What Is Taking So Long to Make a Vaccine?

The pandemic might feel like forever, but the length of time since the COVID-19 research started is short for the amount of information we usually need to develop an effective vaccine. For example, the first drafts of the SARS-CoV-2 genome were assembled in China and Europe only in January 2020^1,2. Developing a new vaccine typically takes 10–15 years³. The process of vaccine development, mass production, and wide distribution travels down a long, twisty road with many regulatory hurdles⁴. This road is designed to ensure the efficacy and safety of a new vaccine, but not for speed.

A vaccine candidate needs to be identified and tested in the laboratory before it is tested in humans in three phases of clinical trials. It needs to be approved by the regulatory agencies before the drug manufacturers get to work. Ideally, a new vaccine can be quickly distributed while remaining affordable through a strong healthcare system and governmental support. Many sectors, each have their regulatory hurdles to clear, are typically involved in this process sequentially.

To accelerate the process and end the COVID-19 pandemic, many public and private sectors now work in parallel, and standard practices have been changed to accommodate this unusual time. For example, academic and industrial research groups are simultaneously testing different types of vaccines with the hope that at least one will be the solution^5,6,7. Some vaccines are entering “combined” phases for clinical trials⁸. Nonetheless, there is a limit to how much this process can be warped and shortened. Prioritizing speed over safety might do more harm than good⁹.

What COVID-19 Vaccines Are Being Developed Right Now?

As of today, we do not yet have an approved COVID-19 vaccine that can be widely distributed, although one vaccine has just been approved for the military use in China¹⁰. However, preclinical research¹¹ of more than 125 vaccines is ongoing in laboratory settings⁷. Twenty-two vaccines have advanced to and being tested in human clinical trials¹². Scientists have taken various approaches to create COVID-19 vaccines. In addition to using an inactivated or weakened form of SARS-CoV-2, researchers are also developing vaccines using just small pieces of the virus. Alternatively, DNA¹³ or RNA¹⁴ vaccines or the viral gene packaged into a non-pathogenic viral vessel¹⁵ also showed promises. Although a DNA or RNA vaccine contains just a small, non-protein portion of the virus, it carries the genetic code that instructs the production of viral proteins in our body once administered, theoretically achieving the same effect of delivering the viral protein itself. Future COVID-19 vaccines, therefore, might come in different forms, all with the same goal of triggering the production of infection-fighting antibodies in humans. It is important to note that we do not know yet which vaccine is both effective and safe for humans—not cultured cells in a laboratory setting or animals, but real humans—and this is where the importance of implementing human clinical trials lies.

Sources and Further Reading

1. Cohen, Jon. “Chinese Researchers Reveal Draft Genome of Virus Implicated in Wuhan Pneumonia Outbreak.” Science, 11 Jan. 2020, www.sciencemag.org/news/2020/01/chinese-researchers-reveal-draft-genome-virus-implicated-wuhan-pneumonia-outbreak.
2. “Institut Pasteur Sequences the Whole Genome of the Coronavirus, 2019-NCoV.” Institut Pasteur, 30 Jan. 2020, www.pasteur.fr/en/press-area/press-documents/institut-pasteur-sequences-whole-genome-coronavirus-2019-ncov.
3. “Vaccine Development, Testing, and Regulation .” The History of Vaccines, 17 Jan. 2018, www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
4. Freyer, Felice J. “Why Does It Take so Long to Make a Vaccine?” Boston Globe, 15 May 2020, bostonglobe.com/2020/05/15/nation/why-does-it-take-so-long-make-vaccine.
5. “Draft Landscape of COVID-19 Candidate Vaccines.” World Health Organization, 9 June 2020, www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines.
6. Mullard, Asher. “COVID-19 Vaccine Development Pipeline Gears Up.” The Lancet, vol. 395, no. 10239, 2020, pp. 1751–52. Crossref, doi:10.1016/s0140-6736(20)31252-6.
7. Corum, Jonathan, and Carl Zimmer. “Coronavirus Vaccine Tracker.” New York Times, 30 June 2020, nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html.
8. “Oxford COVID-19 Vaccine to Begin Phase II/III Human Trials.” University of Oxford, 22 May 2020, www.ox.ac.uk/news/2020-05-22-oxford-covid-19-vaccine-begin-phase-iiiii-human-trials#.
9. Garber, Ken. “Coronavirus Vaccine Developers Wary of Errant Antibodies.” Nature Biotechnology, 5 June 2020, nature.com/articles/d41587-020-00016-w.
10. “CanSino’s COVID-19 Vaccine Candidate Approved for Military Use in China.” Reuters, 29 June 2020, www.reuters.com/article/us-health-coronavirus-china-vaccine/cansinos-covid-19-vaccine-candidate-approved-for-military-use-in-china-idUSKBN2400DZ.
11. “Preclinical Research.” U.S. Food and Drug Administration, 4 Jan. 2018, www.fda.gov/patients/drug-development-process/step-2-preclinical-research.
12. “Clinical Research.” U.S. Food and Drug Administration, 4 Jan. 2018, www.fda.gov/patients/drug-development-process/step-3-clinical-research.
13. “DNA Vaccines.” World Health Organization, www.who.int/biologicals/areas/vaccines/dna/en. Accessed 30 June 2020.
14. “RNA Vaccines.” Nature, 14 Feb. 2020, www.nature.com/subjects/rna-vaccines?error=cookies_not_supported&code=11e4eaf6-622e-49d9-b4e9-1baae9cd1689.
15. “Vaccines Based on Viral Vectors.” World Health Organization, 20 Oct. 2014, www.who.int/biologicals/publications/trs/areas/vaccines/typhus/viral_vectors/en.