Europe’s medicines regulator has launched a “rolling review” of Sinovac’s COVID-19 jab, marking the agency’s first real-time analysis of a Chinese vaccine.
The European Medicines Agency (EMA) announced on Tuesday that its human medicines committee (CHMP) would be assessing data on the COVID-19 Vaccine (Vero Cell) Inactivated as it becomes available.
Sinovac is a Beijing-based pharmaceutical company focused on the research and development of vaccines and its Vero Cell jab gets its name from the fact that it uses an “inactivated” version of the SARS-CoV-2 virus to inoculate patients.
The EMA said its real-time analysis of the jab would help to speed up the potential approval of the vaccine for use in Europe.
In a statement, the EMA said “the CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies”.
“These studies suggest that 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,” it said.
The EMA said it would be using the data that becomes available on the jab to “decide if the benefits outweigh the risks”.
“The rolling review will continue until enough evidence is available for a formal marketing authorisation application,” the agency said.
What is Vero Cell and how does it work?
COVID-19 Vaccine (Vero Cell) Inactivated is meant to protect against COVID-19 by helping the body identify an inactivated version of the virus as “foreign”, the EMA has said.
The vaccine contains SARS-CoV-2 that has been inactivated, or “killed,” which means it cannot cause the recipient of the jab to contract the virus when injected.
The vaccine also contains an “adjuvant”, which is a substance meant to help strengthen the immune system’s response to the vaccine.
“When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it,” the EMA has explained.
“If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend the body against it,” it said.
First Chinese vaccine to be studied by EMA
The rolling review marks the first Chinese vaccine to be studied in real-time.
It is also the fourth COVID-19 vaccine to fall under such a review, with jabs from US vaccine developer Novavax Inc and German biopharmaceutical firm Curevac, as well as Russia’s Sputnik V coronavirus jab being subjected to similar analysis.
It is unclear when the rolling review process for Sinovac’s jab will end.
The EMA has said it “cannot predict the overall timelines” for the endeavour, as research “will continue until enough evidence is available for a formal marketing authorisation application”.
However, the agency said that studying the vaccine on a real-time basis will mean that if the vaccine can be approved, it should “take less time than normal” to start rolling out the jab “because of the work done during the rolling review”.