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EU regulator begins rolling review of Valneva's COVID-19 jab

Early studies suggest French firm's vaccine triggers production of antibodies, says European Medicines Agency

Agnes Szucs   | 02.12.2021
EU regulator begins rolling review of Valneva's COVID-19 jab

BRUSSELS

The European Medicines Agency (EMA) on Thursday said it has started a rolling review of the COVID-19 vaccine developed by French biotech firm Valneva.

The review kicked off after the European Union signed a deal with Valneva last month for 60 million doses over the next two years.

The regulator said it decided to begin the evaluation based on preliminary results from laboratory studies and early clinical trials with adults.

“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,” read an EMA statement.

“The rolling review will continue until enough evidence is available for a formal marketing authorization application.”

The Valneva shot “contains inactivated (killed) SARS-CoV-2 that cannot cause the disease” and will prepare the body’s immune system to defend itself against infection.

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

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

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