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This Simple, Needle-free COVID Vaccination Device Might Stop Transmission

A new study shows intranasal vaccines may do more to stop the spread of infectious respiratory viruses than intramuscular injections. [Image courtesy of Bharat Biotech]

"Finally," many of us thought when we received our first jabs to vaccinate us against COVID-19 back in 2020 and 2021.

Nearly four years later, COVID is still surging, constantly mutating to create new variants that evade our immunity from prior infections and the latest vaccines. And if the immediate and long-term harm from SARS-CoV-2 (the virus that causes COVID-19 disease) wasn't enough to worry about, the deadly H5N1 avian flu variant is circulating in the U.S.

Now, a new study by researchers at Washington University in St. Louis says a different method of immunization can do more to stop the virus than vaccine injections with syringes. In their study with hamsters, vaccines that were sprayed or dropped into the nasal passages reduced the infected rodent's respiratory viral load to help prevent secondary airborne transmission and infection of other hamsters.

An iNCOVACC intranasal COVID vaccine vial and dropper [Image courtesy of Bharat Biotech]

"To prevent transmission, you need to keep the amount of virus in the upper airways low," senior author Jacco Boon, a professor of medicine, molecular microbiology and pathology and immunology, said in a news release. "The less virus that is there to begin with, the less likely you are to infect someone else if you cough or sneeze or even just breathe on them. This study shows that mucosal vaccines are superior to injected vaccines in terms of limiting viral replication in the upper airways and preventing spread to the next individual. In an epidemic or pandemic situation, this is the kind of vaccine you're going to want." Intranasal vaccine device design

The single-use iNCOVACC intranasal COVID vaccine dropper attaches to the top of the multi-dose vial for administration. [Image courtesy of Bharat Biotech]

The researchers used a nasal COVID-19 vaccine based on Washington University technology. That drug, iNCOVACC (for intranasal covid vaccine), is the world's first needleless, intranasal COVID vaccine. It's approved for use in India and manufactured by Hyderabad-based Bharat Biotech International.

iNCOVACC is distributed in glass vials and administered using a simple, disposable plastic piece that snaps on top. That dropper is used to deliver 0.5mL of vaccine in the patient's nose: four drops per nostril for eight drops in total.

After the patient blows their nose to clear their nasal passages, they lay back, tilt their head and receive two drops in one nostril while closing the other nostril with their finger. Then they switch nostrils for two more drops before rolling their head from side to side, and then repeating the process for four more drops.

The single-use dropper is then disposed of, while the multi-dose vial containing the vaccine can be sealed with a rubber stopper and used for the next patient.

The iNCOVACC intranasal COVID vaccine is dropped into a patient's nostrils. [Image courtesy of Bharat Biotech]

When launching the vaccine in January 2023, Bharat Biotech said the it was "designed for efficient distribution and easy, pain-free administration" and specifically formulated for intranasal delivery through nasal drops. Bharat Biotech said it designed and developed the delivery system to be cost-effective in low- and middle-income countries.

"Despite the lack of demand for COVID-19 vaccines, Bharat Biotech continued product development in intranasal vaccines to be well-prepared with platform technologies for future infectious diseases," the company said. "Bharat Biotech has also initiated development of variant-specific vaccines for COVID in an attempt to be future ready."

What's next for intranasal vaccines

Washington University has licensed the intranasal vaccine technology to Malvern, Pennsylvania-based Ocugen for further development in the U.S. That drug developer said last year it planned to test both intranasal (via nasal spray) and inhalable delivery for its COVID-19 vaccine candidate, OCU500.

Ocugen plans to file an investigational new drug (IND) application with the FDA for human trials not just for an inhalable OCU500, but also for an inhalable flu vaccine (OCU510) and flu/COVID combination vaccine (OCU520).

Ocugen says the benefits of inhalable, noninvasive vaccines include the potential for increased compliance, calable manufacturing, storage and shipping in standard refrigeration, and the potential to develop multi-strain and variant specific versions.

Previously: Researchers develop device that detects airborne COVID-19 virus — llamas and 'wet cyclone' tech helped

Troubling Bird Flu Study Suggests Human Cases Are Going Undetected

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A small study in Texas suggests that human bird flu cases are being missed on dairy farms where the H5N1 virus has taken off in cows, sparking an unprecedented nationwide outbreak.

