30 years and older reported significantly more adverse events within 7 days of being vaccinated with VLA2001 than those vaccinated with AZD1222. Reactions on the injected site occurred in 73.2% and 91.1% of participants, respectively. Systemic reactions were found to be significantly lower in the VLA2001 group at 70.2% compared with 91.1% in the AZD1222 group.
Less than 1% of participants in both groups had severe adverse events, according to the manufacturer. In younger people, the safety profile is comparable to that of older people.
An advantage over mRNA vaccines is that the Valneva COVID-19 vaccine can be stored at normal refrigerator temperatures of 2C to 8C.
With the conclusion of European Pharmaceuticals Company Expected soon. The approval process based on the roll review has already begun in early December. As of November 2021, the EU has delivered 60 million doses of VLA2001 over a 2-year period. The manufacturer is currently testing Volneva’s performance on teens. The effectiveness of a booster dose is currently being tested. © rme / aerzteblatt.de
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