PPC China’s Sophia Duan, writing in the January edition of DIA’s Global Forum magazine, details how the emergence of an effective pharmacovigilance ecosystem is helping to safeguard the rollout of COVID-19 vaccines in China.
Since the breakout of COVID-19, many pharmaceutical companies in China have worked to develop preventative vaccines. In response, China’s regulatory authority (RA), the National Medical Products Administration (NMPA), worked closely with the World Health Organization (WHO) and COVID-19 vaccine evaluation experts to establish a standard review system, release relevant clinical development and review guidelines, and provide 24/7 support to facilitate COVID-19 vaccine development. The NMPA has released seven relevant guidelines, including Technical Guidelines for the Development of COVID-19 Vaccine (Trial version), to guide, monitor, and accelerate the development of COVID-19 vaccines in China.
Scientific guidance from regulators has helped speed up development. As of December 2021, six COVID-19 vaccines developed by Chinese pharmaceutical/biotech companies have been authorized for urgent use or conditionally licensed after scientific assessments of all safety and efficacy data by the NMPA; two of these six have also been approved for emergency use by the WHO. By the end of October 2021, more than 2.2 billion COVID-19 vaccine doses were administered domestically, and the Chinese government had provided 1.5 billion vaccine doses to more than 100 countries and international organizations.
Development of COVID-19 vaccines is being fast-tracked in China. To ensure that safety standards are not compromised by fast-track development, the NMPA has consistently worked to enhance safety monitoring to ensure that vaccine candidates have a solid quality and safety profile, and that the benefits of vaccination far outweigh the risks both during clinical trials and post-marketing (after authorization or approval). This rapid development may be attributed to the innovation and due diligence of safety monitoring and risk management applied to COVID-19 vaccine clinical trials by China’s RA in partnership with China’s pharmaceutical/biotech companies.
To maintain the safety and quality of these trials, the NMPA’s Center for Drug Evaluation (CDE) requests that COVID-19 vaccine clinical trial sponsors establish a comprehensive safety monitoring and risk management (pharmacovigilance) system, establish a data and safety monitoring board (DSMB) or data monitoring committee (DMC), develop plans for risk control and long-term safety follow-up, and enhance communication of safety information with RAs, healthcare professionals, and trial participants. Sponsors are also strongly advised to report trial progress, in particular daily enrollment status and results from early phase trials, to the CDE in a timely (expedited) manner.