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 for the novel coronavirus.
Trials for phase 1 and 2 for the vaccine were held in China. Pakistan, under a public-private partnership between the National Institute of Health (NIH) and CanSino, is among the countries which will carry out phase 3, the NCOC statement said.
The country's drug regulator last month gave the go-ahead for the country’s first phase 3 clinical trial for CanSino’s candidate.
Planning, Development and Special Initiatives Minister Asad Umar said that 40,000 people will participate in the trial, which is being held in seven countries across the world. Around 8,000 to 10,000 of these will be from Pakistan, he said.
Umar said initial results of the trial are expected in four to six months.
Addressing a press conference alongside NIH Executive Director Maj Gen 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.
Maj 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 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.
Additional reporting by Naveed Siddiqui.