Yes, the COVID-19 Vaccines Were Made Quickly – Here’s Why

Key Takeaways
  • Vaccines typically take an average of 10-15 years to create; and yet, the COVID-19 Vaccines were made in less than one year.

  • Due to the nature of the pandemic, both private and public institutions came together to fast-track the development of the COVID-19 vaccine research, manufacturing, and distribution.

  • The speed of development has caused some public concerns around vaccine safety, but the reality is that the science behind COVID-19 vaccines has been in the works for over a decade.

In 1901, Dr. Allan Warner photographed a number of smallpox patients in order to study the disease. Both children shown in this particular photo were 13 years old, and they had both been infected by the same smallpox source on the same day. Only one (right) had received a vaccination in infancy. Source: Internet Archive

How and why were vaccines made in the first place?

The story of vaccines traces back to the late 18th century. Smallpox had already plagued human populations for thousands of years — killing approximately 30% of people (an estimated 300 million people around the world) who contracted the disease, and leaving survivors with permanent scarring or deformities (Bradford, 2019). British physician and scientist, Edward Jenner, noticed that dairymaids had natural immunity against the infectious disease after having suffered from cowpox. That became the basis for experimenting with cowpox inoculation (or vaccination) as a means of protection against smallpox. The Latin word for cow is vacca, and cowpox is vaccinia; Jenner called this new procedure “vaccination” and set the stage for further vaccine research and development (Riedel, 2005).

By the mid 1900s, microbiologists and vaccinologists were able to run more comprehensive experiments on viruses in laboratories. This led to the creation of a long list of vaccines for the prevention of measles, mumps, chickenpox, rubella, hepatitis A, hepatitis B, pneumococcal pneumonia, meningitis, pandemic influenza, and chlamydia (Tulchinsky, 2018). After more than 200 years since Jenner’s experiments, and the World Health Organization (WHO) promoted a worldwide vaccination program, smallpox became the only human disease to have been eradicated by vaccination in 1980 (“Smallpox: The disease, now eradicated”, WHO).

The bottom line: vaccines were created to prevent diseases, save lives, and improve health; they have undeniably ​​saved millions of lives across the globe (IFPMA, 2019).

What are the typical phases for developing vaccines?

The traditional vaccine testing process is comprehensive and complex. It involves many layers of research and clinical trials — even more so than the development of conventional drugs. Pathogens can mutate, researchers may have difficulty activating an immune response, or many compounds (antigens) may be required in order for a vaccine to be effective. These added complexities make regulatory assessments more challenging. From start to finish, the vaccine development process takes an average of 10-15 years. This is with the best intent, as additional precautions help ensure a vaccine’s safety and efficacy before it becomes available to the general public.

Here are the typical phases for developing vaccines:

