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Supplemental 1 (PDF) Supplemental Table 1. Summary of Formulations and Subtype Target in Influenza Vaccine Pandemic Clinical Trials. Adapted from the WHO, “Pandemic and Potentially Pandemic Viruses.” (165) Inactivated Whole Inactivated Inactivated Live Viral Virus Split Virus Subunit Attenuated Recombinant Vector DNA Peptide Undefined Total H1N1 20 251 84 26 14 36 431 H2N2 1 2 3 H3N2 1 2 1 6 1 11 H5N1 43 64 29 6 9 5 5 161 H5N2 2 9 11 H5N3 7 7 H6N1 1 1 H7N1 4 4 H7N3 3 3 H7N7 1 1 2 4 H7N9 8 1 7 4 1 21 H9N2 7 1 8 Non- 6 1 4 11 specific Total 73 330 124 57 33 11 8 4 36 676 Supplemental Table 2. Current Phase III SARS-CoV-2 Vaccine Candidates Phase Previous # of Doses Storage Developer Vaccine III Platform Vaccine Antigen Clinical Trial #s References (Days) Temp. Efficacy Use Anhui Zhifei Longcom Adjuvanted NCT04445194, Biopharmaceutical/ Protein RBD- 2 or 3 NCT04466085, Institute of ZF2001 MERS 2-8o C (1) subunit Dimer NCT04550351, Microbiology, Chinese NCT04646590 Academy of Sciences Bharat Biotech/ Indian CTRI/2020/07/026300, Council of Medical NCT04471519, Research/ National COVAXIN Inactivated Whole- 2 2-8o C CTRI/2020/09/027674, (2) Institute of Virology/ (BBV152) virus virion CTRI/2020/11/028976, Ocugen/ Precisa NCT04641481 Medicamentos ChiCTR2000030906, ChiCTR2000031781, NCT04313127, CanSino Biologics/ NCT04341389, Non- Beijing Institute of S NCT04398147, Ad5-nCoV replicating Ebola 1 2-8o C (3, 4) Biotechnology/ protein NCT04526990, viral vector Petrovax NCT04540419, NCT04552366, NCT04566770, NCT04568811 RABV, EudraCT 2020-004066-19, LASV, YFV, NCT04449276, MERS, NCT04515147, CureVac/Bayer CVnCoV RNA-based 2 2-8o C (5) InfA, ZIKV, NCT04652102, DengV, NCT04674189, NIPV PER-054-20 Inovio Pharmaceuticals/ Beijing Advaccine Biotechnology/ VGXI Inc./ Richter-Helm ChiCTR2000038152, BioLogics/ Ology Multiple ChiCTR2000040146, S Bioservices/ INO-4800 DNA-based vaccine 2 2-8o C NCT04336410, (6) protein International Vaccine candidates NCT04447781, Institute/ Seoul NCT04642638 National University Hospital/ Thermo Fisher Scientific/ Kaneka Eurogentec Institute of Medical Inactivated NCT04412538, Biology, Chinese Whole- virus 2 NCT04470609, (7) Academy of Medical virion NCT04659239 Sciences Influenza, rotavirus, NCT04450004, Virus-like norovirus, S Medicago Inc. CoVLP 2 2-8o C NCT04636697, (8) particle West Nile protein NCT04662697 virus, and cancer Novavax/Emergent Biosolutions/ Praha Vaccines/ Biofabri/ Fujifilm Diosynth Biotechnologies/ FDB/ EudraCT 2020-004123-16, NVX- RSV, Serum Institute of NCT04368988, CoV2373 Protein CCHF, S India/ SK bioscience/ 89.3% 2 2-8o C NCT04533399, (9) (SARS- subunit HPV, VZV, protein Takeda NCT04583995, CoV-2 rS) Ebola Pharmaceutical NCT04611802 Company Limited/ AGC Biologics/ PolyPeptide Group/ Endo Osaka University/ jRCT2051200085, AnGes/ Takara Bio/ jRCT2051200088, AG0301 & Cytiva/ Brickell DNA-based 2 -70o C NCT04463472, (10) AG0302 Biotech NCT04527081, NCT04655625 Research Institute for Biological Safety Inactivated Whole NCT04530357, QazCovid-in 2 2-8o C (11) Problems, Republic of virus virion NCT04691908 Kazakhstan NCT04383574, NCT04352608, NCT04456595, Adjuvanted NCT04551547, Sinovac/ Instituto CoronaVac Whole Room 50-91% Inactivated 2 NCT04508075, (12, 13) Butantan/ Bio Farma (PiCoVacc) virion Temp. virus NCT04582344, NCT04617483, NCT04651790, 669/UN6.KEP/EC/2020 ChiCTR2000031809, Wuhan Institute of Inactivated ChiCTR2000034780, Whole Biological Products/ virus 2 2-8o C ChiCTR2000039000, (14) virion Sinopharm NCT04510207, NCT04612972 Zydus Cadila CTRI/2020/07/026352, ZyCoV-D DNA-based (15) Healthcare Limited CTRI/2021/01/030416 1. Yang, S., Y. Li, L. Dai, J. Wang, P. He, C. Li, X. Fang, C. Wang, X. Zhao, E. Huang, C. Wu, Z. Zhong, F. Wang, X. Duan, S. Tian, L. Wu, Y. Liu, Y. Luo, Z. Chen, F. Li, J. Li, X. Yu, H. Ren, L. Liu, S. Meng, J. Yan, Z. Hu, L. Gao, and G. F. Gao. 2020. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials. medRxiv: 2020.2012.2020.20248602. 2. Ella, R., K. M. Vadrevu, H. Jogdand, S. Prasad, S. Reddy, V. Sarangi, B. Ganneru, G. Sapkal, P. Yadav, P. Abraham, S. Panda, N. Gupta, P. Reddy, S. Verma, S. Kumar Rai, C. Singh, S. V. Redkar, C. S. Gillurkar, J. S. Kushwaha, S. Mohapatra, V. Rao, R. Guleria, K. Ella, and B. Bhargava. 2021. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial. Lancet Infect Dis. 3. Zhu, F. C., Y. H. Li, X. H. Guan, L. H. Hou, W. J. Wang, J. X. Li, S. P. Wu, B. S. Wang, Z. Wang, L. Wang, S. Y. Jia, H. D. Jiang, L. Wang, T. Jiang, Y. Hu, J. B. Gou, S. B. Xu, J. J. Xu, X. W. Wang, W. Wang, and W. Chen. 2020. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet 395: 1845-1854. 4. Zhu, F. C., X. H. Guan, Y. H. Li, J. Y. Huang, T. Jiang, L. H. Hou, J. X. Li, B. F. Yang, L. Wang, W. J. Wang, S. P. Wu, Z. Wang, X. H. Wu, J. J. Xu, Z. Zhang, S. Y. Jia, B. S. Wang, Y. Hu, J. J. Liu, J. Zhang, X. A. Qian, Q. Li, H. X. Pan, H. D. Jiang, P. Deng, J. B. Gou, X. W. Wang, X. H. Wang, and W. Chen. 2020. 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 396: 479-488. 5. Rauch, S., K. Gooch, Y. Hall, F. J. Salguero, M. J. Dennis, F. V. Gleeson, D. Harris, C. Ho, H. E. Humphries, S. Longet, D. Ngabo, J. Paterson, E. L. Rayner, K. A. Ryan, S. Sharpe, R. J. Watson, S. O. Mueller, B. Petsch, and M. W. Carroll. 2020. mRNA vaccine CVnCoV protects non-human primates from SARS-CoV-2 challenge infection. bioRxiv: 2020.2012.2023.424138. 