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Yet on rare occasions, this vital evidence-based process of vaccine development and testing has still been ignored. In 1976, concerns about the emergence of a new swine flu strain reminiscent of the lethal 1918 version led President Gerald Ford to convene a panel that recommended a government-backed mass vaccination program.7 Poorly conceived, the attempt to vaccinate the US population at breakneck speed failed in virtually every respect. Safety standards deteriorated as one manufacturer produced the incorrect strain. The vaccine tested poorly on children who, depending on the form of vaccine tested, either developed adverse reactions with high fevers and sore arms or did not mount an immune response at all. Reports emerged that the vaccine appeared to cause Guillain-Barré syndrome in a very small number of cases, a finding that remains controversial, but added to the early momentum of the antivaccine movement.7 Once again, the pressure to rapidly distribute a vaccine undermined the scientific integrity of the process and damaged public trust.
COVID-19 has created intense concern and uncertainty in the US and throughout the world. There are immense public and political pressures to develop a new vaccine, a process that typically takes years, not months. But as history warns, these pressures must not supplant rigorous scientific practice. Proceeding stepwise through the phases of clinical trials is the ethical standard for investigations involving human research participants. Adherence to the scientific method is the only way to safeguard against a SARS-CoV-2 vaccine that is ineffective, or worse, carries unacceptable adverse effects.
Failing to abide by standards of safety and scientific rigor during the COVID-19 crisis will fuel the argument that physicians and scientists cannot be trusted. Vaccination rates, which are declining due to widespread concern about visiting clinicians’ offices, could further decrease. The US could see resurgences of many vaccine-preventable illnesses, and inevitably, massive increases in avoidable deaths and irreversible outcomes.
There are, however, reasons to hope that these scenarios will not come to pass. In response to past failures, vaccine development in the US is subject to increased regulatory oversight designed to protect against substandard practices. Technological advances permit the rapid communication of adverse events in clinical trials, and the understanding of the genetic factors influencing immunologic responses has increased. To proactively address safety concerns, these and other safeguards should be clearly communicated to the public during the vaccine development process.
Both the public and the scientific community want an effective and safe intervention to prevent COVID-19. The morbidity, mortality, and societal and financial devastation that SARS-CoV-2 has caused throughout the world will have wide-reaching consequences for almost every aspect of life for years to come. Nothing should dampen the ardor of researchers worldwide in the aggressive search for effective treatments. In this unprecedented crisis, novel trial designs, such as those that include challenge studies, should be carefully considered.8 But what cannot and must not be allowed is for desperation to result in the suspension of scientific principles and ethical research values. Physicians should not administer inadequately vetted vaccines; researchers should not endorse them without sufficient data. The scientific community has only one chance at winning public acceptance of a SARS-CoV-2 vaccine. The likelihood of achieving that goal will depend on convincing evidence of vaccine safety and efficacy.
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