1932

Abstract

The rapid development and deployment of mRNA and adenovirus-vectored vaccines against coronavirus disease 2019 (COVID-19) continue to astound the global scientific community, but these vaccine platforms and production approaches have still not achieved global COVID-19 vaccine equity. Immunizing the billions of people at risk for COVID-19 in the world's low- and middle-income countries (LMICs) still relies on the availability of vaccines produced and scaled through traditional technology approaches. Vaccines based on whole inactivated virus (WIV) and protein-based platforms, as well as protein particle-based vaccines, are the most produced by LMIC vaccine manufacturing strategies. Three major WIV vaccines are beginning to be distributed widely. Several protein-based and protein particle-based vaccines are advancing with promising results. Overall, these vaccines are exhibiting excellent safety profiles and in some instances have shown their potential to induce high levels of virus neutralizing antibodies and T cell responses (and protection) both in nonhuman primates and in early studies in humans. There is an urgent need to continue accelerating these vaccines for LMICs in time to fully vaccinate these populations by the end of 2022 at the latest. Achieving these goals would also serve as an important reminder that we must continue to maintain expertise in producing multiple vaccine technologies, rather than relying on any individual platform.

Keyword(s): COVID-19immunizationproteinvaccinevirus
Loading

Article metrics loading...

/content/journals/10.1146/annurev-med-042420-113212
2022-01-27
2024-03-29
Loading full text...

Full text loading...

/deliver/fulltext/med/73/1/annurev-med-042420-113212.html?itemId=/content/journals/10.1146/annurev-med-042420-113212&mimeType=html&fmt=ahah

