COVID Vaccine Lawyer Leah V. Durant Takes a Look Back at the Vaccine Development Process and Timeline

There were—and still are—a lot of misconceptions about the COVID-19 vaccine development process. While many people have raised concerns about the development timeline for the COVID-19 vaccines since they were released to the public in record time, the timeline wasn’t nearly as quick as many people think. Additionally, as a vaccine expert and professor at the Mayo Clinic told the AARP, the steps in the process that moved faster than usual, “were essentially the paperwork.” Here, COVID vaccine lawyer Leah V. Durant takes a look back at the development process and timeline for the COVID-19 vaccines at the height of the pandemic.

“A Leg Up from the Beginning”

When scientists got to work developing vaccines in response to the COVID-19 pandemic, they “had a bit of a leg up from the beginning.” As the Mayo Clinic’s vaccine expert also explained, “[t]he virus that causes COVID-19 is related to other coronaviruses that have been under the microscope for years, including those that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).”

This is echoed by other health authorities as well. For example, the U.S. Centers for Disease Control and Prevention (CDC) told the AARP that, “[t]he knowledge gained through past research on coronavirus vaccines helped to accelerate the initial development of the current COVID-19 vaccines,” and the National Institutes of Health (NIH) explain:

“Developing a vaccine and bringing it to market often takes many years. But because of work that NIH was already doing when the COVID-19 pandemic began, researchers were able to come up with vaccines for this new virus much faster. . . .

“Years before the COVID-19 pandemic began, experts at the NIH Vaccine Research Center (VRC) were studying coronaviruses to find out how to protect against them. The scientists chose to focus on one “prototype” coronavirus and create a vaccine for it. That vaccine could then be customized to fight different coronaviruses. . . .”

Thus, while the response to the COVID-19 pandemic itself was rapid, this response was facilitated by years’ worth of prior work. As NIH continues:

“[T]his prototype approach, along with coronavirus research from labs around the world, made it possible for scientists to spring into action when the pandemic hit. Many vaccines take 10 to 15 years to reach the public. But the timeline for the COVID-19 vaccine was very different.

“The COVID-19 outbreak in China was first reported publicly on December 31, 2019. . . . On December 18, 2020, after demonstrating 94 percent efficacy, the NIH-Moderna vaccine was authorized by the U.S. Food and Drug Administration (FDA) for emergency use. Just days earlier, the similar Pfizer/BioNTech vaccine had become the first COVID-19 vaccine to be authorized for use in the United States.”

Due to the “prototype approach” used to develop the COVID-19 vaccines and scientists’ prior experience with other coronavirus vaccines, scientists also already had a general understanding of the COVID-19 vaccines’ safety. Years’ worth of clinical trials weren’t necessary—because these clinical trials had already been done. The CDC warned about some of the health risks linked to the COVID-19 vaccines early on; and, while the CDC generally encouraged widespread vaccination in order to achieve herd immunity, it also advised against getting vaccinated in certain cases. This, too, was based on the testing and research done prior to the COVID-19 pandemic.

mRNA Vaccines Are Not a New Technology

Another concern many people had with the Pfizer-BioNTech and Moderna COVID-19 vaccines was that these were the first-ever mRNA vaccines approved for human use in the United States. However, while these vaccines’ introduction during the COVID-19 pandemic made it appear as though they were a brand new, novel type of vaccine, this wasn’t actually the case.

As the Johns Hopkins Bloomberg School of Public Health explains in an article titled, The Long History of mRNA Vaccines:

“Messenger RNA, or mRNA, was discovered in the early 1960s[ and] research into how mRNA could be delivered into cells was developed in the 1970s. . . . The first mRNA vaccines . . . were developed against the deadly Ebola virus [in the 2010s], but since that virus is only found in a limited number of African countries, it had no commercial development in the U.S.”

