Pakistan approves Russian coronavirus vaccine for emergency use

A local pharmaceutical AGP has been authorised as the sole importer and distributor of the Russian vaccine

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ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has granted approval for emergency use of the Russian coronavirus vaccine Sputnik V, making it the third vaccine approved by the authority against the deadly coronavirus.

The authorities said on Sunday that the government has given a go-ahead to a local pharmaceutical company for the import and distribution of the Russian-developed Sputnik V.

“In a meeting conducted by the registration board of the Drug Regulatory Authority of Pakistan (DRAP), another vaccine has also been given EUA [emergency use authorisation] which was developed with the backing of Russian Development Investment Fund,” an official said.

A local pharmaceutical AGP, he said, has been authorised as the sole importer and distributor of the Russian vaccine.

The DRAP hopes the first batch of the vaccine would reach Pakistan by the end of January. The health authority said that the approval was granted on the recommendation of a committee of experts comprising top infectious diseases experts and pathologists.

“In all likelihood, a double dose of the Sputnik V in Pakistan would cost double the rate at which it is available in India,” the official added.

Developed by M/s Gamaleya National Center of Epidemiology and Microbiology, the vaccine has been approved in 11 countries, including Russia, Argentina, Hungary, and UAE, and registration in the European Union has also been filed.

Earlier on January 17, the DRAP authorised the Oxford University-AstraZeneca Covid-19 vaccine for emergency use in Pakistan. A couple of days later, the regulatory body approved Chinese state-owned firm Sinopharm’s Covid-19 vaccine for emergency use, the second shot to be given approval for the use in the country.

Although the DRAP has granted approval for the emergency use of Oxford-Astrazeneca’s coronavirus vaccine, it is unclear when the inoculations will be available in Pakistan as the pharmaceutical company’s authorised agents are yet to place orders.

Last week, the Sindh Medical Stores (SMS) was allowed to import the vaccine. SMS official Usman Ghani said at the moment the British-Swedish company was supplying the vaccine to countries that had already booked vaccine doses and paid in advance.

“We don’t know when we would be able to get hold of the first consignment of the vaccine as it has already been purchased by the several countries of the world.”

Ghani said AstraZeneca has authorised the manufacture of the vaccine in Serum Institute of India in Pune for bulk production but most of that would be used for vaccinating a sizable population of India before it is allowed to Pakistan. “We have very good business relations with the Serum Institute of India and we would try our best to procure it as early as possible.”

The local firm has offered to provide the vaccine at the cost of $6 to $7 (Rs1,000 to Rs1,200) per dose to the federal and provincial governments if procured in bulk quantity (30 to 50 million doses).

To the private sector, the firm has offered Rs2,000 to Rs2,500 per dose if they place orders of 10,000 or more doses. “But it should be very clear that we would only be providing the vaccine to reputed institutions like Aga Khan University Hospital (AKUH), Shaukat Khanum hospital, and others,” stressed Ghani.