Abstract
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).
Highlights
SARS-CoV-2 was first reported, in late 2019, in humans in Wuhan (China); the virus is believed to have been transmitted to humans from an unknown animal reservoir [1,2,3].Since the virus has spread worldwide; as of 1st December 2020, >63.5 million people have been infected with the virus, with >1.4 million deaths [4]
SARS-CoV-2 is suspected to have evolved from a bat coronavirus, RaTG13 [5]; the spike protein of SARS-CoV-2 is 97.4% identical to that of RaTG13, while it is only 76% and ~35% identical to that of SARS-CoV and the middle east respiratory syndrome (MERS) coronavirus, respectively
BNT162b2 was developed by Pfizer and BioNTech and it is composed of an mRNA of the full length of the spike protein encapsulated in a lipid nanoparticle
Summary
SARS-CoV-2 was first reported, in late 2019, in humans in Wuhan (China); the virus is believed to have been transmitted to humans from an unknown animal reservoir [1,2,3]. The FDA has issued an emergency use authorization (EUA) for an investigational neutralizing monoclonal antibody (bamlanivimab) to treat COVID-19 patients in the same age/weight category [20]. The monoclonal antibody targets the spike protein and prevents binding/entry of the virus into the cell. COVID-19 [21,22,23,24] are currently being used to treat patients with SARS-CoV-2 (in early stages of the disease) worldwide. Two. SARS-CoV-2 candidate vaccines (BNT162b2 and mRNA-1273) have recently been granted an EUA after phase II/III trials; BNT162b2 and mRNA-1273 have been granted an EUA in the U.S [25,26]. Other SARS-CoV-2 candidate vaccines are under phase III trials.
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