  • Research and Discovery Phase – Scientists observe how an infectious organism causes disease, which serves as the basis for developing a vaccine in the first place. Accelerated timing: several months. Non-accelerated timing: one year to several years.
  • Pre-Clinical Testing – This stage involves both in vitro (e.g. cells in a culture) and in vivo tests (on nonhuman subjects) to outline a vaccine’s ultimate safety profile. Scientists will determine if there are practical applications that warrant further research for developing a vaccine that is effective for humans.
  • Clinical Trials
    • Phase I Clinical Trial – This is the first attempt to study immune responses in humans. It typically involves a small group of people so that scientists can closely evaluate a vaccine’s safety and determine what dosage is the most effective. Vaccines intended for children will first be tested on adults. Researchers will continue to test younger age groups gradually until they are able to study their target age.
    • Phase II Clinical Trial – A larger group of people (typically several hundred) participate so that researchers can evaluate the proper dosage and administration schedule in greater detail.
    • Phase III Clinical Trial – Based on the success of Phase II, the study will grow to include several thousand people. The objective is to observe immune responses, safety, and efficacy in more people, particularly those that the vaccine is intended for.
  • FDA Review/Approval – If Phase III is successful, then the manufacturer will submit a Biologics License Application (BLA) to the FDA for review and approval. With this application, they are seeking permission to distribute and market the vaccine for use in the United States. The FDA will inspect the manufacturing plant and confirm that protocols are being followed to ensure that the vaccine can be produced reliably and consistently (U.S. Food and Drug Administration, 2020). The FDA will also review product labeling before it is licensed and approved for the general public to use.
  • Additional Approvals – Once the FDA licenses a vaccine, the Advisory Committee on Immunization Practices (ACIP) develops recommendations on how to use that vaccine to control and prevent disease in the United States. These recommendations are then forwarded to CDC’s Director as well as the U.S. Department of Health and Human Services for approval. Finally, they are published in CDC’s Morbidity and Mortality Weekly Report (MMWR), which is the official resource for immunization of the U.S. population (CDC, 2020).
  • Continued Safety Monitoring – Manufacturers are required to submit samples from each vaccine prior to their release so that the FDA can check their safety, potency, and purity. Environmental factors like temperature can potentially contaminate vaccines during production, so continued safety monitoring is just as important as each preceding step within the vaccine development process.

How were researchers able to develop COVID vaccines so quickly?

Historically speaking, developing a vaccine in less than a decade is considered fast, and to do so in one year or less is unprecedented. The vaccines for the novel coronavirus — including Pfizer-BioNTech, Moderna, and Johnson & Johnson — went through the same layers of review and testing as other vaccines, but there were two key factors that helped accelerate the process: decades of prior research and fewer barriers.

Researchers were not starting from scratch when they learned about SARS-COV-2, the virus that causes COVID-19. SARS-COV-2 is a member of the coronavirus family, and there are hundreds of coronaviruses, which scientists have been studying for over 50 years (O’Connell, 2020). Researchers were basically able to fast-track clinical trials based on research that had already been done. Additionally, both public and private groups, as well as major health institutions stepped up to invest more funding in the development, manufacturing, and distribution of the COVID-19 vaccines.

References

  1. Bradford, A. (2019, April 23). Smallpox: The World’s First Eradicated Disease. LiveScience.  https://www.livescience.com/65304-smallpox.html
  2. Riedel, S. (2005). Edward Jenner and the History of Smallpox and Vaccination. Baylor University Medical Center Proceedings, 18:1, 21-25. https://doi.org/10.1080/08998280.2005.11928028
  3. Tulchinsky, T. (2018). Maurice Hilleman: Creator of Vaccines That Changed the World. Academic Press, 19, 443-470. https://doi.org/10.1016/B978-0-12-804571-8.00003-2
  4. Smallpox: The disease, now eradicated, was once one of the world’s deadliest. National Geographic. https://www.nationalgeographic.com/science/article/smallpox
  5. World Health Organization (WHO). Smallpox. Retrieved from: https://www.who.int/health-topics/smallpox
  6. International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).(2019). The Complex Journey of a Vaccine – The Steps Behind Developing a New Vaccine. https://www.ifpma.org/wp-content/uploads/2019/07/IFPMA-ComplexJourney-2019_FINAL.pdf
  7. U.S. Food and Drug Administration. (2020, December 14). Vaccine Development – 101. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101
  8. Centers for Disease Control and Prevention (CDC). (2020, September 9). Overview, History, and How the Safety Process Works. https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html
  9. O’Connell, M. (2020, June 9). First Human Coronavirus Isolated at UChicago More Than 50 Years Ago. University of Chicago. https://www.uchicagomedicine.org/forefront/coronavirus-disease-covid-19/first-human-coronavirus-isolated-at-uchicago-more-than-50-years-ago

DISCLAIMER: This article is for general information purposes only, does not constitute medical advice and is not intended to be relied upon for medical diagnosis or treatment. If you are experiencing a medical emergency, dial 911 immediately.