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Coordination of COVID-19 Vaccine Clinical Trials Produces a ‘Treasure Trove’ of Data and a Model for the Future



Harmonized approach and vast database of trial participants could bolster future research well beyond SARS-CoV-2

Newswise — SEATTLE – The federally funded COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Center in Seattle, was instrumental in the rapid development of safe, effective and lifesaving COVID-19 vaccines during earlier phases of the pandemic.

Its vital work to expedite Phase 3 COVID-19 vaccine clinical trials also resulted in a highly collaborative and harmonized approach that can serve as a national and even international model for major research initiatives while also guiding responses to future public health emergencies.

That’s the overarching theme from a new study published Monday, Jan. 23, in JAMA Network Open.

“Our success, which depended entirely on the investments into HIV vaccine research, can be replicated for other important research initiatives and highlights the importance of investments that boost pandemic preparedness for years to come,” explained James G. Kublin, MD, MPH, executive director of CoVPN and senior and corresponding author of the study.

Additionally, he and his colleagues, including  Alfredo Mena Lora, MD, assistant professor of medicine at the University of Illinois at Chicago, and co-first author Jessica Long, PhD, MPH, a postdoctoral fellow at the University of Washington Department of Medicine in Seattle, noted that the COVID-19 clinical trials produced a vast database of critical information that could help researchers answer pressing questions about this novel virus moving forward. 

“The harmonization of data across trials is a new strategy that will set the standard for collaboration in future clinical trials,” said Mena Lora. 


The authors detail how CoVPN was able to help secure authorized vaccines in less than a year by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health as part of Operation Warp Speed. Its mission was, and continues to be, to support the rapid development of vaccines for the U.S. and global populations by coordinating and implementing Phase 3 trials for COVID-19 vaccine candidates.

CoVPN officials were able to leverage existing resources, including clinical and laboratory infrastructure, community partnerships and research expertise, to get clinical sites to quickly pivot to conduct the vaccine trials as soon as investigational products were ready for Phase 3 testing.

“The CoVPN approach drew on years of experience and infrastructure from partnering networks and institutions, which not only allowed for rapid rollout of the trials, but also contributed to broader representation of trial participants,” said Long.

Overall, CoVPN deployed five Phase 3 clinical trials involving more than 136,000 participants to test the safety and effectiveness of COVID-19 vaccines. While doing so, it implemented several innovative procedures that were essential to its ultimate success. These included:

  • Harmonized study designs that were similar in relative size, number of endpoints and time to analysis.
  • A model that accelerated vaccine development by allowing phases to occur in parallel rather than sequentially. For example, vaccine manufacturing and scale-up were greenlighted while the trials were ongoing in anticipation of meeting efficacy targets.
  • Establishment of a single Data Safety Monitoring Board for review and oversight of all vaccine studies.
  • Targeted outreach and enrollment efforts supported by an online screening registry to ensure broad and diverse representation among study participants. Extensive engagement was conducted with communities and community leaders to build and enhance trust in the science to help enroll more Black, Indigenous and people of color (BIPOC) volunteers who are historically underrepresented in clinical trials.
  • A cross-platform approach that led to harmonization of data collection across trials and the ability to analyze data from all studies.

“This unique, cross-platform concept allowed for sharing of data from all of the studies and helped bridge gaps in understanding so we could better answer key research questions and guide policy decisions,” explained Kublin, who’s also a principal staff scientist at Fred Hutch. 

Larry Corey, MD, an internationally renowned expert in vaccine development, and principal co-investigator of CoVPN, believes the success of COVID-19 clinical trials should be thought of as an important model for developing vaccines for significant infectious diseases globally.

“Harmonizing study design, enrollment, clinical endpoints and methods for follow-up could very well become best practices that shape the future landscape of major research initiatives and pandemic responses,” he said. 


Kublin and colleagues regard the vast database from more than 130,000 trial participants, including over 2,500 with documented COVID-19 cases, as a “treasure trove” of data that could help unlock mysteries about the virus. For example, they noted that the pooled data from five trials can help address specific questions such as:

  • How effective are vaccines for at-risk groups?
  • Can vaccines have an impact on long COVID?
  • Are safety, immunogenicity and vaccine efficacy different in special populations, such as people living with HIV?
  • What impact do chronic health conditions have on vaccine efficacy or protection duration?
  • What are the impacts of variants on both the population at large and within special communities?

