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January 24, 2021

Russian Covid-19 vaccine allowed in Pakistan

Top Story

January 24, 2021

KARACHI: Pakistani health authorities have granted emergency use authorization to Russian COVID-19 vaccine, Gam-COVID-Vac or Sputnik V to be used in Pakistan, hoping that the first shipment of the vaccine would reach Pakistan by the end of current month, The News has learnt.

In all likelihood, double dose of Sputnik V in Pakistan would cost double the rates at which it is available in India. “The registration board of the Drug Regulatory Authority of Pakistan (DRAP) in its 299th meeting on Friday, granted emergency use authorization to Russian made COVID-19 vaccine Gam-COVID-Vac, whose trade name is Sputnik V. A local pharmaceutical firm, AGP Limited had applied for registration, marketing and distribution of the vaccine in Pakistan,” an official of the DRAP told The News on Saturday.

Pakistani authorities have already granted emergency use authorization to one of the vaccines developed by China’s state-owned Sinopharm as well as to British-Swedish vaccine manufacturer Oxford-AstraZeneca’s AZD1222/Covisheild vaccine but so far none of the vaccines have been supplied to the country where around 11,000 people have lost their lives due to the pandemic.

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.

“The decision to grant Emergency Use Authorization was announced by the registration board of the Drug Regulatory Authority of Pakistan during its meeting being held at 4:00pm yesterday (Friday) following which, the first shipment of the vaccine is expected to reach Pakistan by next week”, the official added.

The vaccine, developed by M/s Gamaleya National Center of Epidemiology and Microbiology, with support from the Russian Direct Investment Fund, a sovereign fund of the Russian Federation, has been approved in 11 countries, including Russia, Argentina, Hungary and UAE and registration in the European Union has also been filed.

The Phase III study comprising data of 19,866 subjects of which 10.8pc were elderly aged 60 years and above determined that the vaccine has a good safety profile with efficacy of over 91pc, with complete protection against severe cases of COVID-19.“All parameters of the vaccine including its efficacy, immunogenicity and safety were found to be acceptable even across the elderly age group”, the DRAP official added.

To a query, the official said the importer has assured the authorities to make the first shipment of vaccine available in Pakistan within next 7-10 days, adding that the first shipment of the vaccine would hopefully comprise 50,000 doses.