April 13, 2021

Summer Surges: Will COVID Vaccines End the Pandemic?

COVID surges and vaccination rates. Are the two inextricably linked? Vaccination rates continue to increase as many states have opened availability to all adults. But also increasing? COVID-19 surges, apparently resulting from a combination of eager travelers, relaxed distancing and mask mandates, and new variants that are more transmissible and perhaps more dangerous. What does that mean for vaccines and the ability to stop this pandemic? Nahid Bhadelia, MD, MALD, the medical director for Bosto...
April 6, 2021

COVID Vaccine Hesitancy: Anti-Vax Craziness or Reasonable Caution?

As more states open up COVID-19 vaccination to anyone 16-years and older, the federal government has now pulled out all the stops. Taking on a full-force media blitz that includes a multi-million dollar ad buy in both English and Spanish, they have enlisted groups from NASCAR and the NFL, to the Catholic Health Association, American Farm Bureau and American Medical Association. The goal is to combat hesitancy, which has dropped considerably but remains substantial among those most susceptible t...
March 30, 2021

Buyer Beware: Fighting COVID Vaccine Fraud

Scams. They are as old as medicine itself. Fraudsters prey on people's fears and concerns by pretending they have a wonder drug or access to a restricted item, then offer it up for sale at a premium. The COVID-19 pandemic seemed to check all the boxes — especially vaccines, when it comes to criminals trying to take advantage of the system. A real-life miracle drug that prevents a real life pandemic, and not enough to go around. Already we've heard of cases from Florida to New York of attempts ...
March 23, 2021

COVID Vaccine Side Effects: Is the System Working?

It's now 100 days since the first COVID shot was given in the largest mass vaccination campaign in U.S. history. With more than 2 million shots administered daily, more vaccines are going in arms each day in America than in all of the clinical trials combined. Each vaccine's clinical trial had 30,000-40,000 participants and was required to produce data for at "least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-ris...
March 16, 2021

Why Women Experience COVID and the Vaccines Differently Than Men

It's been one full year into the pandemic and it's clear: women are bearing the brunt of it. And it's not only because women have been forced out of the workplace at disproportionate rates — hitting the lowest level of female participation in the workplace since 1988 — or because more than 75% of those working in the healthcare sector are women. In fact, women appear hardwired to experience COVID-19 and the vaccines differently. Data from the CDC suggests side effects from the vaccines are wors...
March 9, 2021

When Can I Walk Into a Pharmacy And Get a COVID Shot?

Vaccine distribution nationwide continues to ramp up, with nearly 2-million shots being given daily. President Biden has now said that every adult could be vaccinated by the end of May. A big promise that brings with it hope... a light at the end of the COVID-19 tunnel. But when will COVID vaccination be as simple as getting a flu shot? Many of the doses currently being given are at mass-vaccination sites. Will local and national pharmacies be able to simplify the process? The government still...
March 2, 2021

Latest COVID Vax: One and Done?

Millions of Americans are in line to get one of now three vaccines approved by the FDA for emergency use. The latest — Johnson & Johnson's one-dose adenovirus vector — can be stored for up to three months in a fridge and is easier to transport. Johnson & Johnson is no stranger to the technology, having used it in its Ebola vaccine. Despite its rollout goals of 100 million doses by June, Rick Nettles, MD, vice president of medical affairs at J&J's Janssen division, says researchers are already l...
March 2, 2021

Latest COVID Vax: One and Done?

Millions of Americans are in line to get one of now three vaccines approved by the FDA for emergency use. The latest — Johnson & Johnson's one-dose adenovirus vector — can be stored for up to three months in a fridge and is easier to transport. Johnson & Johnson is no stranger to the technology, having used it in its Ebola vaccine. Despite its rollout goals of 100 million doses by June, Rick Nettles, MD, vice president of medical affairs at J&J's Janssen division, says researchers are already l...
Feb. 23, 2021

What Do We Really Know About Adenovirus Vectors for Vaccines?

