Buzz
Developing a vaccine is usually a time-intensive process. Earlier this year, it was revealed that the fastest previous vaccine development took four years, from initial sample to approval. Many believed a COVID-19 vaccine might take years, if it ever materialized. Yet, just over a year after the novel coronavirus was identified, a vaccine has been authorized for emergency use in the U.S., with several others in advanced trials or already approved elsewhere.
A common question is, 'Was the process rushed?' From my perspective, it doesn’t appear so. After reviewing trial data, attending FDA and CDC meetings, and observing expert opinions, it’s clear that no shortcuts were taken. The rapid development was instead a result of fortunate circumstances, strategic planning, and exceptional collaboration among scientists, manufacturers, and regulatory bodies.
To understand how this was achieved, let’s examine the key stages of vaccine development. I’ll focus on the mRNA vaccines leading the race in the U.S., such as the Pfizer/BioNTech vaccine, which has received emergency authorization, and the Moderna vaccine, which may soon follow. These advancements have also positively impacted numerous other vaccine candidates globally.
Years of foundational research have been dedicated to understanding this category of viruses.
Prior to COVID, there was SARS. This respiratory illness, initially shrouded in mystery, emerged in China in late 2002 and spread globally before being contained through rigorous quarantines and global collaboration.
SARS was also triggered by a coronavirus. The COVID virus bears such a striking resemblance to it that it was named as if it were a sequel: SARS-CoV for the original virus and SARS-CoV-2 for the new one.
The SARS outbreak accelerated research into dangerous, highly contagious coronaviruses. Another disease in this family, MERS, surfaced in the Middle East in 2012. Thus, while the COVID virus is novel, efforts to combat or prevent a coronavirus pandemic have been ongoing for at least 18 years.
Advances in molecular biology have also progressed significantly. Today, scientists can sequence viral RNA so rapidly that the coronavirus's genetic sequence was made public on January 10, 2020, within a month of its initial detection.
mRNA vaccines have a rich and extensive background.
No mRNA vaccine has yet been approved for human use, but the Pfizer/BioNTech vaccine, if fully approved as expected, will mark a historic first. However, the technology behind it wasn’t developed overnight this year.
The concept of using RNA—the virus’s genetic material without other components—in vaccines originated in the early 1990s, meaning nearly three decades of research have been dedicated to this approach. As highlighted in a 2018 review, mRNA vaccines have already shown promise in generating immunity against diseases like influenza, Zika, and rabies.
Over the years, scientists encountered challenges, such as concerns that mRNA vaccines might trigger autoimmune responses, but they also devised solutions. By chemically altering the mRNA and encapsulating it in protective nanoparticles, they ensured its safety. The 2018 review noted, 'Recent advancements have effectively addressed these issues, with mRNA vaccine platforms for infectious diseases and certain cancers showing promising outcomes in both animal and human trials.' Even back then, the method was lauded for its potential for rapid development.
Understanding how to construct a specific type of vaccine can significantly speed up the process. For instance, flu vaccines are developed annually in less than a year. Each year’s flu shot differs from the previous one, but it isn’t created from scratch. Manufacturers already have the infrastructure in place and simply update the vaccine to target the latest influenza strains.
Recall when the virus’s genome was released in January? Moderna informed reporters that their facilities were already equipped to produce mRNA vaccines. Once they accessed the genetic data, they developed a vaccine in just two days.
Vaccine trials typically involve significant delays.
Several vaccine trials began in the spring, coinciding with the U.S. starting to implement lockdowns. Substantial funding flowed in from governments, organizations, and donors worldwide, creating a sense of urgency to move forward quickly.
Pharmaceutical companies aimed to produce vaccines as soon as possible, and regulatory bodies in the U.S. and elsewhere were eager to expedite approvals. Typically, trials face delays due to funding, paperwork, and slow review board processes. Once approved, recruiting volunteers adds more time.
Under normal circumstances, navigating bureaucratic hurdles could take months or even years. However, the urgency of the situation allowed for unprecedented speed. For instance, the FDA usually processes new drug or vaccine applications within 10 months, with expedited reviews taking six months. Yet, for the first COVID vaccine, they held an emergency meeting and approved it in just three weeks.
The worsening pandemic accelerated the pace of the trials.
The duration of the vaccine trials wasn’t fixed to a specific timeframe. Instead, companies and regulators agreed in advance to continue until a predetermined number of COVID cases emerged among volunteers.
The trials don’t involve deliberately exposing participants to the virus, as that would be unethical. Instead, half the volunteers are vaccinated, and researchers wait. If disease rates are low, completing the trial becomes challenging—a situation that has occurred before. However, during the Pfizer/BioNTech and Moderna trials, the pandemic intensified, leading to a rapid increase in cases. This allowed the studies to conclude and results to be analyzed much faster than anticipated.
All processes occurred simultaneously.
Typically, vaccine development follows a sequential process, with each step completed before moving to the next. There’s no reason to mass-produce vials and labels if the vaccine’s efficacy is unproven or regulatory approval uncertain.
In this case, all steps occurred simultaneously. Vaccine manufacturers started producing doses at full capacity even before trials concluded. Regulatory bodies like the FDA, CDC, and various committees began evaluating potential vaccines well before formal applications were submitted.
For instance, the Advisory Committee on Immunization Practices, which advises the CDC on vaccine recommendations, held multiple meetings this year to address high-level questions. These included whether COVID posed a significant enough threat to justify a vaccine (the answer was yes) and how to prioritize different population groups (using a framework balancing science, ethics, and practicality). Typically, this committee meets after FDA approval, but this time, they convened an emergency session to finalize recommendations within 24 hours of the FDA granting emergency authorization.
Speedy, yet thorough
When questioning if the vaccine was rushed, we’re essentially asking whether it would have been approved without the urgency of a pandemic. However, separating the politics of a pandemic from its scientific realities is nearly impossible.
Doctors, regulators, and individuals must weigh risks and benefits when deciding on medical interventions. The FDA and CDC advisors overwhelmingly agreed that the vaccine’s benefits far outweighed its risks. Had COVID been less severe, the balance might have shifted, with uncertainties playing a larger role.
Consider a less severe version of COVID, such as the common cold. If a vaccine for the common cold existed, would it have been approved with only two months of follow-up and unresolved concerns about risks to individuals with severe allergies? Unlikely. The FDA would probably demand a longer trial and more data to address uncertainties.
Delaying too long also carries risks. According to CDC computer models, the key to saving the most lives with a vaccine isn’t about prioritizing specific groups but ensuring widespread distribution as quickly as possible.
To maintain transparency, the FDA recently released the Emergency Use Authorization memorandum for the Pfizer/BioNTech vaccine. This document includes scientific data, summaries, details about manufacturing facilities, and plans for ongoing safety monitoring post-distribution.
As it stands, the vaccine appears safe and effective so far. No one is obligated to take it, so those who prefer to wait and observe for potential side effects can do so. Personally, if I were in a nursing home or worked in one, I’d get vaccinated immediately. Since I’m likely further back in the queue, I’m closely following updates on this vaccine and others as more information emerges.
