ISLAMABAD: With some 40,000 people participating in the process, the National Command and Operation Centre (NCOC) on Tuesday announced the launch of phase 3 clinical trials in Pakistan for a potential vaccine being developed by China’s CanSino Biologics to cure the coronavirus.
Trials for phase 1 and 2 for Ad5-nCoV were held in China. Pakistan, under a public-private partnership between the National Institute of Health (NIH) and pharmaceutical company AJM — the local representative of CanSino — is among the countries which will carry out phase 3, a statement issued by the NCOC said.
Refuting rumors that a falling infection rate in Pakistan will affect the trial, the Drug Regulatory Authority of Pakistan, the country’s drug regulator, last month gave the go-ahead for the country’s first phase 3 clinical trial for CanSino’s candidate.
According to Minister for Planning, Development and Special Initiatives Asad Umar, of the total participants, about 8,000 to 10,000 will be from Pakistan. He said the initial results of the trial are expected in four to six months.
Addressing a press conference alongside National Institutes of Health head Major General Aamer Ikram on Tuesday, Special Assistant to the Prime Minister on Health Dr Faisal Sultan termed the trial an “important step” in which Pakistanis would also take part.
Gen Ikram said it was an “honour” for the country that it was participating in the phase 3 trial of a vaccine for the first time.
“The entire world is looking towards a vaccine right now. There are seven vaccines for which trials are being conducted — three of them developed in China. This CanSino vaccine is based on recombinant technology in which an adino-vector is made deficient. The virus vector and cell culture has been procured from Canada,” he said.
Speaking about how the study is conducted, he said that in the pre-clinical phase, the vaccine is tried on animals. “This was done in China at the start of the year. It was safe and immunogenic.
“Then there is a phase 1 trial which was again conducted in China and its results were good. In this phase, the safety and efficacy [of the vaccine] on the human body is looked at.
“The phase 2 trial was conducted on 508 people — which is considered a big trial — and when the results were found to be good, [the study] was published in scientific journals,” he said.
He added that the technology for the CanSino vaccine was similar to that of the Oxford vaccine being developed by AstraZeneca. A chimpanzee adino-vector was used in the AstraZeneca vaccine while a human adino-vector was used for this vaccine, he disclosed.
He said the phase 3 trial was the biggest and most difficult stage. “[The NIH] has accepted this challenge and we are grateful to the patronage of the NCOC and the Ministry of Health.”
He said that the trials have been launched from today and 8,000 to 10,000 volunteers would be inducted through a formal system.
A medical examination of the volunteers would be carried out after which the vaccine would be administered to them. Ikram added that the NIH would follow up with them for 12 months but the results of the vaccine would be expected in three months.
The vaccine would be available in the market in five to six months once its results were analysed and it was approved, said Ikram.
“This is the vaccine that has already been approved and is being administered to army officials and policemen in China. Therefore, its safety is ensured,” he concluded.