As the world continues to feel the impact of COVID-19, the biopharmaceutical industry is working around the clock to identify and develop safe and effective vaccines to prevent infection, while also researching and developing new ways to treat those infected with the virus.
During this time, biopharmaceutical companies are working continuously with stakeholders across the R&D ecosystem to advance vaccine candidates as quickly and safely as possible.
Step by step, here’s how scientists are aiming to develop a vaccine for COVID-19:
Step 1: Identify and Sequence the Virus
When evidence of a new virus is detected, scientists work to isolate and identify the specific virus in question. Once isolated, scientists can rapidly sequence the unique genetic code of the new virus, which provides information needed to help design diagnostic tests and potential vaccines and treatments.
On January 10, 2020, Chinese health officials released the full genetic sequence of the novel coronavirus that can cause COVID-19, just a few weeks after the first case was discovered. The next day, researchers around the world started work on a vaccine.
By comparison, it took several months after the discovery of SARS in 2002 to sequence the full SARS-CoV-1 genetic code with the tools available at that time. The much faster timeline in the case of COVID-19 illustrates recent improvements technologies that have dramatically shortened the time it takes to decode viruses and create a potential vaccine.
Step 2: Determine the Target
Vaccines work by imitating an infection to teach the immune system how to recognize, remember and target microbial invaders, like viruses and bacteria, without actually causing an infection. The process to determine how to best deliver a vaccine is complex as different approaches may work better for different pathogens.
Historically, some vaccines, such as the measles vaccine, have used live but weakened versions of a pathogen, while others have used viral material that has been chemically inactivated or killed, which is the method used by the polio vaccine.
Newer vaccines, such as the vaccine for hepatitis B, contain only a small part of a pathogen—usually a specific protein that the body can learn to recognize, known as an “antigen.” Given the pressing need for a safe and effective vaccine for the novel coronavirus, along with the volume of information that remains unknown about the disease, a wide range of approaches to vaccine development are being tested by biopharmaceutical researchers throughout the world to greatly improve the odds that one or more of these approaches will be successful.
Step 3: Conduct Preclinical Trials
Once researchers identify a vaccine delivery mechanism, cell cultures or animal models are used to test the vaccine’s potential safety and effectiveness. As of May 1, 2020, 67 vaccine candidates have entered preclinical testing.
Notably, it’s common for vaccine candidates to fail during this part of the process, which is why we need as many shots on goal with as many viable candidates as possible.
Step 4: Conduct Clinical Trials
If a potential vaccine is successful in preclinical studies, scientists begin studying it in humans, which requires multiple types of clinical trials. Initial trials involve just a few dozen participants to provide evidence that a new vaccine is safe and to help researchers optimize dosing amounts. Demonstrating efficacy for vaccines presents unique challenges. Unlike most pivotal clinical trials, subjects in pivotal clinical trials for vaccines are otherwise healthy at the start of the clinical trial. Accordingly, demonstrating efficacy may require longer and larger clinical trials for vaccines than for other products.
Additional trials examine the vaccine in hundreds to even a few thousand people to better understand how the immune system responds to a vaccine, whether it is effective and durable at producing immunity, and to further understand the vaccine’s safety profile. Depending on the vaccine and disease under study, thousands or even tens of thousands of participants may participate to increase understanding of a vaccine’s safety profile. As of May 1, 2020, nine coronavirus vaccine candidates have entered initial clinical trials.
Step 5: Obtain Regulatory Approval
By this point, the majority of vaccine candidates will have failed, underscoring the substantial risks and complexities involved. However, if a vaccine successfully makes it through clinical trial phases, researchers can apply for approval from the U.S. Food and Drug Administration (FDA). Applications for approval must meet FDA’s robust standards for safety, purity and potency to obtain approval, and include data generated pre-clinical testing and clinical trials, in addition to significant information on the manufacturing process.
Step 6: Manufacturing and Distribution
While the vaccine is going through clinical studies, biopharmaceutical researchers are also developing the manufacturing methods that will be used if the new vaccine is successful. For some types of vaccines used in large populations, these methods then undergo massive scale up to enable the manufacture of what can be many millions of doses. This is an enormous undertaking, as the transition from laboratory to manufacturing facility is incredibly complex and must ensure consistency in the vaccine composition and safety and efficacy profiles. As developing the manufacturing strategy can be a multi-year process, biopharmaceutical companies are already seeking to expand their manufacturing capacity. Companies are also initiating manufacturing capabilities at risk, well before a COVID-19 vaccine receives regulatory approval, to speed the production process when a vaccine is ready.
Safely delivering a vaccine to patients around the world is an equally challenging undertaking, especially in less developed regions, as vaccines often require special handling, such as temperature control, during distribution. Biopharmaceutical companies are working closely with local governments and NGO partners to lay the groundwork for potential distribution at global scale.
America's biopharmaceutical companies are committed to developing solutions to help diagnose, treat and prevent COVID-19, a disease caused by a novel strain of coronavirus.READ MORE
What happens during a pandemic?
In these unprecedented times, America’s biopharmaceutical companies are coming together to achieve one shared goal: ending COVID-19.
Amid pandemics such as the one caused by COVID-19, timelines are crucial. Given the current pressing need, biopharmaceutical researchers are exploring ways to develop potential vaccines more quickly by completing some parts of the process simultaneously.
For example, the vaccine material for clinical trials can be developed while early pre-clinical studies are underway. Additionally, as noted above, many companies have begun to expand their manufacturing capabilities as well as collaborating with other companies and governments and NGOs to ensure sufficient capacity to meet demand once a vaccine is approved. This is despite the risks involved, as manufacturing investments can cost hundreds of millions of dollars and are typically reserved for later phases of development, during which the likelihood of a candidate’s success is more clear.
At the same time, the biopharmaceutical industry is partnering with U.S. and global health agencies to speed vaccines to patients. Recently, several leading biopharmaceutical companies joined together with the National Institutes of Health (NIH) and the Foundation for the NIH and others to start a public private partnership aimed at “prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.”
Vaccine development is incredibly complex and risky, but biopharmaceutical researchers have the specialized skills and experience to navigate development successfully, and they understand the pressing need for a safe, affordable and effective vaccine to help combat COVID-19. The industry accepts and is prepared for its unique leading role to play amid the current pandemic, and continues to rapidly mobilize its scientific expertise and resources to tackle these threats head on.
Learn more about PhRMA member company efforts to beat COVID-19 at PhRMA.org/Coronavirus
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