6. Tebas, P., S. Yang, J. D. Boyer, E. L. Reuschel, A. Patel, A. Christensen-Quick, V. M. Andrade, M. P. Morrow, K. Kraynyak, J. Agnes, M. Purwar, A. Sylvester, J. Pawlicki, E. Gillespie, I. Maricic, F. I. Zaidi, K. Y. Kim, Y. Dia, D. Frase, P. Pezzoli, K. Schultheis, T. R. F. Smith, S. J. Ramos, T. McMullan, K. Buttigieg, M. W. Carroll, J. Ervin, M. C. Diehl, E. Blackwood, M. P. Mammen, J. Lee, M. J. Dallas, A. S. Brown, J. E. Shea, J. J. Kim, D. B. Weiner, K. E. Broderick, and L. M. Humeau. 2021. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. EClinicalMedicine 31: 100689. 7. Pu, J., Q. Yu, Z. Yin, Y. Zhang, X. Li, D. Li, H. Chen, R. Long, Z. Zhao, T. Mou, H. Zhao, S. Feng, Z. Xie, L. Wang, Z. He, Y. Liao, S. Fan, Q. Yin, R. Jiang, J. Wang, L. Zhang, J. Li, H. Zheng, P. Cui, G. Jiang, L. Guo, M. Xu, H. Yang, S. Lu, X. Wang, Y. Gao, X. Xu, L. Cai, J. Zhou, L. Yu, Z. Chen, C. Hong, D. Du, H. Zhao, Y. Li, K. Ma, Y. Ma, D. Liu, S. Yao, C. Li, Y. Che, L. Liu, and Q. Li. 2020. An in-depth investigation of the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine. medRxiv: 2020.2009.2027.20189548. 8. Ward, B. J., P. Gobeil, A. Séguin, J. Atkins, I. Boulay, P.-Y. Charbonneau, M. Couture, M.-A. D’Aoust, J. Dhaliwall, C. Finkle, K. Hager, A. Mahmood, A. Makarkov, M. Cheng, S. Pillet, P. Schimke, S. St-Martin, S. Trépanier, and N. Landry. 2020. Phase 1 trial of a Candidate Recombinant Virus-Like Particle Vaccine for Covid-19 Disease Produced in Plants. medRxiv: 2020.2011.2004.20226282. 9. Keech, C., G. Albert, I. Cho, A. Robertson, P. Reed, S. Neal, J. S. Plested, M. Zhu, S. Cloney-Clark, H. Zhou, G. Smith, N. Patel, M. B. Frieman, R. E. Haupt, J. Logue, M. McGrath, S. Weston, P. A. Piedra, C. Desai, K. Callahan, M. Lewis, P. Price-Abbott, N. Formica, V. Shinde, L. Fries, J. D. Lickliter, P. Griffin, B. Wilkinson, and G. M. Glenn. 2020. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 10. Silveira, M. M., G. Moreira, and M. Mendonca. 2021. DNA vaccines against COVID-19: Perspectives and challenges. Life Sci 267: 118919. 11. Balakrishnan, V. S. 2020. COVID-19 response in central Asia. Lancet Microbe 1: e281. 12. Zhang, Y., G. Zeng, H. Pan, C. Li, Y. Hu, K. Chu, W. Han, Z. Chen, R. Tang, W. Yin, X. Chen, Y. Hu, X. Liu, C. Jiang, J. Li, M. Yang, Y. Song, X. Wang, Q. Gao, and F. Zhu. 2021. Safety, tolerability, and immunogenicity of an inactivated SARS- CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double- blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis 21: 181- 192. 13. Wu, Z., Y. Hu, M. Xu, Z. Chen, W. Yang, Z. Jiang, M. Li, H. Jin, G. Cui, P. Chen, L. Wang, G. Zhao, Y. Ding, Y. Zhao, and W. Yin. 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. 14. Xia, S., K. Duan, Y. Zhang, D. Zhao, H. Zhang, Z. Xie, X. Li, C. Peng, Y. Zhang, W. Zhang, Y. Yang, W. Chen, X. Gao, W. You, X. Wang, Z. Wang, Z. Shi, Y. Wang, X. Yang, L. Zhang, L.
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