Nasal spray flu vaccine can now be shipped to your home. Here's how to get it
FluMist, made by the drug company AstraZeneca, has been approved in the United States since 2003, but its use was limited to health care settings like hospitals and flu clinics. In 2024, the FDA approved it for at-home administration, making it the first nasal spray vaccine approved for widespread use at home.
On Friday, AstraZeneca announced a home delivery service for the product, which infectious disease experts hope will lead to more people getting vaccinated against seasonal influenza. The service is available in 34 states including California, for the upcoming 2025-26 flu season.
Prior to the approval for at-home use, FluMust had been given mostly in pediatricians' offices because many children have a fear of needles. As many as 2 in 3 children and 1 in 4 adults have a strong fear of needles, according to CDC estimates.
Here's what you need to know about the nasal spray vaccine:
It's approved for people aged 2 to 49
Adults can self-administer it; it's given through two sprays, one in each nostril. Children should get it administered by a parent or caregiver.
You need a prescription
Adults can go to www.FluMust.com to order the vaccine and will be asked to complete a medical screening questionnaire, AstraZeneca said. A licensed health care provider will review the submission to determine eligibility. Once eligibility is confirmed and insurance is verified, the vaccine will be prescribed and shipped directly to consumers' home on the date they selected. It will come with instructions on how to administer, store and dispose the product.
Cost
Cost will depend on individuals' insurance, but most insurance plans cover flu vaccines at no cost.
There is a $8.99 shipping and processing fee per order.
It may not be for everyone
Anyone who is wheezing, has asthma, has Guillain-Barre syndrome, has a weakened immune system or has problems with the heart, kidneys or lung should check with their health care provider before getting FluMust, according to AstraZeneca. People who are pregnant or nursing, or who have diabetes, should also check with their doctor first.
Children under 5 with a history of wheezing should also check with their doctor.
Children and adolescents up to 17 years old who are taking aspirin or medicines containing aspirin should not get FluMust.
Side effects
The most common side effects are runny or stuffy nose, sore throat and fever over 100 degrees.
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NBC News
8 minutes ago
- NBC News
Time is running out for kids with a rare disease, parents say, unless the FDA acts
Gilbert Dryden probably only has enough medication to get him through the end of October, his mother, Madison, figures. Seven-month-old Gilbert has a rare genetic condition called Barth syndrome, one that can have dire consequences, like heart failure, extreme muscle weakness and a dramatically reduced life expectancy. Children who die early often don't see their fifth birthday. Two infant deaths were reported within the past week, according to the Barth Syndrome Foundation. What's been keeping Gilbert alive and functioning relatively well, according to his family, is an experimental drug called elamipretide, made by Stealth BioTherapeutics. Small studies have suggested it's safe and effective in treating the ultra-rare illness. Just 150 people in the U.S. have the condition. 'Our kids are dying. We have seen that this drug works,' said Kate McCurdy, a co-founder of the Barth Syndrome Foundation. 'This drug totally saves the lives of babies.' After a more than decade-long process to bring the drug to market, the treatment's approval has repeatedly hit roadblocks with the Food and Drug Administration. One setback occurred in the spring, when an FDA inspection found problems at a Stealth manufacturing facility. The problems weren't made public, but apparently weren't egregious enough to warrant regulatory action. The company said the issues have been resolved. In late May, after an advisory panel voted earlier (in October 2024) to recommend the therapy, the FDA declined to approve it. The agency didn't reveal why. An ultra-rare disease like Barth syndrome with an ultra-small population of patients who can be tested for clinical efficacy faces barriers for FDA drug approval. There aren't enough patients to do robust, randomized clinical trials, McCurdy said. 'It is virtually impossible to conduct trials that yield data that are conclusive beyond a reasonable doubt. Statistically, you just can't do that,' she said. Weeks later and following a meeting between Needham, Massachusetts-based Stealth and the FDA in late June, the real bombshell came: The company said the agency informed Stealth on Aug. 4 that it would need to resubmit a new drug application — for the third time. It could use a special pathway called 'accelerated approval' in that submission, but the manufacturing issue would extend the timeline to review elamipretide for at least another six months, according to the company. Stealth said that no additional clinical data or safety data was requested. But without any course correction in the process, the private company could run out of money. The delay is devastating to families like the Drydens. 'When we heard this news, we immediately went to the fridge to count how many vials we have left, because that's how long we have this medication. That's the only guarantee we have right now that Gilbert is not going to die,' said Madison Dryden, 35, of Aurora, Colorado. 'It's the highest level of desperation.' On Monday, Stealth announced that it did submit its third application for approval of elamipretide — asking for an accelerated pathway under a significantly tighter timeline than what the agency initially recommended. What is Barth syndrome? Madison Dryden and her husband, Andrew, weren't sure what was wrong with Gilbert in the hours and days after his Christmas Eve birth in 2024. 'His heart function was so low. He was so sick, his body and his feet were purple, his hands were purple,' Dryden said. 'He couldn't eat.' Gilbert was admitted to the neonatal intensive care unit and received lifesaving care as doctors urgently tried to figure out a diagnosis. Within a matter of days, Dryden said, Gilbert was airlifted to Children's Hospital Colorado with a heart that was struggling to adequately pump blood. The underlying cause was soon revealed: Barth syndrome. The disease impairs cells' mitochondria, which are kind of like tiny batteries that generate energy for cells to function correctly. The chromosomal disorder almost exclusively affects boys. Roughly 85% of early deaths occur before age 5. Those who survive longer are usually given heart medications and may need a heart transplant. Kids with Barth syndrome often rely on drugs like beta blockers and ACE inhibitors to keep their hearts functioning as well as possible. Gilbert was fortunate, at least initially. He found a lifeline through access to the treatment from Stealth. Elamipretide, a daily injection, works by helping to repair the damaged mitochondria. In clinical trials, like the one the Drydens participated in, patients showed a 45% improvement in muscle strength and a 40% improvement in heart function, according to the drugmaker. Most participants have safely remained on the drug for over eight years. In October 2024, an advisory committee to the FDA voted 10-6 in support of the therapy, paving the way for the agency to clear the first drug to treat Barth syndrome. The FDA isn't required to follow the advisory committee's guidance, but it almost always does. A spokesman for the Department of Health and Human Services, which oversees the FDA, wrote in an email that the 'FDA did carefully consider the advice of the advisory committee members, including their rationale for their vote. While there is often a high rate of agreement between FDA and advisory committee recommendations,' the spokesman said, 'there is not always concordance.' 'Compelling medical need' for approval After the advisory committee's recommendation, the FDA's rejection was unexpected. 'It is a small sample size,' said a former FDA official who was involved in the drug approval process. The person asked not to be identified in order to speak freely. But the former official was quick to point out that given the advisory committee recommendation for approval, the 'incredibly compelling medical need' of those living with Barth syndrome and the small sample of individuals who seemed to have benefited from the treatment, it certainly appeared that elamipretide was going to make it across the finish line. A lack of continuity in leadership, however, may have added to the already difficult challenge of guiding the treatment through the final hurdles, the former official said. The FDA has seen many top officials leave the agency in recent months. 'Those who have taken over are not as familiar, or perhaps it'd be more appropriate to say they're inexperienced with how one does drug approvals, how one drives things forward, and they're also somewhat fearful of the current environment,' the former official said. 'And I think that's led to an adverse outcome for some of these rare disease products.' The HHS spokesperson didn't immediately respond to a request Monday for comment about the agency's rejection of the drug or leadership issues. A Wall Street Journal Op-Ed recently offered a scathing evaluation of what's happening at the FDA, questioning whether the agency and Commissioner Marty Makary's stated goal of accelerating lifesaving drugs is matching the reality of their actions. The Journal said that there were averages of 52 annual drug approvals under the first Trump administration and 48 under President Joe Biden, but 'there have been only 22 in the first seven months of this year,' projecting to just 38 for the year. Elamipretide was cited in the Journal piece as a casualty of the current environment. The former FDA official pointed out that the treatment hit stumbling blocks under the previous administration, as well, but it was headed in the right direction. 'Now it feels like a hot potato that's been just thrown around,' the former official said. 'And this is just not right. It's just not right.' Families left with few alternatives The Drydens say the FDA decision pulled the rug out from underneath them — and many other families. Dr. Kathryn Chatfield, Gilbert's doctor and a specialist in pediatric cardiology and genetics at Children's Hospital Colorado, said the FDA's inaction leaves families with few alternatives. 'We just don't know what's going to happen,' Chatfield said. 'We're going to have to watch them really closely because they're at risk for recurrence of heart failure and rehospitalization and potentially decompensation to the point where they have to live in the hospital until they could get a heart transplant.' A transplant addresses the heart problem but doesn't alleviate ongoing muscular and skeletal problems. 'I can't be OK with sacrificing my child's life for a bureaucratic process,' Madison Dryden said. The latest hurdle to approval has Barth syndrome families and advocates alike, including some members of Congress, looking for more information and answers. 'Time is of the essence here, and we need to get these drugs to these patients as soon as possible,' said Rep. Buddy Carter, R-Ga., a member of the Energy and Commerce subcommittee on health. Carter spoke to NBC News days before the FDA requested a resubmission in early August and said he'd sent a letter to the agency asking for 'clarity' on elamipretide. 'There aren't that many options out there,' he said. 'In fact, for Barth Syndrome, this elamipretide is really the only drug that we know of that works.' Carter said that there are six families in Georgia alone he's been in contact with who have a loved one with the rare disease. He's hopeful that an 'accelerated pathway' request might prove a viable option for the families and for the company to continue its research. After the recent FDA decision, Carter told NBC News in a statement that he's 'disappointed' with the recommendation 'now that all issues appear to be resolved.' Carter said he's continuing to put pressure on the FDA and that 'patients will suffer with further delays.' He also acknowledged that the economics of a private company, like Stealth, attempting to continue developing a drug for such a small population of patients would be exceedingly difficult without FDA backing. He said he feels deeply for the families in the middle of a terrifying ordeal. 'I'd be calling everybody I could (too), making sure that my child or my grandchild had this medication,' he said in an interview. Madison Dryden and her husband are left with what they call a 'giant unknown' in the absence of approval, struggling for an explanation for their 7- and 3-year-old daughters as families are in a race against time to keep loved ones alive. 'They know that somebody is not giving permission for Gilbert to have his medicine, and that they keep saying no, and they're our kids — like they can't lose … we can't have them lose their baby brother to this,' she said.
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