Vaccine development—from 10 years to 10 months—how did that happen?

I see many comments about the vaccines being rushed—reasonable and well-meaning comments. For over a decade now I have been working exclusively on vaccines. I am an MD with a Master’s degree in infectious diseases and public health and another Master’s degree in vaccinology and clinical development. Because there’s still so much to learn about this topic, I am doing a PhD in microbiology and immunology, focusing on vaccines.

Please allow me to share my perspective on this.

Yes, development of most of the vaccines we now have took several years to several decades. Here’s a summary of the different vaccine-preventable diseases, the year these pathogens were discovered and the year the respective vaccines became available.

I summarized this in the early months of the pandemic to give people an idea of the speed of development of the different vaccines for different pathogens considering the different scientific “era” these germs were discovered and the different technology available during those times. The keyword is different. We are also in a different situation now—we are in the midst of a once-in-a-century pandemic that has now infected over 100 million and killed over 2 million people worldwide.

The COVID vaccines were developed in about 10 months, yet there was no “cutting corners” in the design, testing, and manufacturing of the vaccines. These vaccines were tested in the so-called prospective, placebo-controlled, randomized Phase 3 clinical trials. Prospective because the trial participants are followed over time for a certain period. Randomized because the researchers decided randomly about which participants receive the vaccine candidate and which ones receive a placebo (a substance that has no therapeutic effect). Placebos were used as inactive controls so researchers could better evaluate that the effect seen is really from the experimental vaccine under study.

Scientists have been studying coronaviruses for over half a century

Although things moved quickly for COVID vaccines, all the standard trials were performed before these vaccines were reviewed by national regulatory authorities (like the US FDA, European Medicines Agency, or the Philippine FDA). How did that happen?

1. Scientific data from other coronaviruses. SARS-CoV-2 is NOT the first coronavirus. Scientists have been studying coronaviruses for over half a century, starting from non-pandemic human coronaviruses, including types 229E, NL63, OC43, and HKU1. These coronaviruses usually cause mild to moderate upper-respiratory tract illnesses, like the common cold. Then we had SARS (severe acute respiratory syndrome) in 2002 and MERS (Middle East respiratory syndrome) in 2012. Scientists had existing data on the structure, genome, and life cycle of coronaviruses.

2. One-of-a-kind global collaboration and data sharing. Chinese researchers quickly sequenced the virus and shared their data with other scientists early in January 2020. Once the genomic sequence became available to the global scientific community, vaccine developers started creating SARS-CoV-2 vaccine candidates. Many labs working on other pathogens stopped their research to focus on COVID-19. There has never been a single time in human history where thousands of physicians and scientists worldwide worked on (and are still working on) a single disease—not even with HIV/AIDS.

3. Unprecedented funding for vaccine research. Vaccine development is expensive. The cost of developing a vaccine—from research and discovery to product registration—is estimated to be between $200 million and $500 million (USD) per vaccine. But because we are in a pandemic, the US, EU, UK, and many other developed countries, with philanthropic organizations and funding agencies like the Bill & Melinda Gates Foundation, Wellcome Trust, pledged billions of dollars to fund research. Dolly Parton even donated $1M to coronavirus vaccine research. I know many other celebrities who wanted to remain anonymous and donated money to help fund vaccine research. The US government’s Operation Warp Speed invested over 10 billion USD in supporting the development of seven vaccine candidates. Yes, billions! In a non-pandemic situation, developers need to apply for funding to start new studies or continue existing ones. Even in private companies doing vaccine development, projects could be postponed or stopped because of competing priorities or lack of funding. Funding is one major bottleneck for vaccine development, and for COVID vaccines, this bottleneck was simply not there.

While the COVID mRNA vaccine is new, the technology is not new. Scientists have been studying it since the 1990s

4. Advancements in science and technology. The vaccine platforms that enabled the first COVID-19 vaccines to reach the finish line used mRNA technology (i.e. Pfizer BioNTech vaccine, Moderna vaccine). Yes, these are the first mRNA vaccines licensed, but scientists have been studying this technology since the 1990s. Another mRNA vaccine in Phase 3 clinical trials is being developed by CureVac, the world’s first company to successfully harness mRNA for medical purposes. The company was founded in 2000, and CureVac has started mRNA vaccine research since then. So, while the COVID mRNA vaccine is new, the technology is not new. The same goes for the viral vector vaccines (i.e. Oxford Astra Zeneca vaccine). There are viral vector vaccines already licensed and in use.

5. There is COVID-19 community transmission almost everywhere. Except for Taiwan and New Zealand, COVID-19 community transmission still happens. Countries like the US, UK, Russia, Mexico, France, India, Indonesia, Portugal, and Italy record over 10,000 new cases every day. When conducting efficacy trials for vaccines, one group is given the vaccine candidate; the other group gets a placebo or an existing vaccine. Then they are monitored for months until the clinical trial reaches a pre-specified number of cases (for example, 200). Next, the data will be analyzed to calculate vaccine efficacy by looking at how many of the 200 infected were vaccinated and unvaccinated. So, if there is a widespread transmission, the clinical trial reaches the required number of cases faster. If there is no community transmission, you need to wait a year or more before a study can be completed.

COVID vaccines are the “moon landing” of our generation—a triumph of science and technology. Each COVID vaccine is a testament to what can be achieved with resources, lots of funding, science, and thousands of smart people and tens of thousands of study participants who volunteered their time and immune systems to ensure we will be out of this pandemic someday soon.

The next time someone tells you, “COVID vaccines were rushed,” please do your part and help stop the spread of misinformation and fear. COVID vaccines were developed quickly, but there were no shortcuts in the development process.