Drug regulator says Russian Sputnik V vaccine not yet approved in Pakistan

In this picture taken on Nov. 25, 2020, volunteers wait to be administered the Chinese-made vaccine for the Covid-19 coronavirus, the first ever Phase 3 clinical trial for any vaccine in Pakistan, at a hospital entrance in Islamabad. (AFP/File)

• Data was reviewed by the expert committee and more information is required before approval: DG health
• So far, Pakistan has approved only two vaccines for emergency use

ISLAMABAD: Pakistan has not yet approved the Russian Sputnik V vaccine for emergency use in the country, the Drug Regulatory Authority of Pakistan (DRAP) told Arab News on Sunday, after local media reported it had been green lighted by the government for ‘emergency use.’
“Emergency use of Russian vaccine is not allowed yet,” Akhtar Abbas, spokesperson for DRAP said.
“The matter is pending with registration and policy boards. Sputnik-V vaccine has been registered by the DRAP and registration is half the procedure,” he said, but added that the company that had applied for the vaccine still required clearance for approval.
“Once (clearance) is done, DRAP will give approval for the third vaccine.”
Last week, Pakistan Drug Regulatory Authority (DRAP) authorized the Oxford University-AstraZeneca Covid-19 vaccine for emergency use in the country, followed a few days later by the Chinese state-owned firm Sinopharm’s Covid-19 vaccine, also for emergency use.
“The emergency use authorization has not been given yet (for Sputnik V). They have applied for it. Their data was reviewed by the expert committee and they asked for more information. It’s in process,” Pakistan’s Director General for health, Dr. Rana Mohammed Safdar, told Arab News on Sunday.
Pakistan has reported 48 deaths from COVID-19 in the last 24 hours and an increase of almost 1,600 cases, bringing the total case count in the country to 532,412, according to the National Command and Operation Centre (NCOC) which overseas the national coronavirus response.