The Beijing pharmaceutical company’s product incorporates an inactivated virus that does not cause disease, but triggers an immune response against pathogens. The serum has been approved in more than 30 countries, including China, and has been tested on more than 25,000 volunteers in Brazil, Turkey, Indonesia and Chile.
Today there is news that the European Medicines Agency (EMA) has begun a rolling review of the anti-Covid vaccine (Vero Cell) produced by Sinovac Pharmaceuticals.This is communicated through the EMA itself In notes, Announced the decision of the Committee for Human Medicinal Products (CHMP) to conduct a review, allowing EU regulators to evaluate the available data until there is sufficient evidence to formally propose a conditional sales authorization. EMA did not specify how long the final decision will take, but said the process “It should take less time than usual“Considering the work done during the rolling review. It applied to the European Union for Italian Life’On srl in Pomezia, Rome.
Coronavac, a vaccine from Sinovac, China
EMA has also conducted a rolling review of three other vaccines, including the Russian satellite, Curevac’s mRna vaccine and Novavax’s protein-based vaccine. Sinovac’s vaccine is called CoronavacInstead, it is based on an inactivated form of Sars-Cov-2, which does not cause disease, but has been shown to induce the production of antibodies against pathogens in response to administration. “Subsequently, if the vaccinated person comes into contact with Sars-Cov-2, the immune system will recognize the virus and be ready to protect the body from it.“Add EMA statement.
Approved More than 30 countriesIncluding China, Sinovac’s vaccine has been tested in a phase 3 clinical trial conducted in 2006 Brazil, Turkey, Indonesia and Chile, Has different efficacy data in different countries/regions.In clinical trials in Brazil and Turkey, the protection rate against all forms of Covid-19 was 51%, effective 84% of prevention cases Mild or moderate without medical care, 100% for severe and fatal forms.It used to be analysis Ad temporary In the Turkish trial data, 91% of the curative effects have no prominent side effects.
Similarly, the Butantan Institute, which conducted this trial in Brazil, initially announced an effectiveness of 78% for mild-to-moderate and 100% moderate-to-severe Covid-19 cases, but the calculation of overall effectiveness should be reviewed because One group”Mild infection“After vaccination. Integration resulted in a protection rate of 50.4% against all forms of Covid-19. On the other hand, in Indonesia, the vaccine has proven effective rate of 65.3%.
Despite the contradictions, it has not yet been supported by scientific publications, and the results are still approved in all countries that have conducted clinical trials (especially in Colombia, Dominican Republic, Uruguay, and Ecuador). Mexico, Malaysia, Thailand, Tunisia, Albania and Ukraine.
There are also concerns and criticisms that these trials have not been subject to the same scrutiny and transparency as their Western counterparts. However, Sinovac’s structure and quality management system have been inspected by many national and local authorities.World Health Organization (WHO), a decision on the vaccine is expected to be made later this week.