January 26, 2020: Pakistan is all set to approve the Russian Sputnik COVID-19 vaccine for emergency use, a government official said on Monday, a week after China's Sinopharm and Oxford University's AstraZeneca vaccine got a similar authorization.
The Drug Regulatory Authority Pakistan (DRAP) has accepted the data submitted by the Russian candidate, a spokesman for the authority told Reuters.
He said the data and its evaluation had been forwarded to the authority's registration board, which will have the final word on granting Sputnik an Emergency Use Authorization (EUA).
“We just need some clarification over its marketing rights,” the spokesman said, adding all the rest was done. He said the AGP Pharma Pakistan had applied to market and distribute the vaccine.
Pakistan has not yet rolled out a vaccination campaign, waiting for the first shipment of Sinopharm's vaccine by the end of this month with a donation of half a million doses from China.
Pakistan hopes to get another donation of over a million doses from China.
“Soon enough,” Pakistan's health minister Faisal Sultan told Reuters when asked when the South Asian nation of 220 million will start getting the vaccine shots.
The health ministry says both the EUA approved vaccines will be reviewed on a quarterly basis for further data regarding safety, efficacy, and quality.
Sultan said the country could get “in the range of tens of millions” of vaccine doses under an agreement with China's Cansino Biologics Inc.
The vaccine company's Ad5-nCoV COVID-19 candidate is nearing completion of Phase III clinical trials in Pakistan, awaiting results likely to come in by mid-February, Sultan said.
Pakistan plans to cover the majority of the population for free, but private companies could also be allowed to import and sell vaccines.
Pakistan reported 1,629 new coronavirus infections and 23 deaths on Monday, taking the total number of cases to more than 534,041 with 11,318 fatalities.