The European Medicine Agency has started a rolling review of the Covid-19 vaccine developed by Chinese company Sinovac, the latest vaccine candidate hoping to win approval for usage in the bloc.
The Brussels-based European Medicine Agency (EMA) has started a rolling review of the COVID-19 vaccine developed by Chinese company Sinovac, the latest vaccine candidate hoping to win approval for usage in the bloc.
A rolling review is a regulatory tool that the EMA uses to speed up the assessment of a promising medicine during a public health emergency.
In a press release on Tuesday, the EMA announced that the application for the vaccine was submitted by the Rome, Italy-based Life’On Srl (Orofino Pharmaceuticals Group).
“The vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes Covid-19, and may help protect against the disease,” said the EMA.
The Chinese vaccine uses an inactivated form of the SARS-CoV-2, which cannot cause the disease. Once inoculated, the vaccinated person will start producing antibodies against the virus, hence becoming ready to fight the virus should contact be made later on, according to the EMA.
Sinovac will be evaluated with the usual European Union (EU) standards for effectiveness, safety and quality, said the agency.
A recent study looked at how the vaccine works against the entire range of clinical symptoms, from mild infections to severe ones, including death. The efficacy data of about 50 per cent is for very mild disease, requiring no treatment. For infections requiring some medical intervention, it’s about 84 per cent and for moderate-to-severe Covid cases, it’s 100 per cent.
So far, four vaccines developed by BioNTech/Pfizer, Moderna, AstraZeneca and Johnson & Johnson, have been granted conditional marketing authorization.
Four other vaccines are under rolling review, including Sinovac, CureVac, Novavax and Sputnik V.
No EU country currently uses the Sinovac vaccine. However, EU-member Hungary has decided to vaccinate its population using the Sinopharm COVID-19 vaccine, another Chinese vaccine.