China’s Sinopharm Covid-19 vaccine gets WHO go-ahead for emergency use

PT Jyothi Datta Mumbai | Updated on May 08, 2021

First with a vial-monitor, but continued watch recommended for older people

The Sinopharm Covid-19 vaccine has been listed for emergency use by the World Health Organization, paving the way for more countries to be able to roll it out.

The vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG) and it becomes the sixth vaccine to receive the WHO validation for safety, efficacy and quality.

An emergency use listing (EUL) also allows countries that may not have a robust regulatory system to expedite their own regulatory approval to import and use the vaccine. It also is a prerequisite for the WHO’s COVAX facility that supplies vaccines to under-served countries.

Acceptance of the Sinopharm vaccine in different countries will be of interest, especially since India has recently opened the door to foreign vaccines. And, given the recent stand-off between the two countries.

Dr Chandrakant Lahariya, public policy and health systems expert told BusinessLine, the Sinopharma vaccine will add to the pool of vaccines available to countries, an important feature given the global supply shortfall. Responding to a query on the acceptability of the vaccine, he said, “science and research and development are not national, it’s global. The purpose of vaccines is to save lives.”

WHO Assistant-Director General for Access to Health Products Dr Mariângela Simão said, “The addition of this vaccine has the potential to rapidly accelerate Covid-19 vaccine access for countries seeking to protect health workers and populations at risk.” She urged the manufacturer to participate in the COVAX Facility and contribute to equitable supply of vaccines.

The other vaccines that have the WHO endorsement include those from Pfizer-BioNTech, Moderna, AstraZeneca (from two producers including Serum Institute of India) and Johnson and Johnson.

Vaccine vial monitor

The EUL also assesses risk management plans and programmatic suitability of the vaccine in terms of cold chain requirements, for example. For the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility, the WHO said.

Sinopharm’s product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). “Its easy storage requirements make it highly suitable for low-resource settings,” the WHO said. Significantly, it is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change colour as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.

WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79 per cent, all age groups combined, it said.

Monitor in older people

For older people, it pointed out that few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, it added, WHO was not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggested the vaccine was likely to have a protective effect in older persons, as well.

“There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations,”it said, recommending that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust.

Published on May 08, 2021

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