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The Covid-19 vaccine from Beijing-based Sinovac has received the WHO’s approval for emergency use, making it the second vaccine from China to get the nod.
The first one was from Sinopharm and was approved less than a month ago. These vaccines join four other companies whose vaccines have already received WHO emergency listings, including those from Pfizer-BioNTech, Moderna, AstraZeneca-OxfordUniversity and Johnson and Johnson. The WHO emergency use listing gives countries, funders, procuring agencies and communities the assurance that the product meets international standards for safety, efficacy and manufacturing. It allows countries without an elaborate regulatory set-up of their own to quickly approve, import and administer the vaccine.
“The world desperately needs multiple Covid-19 vaccines to address the huge access inequity across the globe,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge manufacturers to participate in the COVAX Facility, share their know-how, and data and contribute to bringing the pandemic under control.” The WHO’s EUL is a prerequisite for the COVAX Facility vaccine supply and international procurement. India’s Serum Institute supplies the AstraZeneca-OxfordUniversity vaccine to Covax.On-site inspection
The EUL assesses the quality, safety and efficacy of vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. In the case of the Sinovac’s CoronaVac vaccine, the WHO assessment included on-site inspections of the production facility.
The Sinovac-CoronaVac product is an inactivated vaccine. Its easy storage requirements make it very manageable and particularly suitable for low-resource settings, said the WHO.
The WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule, with a spacing of two to four weeks. Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51 percent of those vaccinated and prevented severe Covid-19 and hospitalisation in 100 percent of the studied population.
Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group, the WHO said, adding however that they were not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.
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