Chinese pharma offers to conduct clinical trials of Covid-19 vaccine in Pakistan
A major Chinese pharmaceutical company has invited the National Institute of Health (NIH), Islamabad, to collaborate in conducting clinical trials of its recently developed inactivated vaccine for Covid-19 in Pakistan, it emerged on Wednesday.
The offer was made in a letter sent to NIH Executive Director Maj Gen Dr Aamer Ikram by the general manager of China Sinopharm International Corp., Li Can, who expressed the hope that “a successful clinical trial in Pakistan will make it one of [the] first few countries for the launch of a Covid-19 vaccine”.
While confirming that he had received the letter on Wednesday, Dr Ikram told Dawn. com that although no action has so far been taken, the collaboration could be “a great thing for Pakistan”.
“We want to increase the trend of clinical trials in the country. There are a number of laws before it can start; it has to be approved by the ethics committee, et al, but we will start when we get the clearance,” he added. According to Dr Ikram, the benefit from the clinical trials being held in Pakistan will be that if the vaccine proves to be successful, the country will be able to procure it on a high-priority basis.
NIH is an autonomous organisation that functions under the ministry of national health services.
The letter, a copy of which has been seen by Dawn.com, stated that Sinopharm is one of the first organisations to have led the development of a vaccine for the novel coronavirus. A state-owned enterprise, Sinopharm produces more than 80 per cent of the mandatory immunisation needs of China and played a leading role in fighting the Covid-19 crisis in the country.
“In the process we developed a lot of practical insights that we would like to share with you,” reads the letter written to the NIH chief, noting that the two organisations have already been collaborating regarding vaccine development in Pakistan.
It said that regulatory authorities worldwide have initiated emergency protocols to facilitate clinical trials and early introduction of a Covid-19 vaccine. In China, Phase I and II of the clinical trials have been combined to speed up the process.
The Chinese pharma recommended that Pakistan adopt a similar approach through the Drug Regulatory Authority of Pakistan (Drap).
Endeavour of `utmost importance’
It noted that the NIH has the necessary technical expertise and elements for conducting clinical trials on recruited participants through a nominated medical institution. In order to achieve this, the letter proposed that Sinopharm, its representative HealthBee Projects Private Limited and the NIH enter into a tripartite memorandum of understanding (MoU) “urgently to plan and commence the implementation of these Phase I and II combined clinical trials”. Li Can noted that the signing of the agreement will enable Siopharm to share “more detailed confidential information for approvals and planning”.
While requesting NIH to facilitate the trials’ approval by the health ministry and
Drap, the company said it will “provide full support” in the provision of supporting documentation, distribution of trial-related funding, planning of logistics and submission of clinical trial dossier to Drap through HealthBee.
“We will work in close collaboration with [the] NIH clinical trial team during the processing for the success of the clinical trial as this endeavour is of utmost importance for our countries in accordance with the current pandemic situation,” the communique added.