As the U.S. hits the half-million death mark from COVID-19 -- a grim milestone that is equal to roughly the entire population of Atlanta and more than that of Miami -- a new weapon is being added to the COVID-19 vaccine arsenal. Johnson & Johnson is seeking emergency use authorization for what would become the U.S.'s first one-dose and non-mRNA COVID vaccine. It employs adenovirus vectors, a technology that has been used in labs for decades and was approved for the Ebola vaccine by the FDA in D...
Feb. 23, 2021

What Do We Really Know About Adenovirus Vectors for Vaccines?

As the U.S. hits the half-million death mark from COVID-19 -- a grim milestone that is equal to roughly the entire population of Atlanta and more than that of Miami -- a new weapon is being added to the COVID-19 vaccine arsenal. Johnson & Johnson is seeking emergency use authorization for what would become the U.S.'s first one-dose and non-mRNA COVID vaccine. It employs adenovirus vectors, a technology that has been used in labs for decades and was approved for the Ebola vaccine by the FDA in D...
Feb. 16, 2021

Can the Same Vaccines Protect Against New COVID Strains?

As many as a dozen COVID-19 variants are knowingly circulating worldwide. Among them, B.1.1.7 and B.1.351, the highly transmissible strains that originated in the U.K. and South Africa, respectively. As more vaccines continue to push forward for emergency approval worldwide, we're still learning the effectiveness of the current vaccines against the new strains; and how the new mutations mean even those who have already had COVID-19 may not be immune from reinfection. To explore the new strains...
Feb. 9, 2021

COVID Vaccines: Too Risky for Some People?

Nearly 1.5 million Americans are being vaccinated every day against COVID-19. Allergic reactions have led some to question if they should get the vaccine; and scant data from clinical trials for the currently approved vaccines in vulnerable populations means we don't fully know how those with certain conditions will react. Does that mean those with certain allergies or conditions like HIV, multiple sclerosis, or cancer should pass on the shot? What about those who are pregnant? Barbara Alexande...
Feb. 2, 2021

Can COVID Vaccination Become Mandatory?

New viral strains continue to spread across the country, which has added to the urgency of getting as many people vaccinated as possible. With supplies of the two vaccines currently available in the U.S. falling well short of demand, mandating vaccination is likely not a realistic scenario now. But it could be in the coming months. Is it legal for states, private employers, and even airlines, to mandate a vaccine that has only been approved for emergency use? Who could be held responsible if so...
Jan. 27, 2021

NIH Director: Collaboration Amid Chaos, and Biden's First 100 Days

A new week, and a new administration that has taken over the pandemic response. Now that 1 million vaccine doses are administered almost daily, President Joe Biden has increased the daily vaccination goal to 1.5 million Americans. What will the COVID national strategy actually look like under a new administration, and is Biden's goal achievable? To explore those questions, and what the future of collaboration in science looks like, we chat with NIH Director Francis Collins, MD, PhD.
Jan. 20, 2021

COVID-19 Vaccine Policies: Ethical Concerns

Eight COVID-19 vaccines have been approved somewhere in the world, at least for emergency use. In the U.S., only Moderna and Pfizer's two-dose mRNA vaccines are now available for distribution. But as the COVID pandemic continues to run rampant, vaccine supply everywhere remains limited. How did different countries decide who gets it and who doesn't? And what happens to the dozens of phase III clinical trials and their placebo participants who possibly qualify for vaccination with a different sh...
Jan. 12, 2021

The Distribution Debacle

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...
Jan. 5, 2021

How Did COVID Vaccine Development Move at Warp Speed?

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 th...
Dec. 28, 2020

Why Aren't Highest-Risk People Better Represented in COVID Vaccine Trials?

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....
Dec. 22, 2020

How Do We Inject Confidence Into Vaccine Hesitant Americans?

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 Me...
Dec. 16, 2020

What Do We Really Know About Pfizer's New COVID Vax?

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.
Dec. 9, 2020

How Do the New COVID-19 Vaccines Work?

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, MD, who holds an endowed chair at Purdue University and serves as editor-in-chief of Virology.
Dec. 1, 2020

FDA Chief Vows Transparency in Vaccine Approvals

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 ...
Nov. 25, 2020

Coming Soon: Track the Vax

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 befor...