SARS-CoV-2 immunity: review and applications to phase 3 vaccin | 🦠 Infecciones virales por Coronavirus, Ebola, Influenza, Zika, VIH.✨

SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates : Part VI

Sinopharm
Sinopharm; Wuhan Institute of Biological Products | Inactivated virus | BBIBP-CorV | The United Arab Emirates; Bahrain; Peru; Morocco; Argentina; Jordan
Sinopharm have developed and are testing two inactivated whole-virus, alum-adjuvanted vaccines. The first vaccine candidate (New Crown COVID-19) was developed by the Wuhan Institute of Biological Products. Both phase 1 and 2 study data have been published.74 The phase 1 trial (n=96) examined a three-dose series, and the phase 2 trial (n=224) studied a 5 µg dose across two study groups: vaccination on day 0 and day 14 (n=84) versus alum only (n=28), or vaccination on day 0 and day 21 (n=84) versus alum only (n=28). This trial included adults aged 18–59 years. The phase 2 trial did not include any comparator, such as convalescent human plasma, but did measure neutralising antibody titres, which were generally similar in concentration to those produced by other COVID-19 vaccines and were higher in the group vaccinated on days 0 and 21 (geometric mean titre 247, 95% CI 176–345) than in the group vaccinated on days 0 and 14 (121, 95–154). In addition, lymphocyte cell subsets and cytokines were measured by flow cytometry and did not show changes across study groups, suggesting that cellular immune responses might not have been generated. The safety profile of this vaccine was excellent, with local and systemic reactions generally on par with those in the alum-only group of the study. A phase 1/2 clinical trial of individuals 6 years and older has also been initiated. A phase 3 clinical trial began in July, 2020, and plans to enrol 21 000 participants in the United Arab Emirates, Bahrain, Peru, Morocco, Argentina, and Jordan. In late August, 2020, Sinopharm researchers revealed that they had already begun to administer the vaccine to health-care personnel and groups at high risk of becoming infected. The second vaccine candidate being tested by Sinopharm was developed by the Beijing Institute of Biological Products. A phase 3 trial (n=5000) is taking place in the United Arab Emirates (table). The United Arab Emirates has granted emergency use of the vaccine in health-care providers. Sinopharm have reportedly administered these experimental vaccines to hundreds of thousands of people under an emergency use condition approved by the Chinese Government.