The underdog coronavirus vaccines that the world will need if front runners stumble

Abstract

clinical-trial holds in future. The transparency bar should be set much higher than this latest example, says Kieny. "When, ultimately, a vaccine will be made available, public trust will be paramount to ensure public-health impact. And trust needs transparency." Leading vaccine The vaccine, AZD1222, is one of the leading candidates being developed to protect against the virus that causes COVID-19, and one of a handful of immunizations in the final stages of clinical testing. The pause in global trials sent a shudder around the world. Such a quick resumption of the trials was the most likely outcome, says Paul Griffin, an infectious-diseases researcher at the University of Queensland in Brisbane, Australia. In large trials, adverse medical events in volunteers are common, and trial holds are designed to ensure that such events are investigated and volunteers are protected, he says. But, most often, it is later decided that the event was probably not related to participation in the trial and does not pose a safety concern to the rest of the volunteers, says Griffin. That seems to be what has occurred in this case, he says. It can be difficult to pin down the cause of adverse events, says Jonathan Kimmelman, a bioethicist who studies clinical trials at McGill University in Montreal, Canada. "Often, the best you can do is say that there is a possible link, and then proceed with collecting more data and monitoring outcomes," he says. The University of Oxford said in a press release on 12 September that the pause, which applied to all trials of the vaccine, was necessary "to allow the review of safety data by an independent safety review committee, and the national regulators". "The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA [Medicines and Healthcare products Regulatory Agency], the trials will recommence in the UK," the statement reads. The university also said that it cannot disclose medical information about the participant's illness for reasons of confidentiality.

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“…It has exposed and reinforced interdependencies among countries, sectors (business, government, civil society), groups, and individuals, while also exacerbating divisions and differences in the form of economic and medical nationalism at the global and national level. As just one example, of the more than 175 vaccine development efforts underway, including 33 in human trials, many involve cross-national, cross-sectoral cooperation, including the Pfizer and BioNTech vaccine, the Oxford-Astra Zeneca vaccine, and the GeoVax/BravoVax vaccine (Calloway, 2020 ). Another area that naturally involves multiple sectors and actors and at multiple levels is the incorporation of the United Nations Sustainable Development Goals (UNSDGs) as an organizing framework for CSR-/sustainability-related activities.…”

COVID-19 vaccines: where we stand and challenges ahead

“…It will be important to compare the intensity and duration of the protective responses elicited by these four vaccines with those induced by vaccines based on technological platforms that are slower to develop. Other vaccine candidates that are coming might work better than the first, provide a longer immunity, while other factors such as cost or side effects might offer benefits to specific groups, such as the elderly, pregnant women, or people in low-income countries [11,12].…”

“…This clever intellectual and technological effort provides myriads of diverse projects, some of which could become important if front runner projects will confer only partial protection or work poorly in certain clusters of the population. High costs and other barriers might make some of the front runner vaccines unsuitable for wide-scale deployment in lower-income countries [11,12,39]. For example, bacteriophage-based vaccines that infect nose and throat microbes and make them produce the Spike protein, or other vaccines that could be administered by nasal insufflation or by mouth appear to be stimulating alternatives.…”

“…The success and approval of the first COVID-19 vaccines should not detract from the enthusiasm and practical possibility of planning new studies leading to the development and production of second and third-generation vaccines [11,12] as well as the design of different types of clinical trials [65]. Indeed, COVID-19 eradication is going to be a long and winding road that will not finish once we have the first vaccine available.…”