Don’t rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees
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None of the mRNA vaccines against COVID-19 at the clinical stage have been evaluated in animal models; the mechanisms of mRNA vaccines against COVID-19 are unclear, and their effectiveness has yet to be proven.
“However, none of these mRNA vaccines at the clinical stage have been evaluated in animal models; the mechanisms of mRNA vaccines against COVID-19 are unclear, and their effectiveness has yet to be proven (Jiang, 2020).”
From A thermostable mRNA vaccine against COVID-19 (2020) · cites this paper as Jiang, 2020
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A thermostable mRNA vaccine against COVID-19
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“However, none of these mRNA vaccines at the clinical stage have been evaluated in animal models; the mechanisms of mRNA vaccines against COVID-19 are unclear, and their effectiveness has yet to be proven (Jiang, 2020).”
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“Such a scenario may lead to the public being hesitant from accepting future vaccines (67, 68).”
BackgroundOngoing Clinical Trials for the Management of the COVID-19 Pandemic
Lythgoe, M. P., & Middleton, P. K. (2020) · Trends in Pharmacological Sciences · doi:10.1016/j.tips.2020.03.006 · Cited by 380 · see citing works
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Zhang, J., Zeng, H., Gu, J., Li, H., Zheng, L., & Zou, Q. (2020) · Vaccines · doi:10.3390/vaccines8020153 · Cited by 280 · see citing works
“Safety is the most important issue that should be taken into consideration during drug and vaccine development, and some scientists urge that we should not rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees [64].”
BackgroundAn online survey of the attitude and willingness of Chinese adults to receive COVID-19 vaccination
Chen, M., Li, Y., Chen, J., Wen, Z., Feng, F., Zou, H., Fu, C., Chen, L., Shu, Y., & Sun, C. (2021) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2020.1853449 · Cited by 188 · see citing works
“Before the COVID-19 vaccine is ready for public inoculation, much work undoubtedly needs to be done to ensure that it is safe and effective through the use of preclinical and clinical evidence.(3) Meanwhile, plans should be made to disseminate the upcoming COVID-19 vaccine to large populations.”
BackgroundStudies of Novel Coronavirus Disease 19 (COVID-19) Pandemic: A Global Analysis of Literature
Tran, B., Ha, G. H., Nguyen, L., Vu, G., Hoang, M. T., Le, H., Latkin, C., Ho, C. S. H., & Ho, R. C. M. (2020) · medRxiv · doi:10.3390/ijerph17114095 · Cited by 172 · see citing works
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Self-citationTagoe, E. T., Sheikh, N., Morton, A., Nonvignon, J., Sarker, A. R., Williams, L., & Megiddo, I. (2021) · Frontiers in Public Health · doi:10.3389/fpubh.2021.709127 · Cited by 155 · see citing works
“People have raised concerns about the safety and efficacy of previous vaccines (42) and COVID-19 vaccines (43), and the media and social media have propagated them (44).”
BackgroundGuo, G., Ye, L., Pan, K., Chen, Y. Z., Xing, D., Yan, K., Chen, Z., Ding, N., Li, W., Huang, H., et al. (2020) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2020.00410 · Cited by 146 · see citing works
“…simultaneous studies along multiple technical routes, including inactivated vaccines, mRNA vaccines, recombinant protein vaccines, viral vector vaccines, DNA vaccines, and so on, and some types of vaccine have entered the animal testing stage or human trials (Chinadaily com.cn., 2020; Jiang, 2020).”
BackgroundPathophysiology and treatment strategies for COVID-19
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“The issue of political pressures to speed up the production process and approval of a vaccine may reduce the accuracy of the various stages of vaccine production, and ultimately make a vaccine available to the public with low efficacy or unexamined side effects [119].”
Tai, W., Zhang, X., He, Y., Jiang, S., & Du, L. (2020) · Antiviral Research · doi:10.1016/j.antiviral.2020.104820 · Cited by 116 · see citing works
“These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.”
InfluentialSelf-citationProgress and Concept for COVID‐19 Vaccine Development
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Recombinant vaccines for COVID-19
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“Therefore, the corresponding regulatory authorities should evaluate the safety profile of potential SARS-CoV -2 vaccines using an array of virus strains and a variety of animal models.(48)”
BackgroundGuzek, D., Skolmowska, D., & Głąbska, D. (2020) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph17165770 · Cited by 103 · see citing works
“The role of hand hygiene [7–9] and other personal protective behaviors [10–12] in the prevention of COVID-19 is also emphasized by major international authorities, as for the time being, there is no vaccine developed for the disease [13] and so prevention is the only way to reduce the transmission of SARS-CoV-2.”
