Safety, efficacy, and immunogenicity of COVID-19 vaccines; a systematic review

References

• Huang P, Liu T, Huang L, et al. Use of chest CT in combination with negative RT-PCR assay for the 2019 novel coronavirus but high clinical suspicion. Radiology. 2020;295(1):22–23.
   PubMed Web of Science ®Google Scholar
• Phan L, Nguyen T, Luong Q, et al. Importation and human-to-human transmission of a novel coronavirus in Vietnam. N Engl J Med. 2020;382(9):872–874.
   PubMed Web of Science ®Google Scholar
• Organization WH. COVID-19 pandemic; 2020. Available from: https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19–-11-march-2020
   Google Scholar
• WHO coronavirus disease (COVID-19) dashboard. Available from: https://covid19.who.int/
   Google Scholar
• Guarner J. Three emerging coronaviruses in two decades: the story of SARS, MERS, and now COVID-19. Clin Infect Dis. 2020;153(4):420–421.
   Google Scholar
• Rajgor D, Lee M, Archuleta S, et al. The many estimates of the COVID-19 case fatality rate. Lancet Infect Dis. 2020;395:497.
   Google Scholar
• Sun Q, Qiu H, Huang M, et al. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu province. Ann Intensive Care. 2020;10(1):1–4.
   PubMed Web of Science ®Google Scholar
• Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020;395(10226):809–815.
   PubMed Web of Science ®Google Scholar
• Singhal T. A review of coronavirus disease-2019 (COVID-19). Indian J Pediatr. 2020;87(4):281–286.
   PubMed Web of Science ®Google Scholar
• Tian S, Hu N, Lou J, et al. Characteristics of COVID-19 infection in Beijing. J Infect. 2020;80(4):401–404.
   PubMed Web of Science ®Google Scholar
• Jiang S, Hillyer C, Du L. Neutralizing antibodies against SARS-CoV-2 and other human coronaviruses. Trends Immunol. 2020;41:355.
   PubMed Web of Science ®Google Scholar
• Guo Y-R, Cao Q-D, Hong Z-S, et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak–an update on the status. Military Med Res. 2020;7(1):1–10.
   PubMed Web of Science ®Google Scholar
• Fehr AR, Perlman S. Coronaviruses: an overview of their replication and pathogenesis. Coronaviruses. New York (NY): Springer; 2015. p. 1–23.
   Google Scholar
• Walls AC, Park Y-J, Tortorici MA, et al. Structure, function, and antigenicity of the SARS-CoV-2 spike glycoprotein. Cell. 2020;183(6):1735.
   PubMed Web of Science ®Google Scholar
• Jayaweera M, Perera H, Gunawardana B, et al. Transmission of COVID-19 virus by droplets and aerosols: a critical review on the unresolved dichotomy. Environ Res. 2020;188:109819.
   PubMed Web of Science ®Google Scholar
• Umakanthan S, Sahu P, Ranade AV, et al. Origin, transmission, diagnosis, and management of coronavirus disease 2019 (COVID-19). Postgrad Med J. 2020;96(1142):753–758.
   PubMed Web of Science ®Google Scholar
• Li Q, Guan X, Wu P, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus–infected pneumonia. N Engl J Med. 2020;382(13):1199–1207.
   PubMed Web of Science ®Google Scholar
• Tang B, Bragazzi NL, Li Q, et al. An updated estimation of the risk of transmission of the novel coronavirus (2019-nCov). Infect Dis Model. 2020;5:248–255.
   PubMedGoogle Scholar
• Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507–513.
   PubMed Web of Science ®Google Scholar
• Abebe EC, Dejenie TA, Shiferaw MY, et al. The newly emerged COVID-19 disease: a systemic review. Virol J. 2020;17(1):96.
   PubMed Web of Science ®Google Scholar
• Ong E, Wong MU, Huffman A, et al. COVID-19 coronavirus vaccine design using reverse vaccinology and machine learning. Front Immunol. 2020;11:1581.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Pfizer-BioNTech COVID-19 vaccine emergency use authorization. Silver Spring (MD): US Department of Health and Human Services, Food and Drug Administration; 2020. Available from: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine
   Google Scholar
• Oliver SE, Gargano JW, Marin M, et al. The advisory committee on immunization practices' interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine – United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1922–1924.
   PubMed Web of Science ®Google Scholar
• Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html
   Google Scholar
• Voysey M, Clemens SA, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397(10269):99–111.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines are currently authorized in the United States; 2021.