Literature Cited

  1. 1. 
    Hotez PJ, Narayan KMV. 2021. Restoring vaccine diplomacy. JAMA 325:232337–38
    [Google Scholar]
  2. 2. 
    Hotez P, Batista C, Ergonul O et al. 2021. Correcting COVID-19 vaccine misinformation. Lancet Commission on COVID-19 Vaccines and Therapeutics Task Force members. EClinicalMedicine 33:100780
    [Google Scholar]
  3. 3. 
    Sanders B, Koldijk M, Schuitemaker H 2014. Inactivated viral vaccines. Vaccine Analysis: Strategies, Principles, and Control BK Nunnally, VE Turula, RD Sitrin 45–80 Berlin/Heidelberg: Springer
    [Google Scholar]
  4. 4. 
    Adkins JC, Wagstaff AJ. 1998. Recombinant hepatitis B vaccine: a review of its immunogenicity and protective efficacy against hepatitis B. BioDrugs 10:2137–58
    [Google Scholar]
  5. 5. 
    Bucci M. 2020. First recombinant DNA vaccine for HBV. Nat. Portf. https://www.nature.com/articles/d42859-020-00016-5
    [Google Scholar]
  6. 6. 
    Liu R, Lin Q, Sun Y et al. 2009. Expression, purification, and characterization of hepatitis B virus surface antigens (HBsAg) in yeast Pichiapastoris. Appl. Biochem. Biotechnol. 158:2432–44
    [Google Scholar]
  7. 7. 
    Kumar R, Kumar P. 2019. Yeast-based vaccines: new perspective in vaccine development and application. FEMS Yeast Res 19:2foz007
    [Google Scholar]
  8. 8. 
    Jiang S, Zhang X, Yang Y et al. 2020. Neutralizing antibodies for the treatment of COVID-19. Nat. Biomed. Eng. 4:121134–39
    [Google Scholar]
  9. 9. 
    Bewley KR, Coombes NS, Gagnon L et al. 2021. Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays. Nat. Protoc. 16:63114–40
    [Google Scholar]
  10. 10. 
    Khoury DS, Cromer D, Reynaldi A et al. 2021. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat. Med. 27:1205–11
    [Google Scholar]
  11. 11. 
    Haynes BF, Corey L, Fernandes P et al. 2020. Prospects for a safe COVID-19 vaccine. Sci. Transl. Med. 12:568eabe0948
    [Google Scholar]
  12. 12. 
    Hotez PJ, Corry DB, Bottazzi ME 2020. COVID-19 vaccine design: the Janus face of immune enhancement. Nat. Rev. Immunol. 20:6347–48
    [Google Scholar]
  13. 13. 
    Hotez PJ, Corry DB, Strych U et al. 2020. COVID-19 vaccines: neutralizing antibodies and the alum advantage. Nat. Rev. Immunol. 20:7399–400
    [Google Scholar]
  14. 14. 
    Gao Q, Bao L, Mao H et al. 2020. Development of an inactivated vaccine candidate for SARS-CoV-2. Science 369:649977–81
    [Google Scholar]
  15. 15. 
    Wu Z, Hu Y, Xu M et al. 2021. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect. Dis. 21:6803–12
    [Google Scholar]
  16. 16. 
    Akova M, Unal S. 2021. A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial. Trials 22:1276
    [Google Scholar]
  17. 17. 
    Sinovac Biotech Ltd 2021. Sinovac announces phase III results of its COVID-19 vaccine News release, Feb. 5 Sinovac Biotech Ltd. Beijing, China: https://www.businesswire.com/news/home/20210205005496/en/Sinovac-Announces-Phase-III-Results-of-Its-COVID-19-Vaccine
  18. 18. 
    Zimmer C, Corum J, Wee S-L. 2020. Coronavirus vaccine tracker. N. Y. Times https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html. Accessed Sep. 20, 2021
    [Google Scholar]
  19. 19. 
    Jara A, Undurraga EA, González C et al. 2021. Effectiveness of an inactivated SARS-CoV-2 vaccine in Chile. N. Engl. J. Med. 385:10875–84
    [Google Scholar]
  20. 20. 
    Wang H, Zhang Y, Huang B et al. 2020. Development of an inactivated vaccine candidate, BBIBP-CorV, with potent protection against SARS-CoV-2. Cell 182:3713–21.e9
    [Google Scholar]
  21. 21. 
    Xia S, Zhang Y, Wang Y et al. 2021. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect. Dis. 21:139–51
    [Google Scholar]
  22. 22. 
    Colak E, Leslie A, Zausmer K et al. 2014. RNA and imidazoquinolines are sensed by distinct TLR7/8 ectodomain sites resulting in functionally disparate signaling events. J. Immunol. 192:125963–73
    [Google Scholar]
  23. 23. 
    Mohandas S, Yadav PD, Shete-Aich A et al. 2021. Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model. iScience 24:2102054
    [Google Scholar]
  24. 24. 
    Yadav PD, Ella R, Kumar S et al. 2021. Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques. Nat. Commun. 12:11386
    [Google Scholar]
  25. 25. 
    Ella R, Vadrevu KM, Jogdand H et al. 2021. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial. Lancet Infect. Dis. 21:5637–46