BackgroundWhat Does Plant-Based Vaccine Technology Offer to the Fight against COVID-19?
Rosales‐Mendoza, S., Márquez-Escobar, V. A., González‐Ortega, O., Nieto‐Gómez, R., & Arévalo-Villalobos, J. I. (2020) · Vaccines · doi:10.3390/vaccines8020183 · Cited by 103 · see citing works
“Therefore, the path for vaccine development will require a detailed characterization, not only in terms of efficacy but also safety [17].”
BackgroundAntibody-dependent enhancement of coronavirus
Wen, J., Cheng, Y., Ling, R., Dai, Y., Huang, B., Huang, W., Zhang, S., & Jiang, Y.-Z. (2020) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2020.09.015 · Cited by 104 · see citing works
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“70 The production of specific antibodies is believed to be effective for virus clearance 71 (Jiang, 2020; Lu, 2020), but we could not reach such a conclusion from these cases.”
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“Applying “quick fix” and “short cuts” can lead to errors with disastrous consequences.(84)What regulators have to worry about is the atmosphere of hype about the COVID-19 vaccine? Public claims about breakthrough research based on poorly conducted studies or data collected through fraud is a real possibility.”
Hanney, S. R., Wooding, S., Sussex, J., & Grant, J. (2020) · Health Research Policy and Systems · doi:10.1186/s12961-020-00571-3 · Cited by 91 · see citing works
“ment of vaccines is much higher than the risk of causing illness in healthy volunteers” [30].”
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“At least a dozen COVID-19 candidate vaccines are under development using different technology platforms [5], with an emphasis on speed, maximizing safety, and avoiding vaccineinduced immunopathology [6].”
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“It is therefore necessary that vaccines developed against SARS-CoV2 should be carefully assessed while conducting clinical trials [29].”
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“Hastening of the development of the vaccines without proper evaluation may be of no value.[82]”
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“Additionally, finding a universal vaccine is also critical to tackling the global pandemic.(62,63)”
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“In addition, the lack of sufficient time for evaluation of the safety and efficacy of the candidates may undermine vaccine quality.(94,96) Although researchers are working around the clock to produce an effective vaccine that would be available as soon as possible, sentiments associated with the heavy death toll assoc…”
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“They will say that the SARS‐CoV‐2 vaccine was made too fast; therefore, it did not pay attention to the safety aspects of the vaccine.(19,118) Indeed, vaccine harms are commonly used as anti‐vaccine advertising messages on Facebook.”
BackgroundCurrent development of COVID-19 diagnostics, vaccines and therapeutics
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“Shibo Jiang’s recent appeal that safety be foremost on the minds of vaccine developers as they begin to engage in preclinical and clinical trials to tackle SARS-CoV-2 [15].”
Self-citationA cross-cultural exploratory analysis of pandemic growth: The case of COVID-19
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“Being a transmissible disease (Jiang, 2020), the spread of COVID-19 will be influenced by individual behavior.”
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“However, even in the face of the current global efforts to develop such strategies, years may pass before successful therapies are available for worldwide use [20,21].”
Ma, C., Su, S., Wang, J., Wei, L., Du, L., & Jiang, S. (2020) · Microbes and Infection · doi:10.1016/j.micinf.2020.05.004 · Cited by 52 · see citing works
“Simultaneously, regulators should also see strong preclinical evidence that vaccines can prevent infection and we should speed up the R&D progress on the premise of ensuring the safety and effectiveness of the vaccine [122].”
Self-citationCan an effective SARS-CoV-2 vaccine be developed for the older population?
Pawelec, G., & Weng, N. (2020) · Immunity & Ageing · doi:10.1186/s12979-020-00180-2 · Cited by 50 · see citing works
“Quite apart from the potential dangers of accelerated vaccine development [2] , and remembering the additional danger of immune enhancement [3] , even were this successful the question remains whether the most susceptible members of the population (say, those over 60) would benefit.”
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“In general, experimental vaccines or therapeutics against the COVID-19 may be associated with safety concerns [50].”
