Emergency Use Vaccines: Do We Really Want It?

Pfizer Inc, one of the leading COVID-19 vaccine research and production companies said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine. This would start the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic. The action comes days after Pfizer and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 cases. The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon. But what does emergency use of a COVID-19 vaccine mean? It is when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing. Before any vaccine is permitted in the U.S., it must be reviewed by the Food and Drug Administration, which requires study in thousands of people. Normally, the process to approve a new vaccine can take about a decade. But the federal government is using various methods to dramatically speed up the process for COVID-19 vaccines. During a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines and other medical products. The first vaccines to get the provisional green light in the U.S. are almost certain to be made available under this process, known as emergency use authorization. However, what does this status of an "emergency use" drug mean to the general public? Backlash regarding the safety of the drug may occur due to its rushed nature. In contrast, government promotion of such a vaccine could be detrimental to public trust. If the vaccine were to have unforeseen widespread negative affects or failure rates it could cause a problem worse than the pandemic. An even further rift between the public and the government is likely to form if emergency COVID-19 vaccinations become mandatory. In the age of anti-vaxers and growing disinformation/misinformation campaigns a rushed drug mandated by the federal or even state governments will likely be met with significant resistance, further slowing the race to a cure. Regardless however, we must remain vigilant as the time of emergency use vaccines draws near in an attempt to stifle even larger issues which may arise from it.