Friday, January 28

What is Vero Cell? EMA Launches ‘Continuous Review’ of Chinese COVID-19 Vaccine


The European drug regulator has launched a “continuous review” of Sinovac’s COVID-19 vaccine, marking the agency’s first real-time analysis of a Chinese vaccine.

The European Medicines Agency (EMA) announced on Tuesday that its committee for human medicines (CHMP) would evaluate data on the inactivated COVID-19 (Vero Cell) vaccine as it becomes available.

Sinovac is a Beijing-based pharmaceutical company that focuses on vaccine research and development 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 speed up the possible approval of the vaccine for use in Europe.

In a statement, the EMA said that “the CHMP’s decision to initiate continuous review is based on preliminary results of 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,” he said.

The EMA said it would use the data that is available in the jab to “decide whether the benefits outweigh the risks.”

“Ongoing review will continue until sufficient evidence is available for a formal marketing authorization application,” the agency said.

What is Vero Cell and how does it work?

The Inactivated COVID-19 (Vero Cell) vaccine is intended to protect against COVID-19 by helping the body identify an inactivated version of the virus as “foreign,” the EMA said.

The vaccine contains SARS-CoV-2 that has been inactivated or “killed,” meaning that it cannot make the injection recipient contract the virus when injected.

The vaccine also contains an “adjuvant,” which is a substance intended to help strengthen the immune system’s response to the vaccine.

“When a person receives the vaccine, their immune system identifies the inactivated virus as foreign and produces antibodies against it,” explained the EMA.

“If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the virus and will be ready to defend the body against it,” he said.

First Chinese vaccine studied by the EMA

The ongoing review marks the first Chinese vaccine to be studied in real time.

It is also the fourth COVID-19 vaccine to undergo such a review, with jabs from American vaccine developer Novavax Inc and German biopharmaceutical firm Curevac, as well as Russia’s Sputnik V coronavirus jab undergoing similar testing.

It’s unclear when the ongoing review process for the Sinovac jab will end.

The EMA has said it “cannot predict the overall timelines” for the effort, as the investigation “will continue until sufficient evidence is available for a formal application for marketing authorization.”

However, the agency said that studying the vaccine in real time will mean that if the vaccine can be approved, it should “take less time than normal” to start implementing the vaccine “due to the work done during ongoing review.”


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