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Updating the diagnostic criteria of COVID-19 “suspected case” and “confirmed case” is necessary
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“Note however that COVID-19 is a new disease, our awareness and knowledge is gradually increasing based on the ongoing research findings and clinical practice experience [3] [4] [5] [6] [7] [8] ; hence, the strategies of diagnosis and treatment are also continually updated.”
BackgroundPromise and challenges in the development of COVID-19 vaccines
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COVID ‐19 and plasma cells: Is there long‐lived protection?*
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“regulators need to evaluate their safety in more than one animal model.(9)”
BackgroundThe bumpy road to achieve herd immunity in COVID-19
Neagu, M. T. (2020) · Journal of Immunoassay and Immunochemistry · doi:10.1080/15321819.2020.1833919 · Cited by 37 · see citing works
Rethinking Evidence in the Time of Pandemics
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Self‐Assembled Nanoparticles: Exciting Platforms for Vaccination
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“severe pathological changes in the lung or liver [37,38] when vaccinated individuals after being exposed to attack by wildtype virus.”
BackgroundRepurposing minocycline for COVID-19 management: mechanisms, opportunities, and challenges
Singh, H., Kakkar, A. K., & Chauhan, P. (2020) · Expert Review of Anti-infective Therapy · doi:10.1080/14787210.2020.1782190 · Cited by 31 · see citing works
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“Rabies glycoprotein/NCT02241135/ Phase I 18–40 years (volunteers), 101 healthy individuals ID and IM 94% of ID and 97% of IM vaccinated populations received severe injection site reactions, and 78% ID and 78% of IM injected peoples demonstrated severe systemic reactions, induce antibody response when administered with…”
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Self-citationEvidence-based guiding principles to build public trust in personal data use in health systems
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“In the context of COVID-19 vaccination, Jiang argues that trust cannot and should not be rushed.(61) Therefore, policy implementation should not be undertaken in a way that suggests haste.”
BackgroundRad, R. E., Kahnouji, K., Mohseni, S., Shahabi, N. A., Noruziyan, F., Farshidi, H., Hosseinpoor, M., Kashani, S., Takhti, H. K., Hassaniazad, M., et al. (2022) · BMC Public Health · doi:10.1186/s12889-022-12517-1 · Cited by 26 · see citing works
Vaccination against SARS-CoV-2 and disease enhancement – knowns and unknowns
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“While rapidly building a solid diagnostic, therapeutic, and vaccine arsenal is an absolute priority, safety should not be shrouded by the extraordinary nature of the situation [60].”
BackgroundThe growing complexity of COVID-19 drug and vaccine candidates: challenges and critical transitions
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Bridging animal and clinical research during SARS-CoV-2 pandemic: A new-old challenge
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“Such an accelerated development, however, is considered very controversial by many experts [70,71] as it risks exposing human recipients to: i) potential adverse effects and ii) to non-toxic but no/low-efficacy vaccines.”
Return to Work: Managing Employee Population Health During the COVID-19 Pandemic
Fragala, M. S., Goldberg, Z. N., & Goldberg, S. E. (2020) · Population Health Management · doi:10.1089/pop.2020.0261 · Cited by 22 · see citing works
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“However, as some of the structural components and their post-translational modifications in the whole inactivated virions may be immunopathological, detailed studies of the structure, conformation immunogenicity and functions of these proteins are required for the generation of safe and efficacious vaccines against th…”
BackgroundSARS-CoV-2 induces “cytokine storm” hyperinflammatory responses in RA patients through pyroptosis
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Is Mandatory Vaccination for COVID-19 Constitutional under Brazilian Law?
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“Clearly, vaccine administration without time to fully understand resultant health implications would cause an even greater global setback to the current pandemic [27].”
Volatile molecules for COVID ‐19: A possible pharmacological strategy?
Colalto, C. (2020) · Drug Development Research · doi:10.1002/ddr.21716 · Cited by 18 · see citing works
“Government regulatory agencies are called upon to guarantee an accurate and careful evaluation process to satisfy all the necessary safety, quality and efficacy requirements, avoiding any shortcuts in assessment (Jiang, 2020).”
Potential therapeutic approaches of microRNAs for COVID-19: Challenges and opportunities
Farshbaf, A., Mohtasham, N., Zare, R., et al. (2020) · Journal of Oral Biology and Craniofacial Research · doi:10.1016/j.jobcr.2020.12.006 · Cited by 18 · see citing works
“42 Similarly, this virus is undergoing evolution, natural selection effect and purifying selection, 43 so detection and evaluation of exact molecular pathogenesis open up opportunities to apply best therapeutic approaches.”
