A Chinese pharmaceutical company asked the National Institute of Health (NIH) to join hands for initiation of clinical testing of a potential coronavirus vaccine, local media reported. The Chinese company, ‘Sinopharm’, proposed that the clinical trials of its ‘inactive COVID-19 vaccine’ would be conducted in Pakistan for the mutual benefit of both countries.
The pharmaceutical company, in its letter to the NIH, said that “A successful clinical trial in Pakistan will make it one of [the] first few countries for the launch of a COVID-19 vaccine.” However, experts believe that the authorities in Pakistan have to be careful before they take any decision regarding clinical testing of the coronavirus vaccine. There can be serious complications if proper protocols are not in place, they warned.
NIH Executive Director Maj Gen Dr Aamer Ikram told local media that no progress was made so far, albeit, it would be a good thing for Pakistan if the trials would take place. Dr Ikram said that there were several hurdles before the trials could begin in the country and that prior approval of the board of the ethics was needed, the publication stated.
The company believes that the task is of utmost importance. “We will work in close collaboration with [the] NIH clinical trial team during the processing for the success of the clinical trial of coronavirus vaccine as this endeavour is of utmost importance for our countries in accordance with the current pandemic situation,” Sinopharm added.
The letter further said that “PRC (Peoples Republic of China), Phase-I and Phase-II for the clinical trial have been combined. We recommend and hope that Pakistan will adopt a similar approach through its regulatory authority. We hope that a 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 the 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 any potential unreasonable risk that can be avoided.
“Data is required to evaluate the theoretical risk for vaccine-induced conditions, which may be worse if a subject catches infection in real-time during the 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 to previous correspondence through the embassy of PRC with Maj. Gen Dr Aamir Ikram at National Institute of Health (NIH), Sinopharm considers that NIH has the necessary technical expertise and elements for conducting the clinical trial on recruited participants, through a nominated medical institution, under Phase-I and II protocol requirements 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 Phase I and II combined clinical trials. This will enable Sinnopharm to share more detailed confidential information for approvals and planning.