ISLAMABAD: In a major development on Monday, the Drug Regulatory Authority of Pakistan (Drap) gave a nod to holding clinical trial of Covid-19 vaccine in the country.

According to a document, signed by Drap Clinical Studies Committee secretary Shafqat Hussain Danish, and available with Dawn, the committee recommended that the trial be held in Indus Hospital, Karachi.

This test will be carried out by the International Centre for Chemical and Biological Sciences, Karachi, in collaboration with a Chinese company already conducting trials in China.

As many as 200 volunteers from Karachi, representing various ethnic groups, have been registered. The trial will be completed in 56 days during which three injections of inactivated virus will be administered to the volunteers — both male and female.

The document said the National Data Safety Monitoring Committee will closely monitor the safety of the patients and submit reports on a monthly basis.

200 volunteers from Karachi to participate in test

A Drap official, not authorised to speak on record, said it was a major development as, in case of a successful trial, the vaccine would become available to people.

“Though vaccines are being prepared in different countries, we cannot surely say whether we will get them as there will be high demand for the vaccines across the globe. If this trial is successful, the vaccine will be easily available to us at affordable rates,” the official said.

Minister for Planning, Development and Special Initiatives Asad Umar, who also heads the National Coordination and Operation Centre on Covid-19, said he was hopeful that the trials on the vaccine would be successful.

“It is one of the potential vaccines which can become successful,” he added.

Mr Umar said Pakistan was unable to participate in the phase-III trials held in different countries. However, he added, an opportunity had finally been created wherein volunteers could participate in the trials within the country.

The phase-III clinical trial is designed to evaluate whether an investigational vaccine can prevent symptomatic Covid-19 among adults.

On March 24, Minister for Science and Technology Fawad Chaudhry had constituted a committee — Scientific Task Force on Covid-19 — which was headed by renowned scientist Prof Dr Attaur Rehman.

Its other members are University of Health Sciences Vice Chancellor Prof Dr Javed Akram, Dr Ghazna Khalid, Prof Al Fareed Zafar, Prof Iqbal Chaudhry, Prof Dr Khalid Khan and Prof Mariam Riaz Tarar.

One of the committee members, requesting not to be quoted, said: “The trial will commence from next week which will be participated by 200 volunteers, all over 18 years of age. We have selected volunteers from various ethnic groups to analyse their results. I believe Karachi is the most appropriate city as people from all backgrounds are settled there.”

He said inactivated virus would be injected in each volunteer on zero day, day 28 and on the 56th day after which they would be tested for antibodies.

“An amount of Rs50,000 will be paid to each volunteer. After completion of the trial, we will move to other cities of the country,” he added.

When asked about the side effects of the vaccine, the committee member said though its safety profile was very good, every medicine had a side effect in one per cent cases with mild fever, tiredness, headache or allergy.

“These are mild symptoms and people should know that even the committee members are willing to volunteer themselves for the trial. We are taking part in global efforts against Covid-19. Moreover, as we are passing through the ‘fifth generation warfare’ phase, the trial will build a positive image of Pakistan,” the committee member added.

Meanwhile, according to a statement issued by the National Institute of Health (NIH), this would be the first-ever phase-III clinical trial for any vaccine in Pakistan.

Recombinant Novel Coronavirus Vaccine Adenovirus Type 5 vector (Ad5-nCoV) has been developed by CanSinoBio and Beijing Institute of Biotechnology China.

“It is a multi-country multi-centre clinical trial which CanSinoBio is already conducting in China, Russia, Chile, Argentina and will shortly start in Saudi Arabia. The principal investigator of the multi-centre clinical trial in Pakistan is NIH executive director Maj Gen Aamer Ikram,” the statement said.

It added: “AJM Pharma CEO Adnan Hussain signed an agreement with the NIH last month for collaborating on the phase-III clinical trial of CanSinoBIO Ad5-nCoV in Pakistan. The study will be conducted in prestigious medical research centres in the country — Aga Khan Medical University, Karachi; Indus Hospital, Karachi; Shaukat Khanum Memorial Hospital, Lahore; Shifa International Hospital, Islamabad, and UHS Lahore.”

Published in Dawn, August 18th, 2020