ISLAMABAD: While the number of active cases of the novel coronavirus (Covid-19) has again started rising, in a major development the country started clinical trials of a vaccine on Tuesday.

Special Assistant to the Prime Minister (SAPM) on Health, Dr Faisal Sultan, who was accompanied by the Executive Director of National Institute of Health (NIH), Maj Gen Aamar Ikram, announced the launch of the clinical trial.

He said trials would be held in different cities and a vaccine prepared in collaboration with China would be used to monitor the development of antibodies.

Maj Gen Ikram told Dawn the trial had started from the federal capital.

“Islamabad’s Shifa International Hospital, Shaukat Khanum Memorial Cancer Hospital and the University of Health Sciences in Lahore, and the Aga Khan University and the Indus Hospital (in Karachi) have been collaborating for the clinical trial,” he said.

Minister says a total of 40,000 people across seven countries will participate in trial, including up to 10,000 in Pakistan

“The vaccine will be administered to 8,000-10,000 volunteers across the country. Volunteers will be over 18 years of age and most of them will be under the age of 60 years,” he said.

In reply to a question about the process of registration as a volunteer, he advised people to contact the hospitals conducting the clinical trials. Moreover, he added, people would soon be able to register themselves as volunteers through websites of the National Institute of Health and other hospitals.

“It is the first-ever phase III clinical trial in Pakistan and will be hailed as a great success if the vaccine is found to be effective. If the vaccine turns out to be effective, we will transfer the manufacturing technology from China to Pakistan as it will not be possible for any single country to meet the high demand.

“We have already installed a plant at NIH as manufacturing of vaccines is a multi-billion dollar industry,” he said.

The Drug Regulatory Authority of Pakistan (Drap) gave a nod to conducting clinical trials of Covid-19 vaccine last month.

According to a document signed by the secretary of Drap’s clinical studies committee, the body had given the go-ahead to trials last month.

An official of the Ministry of National Health Services said three injections of an inactivated virus would be administered to volunteers — both men and women — during the 56-day trial.

“The National Data Safety Monitoring Committee will closely monitor the patients’ safety and submit monthly reports. Although vaccines are being prepared in different countries, we cannot be sure whether we will get them as there will be a high demand across the globe.

“But if this trial is successful, the vaccine will be easily available to us at affordable rates,” the Ministry of Health Services official said.

On March 24, Science and Technology Minister Fawad Chaudhry had constituted a committee, known as Scientific Task Force on Covid-19. It was headed by Prof Dr Attaur Rehman, a well-known scientist.

One of the committee members said: “An amount of Rs50,000 will be paid to each volunteer. We will move to other cities of the country soon.”

Asked about side effects, the committee member said every medicine had a side effect in one per cent of the cases.

Highest number of tests

The National Command and Operation Centre (NCOC) on Covid-19 claimed that the highest number of tests in a single day — 36,155 — were conducted across the country on Tuesday.

The number of active Covid-19 cases, which had dipped below 7,000 last week, has again climbed above 7,000.

Agencies add: Pakistan launched Phase III clinical trials for CanSino Biologics’ Covid-19 vaccine candidate, according to a minister and an official at the Chinese pharmaceutical company.

The trial is being conducted by the government-run NIH and a pharmaceutical company, AJM, the local representative of CanSino, for the latter’s candidate, Ad5-nCoV.

“Just launched the Phase III trials for a Covid-19 vaccine in Pakistan,” said the minister for planning, Asad Umar, who also oversees command and control operations headed by the country’s military to combat the coronavirus outbreak.

He said a total of 40,000 people across seven countries will participate in the trial, including up to 10,000 in Pakistan. Initial results are expected in four to six months, the minister said in a tweeted statement.

The trial began at a hospital in Islamabad, where 20-25 subjects were expected to be enrolled daily, and will expand to several other cities in the coming days, Hassan Abbas Zaheer, who is heading the trial for AJM, told Reuters.

“Our team is there and they have told us a lot of people have turned up to participate, and it is very encouraging,” Zaheer said.

Published in Dawn, September 23rd, 2020