Around the world, several pharmaceutical research groups have undertaken the development of vaccines for the pandemic produced by SARS-CoV-2. The global health emergency caused by the pandemic made the scientific community to pool resources for the development of vaccines against COVID-19.
The process of research, creation and approval of a vaccine usually takes several years, so the FDA has granted an authorization for emergency use (EUA) in order to accelerate its distribution worldwide. The process of creating a vaccine is based on the preclinical and clinical phases, in which safety, efficacy and immunogenicity are analyzed; however, the manufacturing of the vaccine is not enough and its pharmacosurveillance is critical.
Our latest project, it’s a Chinese Biotech sponsored Phase III multicentric trial for a SARS-COV2 vaccine. This CHO cell vaccine has been jointly developed with the Microbiology Institute of the Chinese Academy of Sciences (IMCAS), Ecuador was selected in the country mix alongside countries like China, Indonesia, Pakistan and Uzbekistan
Accuracy Research. Health Consulting & Clinical Research Office was designated by the sponsor as its legal and technical representative in Ecuador, responsible for study’s Startup, Regulatory Affairs, Clinical Operations, Logistics and full Quality Assurance processes.
This study was approved by the ethics committee of Universidad San Francisco de Quito (USFQ-CEISH) and the National Regulatory Agency (ARCSA).
In Ecuador, the clinical trial “Phase III randomized, double-blind, placebo-controlled Clinical Study to determine the efficacy and safety of sponsor vaccine ZF2001, a new recombinant coronavirus (CHO cell) vaccine for people over 18 years of age, 2021-2022” started the participant recruitment in mid-March 2021. This screening process had a great reception with 7,450 subjects across 3 sites in Ecuador’s main two cities (Quito & Guayaquil), recruiting 5308 voluntaries who complied the inclusion/exclusion criteria. At the moment, 4630 subjects continue in the study (13% Drop-Out rate).
Our organization has been carrying out the development of this study with a local SMO. Our trained CRAs and multidisciplinary support team guarantee the verification and accuracy of input data and site performance according to Good Clinical Practices (GCP). The study was inspected by ARCSA and the Chinese National Medical Products Administration (NMPA) with satisfactory results.
On July 2021, the interim data analysis from this study demonstrated excellent safety and efficacy results. This vaccine obtained a conditional marketing authorization in individuals aged 18 years and older by the NMPA in China (PAHO site)