Further Reading US prepares for bird flu pandemic with $176M Moderna vaccine deal The finding adds some data to what many experts have suspected amid the outbreak. But the authors of the study, led by researchers at the University of Texas Medical Branch in Galveston, went further, stating bluntly why the US is failing to fully surveil, let alone contain, a virus with pandemic potential.

"Due to fears that research might damage dairy businesses, studies like this one have been few," the authors write in the topline summary of their study, which was posted online as a pre-print and had not been peer-reviewed.

The study authors, led by Gregory Gray, were invited to two undisclosed dairy farms in Texas that experienced H5N1 outbreaks in their herds starting in early and late March, respectively. The researchers had a previously approved research protocol to study novel respiratory viruses on dairy farms, easing the ability to quickly begin the work.

Rare study

"Farm A" had 7,200 cows and 180 workers. Illnesses began on March 6, and nearly 5 percent of the herd was estimated to be affected during the outbreak. "Farm B" had 8,200 cows and 45 workers. After illnesses began on March 20, an estimated 14 percent of the herd was affected.

The researchers first visited Farm A on April 3 and Farm B on April 4, collecting swabs and samples at each. Based on the previously approved protocol, they were limited to taking nasal swabs and blood samples from no more than 10 workers per farm. On Farm A, 10 workers provided nasal swabs and blood samples. On Farm B, only seven agreed to give nasal swabs, and four gave blood samples.

While swabs from cows, milk, a dead bird, and a sample of fecal slurry showed signs of H5N1, all of the nasal swabs from the 14 humans were negative. However, when researchers looked for H5N1-targeting antibodies in their blood—an indicator that they were previously infected—two of the 14, about 14 percent, were positive.

Both of the workers with previous infections, a man and a woman, were from Farm A. And both reported having flu-like symptoms. The man worked inside cattle corrals, close to the animals, and he reported having a cough at the time the samples were taken. The woman, meanwhile, worked in the cafeteria on the farm and reported recently recovering from an illness that included fever, cough, and sore throat. She noted that other people on the farm had similar respiratory illnesses around when she did.

The finding suggests human cases of H5N1 are going undetected. Moreover, managing to find evidence of two undetected infections in a sample of just 14 workers suggests it may not be hard to find more. The Centers for Disease Control and Prevention estimates that around 200,000 people work with livestock in the US.

A "compelling case"

To date, the virus has infected at least 175 dairy farms in 13 states. The official tally of human cases in the dairy outbreak is 14: four in dairy farm workers and 10 in workers on poultry farms with infections linked to the dairy outbreak.

"I am very confident there are more people being infected than we know about," Gray told KFF, which first reported on the study. "Largely, that's because our surveillance has been so poor."

Known infections in humans have all been mild so far. But experts are anxious that with each new infection, the wily H5N1 virus is getting new opportunities to adapt further to humans. If the virus evolves to cause more severe disease and spread from human to human, it could spark another pandemic.

Federal officials are also worried about this potential threat. In a press briefing Tuesday, Nirav Shah, the CDC's principal deputy director, announced a $5 million effort to vaccinate farm workers—but against seasonal flu.

Shah explained that the CDC is concerned that if farm workers are infected with H5N1 and the seasonal flu at the same time, the viruses could exchange genetic segments—a process called reassortment. This could give rise to the pandemic threat experts are worried about. By vaccinating the workers against the seasonal flu, it could potentially prevent the viruses from comingling in one person, Shah suggested.

The US does have a bird flu-specific vaccine available. But in the briefing, Shah said that the use of that vaccine in farm workers is not planned for now, though there's still active discussion on the possibility. The lack of severe disease and no documented human-to-human transmission from H5N1 infections both argue against deploying a new vaccine, Shah said. "There has to be a strong and compelling case," he added. Shah also suggested that the agency expects vaccine uptake to be low among farm workers.

Walgreens Flu Shot Appointments Now Available Nationwide For Everyone Aged 3 And Up

Community pharmacies continue to serve as a convenient, trusted destination for vaccinations and other preventive healthcare services

DEERFIELD, Ill., August 01, 2024--(BUSINESS WIRE)--Walgreens is now offering flu shots for anyone aged 3 years and up at stores nationwide ahead of respiratory illness season. Individuals and families can visit the pharmacy or schedule an appointment through the Walgreens app, by visiting Walgreens.Com/ScheduleVaccine or by calling 1-800-WALGREENS.

