Bangladesh approves Sinovac COVID-19 vaccine for emergency use

The Directorate General of Drug Administration has approved the emergency use of a Sinovac COVID-19 vaccine amid a spike in coronavirus cases and deaths in parts of Bangladesh.

The authorisation came on Sunday, five days after the World Health Organization (WHO) approved the Sinovac vaccine for emergency use listing, paving the way for a second Chinese shot to be used in poor countries.

A WHO emergency listing is a signal to national regulators of a product's safety and efficacy and will allow the Sinovac shot to be included in COVAX, the global programme providing vaccines mainly for poor countries, which faces major supply problems due to curbs on Indian exports.

Dhaka-based Incepta Vaccine Ltd will import the vaccine, the Bangladesh drug regulator said in a notice on Sunday. Sinovac is the fifth COVID-19 vaccine to get approval in Bangladesh.

Bangladesh’s Directorate General of Drug Administration approved the Sinopharm vaccine in April amid a supply squeeze that derailed the country’s inoculation campaign, after India banned vaccine exports.

The WHO's independent panel of experts said in a statement it recommended Sinovac's vaccine for adults over 18. There was no upper age limit as data suggested it is likely to have a protective effect in older people.

The WHO's technical advisory group, which began meeting on May 5, made the decision after reviewing the latest clinical data on the Sinovac vaccine's safety and efficacy as well as the company's manufacturing practices.

WHO Director-General Tedros Adhanom Ghebreyesus welcomed the move, calling the vaccine safe and effective and noting its easy storage requirements make it suitable for low-income countries.

Branded CoronaVac in some regions, it is the eighth vaccine to win such a WHO listing to combat COVID-19 and the second developed by a Chinese company, after the May 7 approval of a shot developed by state-backed Sinopharm.

While a third Chinese vaccine, produced by CanSino Biologics, has submitted clinical trial data, no WHO review has been scheduled.

Sinovac said that it had supplied more than 600 million doses of its vaccine at home and abroad as of end-May and over 430 million doses have been administered.

BIG BOOST

The endorsement is a big boost for Sinovac's vaccine after data in clinical trials showed a wide range of efficacy rates.

The WHO said results showed it prevented symptomatic disease in 51 percent of those vaccinated and prevented severe COVID-19 and hospitalisation in 100 percent of the studied population.

The WHO's separate Strategic Advisory Group of Experts had said previously that vaccine efficacy in multi-country Phase III clinical trials ranged from 51 percent to 84 percent.

China has already deployed hundreds of millions of doses of both Sinopharm and Sinovac vaccines at home and exported them to many countries, particularly in Africa, Asia and Latin America.

[With details from Reuters]