Vaccines have played a critical role in reducing the spread of, and in some cases, eliminating the threat of many devastating infectious diseases. They are often cited as second only to clean drinking water in leading to some of the most impactful public health advances in history, including the eradication of smallpox and near global elimination of polio.
Today, researchers are working around the clock to research and develop a safe and effective vaccine that will help the body develop immunity to COVID-19, the disease caused by the novel strain of the coronavirus. As of May 29, 2020, there are more than 120 vaccines for COVID-19 in the research pipeline worldwide, ten of which are currently in human trials.
The unprecedented progress in such a short time is due in part to active collaboration across the industry and with public partners, as well as the U.S. Food and Drug Administration (FDA) who conduct “a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products.” Importantly, the FDA also “has a stringent regulatory process for licensing vaccines that serves as a model for other countries.”
The Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office further “uses many strategies to assess vaccine safety, to identify health problems possibly related to vaccines, and to conduct studies that help determine whether a health problem is caused by a specific vaccine. CDC also works with other federal government agencies and other stakeholders to determine the appropriate public health response to vaccine safety concerns and to communicate the benefits and risks of vaccines.”
Here is a closer look at comments from public health experts about the robust and thorough safety protocols in place that governs vaccine approval and review, even during public health emergencies:
- “The urgent public-health need demands speed. But that doesn’t mean compromising robust data to prove safety and efficacy.” – Scott Gottlieb, former FDA Commissioner and Luciana Borio, former director for medical and biodefense preparedness policy at the National Security Council
- “Even with the accelerated timelines attempted in the development of a coronavirus vaccine, safety is still prioritized by what doctors describe as many steps being executed in parallel compared to the traditional linear, years-long model of vaccine development.” – John Hewko, CEO of Rotary International, and Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital and professor and dean of the National School of Tropical Medicine at the Baylor College of Medicine
- “There are multiple aspects of safety of vaccine trials. There’s the gradual phasing in of clinical trials before a vaccine is approved. You do a Phase I in very few people, determine the right dose, make sure it’s safe. You do a Phase II in a larger number of people, make sure you get the right immune response, make sure it’s still safe. Then you do a Phase III to nail down the efficacy and show in a large number of people that it really is effective and safe. But it doesn’t stop there, because after the vaccine is licensed, there’s the post-licensing observation of adverse events, both by the FDA [Food and Drug Administration] and by a combination of the FDA and the CDC [Centers for Disease Control and Prevention] and a number of other monitoring groups. So there’s a constant monitoring to make sure that something that looked pretty clearly like it was safe in the beginning, even if you follow it for several years, it still is safe.” – Dr. Anthony Fauci, Director of the National Institutes of Allergy and Infectious Disease (NIAID)
- “Vaccines are safe. Before a vaccine is licensed in the United States, the Food and Drug Administration (FDA) reviews all aspects of development, including where and how the vaccine is made and the studies that have been conducted in people who received the vaccine. The FDA will not license a vaccine unless it meets standards for effectiveness (how well the vaccine works) and safety… Every lot of vaccine is tested to ensure quality (including safety) before the vaccine reaches the public. In addition, FDA regularly inspects places where vaccines are made.” – The American Academy of Pediatrics
- “Before anyone gets a shot at a clinic or the doctor’s office, scientists do a lot of work to make sure the vaccine is safe. The FDA and the CDC are the government offices in charge of vaccine safety. When a company makes a new vaccine, these agencies must go through many steps before it reaches to the public.” – Department of Health and Human Services
- “Clinical trials are conducted according to plans that FDA reviews to ensure the highest scientific and ethical standards. The results of the clinical trials are a part of FDA’s evaluation to assess the safety and effectiveness of each vaccine. In addition to evaluating the results of the clinical trials, FDA scientists and medical professionals carefully evaluate a wide range of information including results of studies on the vaccine’s physical, chemical, and biological properties, as well as how it is manufactured, to ensure that it can be made consistently safe, pure, and potent.” – The Centers for Disease Control and Prevention
- “From the initial stages of early research and clinical development through regulatory approval and use, vaccines are painstakingly evaluated for safety and efficacy. By the time a physician prepares an injection and administers it to stimulate a child’s immune system, the vaccine contained within has been carefully studied in the laboratory and through several phases of clinical trials. Each phase builds on the information received from the previous one, and if safety is not assured at any point, the vaccine candidate simply does not advance.” – PATH
In vaccine development, there is no guarantee of success, in fact most vaccines do not make it through development for one reason or another. Biopharmaceutical researchers have the specialized skills and experience to navigate development successfully, and they understand the pressing need for a safe and effective vaccine to help combat COVID-19. The industry is playing a leading role during the current pandemic and is rapidly mobilizing its scientific expertise and resources to tackle these threats head on.