Walgreens trusted pharmacy teams are working to keep communities protected this upcoming respiratory season by helping to ensure everyone has convenient and timely options for vaccination, testing and treatment – all in one place.

Vaccinations: Flexible vaccination appointments are available – including nights, weekends and walk-ins* – with the option to schedule additional vaccines in the same visit, making it easy and convenient to stay up to date on all recommended vaccines, such as RSV, shingles, pneumococcal pneumonia and others. Walgreens will also provide the updated COVID-19 vaccine once available, recommended by the CDC to better protect against newer coronavirus variants.

Testing: Individuals who are experiencing a runny nose, cough or other respiratory symptoms should get tested to help ensure they can quickly take the necessary steps toward recovery. Walgreens offers a variety of convenient options for flu and COVID-19 testing, including over-the-counter, PCR, and an easy "2 results in 1" in-store rapid test for COVID-19 and influenza A and B with results in 30 minutes, for $24.99.

Treatments: Walgreens offers a full range of over-the-counter and prescription medications to help individuals minimize symptoms and recover as soon as possible. In many states, Walgreens pharmacists can evaluate and prescribe antiviral medicine, including Paxlovid or Tamiflu, if an individual tests positive for flu or COVID-19. Walgreens also offers 1-hour delivery for medicine cabinet essentials and Same Day Rx Delivery for eligible prescriptions.

Data from the CDC and IQVIA show that patients are increasingly turning to pharmacies for their routine vaccinations. According to a 2023 IQVIA study, approximately 70% of adult flu vaccinations were administered in retail pharmacies during flu season.1,2

"Pharmacies continue to be the cornerstone of healthcare in communities across the U.S. And patients rely on our trusted pharmacists for everyday care, and respiratory illness season is no different," said Rick Gates, chief pharmacy officer, Walgreens. "Our pharmacists play a critical role in ensuring communities stay protected from viruses, providing accessible, quick and routine preventive services, including vaccinations, testing and treatment."

More than 50,000 immunizing Walgreens pharmacy team members continue to play a critical role in helping to protect patients and their families from vaccine-preventable illnesses. Since 2010, they have administered more than 105 million vaccinations in communities throughout the U.S. Thanks to their efforts, neighborhood pharmacies like Walgreens continue to be the most accessible destinations for care during fall respiratory virus season.

How to prepare for a visit:

Schedule an appointment – visit Walgreens.Com/ScheduleVaccine or call 1-800-Walgreens, both available in Spanish and English.

Complete vaccination consent paperwork digitally prior to your appointment to automatically send to the pharmacy and save time during your appointment.

Use the digital check-in feature at the pharmacy to skip the line and confirm your arrival.

Wear loose-fitting clothing and bring insurance information.

About Walgreens

Walgreens (www.Walgreens.Com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. True to its purpose of "more joyful lives through better health," Walgreens has a more than 120-year heritage of caring for communities and providing trusted pharmacy services, and today is playing a greater role as an independent partner of choice offering healthcare services that improve care, lower costs, and help patients. Operating nearly 9,000 retail locations across the U.S. And Puerto Rico, Walgreens is proud to serve nearly 9 million customers and patients daily. The company's pharmacists are playing a more critical role in healthcare than ever before, providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for some of the nation's most underserved populations. Walgreens offers customers and patients a true omnichannel experience, with fully integrated physical and digital platforms designed to deliver high-quality products and healthcare services. Within the U.S. Healthcare segment, Walgreens portfolio also includes businesses in primary care, multi-specialty, post-acute care, urgent care, specialty pharmacy services, population health and provider enablement.

1 IQVIA. Trends in vaccine administration in the United States. January 13, 2023. Www.Iqvia.Com/insights/the-iqvia-institute/reports/trends-in-vaccine-administration-in-the-united-states2 Influenza Vaccinations Administered in Pharmacies and Physician Medical Offices, Adults, United States. May 4, 2024. Https://www.Cdc.Gov/flu/fluvaxview/dashboard/vaccination-administered.Html.

*Please note that walk-in appointments are based on availability.

View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20240801817763/en/

Contacts

Jim CohnWalgreens Media Relationsmedia@walgreens.Com

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