DRAP authorises AGP to import Sputnik V vaccine in Pakistan

(Karachi) The Drug Regulatory Authority of Pakistan (DRAP) has authorised a local pharmaceutical firm, AGP, to import and introduce Russia's Sputnik V vaccine in Pakistan, local media reported on Wednesday.

As per details, AGP Pharmaceutical company has been granted approval to import the vaccine doses in the country. “DRAP on February 1 has granted Emergency Use Authorization (EUA) for ‘Gam-COVID-Vac’ combined vector vaccine to prevent coronavirus infection caused by SARS-CoV-2 virus (‘Sputnik V’ or the ‘vaccine’) to the company,” a notification by AGP stated.

It added the company has also been authorised to import and introduce the vaccine in Pakistan and it is now making efforts to ensure the availability of sufficient supplies on an emergency basis.

The said vaccine has been developed by the Gamaleya National Center of Epidemiology and Microbiology, Russia.

The firm said the vaccine has been approved by 15 countries including Russia, Hungary, Argentina, and the United Arab Emirates with registrations under way in several other countries.

“The vaccine has a good safety profile and in particular, there are no strong allergies caused by the vaccine. This is by far, the most effective COVID-19 vaccine to have received EUA in Pakistan and can be administered to persons aged 18 and above, including persons aged above 60,” the notification said.

Earlier, as part of measures to protect the population from coronavirus, the government gave approval for Russian developed Sputnik V vaccine under “emergency use authorisation”.

As per details, Russia’s Sputnik V Covid-19 vaccine has become the third to be approved for emergency use in the country. The double dose of Sputnik V in Pakistan would cost double the rates at which it is available in India.

DRAP officials said a committee of experts comprising top infectious diseases experts and pathologists for the evaluation of clinical trials data for registration of COVID-19 vaccines on January 21, 2020 recommended the granting of Emergency Use Authorization for Sputnik-V vaccine in Pakistan.

Vaccine developed by Russia proved to be 92 percent effective in preventing coronavirus, the interim results showed. Russia registered Sputnik V for public use in August, the first country to do so, though the approval came before the start of the large-scale trial in September.

The Phase III trial of the shot developed by the Gamaleya Institute took place in 29 clinics across Moscow and involved 40,000 volunteers in total. The chances of contracting COVID-19 were 92% lower among people vaccinated with Sputnik V, the Russian Direct Investment Fund stated.