   Google Scholar
• Corbett KS, Edwards DK, Leist SR, et al. SARS-CoV-2 mRNA vaccine design enabled by prototype pathogen preparedness. Nature. 2020;586(7830):567–571.
   PubMed Web of Science ®Google Scholar
• Hernández-Bello J, Morales-Núñez JJ, Machado-Sulbarán AC, et al. Neutralizing antibodies against SARS-CoV-2, anti-Ad5 antibodies, and reactogenicity in response to Ad5-nCoV (CanSino biologics) vaccine in individuals with and without prior SARS-CoV-2. Vaccines. 2021;9(9):1047.
   Web of Science ®Google Scholar
• Available from: https://ncoc.gov.pk/sop/vac/20210503%20Guidelines%20for%20Cansino%20Bio%20Vaccine-5902.pdf
   Google Scholar
• Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
   PubMed Web of Science ®Google Scholar
• BioNTech SE. Study to describe the safety, tolerability, immunogenicity, and efficacy of RNA vaccine candidates against COVID-19 in healthy individuals. ClinicalTrials.gov: NCT04368728; 2020.
   Google Scholar
• Available from: https://clinicaltrials.gov/ct2/show/record/NCT04324606
   Google Scholar
• AstraZeneca, Iqvia Pty Ltd. Phase III double-blind, placebo-controlled study of AZD1222 for the prevention of COVID-19 in adults. 2020.
   Google Scholar
• Pollard AJ. A randomized controlled, phase III study to determine the safety, efficacy, and immunogenicity of the non-replicating ChAdOx1 nCoV-19 vaccine. 2020.
   Google Scholar
• ModernaTX A. A study to evaluate the efficacy, safety, and immunogenicity of the mRNA-1273 vaccine in adults aged 18 years and older to prevent COVID-19. ClinicalTrials. Gov; 2020.
   Google Scholar
• ClinicalTrials.gov. Safety and immunogenicity study of 2019-nCoV vaccine (mRNA-1273) for prophylaxis of SARS-CoV-2 infection (COVID-19). 2020.
   Google Scholar
• Available from: https://clinicaltrials.gov/ct2/show/NCT04813796?term=safety±and±immunogenicity±study±of±2019-nCoV±vaccine±%28mRNA-1273%29±to±prevent±SARS-CoV-2±infection&draw=2&rank=3
   Google Scholar
• Petrovax NP. Clinical trial of recombinant novel coronavirus vaccine (adenovirus type 5 vector) against COVID-19. 2020.
   Google Scholar
• Available from: https://clinicaltrials.gov/ct2/show/NCT04526990
   Google Scholar
• Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine. N Engl J Med. 2020;383(27):2603–2615.
   PubMed Web of Science ®Google Scholar
• Frenck RW Jr., Klein NP, Kitchin N, et al. Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents. N Engl J Med. 2021;385(3):239–250.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Baillie V, Cutland CL, et al. Efficacy of the ChAdOx1 nCoV-19 covid-19 vaccine against the B. 1.351 variant. N Engl J Med. 2021;384(20):1885–1898.
   PubMed Web of Science ®Google Scholar
• Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403–416.
   PubMed Web of Science ®Google Scholar
• Walsh EE, Frenck RW Jr., Falsey AR, et al. Safety and immunogenicity of two RNA-based covid-19 vaccine candidates. N Engl J Med. 2020;383(25):2439–2450.
   PubMed Web of Science ®Google Scholar
• Ramasamy MN, Minassian AM, Ewer KJ, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomized, controlled, phase 2/3 trial. Lancet. 2020;396(10267):1979–1993.
   PubMed Web of Science ®Google Scholar
• Folegatti PM, Ewer KJ, Aley PK, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomized controlled trial. Lancet. 2020;396(10249):467–478.
   PubMed Web of Science ®Google Scholar
• Anderson EJ, Rouphael NG, Widge AT, et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. N Engl J Med. 2020;383(25):2427–2438.
   PubMed Web of Science ®Google Scholar
• Chu L, McPhee R, Huang W, et al. mRNA-1273 study group. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021;39(20):2791–2799.
   PubMed Web of Science ®Google Scholar
• Zhu FC, Li YH, Guan XH, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomized, first-in-human trial. Lancet. 2020;395(10240):1845–1854.
   PubMed Web of Science ®Google Scholar
• Zhu FC, Guan XH, Li YH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020;396(10249):479–488.
   PubMed Web of Science ®Google Scholar
• Available from: http://www.prisma-statement.org/PRISMAStatement/FlowDiagram
   Google Scholar