Lead SARS-CoV-2 Candidate Vaccines: Expectations from Phase III Trials and Recommendations Post-Vaccine Approval

• Published in: Viruses Vol. 13; no. 1; p. 54
• Main Author: Tumban, Ebenezer
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 31.12.2020; MDPI
• Subjects: 2019-nCoV Vaccine mRNA-1273; ACE2; Angiotensin; Angiotensin-converting enzyme 2; Antibodies, Neutralizing - immunology; BNT162 Vaccine; Canada; Clinical trials; Clinical Trials as Topic; Clinical Trials, Phase III as Topic; Clinical Trials, Phase IV as Topic; Coronaviruses; COVID-19; COVID-19 - prevention & control; COVID-19 Vaccines; Drug Approval; Epithelial cells; Europe; FDA approval; Humans; Immunization; Minority & ethnic groups; mRNA; mRNA Vaccines; Peptidyl-dipeptidase A; Review; SARS-CoV-2; SARS-CoV-2 vaccines; Severe acute respiratory syndrome coronavirus 2; Spike Glycoprotein, Coronavirus - immunology; Spike protein; United Kingdom; United States; Vaccines; Vaccines, Synthetic; Canada; United Kingdom; United States; Europe; Saudi Arabia; United Arab Emirates; United Kingdom > UK; United States > US; COVID-19; SARS-CoV-2; clinical trials; SARS-CoV-2 vaccines
• ISSN: 1999-4915; 1999-4915
• DOI: 10.3390/v13010054

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted primarily through respiratory droplets/aerosols and it causes COVID-19. The virus infects epithelial cells by using the spike protein on its surface to bind to angiotensin-converting enzyme 2 receptor on the cells. Thus, candidate vaccines targeting the spike protein are currently being developed to prevent against infections. Approximately 44 SARS-CoV-2 candidate vaccines are in clinical trials (phase I-III) and an additional 164 candidates are in preclinical stages. The efficacy data from phase I/II trials of lead candidate vaccines look very promising with virus-neutralizing geometric mean antibody titers in the range of 16.6-3906. Most recently, two SARS-CoV-2 candidate vaccines, BNT162b2 and mRNA-1273, have been granted the first emergency use authorization (EUA) in the U.S.; BNT162b2 has also been granted an EUA in the United Kingdom, Canada, and in the European Union. This review assesses whether SARS-CoV-2 candidate vaccines (with approved EUA or in phase III trials) meet the criteria for an ideal SARS-CoV-2 vaccine. The review concludes with expectations from phase III trials and recommendations for phase IV studies (post-vaccine approval).