When the COVID-19 outbreak began in late 2019, “[t]hanks to decades of research and innovation, mRNA vaccine technology was ready.” So, even though it seemed like Pfizer-BioNTech and Moderna came up with the mRNA COVID-19 vaccines in a matter of months, this wasn’t actually the case.

The Accelerated Timeline for COVID-19 Vaccine Approval

Typically, when drug companies start from scratch, it can take them anywhere from five to 10 years to bring a new vaccine to market. There are four phases in the regulatory approval process—with the final phase involving approval by the U.S. Food and Drug Administration (FDA). After that, drug companies typically need time to market new vaccines and set up their distribution networks; and, even though the drug companies want to do this as quickly as possible so that they can start providing from their newly approved vaccines, this still adds to the overall timeline.

Even with past research on coronavirus vaccines and mRNA vaccines, going through this process would still typically take one to two years on the FDA’s accelerated timeline. As the Johns Hopkins Coronavirus Resource Center explains, the accelerated timeline for vaccine approval generally involves:

  • Phase I – On the FDA’s accelerated timeline, clinical trials can be completed in two to three months—instead of the years-long process typically required.
  • Phase II – Phase II involves additional clinical trials focused on safety and immune response. While these also typically take several years, the FDA’s accelerated timeline allows them to be completed in three to four months.
  • Phase III – Phase III involves yet more clinical trials focused on safety and efficacy. When conducted in connection with a high-risk infection (like COVID-19), the FDA’s accelerated timeline allows them to be completed within six to nine months.
  • Phase IV – While getting the FDA to fully review a drug company’s application for approval can also take years, the FDA prioritizes applications for high-risk infections, especially when the President has declared a national emergency.
  • Marketing, Manufacturing and Distribution – With the COVID-19 pandemic and vaccines making worldwide headlines, the drug companies didn’t need time to market their vaccines. Additionally, as they were anticipating swift FDA approval, they began developing their manufacturing and distribution systems during the development process.

So, how did the first COVID-19 vaccines get approved in less than a year? This was due to the FDA’s Emergency Use Authorization (EAU) process. As the FDA explains, the EAU process, “allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.” In other words, the FDA can even further shorten the vaccine approval timeline when necessary. In the case of the COVID-19 vaccines, securing EAU was the final step in the approval process—and this allowed Johnson & Johnson/Janssen, Pfizer-BioNTech, and Moderna to start shipping doses of their vaccines less than 12 months after the pandemic began.

Despite the COVID-19 Vaccines’ Roadmap for Success, All Vaccines Present Some Risk

Even though the COVID-19 vaccines were backed by decades’ worth of research and development into coronavirus vaccines and mRNA vaccines generally, they still presented—and continue to present—risks. It is important to recognize, however, that this has less to do with the timeline than it does with the vaccines themselves.

In fact, regardless of how long it took to develop the COVID-19 vaccines, they would likely still present the same risks for two reasons: First, the vaccines are what they are—extending the timeline would not have changed their chemical composition. Second, some of the risks associated with vaccination are not specific to the vaccines involved. For example, one of the most common risks associated with vaccination is the risk of shoulder injuries related to vaccine administration (SIRVA), and these injuries can result from errors during immunization regardless of the vaccine that is being administered.

The other primary risks associated with the COVID-19 vaccines—including anaphylaxis, myocarditis, pericarditis and Guillain Barre Syndrome (GBS)—would all almost certainly exist regardless of the COVID-19 vaccines’ development timeline (again, because the timeline did not affect the research or science that went into the vaccines). While vaccines save lives, they also present risks. When these risks lead to serious injuries or illnesses, it is time to contact a COVID vaccine lawyer for help.

Request an Appointment with COVID Vaccine Lawyer Leah V. Durant

If you have questions about an illness or injury linked to immunization against COVID-19, we encourage you to contact us for more information. To request an appointment with COVID vaccine lawyer Leah V. Durant, give us a call at 202-800-1711 or tell us how we can reach you online today.