Health
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.
Lifestyle
Massive eye drop recall reflects ongoing issues with manufacturing and FDA inspection

C. Michael White, University of Connecticut
Massive eye drop recall
A California company has recalled more than 3.1 million bottles of lubricating eye drops because it had not properly tested – and thus could not prove – whether the products were sterile.
These products are sold under several names at major retailers across the country. The company, K.C. Pharmaceuticals, initiated the recall on March 3, 2026.
I am a clinical pharmacologist and pharmacist who has assessed risks of poor-quality manufacturing practices and lax oversight for prescription drugs, eye drops, dietary supplements and nutritional products in the United States for many years. This recall is very large, potentially affecting over a million people. Using nonsterile eye drops that harbor bacteria and fungus can cause eye infections, which can become severe because the immune system has a hard time accessing the eyeball and fighting the microbes.
This is not the first time that a major recall has occurred in the eye drop market – and it is the second time since 2023 that the Food and Drug Administration has become aware of sterility issues at K.C. Pharmaceuticals.
Multiple products affected
Eight products are being recalled: Dry Eye Relief Eye Drops, Artificial Tears Sterile Lubricant Eye Drops, Sterile Eye Drops Original Formula, Sterile Eye Drops Redness Lubricant, Eye Drops Advanced Relief, Ultra Lubricating Eye Drops, Sterile Eye Drops AC and Sterile Eye Drops Soothing Tears.
These products are sold under different company names, including Top Care, Best Choice, Good Sense, Rugby, Leader, Good Neighbor Pharmacy, Quality Choice, Valu Merchandisers, Geri Care, Walgreens, CVS and Kroger.
Their expiration dates range from April 30, 2026, to Oct. 31, 2026. They were sold at stores including Walgreens, CVS, Rite Aid, Kroger, Harris Teeter, Dollar General, Circle K and Publix.
If you purchased an eye drop product since April 2025, check to see whether the name matches any of these. If it does, go to the FDA site, where you can see the exact lot numbers and expiration dates for those products. https://www.youtube.com/embed/KJYebZC2MWo?wmode=transparent&start=0 As of early April, no infections from the recalled eye drops have been reported.
How to tell whether your eye drops were recalled
You can determine whether your eye drop product is part of the recall by looking at two columns in the table. Column 2 of the table lists the names of the products, with one name per row. Column 5 provides the specific lot numbers of the affected products and their expiration dates. For example, recalled Sterile Eye Drops AC products – row 1, column 2 – have the lot number AC24E01 with an expiration date of May 31, 2026, listed in row 1, column 5.
If the product you purchased has the same name but a different lot number or expiration date than the ones listed on the FDA website, it is not subject to this recall and you can safely keep using it. If you find your product has been recalled, stop using it and bring it back to the store for a refund.
The FDA has not received reports of any infections as of early April. However, if after using one of these recalled products you experience redness in your eyes, eyelids stuck together, unusual eye discharge such as goo or pus, vision changes, eyelid swelling or eye pain itchiness or irritation, these symptoms could be due to an eye infection.
If you experience these symptoms, seek medical attention – and also, if possible, report your symptoms to the FDA.
A history of eye drop sterility issues
The FDA has many important public health roles: approving new drugs and medical devices; overseeing the manufacturing quality of prescription and over-the-counter drugs, dietary supplement and food products; and protecting the public from counterfeit medications.
With its limited personnel, the agency focuses its time on areas where the risks are greater. This means manufacturers of more dangerous products, or product types that were previously found to have issues, are inspected more frequently.
The FDA had inspected over-the-counter eye drop manufacturers only a few times before 2023, when cases of rare eye infections due to a drug-resistant Pseudomonas bacteria strain started occurring.
In total, 81 people from 18 states developed severe eye infections during the 2023 outbreak. Fourteen people experienced vision loss because of the product, an additional four people had their eyeballs removed and four people died.
The agency identified two products as the culprits: Global Pharma’s EzriCare Artificial Tears and Delsem Pharma’s Artificial Tears and Eye Ointment.
Later in 2023, the FDA issued recalls for Dr. Berne’s, LightEyez Limited, Pharmedica LLC and Kilitch Healthcare eye drop products for sterility issues. Kilitch Healthcare had serious quality lapses, in which the facility was filthy, employees were barefoot on the manufacturing floor and the company fraudulently passed products that failed sterility tests.
Repeated manufacturing problem
At the time, the FDA also inspected K.C. Pharmaceuticals and issued the company a warning letter. The FDA was concerned that the manufacturer failed to establish and follow appropriate written procedures designed to prevent microbiological contamination.
Although the agency did not request a recall, it did ask that the company immediately change its protocols and consult outside experts to prevent these issues from recurring.
The current massive recall of K.C. Pharmaceuticals’ eye drop products suggests lingering quality control issues in the manufacturer’s Pomona, California, plant that need to be urgently addressed. If the company had heeded the FDA’s recommendations, it would have detected the nonsterility issue before so many batches of the products were manufactured.
