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The European Medicines Agency (EMA) has announced that it is beginning the continuous review of the
Vero Cell
vaccine
, developed against Covid by the
Chinese pharmaceutical company Sinovac
.
It is the
first Chinese vaccine
to be reviewed by European authorities.
Currently, in addition to the four approved vaccines, three other candidates are under evaluation: CureVac, Novavax and Sputnik V.
Sinovac, which is already approved in China, Indonesia, Brazil and Turkey, has shown an efficacy of between 50% and 90% in different studies.
Available evidence shows that the product induces the immune response against SARS-CoV-2.
The EMA states that, as is customary with Covid vaccines, it will evaluate the data as it becomes available to decide "whether the benefits outweigh the risks" of this drug.
The continuous review will continue "until sufficient evidence is available" for the pharmacist to
formally request a marketing authorization
.
Since the screening process is still in a very preliminary phase, the agency does not have a set timetable nor "can it predict the general timelines" for the possible approval of this vaccine in the EU.
This vaccine is based on the use of an inactivated SARS-CoV-2 virus.
In addition, it also contains an
adjuvant
, a substance that helps to enhance the immune response against a certain antigen.
In early April, Sinovac announced that it currently has three plants producing the vaccine.
According to its data, it has already distributed more than 200 million doses of the product and anticipates a capacity to produce 2 billion doses per year.
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