A glimpse into FDA advisor perspective just weeks before EUAs are anticipated to be sent.
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Episode highlights
0:17 Remdesivir approved by the FDA 1:07 The remdesivir timeline 3:21 COVID-19 Vaccine Tracker 5:47 What was the VRBPAC meeting? 7:18 Challenging the FDA 10:02 What are secondary vaccine endpoints? 11:58 Will the vaccine be mandated? 15:12 Vaccine research representation 18:17 When will pediatric patients be assessed? 23:31 The inflection point of vaccine development 31:13 The implication of remdesivir 37:34 Takeaways from VRBPAC meeting 39:23 What is the trial participation commitment? 41:45 Outro
Last Friday, the US Food and Drug Administration (FDA) hosted a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to discuss coronavirus 2019 (COVID-19) research, development, and eventual licensing with the Center for Biologics Evaluation and Research (CBER).
Though the live-broadcast meeting did not weigh any regulation decision nor tailor its agenda to any single vaccine candidate or company, it provided the public a glimpse into the mindset of the FDA’s key experts weeks prior to anticipated Emergency Use Authorization (EUA) applications for COVID-19 vaccines.
The advisory committee meeting also allowed for community-based input—of which there was plenty, as advocacy and health organizations alike represented differing patient populations, issues in disparity, and calls for scrutinous, transparent regulation of any possible vaccines.
In this week’s episode of Vaccine Race, Donald Alcendor, PhD, rejoined the limited series to give real-time takeaways from the VRBPAC meeting and what discussion could implicate for COVID-19 vaccine regulation. Among topics, the expert from Maharry Medical College and Vanderbilt University School of Medicine provided perspective on secondary phase 3 assessment endpoints, mandated vaccination groups, pediatric treatment arms, and advocacy representation at the meeting.
With the news of remdesivir’s FDA approval for the treatment of adult and children hospitalized with COVID-19 breaking a day prior, Alcendor also discussed what the decision could mean for eventual vaccine authorization.
The first animal model of neonatal sepsis to evaluate protection by maternal vaccination evidences transfer of immunity against virulent, often antibiotic-resistant Klebseilla pneumoniae.
As the Bundibugyo virus outbreak in the Democratic Republic of the Congo surpasses 9300 confirmed cases and 4400 deaths, this FAQ explains how the virus spreads, how it presents, why it is hard to diagnose and treat, which vaccines and therapies are being tested, and why CDC considers the risk to the United States low.
Projected disease burden from declining childhood vaccine coverage shows increases in vaccine-preventable diseases. Benjamin Lopman, PhD, provides insights on how VaxImpactMap works and the potential long-term disease consequences of decreased immunization rates.
A 39-year-old unvaccinated Franklin County woman has died after a recent measles diagnosis. Nationally, numbers continue to increase and the US has passed 4,000 cases.
The National Foundation for Infectious Diseases (NFID) recently held its respiratory season kick-off, which included the release of its annual respiratory disease survey. This year, the survey revealed the gap between vaccine support and uptake. Robert Hopkins Jr, MD, medical director of NFID delves deeper into the findings of the survey and the vaccine uptake challenges associated with certain immunizations.
With US measles cases nearing 3,900 this year and Pennsylvania reporting its fifth measles-related death, here is a review of how the virus spreads, how it is prevented and managed, and what severe disease looks like.
