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The US is In The Golden Age of Vaccine Development

NOV 13, 2017 | DANIELLE MROZ
“We are at a golden age right now in vaccinology. The opportunities that we have to take advantage of the knowledge we have gained from immunology, biology, microbiology, and genomics, and to translate this into advances in patient care—this is absolutely incredible.” Those were the words of Leonard Friedland, MD, vice president, director of scientific affairs and public health, Vaccines, North America, at GlaxoSmithKline, and a representative member of the National Vaccine Advisory Committee (NVAC) during the opening presentation at the recent Vaccines + Immunity: Examining Modern Medicine meeting presented by The Atlantic on November 9, 2017, in Philadelphia, Pennsylvania.

With 264 vaccines in the pipeline in the United States to prevent a host of conditions from infectious diseases, to cancer, allergies, and more, the future for the prevention of diseases appears to be extremely bright. Indeed, in the past 2 years alone, several vaccines have been approved for infectious diseases, including Vaxchora, a live oral vaccine to prevent cholera for adult travelers, Flublok Quadrivalent for prevention of influenza in adults 18 and older, Shingrix, a new vaccine to prevent shingles in adults, and recently, HEPLISAV-B for the prevention of infection by all known subtypes of hepatitis b in adults 18 and older.

Health care researchers from all different scientific backgrounds are bringing their particular expertise to the development of these life-saving tools against some of the most virulent pathogens. It is this collaboration that has really changed the game of vaccine development, enabling researchers to develop vaccines that are more targeted. “The game-changer that changed the terrain is understanding science, and then rationally developing vaccines,” according to Dr. Friedland. “We’ve moved from empiric approaches to vaccine development, to rationale approaches to vaccine development.” He continued, “One of the goals of the future is to move through clinical development faster because we will be able to understand the science faster and be able to test in fewer patients.”

One area of research that has really moved the science of vaccine development forward has been research on HIV, according to Frances Priddy, MD, chief medical officer and executive director of Medical Affairs at the International Aids Vaccines Initiative. “The HIV community is seeing the same excitement [as the rest of the scientific community when it comes to vaccine development]. Because HIV is such a challenging virus to create a vaccine for, [working on the vaccine] really has accelerated science.”

Despite all the progress that has been made in moving vaccine development forward, and the countless number of lives that have been saved, skepticism about the safety of vaccines remains high among the public. To this end, Dr. Friedland stressed that patient safety is paramount when it comes to vaccine development. “Patient safety is on the top of the list,” he said. “We are very fortunate in the United States that we have the best safety monitoring system. We are always looking at benefit versus harm.”

Speaking on safety monitoring and the process of moving a vaccine through regulatory review in the United States, Raul Isturiz, MD, vice president and head of the North America Region of Pfizer Vaccines Medical said, “Once you have product that you feel will be safe and will produce an immunological response, then you move to testing. These are under strict guidelines. First in animals, then in humans. Testing in humans takes a long time [and is] complex. The first phase deals with safety. Phase 2 is proof of concept. It produces the response you think will work. Then larger trials (phase 3) test the response in larger sets of patients. Sometimes phase 4 is required to ensure long-lasting results. Then, we move on to manufacturing.”

If individuals remain unconvinced, Dr. Isturiz has a story to tell them. He remarked on the stark differences between growing up and completing medical school in Venezuela—where he saw many vaccine-preventable diseases (but no vaccines)—and the 7 years he spent in New Haven, Connecticut completing his residency and fellowship—where he did not see these diseases. When he returned to Venezuela and once again, saw these diseases in the population, he was convinced of the efficacy of vaccines, stating that he believed, “vaccine-preventable diseases are a) preventable, and b) need to be prevented by us.”

With the surprising resurgence of vaccine-preventable diseases that the United States has seen in recent years because of increased globalization and more parents choosing not to vaccinate their children, the time for renewed focus on these life-saving tools is stronger than ever. Health care providers can do their part by committing to educating their patients on the importance of vaccines and the protection that vaccines provide against diseases not only for the patient themselves but for the rest of the community.
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