Vaccines represent some of the most impactful public health advances seen to date, playing a critical role in reducing the spread of, and, in some cases, eliminating the threat of the world’s many devastating infectious diseases.

The human immune system is incredibly powerful and versatile, working continuously to keep a variety of invaders from causing infection and disease. From bacteria, to viruses, to parasites, the immune system recognizes invading threats and triggers a response in the body to contain and combat invaders. And although the immune system is incredibly robust, it is not invincible which is why vaccines are needed to help support the body’s defenses.

Vaccines present a number of unique challenges that make them particularly complicated to research, including scientific, clinical and logistical hurdles throughout the development process. These challenges are made more difficult during public health emergencies. Even with these challenges, some of the newer types of vaccines have the potential to move faster from initial virus identification to a viable vaccine, and faster from there to a licensing application and manufacturing scale up.

As of April 2020, there are nearly 260 vaccines in development by America’s biopharmaceutical companies to both prevent and treat diseases including cancer, Alzheimer’s disease, allergies and autoimmune disorders. These vaccines offer significant hope for the future, with many vaccines in the pipeline using new technologies that have the potential to prevent the transmission of the human immunodeficiency virus (HIV), protect against malaria and even therapeutic vaccines to treat several types of cancer.

Responding to Public Health Emergencies

The biopharmaceutical industry is uniquely positioned to respond rapidly to the current coronavirus and other public health emergencies. Biopharmaceutical companies have long been at the forefront in conducting R&D and providing manufacturing support for global public health emergencies including West Nile virus, SARS, Zika and Ebola. It can take more than 10 years to develop a novel vaccine from the discovery stage all the way through to approval by the U.S. Food and Drug Administration (FDA). Although efforts are underway to significantly shorten that timeline for a COVID-19 vaccine.

Vaccine Safety

Vaccines undergo a rigorous research and development process in order to ensure safety and efficacy, and continue to be monitored long after U.S. Food and Drug Administration (FDA) approval. Manufacturers and health authorities coordinate to ensure strict manufacturing and delivery schemes, in order to guarantee the quality and purity of vaccines. Data show that the current U.S. vaccine supply is the safest in history, due in part to the U.S. Centers for Disease Control and Prevention’s (CDC’s) long-standing vaccine safety program, which closely and constantly monitors the safety of vaccines. One important element of the program, the Immunization Safety Office, monitors possible vaccine side effects and works with public health stakeholders to assess possible connections to vaccines. For example, while some have had concerns that autism spectrum disorder might be linked to the vaccines children receive, studies have shown that there is no link between receiving vaccines and developing autism spectrum disorder.

For more information about vaccines and vaccine safety, visit www.cdc.gov