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szdaily -> Markets -> 
EU begins real-time review of Sinovac vaccine
    2021-05-06  08:53    Shenzhen Daily

EUROPE’S medicines regulator said Tuesday it has started a real-time review of Sinovac’s COVID-19 vaccine, based on preliminary results from animal and human trials that suggested the vaccine produces an immune response against the coronavirus.

Data on the vaccine, COVID-19 Vaccine (Vero Cell) Inactivated, will be assessed as they are made available to help speed up potential approvals, the European Medicines Agency (EMA) said.

The EMA’s decision to start the review is to assess Sinovac vaccine’s effectiveness and safety, the first step toward possible authorization of the shot in the 27-member bloc.

“The EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorization application,” the agency said in a statement.

The announcement from the Amsterdam-based agency came a day after a top World Health Organization (WTO) official said the WHO is set to decide very soon whether to approve two Chinese COVID-19 vaccines for emergency use, one from Sinovac and another developed by China’s Sinopharm.

Such approval would mark the first time that a Chinese vaccine had been granted a so-called emergency use listing from the U.N. health agency, and would trigger a broader rollout of Chinese vaccines that are already being used in some countries beyond China.

The EMA’s move also comes a day after Denmark became the first EU country to exclude the COVID-19 vaccine developed by health care company Johnson & Johnson from its immunization program, over blood clot concerns.

Last month, Denmark also permanently stopped using the vaccine developed by U.K.-Swedish drug company AstraZeneca, citing similar concerns.

This is the first Chinese vaccine the EMA is studying in real time and the fourth COVID-19 vaccine under such a review, including those from CureVac, Novavax Inc and Russia’s Sputnik V.

Sinovac’s vaccine has shown efficacy rates between 50 percent and 90 percent in different studies and is currently authorized for use in China, Indonesia, Brazil and Turkey.

The vaccine contains inactivated or dead versions of the SARS-CoV-2 virus to help the human body’s immune system make antibodies.

Sinovac’s COVID-19 vaccine is 100 percent effective in preventing severe and moderate infections, 77.96 percent effective in preventing mild cases and has an overall efficacy of 50.4 percent in Brazil’s final-stage trials, according to researchers in Brazil.

Experts said the result is “good enough” considering almost all the trial participants in Brazil were high-risk medical workers, and the 77.96 efficacy for mild-case protection means the vaccine will reduce the amount of people needing hospitalization by 78 percent, according to a Global Times report in January.

In early April, Sinovac said its third production plant for its vaccine, branded CoronaVac in some regions, was ready, doubling its annual capacity to 2 billion doses. The firm said more than 200 million doses of Sinovac’s vaccine have been delivered globally.

Rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data are available. (SD-Agencies)

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