Additional CoVPN publications planned for the months ahead will address many of these topics. Researchers who have ideas for further investigation and want to collaborate with CoVPN can find more information here.

Source: Covid-19 Prevention Network (CoVPN)


How Melissa Joan Hart Gets Relief for Her Dry Eyes

Whether Melissa Joan Hart is on set directing her latest movie, recording an episode of her podcast or driving her kids to school, she is always on the move.



(Family Features) Whether Melissa Joan Hart is on set directing her latest movie, recording an episode of her podcast or driving her kids to school, she is always on the move. When she first began experiencing dry, irritated eyes, she wasn’t sure how to relieve her symptoms. However, after a recommendation from her friend, she learned there was a line of eye lubricant products designed to relieve dry eye symptoms of eye dryness, burning, itching and discomfort.

“My eyes get dry and irritated, especially during long days on set when I’m spending hours staring at monitors,” Hart said. “I learned I am one of 35 million people in the United States who experience dry eyes. I didn’t know how I could find relief – until I discovered Refresh.”

Hart is teaming up with Allergan, an AbbVie company, to share her experience using the number one doctor-recommended family of products. The Refresh line was developed from more than 30 years of dedicated eye research and includes artificial tears, ointments and gel drops to relieve symptoms of eye dryness. The drops offer fast-acting relief for a wide range of individuals based on their symptoms and severity levels, including products for daytime, nighttime and anytime use.

“Many people experience eye dryness for many reasons and have different needs, which is why I like that the Refresh portfolio has several different products that offer fast-acting relief for a wide range of individuals,” Hart said. “Right now, I use Optive Mega-3 and Relieve PF Multidose to relieve my eye dryness and prevent further irritation. There’s a great tool on the Refresh website to help you figure out which product may be right for you.”

Hart continued, “Refresh has quickly become a part of my daily routine, on and off set. I have a few bottles tucked away in different rooms around the house and in my purse to use throughout the day. I don’t leave the house without them.”

Refresh eye drops can be found at all major retailers and online. Learn more at and take the quiz to see which product may help relieve your symptoms.  

Use only as directed. For US consumers only.


Source: Allergan, an AbbVie company.

US-RFS-220152 2/23

Allergan, an AbbVie company

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Monitoring Your Kidney Health



(Family Features) Kidney disease is one of the most common complications of living with diabetes and can increase your risk for heart disease and stroke. There are steps you can take to keep your heart, brain and kidneys healthy, including an annual kidney screening. A urine Albumin-to-Creatinine Ratio test is a simple urine test used to identify early signs of kidney disease and give you and your health care team important information to manage your risk. Learn more about taking charge of your health at

American Heart Association

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Colon Cancer Awareness Month: How Artificial Intelligence (AI) is now saving more lives for those with potential cancer

Spreading awareness that colon cancer can be detected and treated earlier than ever with new technology.



Dr. Rosario Ligresti, chief of Gastroenterology at Hackensack University Medical Center
« Colon Cancer Awareness Month: How Artificial Intelligence (AI) is now saving more lives for those with potential cancer

Hackensack University Medical Center in New Jersey is working to spread awareness that colon cancer can be detected and treated earlier than ever with new technology. 

Colorectal cancer is the third deadliest cancer and  is expected to cause more than 52,000 deaths in 2023.

While the rate of adults diagnosed with colon or rectal cancer has been declining since the 80’s, rates of colon cancer in people younger than 50 is now on the rise – concerning many experts.  

The latest screening test – the Medtronic GI Genius™ uses artificial intelligence to identify colorectal polyps of varying shapes and sizes in real time, facilitating the diagnosis and prevention of colorectal cancer, the second leading cause of cancer-related death in the U.S.

“I was four years overdue for a colonoscopy,” said 49 year old Twinique Wright. “I was dreading it but I took comfort in knowing that my doctor was going to use the latest technology with a much greater chance of detecting polyps.” 

The GI Genius intelligent endoscopy module, authorized by the FDA in April 2021 uses computer-aided detection algorithms to identify colorectal polyps of varying shapes and sizes in real time, facilitating the diagnosis and prevention of colorectal cancer. GI Genius has demonstrated the ability to improve detection of colorectal polyps – by as much as 40% – that can lead to CRC.

For more information on the GI Genius or for an interview with one of our colorectal cancer specialists, contact [email protected]


Source: Hackensack Meridian Health

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