Vaccines

July 9, 2021: COVID-19 Vaccine Efficacy Studies: Challenges and Successes (Hana El Sahly, MD)

Posted on by Gina Uhlenbrauck

Speaker

Hana El Sahly, MD
Professor of Molecular Virology and Microbiology
Baylor College of Medicine

Topic

COVID-19 Vaccine Efficacy Studies: Challenges and Successes

Keywords

COVID-19; Vaccines; Clinical endpoints; Phase 3 trials

Key Points

  • The design of Phase 3 clinical trials varies—from individual randomized clinical trials (RCTs) within sites, multiple arm trials within sites, parallel cluster RCTs, and stepped-wedge cluster RCTs—and each design produces different efficiencies and potential for evaluating the vaccine’s effectiveness.
  • The primary endpoints of vaccine trials are infection, disease, and severe disease; however, a study with a primary endpoint that captures all the endpoints of public health importance is likely not feasible.
  • A principle of clinical trials is that the study population should represent the vaccine target population. Yet, clinical trial participants traditionally are predominantly Caucasian, whereas COVID-19 disproportionately affects minorities, including a higher incidence and higher mortality.

Discussion Themes

Conducting effectiveness studies is essential to understanding how vaccines affect severe disease.

What are the arguments for or against human challenge trials?

Based on your experience during the past year, and the success of the COVID-19 vaccine trials, what applications do you see for future viruses outside a pandemic?

While some successes have been achieved, we do not know everything yet; it will be important to study other pathogens on other platforms to find approaches that ensure reliability.

Read more about Operation Warp Speed, a federal collaboration that has supported the acceleration of testing, supply, development, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Tags

#pctGR, @Collaboratory1

July 7, 2021: COVID-19 Grand Rounds Continues With Vaccine Efficacy Studies

Posted on by Damon Seils

Headshot of Dr. Hana El Sahly
Dr. Hana El Sahly

In this Friday’s COVID-19 Grand Rounds session, Dr. Hana El Sahly of the Baylor College of Medicine will present “COVID-19 Vaccine Efficacy Studies: Challenges and Successes.” The Grand Rounds session will be held on Friday, July 9, at 1:00 pm eastern. Join the online meeting.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

May 3, 2021: HERO Registry and HERO-TOGETHER Expand Beyond Healthcare Workers

Posted on by Damon Seils

Logo for the Healthcare Worker Exposure Response & Outcomes (HERO) project.The Healthcare Worker Exposure Response & Outcomes (HERO) Registry and the HERO-TOGETHER study are now open to anyone who lives, works, or interacts with healthcare workers in their households or anyone in the surrounding community. The HERO program enables participants to share their experiences after receiving a COVID-19 vaccine, contribute to the science, and help to build vaccine confidence over time.

HERO-TOGETHER is a nationwide paid study focused on the long-term impact of the COVID-19 vaccines. Healthcare workers around the country have already signed up. Now all healthcare workers and anyone who lives, works, or interacts with them are invited to join the study. Participants answer brief surveys about how they’re feeling and any health changes since receiving a COVID-19 vaccine. Participants receive information back and up to $200 compensation for their time. Sign up here.

View the NIH Collaboratory’s recent COVID-19 Grand Rounds session on HERO-TOGETHER.

 

March 19, 2021: HERO-Learning Together about Vaccines for SARS-CoV-2 (Emily O’Brien, PhD; Robert Califf, MD)

Posted on by Gina Uhlenbrauck

Speakers

Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
 
Robert M. Califf, MD, MACC
Head of Clinical Policy and Strategy
Verily Life Sciences and Google Health

Topic

HERO-Learning Together about Vaccines for SARS-CoV-2

Keywords

COVID-19; Vaccine confidence; Side effects; Postmarketing surveillance; Long-term vaccine safety; Virus variants; PCORI; HERO Registry

Key Points

  • In the United States to date, more than 100 million doses of COVID-19 vaccine have been administered. Yet there remains concern about the increase in variants of the coronavirus.
  • Postmarket evidence generation around COVID-19 vaccines is critically important to understanding the long-term safety of vaccines and building confidence around their use.
  • A “pod” is the group of people you live with or relate to as family and have regular household contact with at least once per week for the past 3 months.

Discussion Themes

What does it mean to be a “safe vaccine”?

We’re still learning about how families are navigating the psychosocial aspects of this pandemic.

Over time, manual processes will be replaced by algorithms and automated systems. But we need to develop digital technologies that support human interactions in health.

What will be the key issues around COVID-19 in 2022?

HERO-TOGETHER is a paid observational research study for people aged 18 and older working in healthcare who have received a COVID-19 vaccine. Eligible participants include anyone who works in a setting where people receive healthcare. Read more about the HERO Program and how to join the registry.

Tags

#pctGR, #HEROTOGETHER, @Collaboratory1, @heroesresearch

March 16, 2021: Drs. Emily O’Brien and Robert Califf Will Discuss HERO Collaboration in Special COVID-19 Grand Rounds

Posted on by Damon Seils

In this week’s COVID-19 Grand Rounds session, Dr. Emily O’Brien of Duke University and Dr. Robert Califf of Verily Life Sciences and Google Health will present “HERO—Learning Together About Vaccines for SARS-CoV-2.” The Duke Clinical Research Institute and Verily are using the Healthcare Worker Exposure Response & Outcomes (HERO) Registry and its community of participants and researchers to gain long-term insights about the COVID-19 vaccine developed by Pfizer and BioNTech, including real-world safety data.

The Grand Rounds session will be held on Friday, March 19 at 1:00 pm eastern. Join the online meeting.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

January 25, 2021: Grand Rounds Podcast with Dr. Emily O’Brien on HERO-TOGETHER is Available

Posted on by Gina Uhlenbrauck

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez and Dr. Emily O’Brien continue the discussion about the HERO-TOGETHER initiative that aims to understand how healthcare workers do after receiving the COVID-19 vaccination. The full January 8 Grand Rounds webinar with Dr. O’Brien is also available.

January 8, 2021: HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data (Emily O’Brien, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Emily O’Brien, PhD
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences

Topic

HERO-TOGETHER: Building Vaccine Confidence With Long-Term Outcomes Data

Keywords

Vaccine development; COVID-19; Pandemic: Vaccine hesitancy; HERO-TOGETHER; Healthcare workers; Clinical outcomes: Observational study

Key Points

  • According to the World Health Organization, vaccine hesitancy refers to the delay in acceptance of, or refusal of, vaccines despite availability of vaccination services.

  • Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience, and confidence. Hesitancy occurs on a continuum, from acceptance of all vaccines, to acceptance but doubt, to vaccine delayers, refusers, and deniers.

  • HERO-TOGETHER is a prospective, observational, multicenter cohort study of 20,000 adult U.S. healthcare workers who received a COVID-19 vaccine within the past 60 days. The study will collect data from participants that includes their experience with receiving the vaccine, medical history, unexpected medical care, safety events, and quality of life.

Discussion Themes

There is no universal best practice to address vaccine hesitancy in all its contexts. Locally tailored and multicomponent approaches will be needed.

How has the political environment influenced the hesitancy around receiving the COVID-19 vaccine?

What are your approaches to evaluating vaccine safety? What about safety for women during child-bearing years?

Read more about the HERO-TOGETHER study.

Tags

#pctGR, @Collaboratory1