ISLAMABAD - The National Institute of Health (NIH) in collaboration with China has decided to conduct clinical trials of inactivated novel coronavirus (COVID-19) vaccines in the country, The Nation learnt on Wednesday.
Meanwhile, expert on vaccines stressed upon open trial and data sharing as non-implementation on trials protocol could be dangerous for healthy individuals picked for the trial.
Executive Director (ED) NIH Maj. General Prof. Aamer Ikram and General Manager China Sinopharm International Corporation in this regard held a correspondence for the clinical trials and agreed for expediting the documentation to start the process.
“We will be part of clinical trial with China,” said ED NIH Maj Gen Aamer Ikram to The Nation. In a letter written to the Sinopharm International, ED NIH said that that “our two organizations have already been collaborating in vaccine development in Pakistan. Through our representative HealthBee projects private limited, we would like to extend our offer for cooperation on conducting clinical trials of our recently developed inactivated Covid-19 vaccine to the National Institute of Health in our brotherly country, Pakistan”.
Sinopharm, HealthBee and NIH finalising agreements to kick start trials
The letter said that “PRC (Peoples Republic of China), Phase-I and Phase –II for clinical trial have been combined. We recommend and hope that Pakistan will adopt a similar approach through its regulatory authority. We hope that successful clinical trial in Pakistan will make it one of the few countries for the launch of Covid-19 vaccine”.
However, a pharmacist and former secretary biological drugs of DRAP Dr. Obaid Ali viewed that disclosure of preclinical data to demonstrate safety of human trial should be the first priority. He said that preclinical and clinical risk mitigation strategies need to be in place, so that those enrolled in clinical trials may not experience to any potential unreasonable risk that can be avoided.
“Data is required to evaluate theoretical risk for vaccine-induced conditions, which may be worse if subject catches infection in real time during trial,” he said.
Meanwhile the GM China Sinopharm International Corporation Li Can, writing to NIH about the tripartite Memorandum of Understanding (MoU) said that with reference of previous correspondence through the embassy of PRC with Maj. Gen Dr. Aamir Ikram at National Institute of Health (NIH), Sinophrm considers that NIH has the necessary technical expertise and elements for conducting the clinical trial on recruited participants, through a nominated medical institutions, under Phase-I and II protocol requirements and as per clinical trial guidelines.
It said that in order to achieve the objective, we recommend that Sinopharm, HealthBee and NIH enter into tripartite MOU urgently to plan and commence the implementation of these Phase I and II combined clinical trials. This will enable Sinnopharm to share more detailed confidential information for approvals and planning.
It also said that NIH is requested to first kindly facilitate the approval of the Ministry of National Health Services and Drug Regulatory Authority of Pakistan (DRAP) for the clinical trial. We believe that the MOU will expedite the local documentation, regulatory approvals process as well as help clearly identify the roles of various entities involved.
“Given the escalating spread of the pandemic, urgency is critical to the launch of any clinical trial in Pakistan and the subsequent introduction of the vaccine in Pakistan,” said the letter.
It further said that through our representative HealthBee Projects Private Limited we will provide full support in the provision of the supporting/regulatory documentation, distribution of trial related funding, planning of logistics, and submission of clinical trial dossier to DRAP.
It added “we will work in collaboration with MIH clinical trial team and during the processing for the success of clinical trials as this endeavour is of utmost importance for our countries in accordance with the current pandemic situation”.
The letter said will be grateful if an in-principal approval for our cooperation can be provided to us before progressing further. We look forward for your kind support and urgent response, after consulting the relevant ministries of the government of Pakistan