This article was updated to replace an image that showed non-recalled products.
C. Michael White, Distinguished Professor of Pharmacy Practice, University of Connecticut
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
Lifestyle
8 Ways to Help Protect Your Vision Right Now
As you get older, your risk for some eye diseases may increase. However, there are steps you can take to keep your eyes healthy – and it starts with taking care of your overall health. Set yourself up for a lifetime of seeing your best with these eight tips in honor of Healthy Vision Month. Protect Your Vision!

8 Ways to Help Protect Your Vision Right Now
(Feature Impact) As you get older, your risk for some eye diseases may increase. However, there are steps you can take to keep your eyes healthy – and it starts with taking care of your overall health.
Set yourself up for a lifetime of seeing your best with these eight tips from the experts at the National Eye Institute in honor of Healthy Vision Month:
1. Find an eye doctor you trust.
Many eye diseases don’t have any early symptoms, so you could have a problem and not know it. An eye doctor can help you stay on top of your eye health. Find an eye doctor you trust by asking friends and family if they like their doctors. You can also check with your health insurance plan to find eye doctors near you.
2. Ask how often you need a dilated eye exam.
Getting a dilated eye exam is the single best thing you can do for your eye health. It’s the only way to find eye diseases early, when they’re easier to treat – and before they cause vision loss. Your eye doctor will decide how often you need an exam based on your risk for eye diseases.
3. Add more movement to your day.
Physical activity can lower your risk for health conditions that can affect your vision, like diabetes and high blood pressure. If you have trouble finding time for physical activity, try building it into other activities. Walk around while you’re on the phone, do push-ups or stretch while you watch TV or dance while you’re doing chores. Anything that gets your heart pumping counts.
4. Get your family talking about eye health history.
Some eye diseases – like glaucoma and age-related macular degeneration – can run in families. While it may not be the most exciting topic of conversation, talking about your family health history can help everyone stay healthy. The next time you’re chatting with relatives, ask if anyone knows about eye problems in your family. Be sure to share what you learn with your eye doctor to see if you need to take steps to lower your risk.
5. Step up your healthy eating game.
Eating healthy foods helps prevent health conditions – like diabetes or high blood pressure – that can put you at risk for eye problems. Eat right for your sight by adding more eye-healthy foods to your plate, such as dark, leafy greens like spinach, kale and collard greens, and fish high in omega-3 fatty acids like halibut, salmon or tuna.
6. Make a habit of wearing your sunglasses – even on cloudy days.
The sun’s UV rays can not only harm your skin, but the same goes for your eyes. However, wearing sunglasses that block 99-100% of both UVA and UVB radiation can protect your eyes and lower your risk for cataracts.
7. Stay on top of long-term health conditions like diabetes and high blood pressure.
Diabetes and high blood pressure can increase your risk for some eye diseases, like glaucoma. If you have diabetes or high blood pressure, ask your doctor about steps you can take to manage your condition and lower your risk of vision loss.
8. If you smoke, make a plan to quit.
Quitting smoking is good for your entire body, including your eyes. Kicking the habit can help lower your risk for eye diseases like macular degeneration and cataracts. Quitting smoking is hard, but it’s possible – and a plan can help.
Test your eye health knowledge with a quick quiz and find more vision resources at nei.nih.gov/hvm.
Photo courtesy of Shutterstock

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Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
Lifestyle
Tobacco is still one of the world’s top killers – here are the key obstacles to enacting generational smoking bans

Marie Helweg-Larsen, Dickinson College
Smoking is really bad for you. Most people know that. Even smokers think smoking is bad for one’s health. But most people don’t know just how bad it is.
More people in the United States die every year from smoking than from alcohol, illegal drug use, car accidents, suicides and murders combined. Cigarette smoking costs an estimated US$240 billion annually in health care costs, which harm not only smokers but also nonsmokers, communities and the economy. Smoking is the top preventable cause of death and disease in the U.S. and worldwide.
The number of smokers in the U.S. has declined from 41% in 1944 to 11% in 2024. However, over 25 million Americans still smoke.
This drop is partly the result of many smoking laws enacted in the past 50 years. They include national bans on cigarette advertising on television and radio (1971), smoking on commercial flights (2000), sale of fruit- or candy-flavored cigarettes (2009), and sale of cigarettes to people ages 18 to 20 (2019). New policies might seem as strange or unfamiliar as these measures did at the time.
One potentially transformative idea – creating a tobacco-free generation – would build on these past laws. It would phase out smoking by banning it permanently for anyone born after a specific date. For example, a law could make it illegal for anyone under 21 to ever buy cigarettes, whereas people age 21 or older at the time would not be affected. The focus would be on tobacco sales, which already require age verification in the U.S., not on criminalizing tobacco use.
As a psychological scientist, I have studied for decades how people think about smoking. In my view, the key obstacle to creating future generations of nonsmokers is that people do not fully understand how dangerous smoking is and do not realize the formidable influence of the tobacco industry.
