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News > China

WHO Grants Emergency Authorization for China's Sinovac Vaccine

  • The WHO has approved the Sinovac vaccine for emergency use for adults over 18.

    The WHO has approved the Sinovac vaccine for emergency use for adults over 18. | Photo: Twitter/@MothershipSG

Published 1 June 2021
Opinion

Sinovac is the second vaccine developed by China and the sixth worldwide to be approved and incorporated into the Covax mechanism.

The World Health Organization (WHO) approved the emergency use of the CoronaVac covid vaccine this Tuesday, developed by the Chinese pharmaceutical company Sinovac, a condition that guarantees that it meets international safety, efficacy, and manufacturing standards.

This is the second drug of this type developed by Chinese scientists to obtain the approval mentioned above after the one patented by Sinopharm received at the beginning of May.

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The emergency use approval allows its incorporation into the Covax program, organized by the WHO and other agencies to distribute antiviral vaccines worldwide at a low price and equitably.

In light of the spread of the Covid-19 pandemic, WHO Assistant Director-General for Access to Health Products Mariângela Simão recalled that "the world desperately needs multiple vaccines to address the huge inequity in access across the globe."

Before CoronaVac, immunizers from Pfizer, Moderna, AstraZeneca, Johnson, and Johnson, and Sinopharm were approved for emergency use.

Media reports note that Sinovac and Sinopharm are the first SARS-CoV-2 vaccines to be given the green light by the WHO without prior approval by the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA).

According to the WHO website, the evaluation of these vaccines is carried out by the product evaluation group, which is composed of regulatory experts worldwide.

In addition, this group incorporates a second technical advisory group that evaluates the risks and benefits to make an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under what conditions.

According to international media, the evaluation of CoronaVac included WHO on-site inspections of production facilities.

The agency states on its website that this serum has requirements that make it easy to store, highly manageable, and particularly suitable for low-resource settings.

Based on scientific evidence, the WHO recommends its use in adults 18 years of age or older in a two-dose schedule with an interval of two to four weeks.

In terms of results, it was concluded that the immunizer prevented symptomatic disease in 51 percent of those vaccinated. In addition, the development of severe COVID-19 symptoms and hospitalization was prevented in 100 percent of the sample studied.

Although the efficacy of CoronaVac in adults over 60 years of age could not be estimated, WHO considers it "likely" to "have a protective effect" in this population segment and recommends detailed monitoring of the impact.

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