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.

Typical Process

6+ Years

 

Scientists Develop Vaccine Candidates
Phase 1 Clinical Trial
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Review by FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Biologics License Application (BLA)
CDC Advisory Committee on Immunization Practices (ACIP) Recommendation
Manufacturing
Distribution
Phase 4 Safety Monitoring

COVID-19 Vaccine Process

12-18 months

Hover over the boxes below to learn more about the step in the process.

 
Manufacturing
Scientists Develop Vaccine Candidates
Phase 1 Clinical Trial
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Review by FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)
FDA Emergency Use Authorization (EUA)
CDC Advisory Committee on Immunization Practices (ACIP) Recommendation
Allocation and Distribution
Phase 4 Safety Monitoring
Biologics License Application (BLA)

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.

Information for Pharmacy Teams

Utilize APhA’s conversation guide to address concerns that the COVID-19 vaccines were “rushed.” This resource can be used as a playbook to effectively talk with patients and address their specific concerns.
Watch APhA’s short video on the Accelerated Vaccine Development of COVID-19 vaccines to learn how their development was accelerated without compromising safety.
Read At the Oldest Pharmacy in Nation’s Capital, There’s Always Room to Vaccinate to learn how Damika Walker, PharmD, successfully explained to a concerned patient how COVID-19 vaccines had been developed in such a seemingly short time.
Participate in APhA’s Trigger Tape Training, which reviews key points to communicate with patients by providing patient scenarios and the recommended response to each one.
Read FDA’s Vaccine Development 101 resource to review the process that FDA expects vaccine developers to follow in order to generate the information needed to assess the safety and effectiveness of a vaccine.
Watch APhA’s open forum webinar on the COVID-19 Vaccine Clinical Trial Process to learn about the pharmacist’s role in COVID-19 vaccine safety monitoring and the COVID-19 vaccine clinical trial process, including enrollment of volunteers in clinical trials.
Read CDC’s Role of the Advisory Committee on Immunization Practices [ACIP] in CDC’s Vaccine Recommendations to gain an understanding of what ACIP is and how they make decisions about vaccine recommendations.
Review the Reagan-Udall Foundation’s infographic that explains how time was saved in vaccine development. Hear from the pharmacist who helped develop the infographic, Susan Winckler, RPh, Esq., CEO of the Reagan-Udall Foundation for FDA, beginning at minute 29:20 during this APhA open forum webinar.

Information for Patients

Share CDC’s brochure that describes How a COVID-19 Vaccine Is Recommended for Public Use. This brochure reviews how ACIP recommends a vaccine and how the safety of a vaccine continues to be monitored while it is administered to the public.
Review the National Institutes of Health’s webpage on COVID-19 Vaccine Development with your patients to explain how the COVID-19 vaccines were developed.