Creating a tobacco-free generation
The idea of creating a tobacco-free generation was first proposed by health researchers in 2010. In 2021 the town of Brookline, Massachusetts, became the first U.S. community to adopt it. Brookline’s ordinance prohibits tobacco and vape sales to anyone born on or after Jan. 1, 2000. It has survived a legal challenge and has been emulated in 22 more Massachusetts towns.
As of early 2026, Hawaii and Massachusetts are considering statewide tobacco-free generation bills. Abroad, the Maldives enacted the first countrywide ban in 2025.
Similar proposals have faced pushback elsewhere. In New Zealand, a ban was adopted in 2022 but repealed in 2024. The United Kingdom is considering a similar bill after an earlier version was scrapped due to a snap election.
Why people underestimate harm from cigarettes
It is hard to visualize what exactly it means that 480,000 people in the U.S. die from smoking every year or that each cigarette that you smoke shortens your life by 20 minutes. It is also easy to feel optimistically biased about one’s personal risk as a smoker and believe that others are more likely to become addicted or die prematurely.
Studies show that nonsmokers, former smokers and current smokers underestimate smoking risks. One likely reason is messaging by the tobacco industry, which claimed for decades that cigarettes were safe, even though tobacco industry scientists knew as early as 1953 that smoking caused lung cancer.
Another factor is glamorization of cigarettes in movies. Fully half of the top films released in 2024 showed tobacco imagery, typically of cigarettes. Research shows that adolescents and young adults who watch smoking in movies are more interested in taking up smoking.
Finally, smoking deaths may seem to be unremarkable because some of the illnesses that cigarette smoking causes, such as heart disease or cancer, are commonplace. And unlike deaths from drug overdoses, we do not always see the consequences of a lifetime of smoking. https://www.youtube.com/embed/2mKyosQbFNY?wmode=transparent&start=0 Smoking imagery is widespread in popular culture and may be one driver of tobacco use, especially among young Americans.
What about freedom of choice?
A common argument against laws that regulate personal choices, such as whether to smoke or wear seat belts, is that people prize their autonomy and don’t like governments telling them how to live. This isn’t a new challenge for public health policies, which often restrict private citizens’ freedom to do as they wish.
People can be persuaded that community action should trump individual choice if a behavior, such as smoking cigarettes or driving while drunk, harms others who don’t engage in it. Many public health laws are designed to protect people who are innocent or vulnerable. For example, current smoking laws have been enacted in part to protect nonsmokers who are exposed to secondhand smoke, especially children. And smoking increases health care costs for everyone, not just smokers.
By preventing people in the U.S. who cannot legally buy cigarettes now from ever doing so, generational smoking bans balance the rights of current adult smokers against the major public health benefits of a phased smoking ban that will eventually end the smoking epidemic.
Arguments against generational smoking laws
The tobacco industry’s attempts to undermine tobacco health policies are well documented and follow a predictable pattern. For example, when the U.K. government considered a generational smoking policy in 2023, tobacco companies and their supporters argued that smoking was a minor problem, that individuals should be responsible for their own choices, and that a nationwide ban would lead to illegal behavior or hurt business profits.
In a 2025 study assessing how Belgian politicians viewed generational smoking bans, researchers heard similar arguments. Respondents across the political spectrum valued personal freedom and informed individual choice more highly than protecting children. The politicians also believed that young people could understand how smoking affected their health, and that raising awareness was more important than bans. These arguments aligned with tobacco industry positions.
However, research shows that young people hold many optimistic beliefs about smoking, especially with respect to the addictiveness of nicotine and the likelihood that they will avoid becoming lifelong smokers. Studies have also found that adolescents don’t know enough to make an informed choice to smoke. These findings matter because the tobacco industry routinely targets young people in an effort to create lifelong smokers.
The tobacco industry’s harm reduction approach frames e-cigarettes, also known as vapes, as a way to create a smoke-free future by transitioning smokers to other nicotine products. But research shows that the tobacco industry actively markets nicotine products such as vapes to young people to create a new generation of nicotine users.
Not a silver bullet
Curbing the use of an addictive product is challenging, and there are ways for young people to obtain cigarettes illegally, as they do now in places where cigarette buyers must be at least 21. Tactics include shopping at stores that don’t check IDs, having older friends buy cigarettes and purchasing cigarettes illegally online.
Tobacco-free generation policies aren’t a silver bullet. They work most effectively in conjunction with other measures, such as plain packaging; high prices; bans on displays, advertising and flavored products; smoking cessation support; and public health messages making clear that cigarettes are unsafe at any age.
Still, health experts and groups including the American Heart Association and the American College of Cardiology argue that creating a tobacco-free generation could dramatically reduce preventable deaths and secure a healthier future for today’s children and future generations. In my view, understanding the obstacles to change is a critical step toward achieving this goal.
Marie Helweg-Larsen, Professor of Psychology, Dickinson College
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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