Change in FluMist Recommendations

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Vol. 25 No. 11 Page 27

A previously preferred alternative to injectable flu vaccines is now ineffective.

Every fall and winter, flu season brings with it seemingly omnipresent sniffling, incessant hand washing and, of course, the inevitable flu shots. