With FluMist deemed ineffective this year, patients have to roll up their sleeves

October 10, 2016

For the past few years, most adults and children had a choice of how to get vaccinated against the flu: the more common shot in the arm or the FluMist spray in the nostrils.

But the less painful method no longer is an option, at least not for the foreseeable future. National health authorities determined FluMist essentially was useless last year in protecting against the dangerous influenza virus. The Centers for Disease Control and Prevention ruled FluMist should not be used at all for the upcoming season.

The disavowal of the nasal spray meant health providers had to shift gears and stock up on more injected vaccines to meet demand. And it means patients will have to grit their teeth this fall and endure the uncomfortable, brief pinch of the shots.

Needle-averse children and their parents are expected to be most dismayed by the change, since about a third of all children who were immunized in 2015 chose the nasal spray.

"It could be an issue for some people, but in order to provide an effective vaccine that will protect their child against influenza, the only vaccine thatís currently available is injectable," said Dr. Tina Tan, an infectious disease physician at Lurie Childrenís Hospital and professor at Northwestern Universityís Feinberg School of Medicine. "Thereís no use giving someone a vaccine if it doesnít work."

The Food and Drug Administration first licensed FluMist in 2003, approving it for people ages 5 to 49. That first spray vaccine was a trivalent, meaning it had three antigens, or components that trigger the immune system to build up defenses against disease. After successful clinical trials, the FDA later approved expanding the use of FluMist to children ages 2 to 5.

In 2012, the FDA gave the green light to a new concoction of the vaccine, a quadrivalent, which had four antigens instead of three. The nasal spray vaccine was not recommended for children younger than 2, adults older than 50, pregnant women, as well as some kids with asthma, egg allergies or immunodeficiency diseases.

FluMist contains a weakened, live flu virus intended to provoke a stronger reaction from the bodyís defenses. The flu shot delivers an inactivated virus.

Early clinical trials suggested FluMist worked as well as the flu shot for groups of young children. CDC leaders even favored the nasal spray over the shot during the 2014-15 flu season.

Approximately 20 million people received the nasal spray last year, about 14 percent of the estimated 144.5 million who got any sort of flu vaccination, according to the CDC.

But FluMistís results slumped over the last three flu seasons. A CDC committee determined in June that the nasal spray showed just a 3 percent effectiveness rate in protecting against the flu among kids 2 to 17 in the 2015-16 season.

"It is no better than if you gave somebody salt water," Tan said.

Why FluMist performed so poorly last year is a mystery for now. Even the flu shot has different success rates year to year because the predominant strains of flu change, which in turn compels adjustment to the vaccine mixtures, according to health leaders. But the prevalent flu strain last year was H1N1 ó the variety that affects children most severely and that responded least well to the nasal spray, according to Dr. Marielle Fricchione of the Chicago Department of Public Health.

Whatever the scientific reasons for FluMist failing so spectacularly, CDC leaders swiftly rejected its use and urged medical providers only to administer injected vaccines this year. The American Academy of Pediatrics followed suit, saying children who received the nasal spray vaccine were more than 2.5 times more likely to contract any type of flu virus than those who received a flu shot.

Doctors in the Chicago area said that while the news was surprising, the CDC research was incontrovertible. They also said there was a silver lining to the development, even if it meant eliminating a promising alternative to the flu shot.

"To me, and to the medical community, itís a good example of medicine and public health constantly and continuously looking at the data and reassessing the decisions they make," said Fricchione, medical director of the public health departmentís immunization program. "It was the right decision to make for the individual patient, and (the CDC) felt it was not ethical to recommend a vaccine with no efficacy."

Dr. Asit Vora, a pediatrician at Advocate Childrenís Hospital in Oak Lawn, Ill., agreed.

"This is why we do the research," Vora said. "This is why we look at vaccination rates. Because weíre constantly re-evaluating what weíre doing, we found this out now. If something is not working, we shouldnít be doing it."

Fortunately, doctors say, the policy shift occurred long enough before cold and flu season to not cause panic or crisis. The CDC and the American Academy of Pediatrics worked closely with providers and vaccine manufacturers to replace all the now-worthless nasal spray vaccines with injectable doses.

"As soon as it became apparent that (FluMist) would not be recommended, the other manufacturers increased their production and increased distribution," CDC director Dr. Tom Frieden said at a news conference Thursday. "With the availability of up to 168 million doses this year, we donít think there will be any shortage."



Fricchione said about 10 percent of the vaccines the cityís public health department ordered from the CDC were the nasal sprays, but the department has received its full supply of injected doses for the season.

Advocate canceled its order of 7,000 FluMist doses for its pediatric and family medicine practices, and ordered injected versions instead, pharmacist Rami Rihani said. It was approved for 5,000 flu shots and put on a wait list for the other 2,000.


Physicians said they have had plenty of time to discuss flu shots with parents, and in many cases, parents have arrived at appointments already well-versed on the issues.

"We were able to start early with our parents to educate them," Vora said. "We told them the FluMist is basically the same as not vaccinating your child against the flu."

Doctors said the vast majority of parents are fine with giving their children the flu shot. Fricchione said some parents may have had to make that same choice in past years.

"Some of the problems we had historically were that parents would go in and ask for the nasal spray vaccine, and it would be out of stock," Fricchione said. "So I donít think the new decision is going to change how many kids are vaccinated. I think parents will adapt fairly quickly, and I think the providers will be able to get the same (vaccination) rates."

For Bobbi Selvik, mother of two teenagers who used the spray for years, going back to the shots is a no-brainer. Selvik, of Palatine, said her 13-year-old son contracted the H1N1 flu virus years ago.

"I never, never want my kids to experience anything like that again," she said. "It was so much worse than the regular flu. So if thereís a flu shot, FluMist, whatever it is thatís going to prevent the kids from getting this terrible disease ó absolutely, weíre going to do it."

The future of FluMist is uncertain.

Experts have noted that the nasal spray vaccine has been shown to work well in other countries, like the United Kingdom and Finland. The FDA challenged the reliability of the research findings, pointing to studies showing FluMistís success overseas, and still endorses the nasal spray. AstraZeneca stands by its product and is continuing to distribute FluMist in other countries this year.

Frieden, of the CDC, said federal authorities want to bring that type of immunization back into the fold if it can be proven to work. CDC figures show around 42 million children total got a flu vaccine last year, so about 14 million chose the nasal spray version.

"This is a significant number, and for a lot of kids, itís certainly preferable to getting a shot," Frieden said. "So we hope that this option will be available as soon as possible."

Dr. Robert S. Daum, professor of pediatrics, microbiology and molecular medicine at the University of Chicago, said he understands the ambivalence some may feel about flu shots because of this. But whatever limitations flu vaccines have, medical professionals agree they still are vital tools to keep people healthy.

"If you look at the health care advances in the last 100 years, there are vaccines," Daum said. "My parents used to get scared stiff about paralytic polio. Thatís not a problem anymore. People can be skeptical all they want, but (flu vaccines) are still the best way we have to prevent this terrible disease."



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