EMA opens review of China's Sinovac coronavirus jab

The EMA's human medicines committee's "decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies," the Amsterdam-based agency said.

AFP
May 04, 2021 / 05:13 PM IST

Source: Reuters

The European Medicines Agency said Tuesday it has started a "rolling review" of China's Sinovac coronavirus jab, a process that could lead to eventual approval for the European market.

Made by Sinovac's Beijing-based Life Sciences unit, the vaccine contains an inactivated coronavirus that cannot cause a disease, but helps a person to develop antibodies against the virus.

The EMA's human medicines committee's "decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies," the Amsterdam-based agency said.

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"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 in a statement.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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The EMA will now continue the review until there is enough information for the company to make a formal application for it to be released to the market.

"While the EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review," it said.

Sinovac's shot was approved by China's medicines regulator for use in February.

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AFP
TAGS: #China #coronavirus #COVID-19 vaccine #European Medicines Agency #Health #Sinovac #World News
first published: May 4, 2021 05:13 pm