    [Google Scholar]
  26. 26. 
    Ella R, Reddy S, Jogdand H et al. 2021. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial. Lancet Infect. Dis. 21:7950–61
    [Google Scholar]
  27. 27. 
    Sapkal GN, Yadav PD, Ella R et al. 2021. Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B.1.1.7 variant of SARS-CoV-2. J. Travel Med. 28:4taab051
    [Google Scholar]
  28. 28. 
    Sapkal G, Yadav PD, Ella R et al. 2021. Neutralization of B.1.1.28 P2 variant with sera of natural SARS-CoV-2 infection and recipients of inactivated COVID-19 vaccine Covaxin. J. Travel Med. https://doi.org/10.1093/jtm/taab077
    [Crossref] [Google Scholar]
  29. 29. 
    Chen W-H, Wei J, Kundu RT et al. 2021. Genetic modification to design a stable yeast-expressed recombinant SARS-CoV-2 receptor binding domain as a COVID-19 vaccine candidate. Biochim. Biophys. Acta Gen. Subj. 1865:6129893
    [Google Scholar]
  30. 30. 
    Pollet J, Chen W-H, Versteeg L et al. 2021. SARS-CoV-2 RBD219-N1C1: a yeast-expressed SARS-CoV-2 recombinant receptor-binding domain candidate vaccine stimulates virus neutralizing antibodies and T-cell immunity in mice. Hum. Vaccin. Immunother. 17:8235666
    [Google Scholar]
  31. 31. 
    Lee J, Liu Z, Chen W-H et al. 2021. Process development and scale-up optimization of the SARS-CoV-2 receptor binding domain-based vaccine candidate, RBD219-N1C1. Appl. Microbiol. Biotechnol. 105:104153–65
    [Google Scholar]
  32. 32. 
    Valdes-Balbin Y, Santana-Mederos D, Quintero L et al. 2021. SARS-CoV-2 RBD-tetanus toxoid conjugate vaccine induces a strong neutralizing immunity in preclinical studies. Chem. Biol. 16:71223–33
    [Google Scholar]
  33. 33. 
    Gorry C. 2020. SOBERANA, Cuba's COVID-19 vaccine candidates: Dagmar García-Rivera PhD. MEDICC Rev 22:410–15
    [Google Scholar]
  34. 34. 
    Hsieh SM, Liu WD, Huang YS et al. 2021. Safety and immunogenicity of a recombinant stabilized prefusion SARS-CoV-2 spike protein vaccine (MVC-COV1901) adjuvanted with CpG 1018 and aluminum hydroxide in healthy adults: a phase 1, dose-escalation study. EClinicalMedicine 38:100989
    [Google Scholar]
  35. 35. 
    Ward BJ, Gobeil P, Séguin A et al. 2021. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nat. Med. 27:1071–78
    [Google Scholar]
  36. 36. 
    Gobeil P, Pillet S, Séguin A et al. 2021. Interim report of a phase 2 randomized trial of a plant-produced virus-like particle vaccine for Covid-19 in healthy adults aged 18–64 and older adults aged 65 and older. medRxiv 21257248. https://doi.org/10.1101/2021.05.14.21257248
    [Crossref]
  37. 37. 
    Liang JG, Su D, Song T-Z et al. 2021. S-Trimer, a COVID-19 subunit vaccine candidate, induces protective immunity in nonhuman primates. Nat. Commun. 12:11346
    [Google Scholar]
  38. 38. 
    Richmond P, Hatchuel L, Dong M et al. 2021. Safety and immunogenicity of S-trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial. Lancet 397:10275682–94
    [Google Scholar]
  39. 39. 
    Bengtsson KL, Song H, Stertman L et al. 2016. Matrix-M adjuvant enhances antibody, cellular and protective immune responses of a Zaire Ebola/Makona virus glycoprotein (GP) nanoparticle vaccine in mice. Vaccine 34:161927–35
    [Google Scholar]
  40. 40. 
    Guebre-Xabier M, Patel N, Tian J-H et al. 2020. NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways against SARS-CoV-2 challenge. Vaccine 38:507892–96
    [Google Scholar]
  41. 41. 
    Keech C, Albert G, Cho I et al. 2020. Phase 1–2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. N. Engl. J. Med. 383:242320–32
    [Google Scholar]
  42. 42. 
    Shinde V, Bhikha S, Hoosain Z et al. 2021. Efficacy of NVX-CoV2373 Covid-19 vaccine against the B.1.351 variant. N. Engl. J. Med. 384:201899–909
    [Google Scholar]
  43. 43. 
    Parsons L. 2021. Novavax announces further delays for regulatory filings of COVID-19 vaccine. PMLiVE May 12. https://www.pmlive.com/pharma_news/novavax_announces_further_delays_for_regulatory_filings_of_covid-19_vaccine_1369844
    [Google Scholar]
/content/journals/10.1146/annurev-med-042420-113212
Loading
/content/journals/10.1146/annurev-med-042420-113212
Loading

Data & Media loading...

  • Article Type: Review Article
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error