To date, five coronavirus disease 2019 (COVID-19) vaccines have been conditionally approved for market authorization or granted emergency use authorization in China by the National Medical Products Administration (NMPA). Three inactivated COVID-19 vaccines and one adenovirus-vectored vaccine were granted conditional approval, as phase Ⅲ clinical trial data for these four conditionally-approved vaccines have demonstrated protective efficacy levels that meet requirements of NMPA’s Guidelines for Clinical Evaluation of COVID-19 vaccine (interim version) and also meet requirements recommended by the World Health Organization (WHO) in their COVID-19 Vaccines Target Product Profile. Adverse event surveillance data from clinical trials, emergency use, and large-scale vaccination of key populations have demonstrated that the approved COVID-19 vaccines have excellent safety profiles. One recombinant subunit COVID-19 vaccine was approved for emergency use, as phase Ⅱ clinical trial results showed good immunogenicity and safety of the recombinant subunit COVID-19 vaccine (CHO cell).
Based on clinical trial data of the NMPA-approved domestic vaccines and the epidemiological characteristics of COVID-19, the COVID-19 Vaccine Technical Working Group of China CDC drafted technical vaccination recommendations. The National Immunization Advisory Committee (NIAC) reviewed, discussed, and refined the recommendations. The National Health Commission accepted and published these recommendations (1).
These recommendations can be used by health departments and disease control institutions at all levels in China to guide COVID-19 vaccination.