Peng, Z., Song, W., Ding, Z., Guan, Q., Yang, X., Xu, Q., Wang, X., & Xia, Y. (2020) · Frontiers of Medicine · doi:10.1007/s11684-020-0788-3 · Cited by 17 · see citing works
Abu-Raya, B., Migliori, G. B., O’Ryan, M., Edwards, K. M., Torres, A., Alffenaar, J. C., Märtson, A., Centis, R., D’Ambrosio, L., Flanagan, K. L., et al. (2020) · Frontiers in Medicine · doi:10.3389/fmed.2020.572485 · Cited by 17 · see citing works
“This could hinder the development of safe and effective SARS-CoV-2-specific vaccines (46), however, ADE has not yet been described in patients suffering from COVID-19 (43).”
BackgroundGuérin, P., Yahi, N., Azzaz, F., Chahinian, H., Sabatier, J., & Fantini, J. (2022) · Molecules · doi:10.3390/molecules27123851 · Cited by 16 · see citing works
“A similar warning on vaccine safety due to potential risks of ADE was independently published by Shibo Jiang [19].”
BackgroundSu, S., Wang, Q., & Jiang, S. (2021) · Clinical and Translational Medicine · doi:10.1002/ctm2.284 · Cited by 15 · see citing works
Self-citationAnalyzing the COVID-19 vaccination behavior based on epidemic model with awareness-information
Zuo, C., Zhu, F., Meng, Z., et al. (2022) · Infection Genetics and Evolution · doi:10.1016/j.meegid.2022.105218 · Cited by 15 · see citing works
“…the potential risks of vaccine, e.g. quality control, potential side effects, and associated COVID-19 illness, individuals will reduce their willingness to get vaccinated, which induces substantial obstacles to achieve coverage and herd immunity (Kadali et al., 2021; Su et al., 2021; Jiang, 2020).”
Mohammed, A. H., Hassan, B. A. R., Wayyes, A. M., Gadhban, A. Q., Blebil, A. Q., Alhija, S. A., Darwish, R. M., Al‐Zaabi, A. T., Othman, G. Q., Jaber, A. A. S., et al. (2022) · Vaccine · doi:10.1016/j.vaccine.2022.09.052 · Cited by 15 · see citing works
“Due to their young age, younger children are often more vulnerable to severity of infections and illnesses [46].”
BackgroundPotential of live pathogen vaccines for defeating the COVID‐19 pandemic: History and mechanism
Chen, J., & Chen, J. (2020) · Journal of Medical Virology · doi:10.1002/jmv.25920 · Cited by 14 · see citing works
“Due to the difficulty in vaccine development, it is possible that no safe and effective vaccines will be marketed before 2022 when the pandemic will likely end worldwide, although various vaccines against COVID‐19 are under development with unprecedented rapidity.(3,10) This possibility puts the whole world into a ter…”
BackgroundLi, G., Yang, F., He, X., Liu, Z., Pi, J., Zhu, Y., Ke, X., Liu, S., Ou, M., Guo, H., et al. (2019) · Microbes and Infection · doi:10.1016/j.micinf.2019.10.001 · Cited by 14 · see citing works
Analogies between SARS-CoV-2 infection dynamics and batch chemical reactor behavior
Manenti, F., Galeazzi, A., Bisotti, F., et al. (2020) · Chemical Engineering Science · doi:10.1016/j.ces.2020.115918 · Cited by 13 · see citing works
SARS-CoV-2: Unique Challenges of the Virus and Vaccines
Mahmoodpoor, A., Sanaie, S., Samadi, P., Yousefi, M., & Nader, N. D. (2021) · Immunological Investigations · doi:10.1080/08820139.2021.1936009 · Cited by 13 · see citing works
“Therefore, it is necessary to establish trust and efficient communication, and maintain public faith in the healthcare system, including accountability and regular reporting of reliable vaccinerelated data (Jiang 2020).”
BackgroundMurali, M., Gowtham, H. G., Shilpa, N., et al. (2022) · Molecules · doi:10.3390/molecules27238288 · Cited by 13 · see citing works
“Even though several safe and effective COVID-19 vaccines are being used to break viral spread and infection, COVID-19 safety guidelines must be followed worldwide [3].”
