Address Concerns About Vaccine Development

Concerns about the speed with which COVID-19 vaccines were developed can reduce vaccine confidence among the general public. Some people fear that the vaccines were “rushed” at the expense of effectiveness or safety.

An editorial in Science correctly stated, “the development of several highly efficacious vaccines against a previously unknown viral pathogen [SARS-CoV-2] in less than 1 year from the identification of the virus is unprecedented in the history of vaccinology.” It usually takes more than 6 years to bring a new vaccine to market. But the U.S. Food and Drug Administration (FDA) states that there is no predetermined timeline for vaccine development. When enough data are available, FDA decides whether to approve.

Speed in evaluating the COVID-19 vaccines was due in part to “an extraordinary multidisciplinary effort involving basic, preclinical, and clinical science that had been underway—out of the spotlight—for decades” before this pandemic according to the editorial in Science. Researchers have been studying coronaviruses and the novel vaccine technologies that would be used to create the vaccines for many years. So, it took days, rather than months or years, to sequence the SARS-CoV-2 viral genome and begin developing vaccine candidates.

The urgency of a global pandemic demanded that the usual timelines for testing and manufacturing vaccines be accelerated. Faster timelines were made possible by infusions of government and private funding. The U.S. government alone spent more than $12 billion. This financial investment was coupled with worldwide collaboration to improve efficiency, which reduced or removed some hurdles to vaccine development, production, and distribution. None of the usual steps in the process were skipped, but as shown in the following figure, some steps were conducted in an overlapping schedule to gather data faster.

Key Points

• COVID-19 vaccines used in the United States were developed in record time but were not “rushed.”
• Speediness does not equal carelessness. All the usual steps for testing, evaluation, and review were done properly and thoroughly.
• None of the usual steps in the vaccine development process were skipped. Rather, some steps were conducted on an overlapping schedule to gather important data faster.
• The vaccine developers did not cut corners—they cut “red tape.” Because the pandemic was a true global emergency, there was a worldwide effort to remove usual bureaucratic hurdles, with governments funding concurrent activities.
• The vaccines were reviewed by independent panels of experts and approved under an Emergency Use Authorization (EUA) process set up in the early 2000s, before the COVID-19 pandemic. The EUA process is used only when there is a serious and immediate risk to the public’s health.
• COVID-19 vaccines were authorized for emergency use after extensive clinical testing in tens of thousands of volunteers from many diverse backgrounds, races, ethnicities, ages, and geographic areas. The vaccines have gone through the same safety tests and meet the same standards as other vaccines produced through the years. And the COVID-19 vaccines continue to be monitored through multiple safety systems to learn all we can.
• Developers began making vaccines early in the process—while FDA was completing its reviews—so supplies would be available as soon as possible. The doses would have been thrown away if the vaccines were found not to be safe and effective.

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