October 2020 – Drug and Device Digest

COVID-19 News: VEKLURY for COVID treatment, Advisory committee for vaccines, Evidence Accelerator for real world data, New NextGen portal for manufacturing capacity, New Sentinel website for pandemic activities

VEKLURY (remdesivir) injection


INDICATION: For adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care

ADDRESSING UNMET NEED: First treatment for COVID-19

MECHANISM OF ACTION: Inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication

EFFICACY: Three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care

  • Median time to recovery was significantly lower with Veklury vs. placebo
  • Odds of clinical improvement were also statistically significantly higher or numerically better in the Veklury group when compared to the placebo group. 

SAFETY: Possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering


  • Prior EUA approval
  • Fast Track and Priority Review designations
  • Material Threat Medical Countermeasure Priority Review Voucher
  • Postmarketing pediatric study requirement (birth to <18 years, including neonates)
  • Postmarketing study in or remdesivir resistant SARS-CoV-2 variants  

LABEL , FDA Review Summary

COVID-19 Vaccines and FDA Advisory Committee

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 10/22 to discuss development, authorization and/or licensure of COVID-19 vaccines

  • Committee members are external scientific and public health experts from around the country, specializing in fields such as immunology, virology, infectious diseases, pediatrics, vaccine development, and vaccine safety.
  • Presentations from the experts as well as FDA scientists on COVID-19 disease and vaccine development
  • Thorough discussion on studies needed to support authorization or approval, post-marketing safety studies, ongoing safety monitoring following issuance of an emergency use authorization
  • Members of the public speak and provide input
  • Overall, to help ensure clear public understanding of the data needed for FDA authorization or approval of COVID-19 vaccines, as well as plans for their continued evaluation following authorization or approval  

Read , Event materials , To view the webcast replay, visit FDA’s YouTube Channel.

COVID-19 Evidence Accelerator: An initiative launched by the Reagan-Udall Foundation for the FDA

To gather Real world data (RWD) to help advance our nation’s ability to respond to the pandemic

  • Informing and safely speeding diagnostic and therapeutic processes
  • Provide a unique venue for major data organizations, government and academic researchers, and health systems to gather and design quick-turn-around queries and share their results
  • Bring together leading experts in health data aggregation and analytics to share insights, compare results, and answer key questions about COVID-19 treatment and response as quickly as possible


CDER NextGen portal includes manufacturing capacity data for COVID-19 drugs

CDER is gathering more information about manufacturing capacity for investigational COVID-19 products

  • Portal captures information about the specific IND, manufacturer, production rates, treatment courses, and allocations 
  • To analyze and support manufacturing efforts for potential vaccines and therapeutics such that there is a capability for mass production to meet the population need


New Sentinel website for the pandemic

Launch of newly redesigned Sentinel Initiative website to increase organization and usability and assist the Sentinel community

  • Coronavirus (COVID-19) activities, to keep up with how FDA is using Sentinel activities to protect and promote public health during the COVID-19 pandemic
  • Completed ARIA assessments & impact, for a list of safety-related outcomes, results, and regulatory impacts
  • Drug assessments, where you can search materials based on medical product, safety outcome, and study type
  • Publications & presentations, so you can read up on Sentinel activities in journals and conference materials


Image credit: FDA

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