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Vaccine distribution — it's been a rocky road. While millions of doses have been shipped, only about one-third have been administered. The federal government has said a lag in reporting as well as the holiday season are partly to blame. But as long lines were seen across the country and in some states a bit of chaos, what happened? Was Operation Warp Speed more about vaccine development than distribution? To examine the issues of what went wrong and what can be done to fix it, in this episode we speak with emergency physician and former Baltimore Health Commissioner Leana Wen, MD, as well as Mike Alkire, president of Premier, the giant medical supply and healthcare technology firm, and host of the "Inside Out" podcast.

As vaccine distribution ramps up across the U.S., and globally, skepticism remains. Many cite the speed at which vaccines have rolled out as one of their main concerns. In this episode we explore how we got here, how the biopharmaceutical industry readied for this very moment that allowed them to move at warp speed. The vice president for science and regulatory advocacy at PhRMA, Jim Mayne, PhD, joins us to explain how the science-based, public-private partnerships aided in the momentum, how the R&D ecosystem has evolved and why he believes the bio-pharmaceutical industry was not caught off guard by the pandemic.

Vaccination across the nation is now underway, with healthcare workers and those living and working in long-term care facilities among the first to receive the vaccines. Long-term and nursing home residents make up about 1% of the U.S. population, but have accounted for roughly 40% of all COVID-19 deaths, while those older than 50 are more likely to die from COVID-19 than younger age groups. However, they’ve accounted for less than a quarter of total COVID-19 vaccine clinical trial participants. Why are they so scarcely represented in trials? To learn more, we chatted with Sharon Inouye, MD, MPH, a professor of medicine at Harvard Medical School and geriatrician at Hebrew Senior Life. She is also director of the Aging Brain Center at the Hinda and Arthur Marcus Institute for Aging Research. The episode kicks off with a discussion with 60-year old clinical trial participant Kelley Pick, to hear about her experience in a trial.

With a 'return to normal' from the pandemic practically hinging on COVID-19 vaccines, how do you overcome those who are vaccine hesitant? How does vaccination history impact perception and what role do medical professionals have in explaining the science? To learn more we chatted with MedPage Today Editorial Board member Peter Hotez, MD, PhD, Co-Director of the Center for Vaccine Development at Texas Children's Hospital and Dean of the National School of Tropical Medicine at Baylor College of Medicine.

The first vaccine in the U.S. has been granted Emergency Use Authorization and begun distribution and inoculation among the first group of recipients: frontline healthcare providers and assisted-living residents. Questions remain, however, about Pfizer's data and long-term studies. To learn more we chatted with Pfizer's Vice President and Chief Scientific Officer for viral Vaccines, Dr. Phil Dormitzer, who leads Pfizer's research and development into viral vaccines.

The two vaccines showing most promise - and moving first through the regulatory process - are a new type of vaccine known as messenger RNA vaccines. Before COVID-19, mRNA vaccines have never been on the market, but they have been studied. To learn more about the mRNA vaccine technology we chatted with Richard Kuhn, Ph D, who holds an endowed chair at Purdue University and serves as editor-in-chief of Virology.

As pharmaceutical companies move at warp speed to develop a vaccine, the U.S. agency at the center of emergency approvals is "working around the clock" to evaluate whether the limited data meets the standard for emergency approval, FDA commissioner Dr. Stephen Hahn tells our weekly podcast Track the Vax. So far, U.S.- based Moderna as well as Pfizer and BioNTech have both submitted requests for emergency FDA authorization for their respective vaccines. "We're looking at the data right now and it's too early to draw any conclusions but I can assure you our team is working night and day on this," Hahn said. "When the data analysis is ready... we'll make that available to the american people and the committee." The first immunisations using the BioNTech and Pfizer vaccine could take place in the U.K as early as this week. The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss the request for emergency use authorization on December 10. Hahn told us he won’t prejudge what their decision will be, but says their job is to weigh a variety of criteria as it reviews the data, including the participants included in the studies.

Following the race to the COVID-19 Vaccine. Track the Vax will be a limited-series podcast with a goal of explaining how the COVID vaccines work, understanding the mechanism behind their effectiveness, talking to those behind the safety goggles...and trying to stay out of the political fray…and get back to the science. However, like all things these days, when it comes to FDA approval, we may have to step into the political ring. As the government possibly prepares to fast-track a vaccine before phase 3 trials end and a recent vaccine trial was "paused" due to political pressure, we will offer either episodes or perhaps supplemental shows to dive into those issues (in addition to the weekly drop).