BackgroundCOVID-19 pandemic may fuel academic bullying
Mahmoudi, M., & Keashly, L. (2020) · Bioimpacts · doi:10.34172/bi.2020.17 · Cited by 13 · see citing works
The significance of bioengineered nanoplatforms against SARS-CoV-2: From detection to genome editing
Hassanzadeh, P. (2021) · Life Sciences · doi:10.1016/j.lfs.2021.119289 · Cited by 13 · see citing works
Does COVID-19 Vaccination Warrant the Classical Principle “ofelein i mi vlaptin”?
Doulberis, M., Papaefthymiou, A., Kotronis, G., Gialamprinou, D., Soteriades, E. S., Kyriakopoulos, A. M., Chatzimichael, E., Kafafyllidou, K., Liatsos, C. N., Chatzistefanou, I., et al. (2021) · Medicina · doi:10.3390/medicina57030253 · Cited by 14 · see citing works
Nawaz, M., Huiyuan, Y., Akhtar, F., Ma, T., & Zheng, H. (2025) · Molecular Diversity · doi:10.1007/s11030-025-11173-y · Cited by 11 · see citing works
Prasad, V. K., & Haslam, A. (2024) · Bioethics News · doi:10.1007/s40592-024-00189-z · Cited by 11 · see citing works
“In March of 2020, in the journal Nature , Shibo Jiang, a vaccine researcher wrote an article entitled, “Don’t rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees” (Jiang 2020).”
BackgroundPiplani, S., Singh, P. K., Petrovsky, N., et al. (2022) · Frontiers in Molecular Biosciences · doi:10.3389/fmolb.2022.781039 · Cited by 11 · see citing works
“…coronaviruses such as SARS and MERS CoV (Ciotti et al., 2019; Zhang J. et al., 2020; Berkley, 2020; Zhang J.-J. et al., 2020; Zhang T. et al., 2020; Jiang, 2020; Lu, 2020; Mendes, 2020; Olsen et al., 2020; Rosa and Santos, 2020; Rosales-Mendoza et al., 2020; Sanders et al., 2020; Schlagenhauf et…”
BackgroundKurashima, K., Kagiyama, N., Ishiguro, T., et al. (2020) · medRxiv · doi:10.1101/2020.07.16.20154088 · Cited by 11 · see citing works
Larson, C., Oronsky, B. T., Goyal, S., Ray, C. M., Hedjran, F., Hammond, T., Kesari, S., Caroen, S. Z., Lybeck, M., Dobalian, V. E., et al. (2020) · Biochimica et Biophysica Acta (BBA) - Reviews on Cancer · doi:10.1016/j.bbcan.2020.188412 · Cited by 10 · see citing works
“Unlike SARS-CoV-1, which seems to have disappeared/died out [11], and MERS, which reappears only sporadically, SARS-CoV-2 is less lethal with a fatality rate between 2 and 4% (although this number is highly uncertain and debated) [12] but much more infective.”
BackgroundThe Recent Updates on Approaches and Clinical Trials Status of Covid-19 Vaccines Developed Globally
Chaudhary, S., El‐Shorbagi, A., Gupta, R. K., & Kumar, A. (2021) · Biomedical & Pharmacology Journal · doi:10.13005/bpj/2214 · Cited by 10 · see citing works
- Authors
- Jiang, S.
- Affiliations
- Shanghai Medical College of Fudan University (CN)
- Corresponding author
- Jiang, Shibo
- ORCID
- Jiang, Shibo
- Venue
- Nature
- Published
- 2020-03-16
- Volume
- 579
- Issue
- 7799
- Pages
- 321-321
- ISSN
- 0028-0836 (ISSN-L)
- 1476-4687
- OpenAlex
- W3011324254
- Cited by
- 174
- References
- 0
- Citations by year
- 2025: 2 · 2024: 5 · 2023: 10 · 2022: 28 · 2021: 42 · 2020: 86 · 2019: 1
- FWCI
- 5.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Nature (publishedVersion)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Legal, Health, Environmental and COVID-19 Challenges
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- COVID-19 pandemic, vaccine rollout, drug development, drug safety, safety guarantees, pandemic response
- MeSH terms
- Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Vaccines, COVID-19 Drug Treatment, China, Clinical Trials as Topic, Drug Evaluation, Preclinical, Humans, Immunity, Pneumonia, Viral, Viral Vaccines, Coronavirus Infections, Models, Animal, Severe Acute Respiratory Syndrome, Severe acute respiratory syndrome-related coronavirus, Patient Safety
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