India’s made-in-the-USA nasal Covid vaccine

The ideas and innovators shaping health care

Oct 17, 2022 View in browser   By Carmen Paun , Ben Leonard , Grace Scullion and Ruth Reader INNOVATORS Nasal vaccines have long been used to control the flu, raising the prospect they could work for Covid-19. | AP Stopping Covid-19 transmission is the aim of next-generation vaccines. And many experts believe those vaccines won't be injectable . Instead, people will use a nasal vaccine. Scientists say the mode of delivery could stop transmission by generating immunity where the coronavirus enters the body — in the nose. India already has a nasal vaccine, though its effectiveness is unknown, and it was designed in the U.S. The researchers: Michael Diamond and David Curiel, both professors at the Washington University School of Medicine, pitched their nasal vaccine to the big U.S. pharmaceutical companies first. But "there was not as much excitement as we would have thought," Diamond, a molecular microbiologist, told Future Pulse. In the end, they licensed iNCOVACC to Indian vaccine maker Bharat Biotech, which received emergency approval last month to give it to adults in India. Diamond and Curiel, a radiation oncologist, said they created it with the needs of the developing world in mind, given the lack of ultracold freezers needed to store mRNA vaccines. Biosecurity concerns: Biden administration officials said they're worried that the U.S. could fall behind other countries in developing nasal Covid vaccines. "Intranasal vaccines, vaccines that are variant-resistant, those are critical tools to have in the toolbox for protecting Americans — not just for Covid but also for future pandemics and also for future biosecurity threats," Ashish Jha, the administration's Covid-19 response coordinator, told POLITICO. A vaccine that prevents coronavirus spread would better protect people if a deadlier variant emerges, added Karin Bok, the acting deputy director of pandemic preparedness and emergency response at the National Institute of Allergy and Infectious Diseases' Vaccine Research Center. Nasal vaccines could also be more appealing to people who didn't get vaccinated because they fear needles or to parents hesitant to vaccinate their children. Why is the U.S. behind? Congress has refused to put more money into the Covid-19 response and major drugmakers don't think nasal vaccines would be profitable, given the plummeting demand for shots.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today .     WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. New research shows that spending time at the beach and not reading the news can help mental health. Who knew? Share news, tips and feedback with Ben at bleonard@politico.com, Ruth at rreader@politico.com, Carmen at cpaun@politico.com or Grace at gscullion@politico.com.  Send tips securely through SecureDrop, Signal, Telegram or WhatsApp . TODAY ON OUR Pulse Check Podcast , Grace Scullion talks with Lauren Gardner about the worrisome state of America's mental health and what lawmakers propose to do about it. Plus, David Lim on the FDA's new rule allowing the sale of over-the-counter hearing aids. Listen to today's Pulse Check podcast TECH MAZE Tech companies believe watches that track vital signs will appeal to health-conscious consumers. | Getty Images Apple says the "future of health is on your wrist ." But researchers from Northwestern University found that wearables developers still have a lot of refining to do before the devices really help people manage their health. Some problems they identified: Close to three in 10 users stop wearing smartwatches over time. Patients sometimes can't tolerate having patches designed to track vital signs attached to their skin. The devices aren't always reliable. Fixing thse issues will require "fundamental advances in materials science and systems engineering," the researchers wrote. Privacy safeguards will be key, they added, as will clinical trials and regulations that assure the technology works as intended. Hope for the future: There's certainly reason to be enthused about medical wearables. Companies are evolving wellness tools like step counters to become more like medical devices, with wearable glucose monitors that let patients track diabetes data on their smart devices. The gadgets can connect with health care organizations' digital systems and allow doctors to remotely monitor patients. New miniaturized devices and patches hold promise because they can reduce discomfort. The researchers are also enthused about monitoring via sweat for indicators of health. "Ultimately, future medical wearables and the data insights they generate will operate within an ecosystem where remote monitoring, clinician engagement, telemedicine, and even therapy integrate seamlessly with the traditional health care system," the researchers wrote.   TUNE IN TO THE PULSE CHECK PODCAST: Keep your finger on the pulse of the biggest stories in health care by listening to our daily Pulse Check podcast. POLITICO's must-listen briefing decodes healthcare policy and politics, and delivers reality checks from health professionals on the front lines. SUBSCRIBE NOW AND START LISTENING .     FOLLOW THE MONEY A hearing aid specialist examines a patient's ear last year in Fort Lauderdale, Fla. | Getty Images People with hearing loss can save a bundle starting today. New FDA rules permitting the sale of over-the-counter hearing aids have taken effect, and patients can buy the devices at drugstores, major retailers and online. Big savings foreseen: Prescription hearing aids, the only types previously available, cost thousands of dollars: Lower-end models run about $2,000 and high-end versions can set patients back $7,000. Manufacturers say they can bring prices down to $300 to $500 for over-the-counter models. What's happening now: Customers shouldn't expect to find those prices today , since hearing-aid makers are still developing products and gauging what the market will bear. People who choose to go it alone could also miss out on the guidance of audiologists who help patients buy prescription models, ensure they fit properly and set the correct sound levels. Back story: As POLITICO reported in August when the FDA announced the decision, it was a long time in coming. Congress passed a law ordering the FDA to approve over-the-counter hearing aids five years ago, and the agency has faced bipartisan pressure to finish the job from lawmakers led by Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa).   Follow us on Twitter Ben Leonard @_BenLeonard_ Ruth Reader @RuthReader Carmen Paun @carmenpaun   Follow us

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