The European Medicines Agency (EMA) announced on Tuesday the launch of a “continuous review” procedure for the Chinese laboratory Sinovac’s vaccine against Covid-19. This paves the way for a possible application for future authorization in the European Union. EMA Committee for Medicinal Products for Human Use ‘Decision to Begin Continuous Review Based on Preliminary Results from Laboratory Studies [données non-cliniques] and clinical studies “, explains in a press release the European regulator based in Amsterdam.
- How does the Sinovac vaccine work?
The vaccine from Chinese laboratory Sinovac uses the classic technique of inactivated virus which helps the vaccinated person to produce antibodies against the virus. This is also the technique used for the flu vaccine, for example. Viral particles are injected in order to expose the body’s immune system to the virus, but without risk, in order to trigger a response to the disease.
Sinovac is inoculated twice, but does not need to be stored at extremely low temperatures. Unlike vaccines from Pfizer-BioNTech or Moderna, it can therefore be stored in a simple fridge.
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- How effective is it?
The studies on which the EMA is based “suggest that the vaccine triggers the production of antibodies that target Sars-CoV-2, the virus that causes Covid-19, and could help protect against the disease,” adds the EMA.
Currently, the various studies carried out on the Sinovac vaccine have demonstrated efficacy rates between 50% and 90% of this serum, according to Reuters. The results obtained with regard to clinical trials are very different from one region to another. In February, AFP reported that Turkey claimed Sinovac’s vaccine was 91.25% effective while Chile reported 78%, Indonesia 65.3% and Brazil 50, 38%. On April 16, the government of Chile, one of the most advanced countries in the world in terms of vaccination, published a Coronavac study: according to it, Sinovac’s vaccine is 67% effective in preventing symptomatic cases of Covid -19, and 80% to prevent fatalities.
Few days ago, on April 10, the director of the Chinese Center for Disease Control and Prevention, Gao Fu, admitted that the vaccines of Sinopharm and Sinovac “do not have a very high rate of protection,” at a scientific conference in Chengdu. He explained that the country was exploring two options to “solve the problem that the effectiveness of its existing vaccines is not high”, on the one hand by adjusting the dosage, on the other hand by mixing with other vaccines. The next day, Gao Fu had reconsidered his words in the Global Times, saying he was talking about vaccines in general, a statement relayed by Chinese officials.
China’s Sinovac vaccine is used in at least 22 countries and territories (out of 209 that have started to vaccinate), including several countries in Latin America, Africa and Asia, according to an AFP count. It was authorized in February in China and is also authorized in Chile, Brazil, the Philippines, Ukraine and Turkey.
Sinovac is used less than the two Chinese vaccines developed by Sinopharm, already present in at least 42 countries, including Hungary in the European Union. Currently, four vaccines are authorized in the EU: Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson – the latter two under certain age conditions in most European countries.
- How long will the European procedure take?
The European agency will continue its procedure until it has sufficient information for the laboratory to be able to submit a formal application for marketing authorization. “The EMA cannot foresee an overall timetable but the assessment of a possible application should take less time than usual due to the work carried out during the continuous review”, according to the agency.
This is the first Chinese vaccine that the EMA is studying as part of a “continuous review”, Reuters recalls. Before him, vaccines from CureVac (Germany), Novavax Inc (United States) and Russian Sputnik V went through a similar procedure.
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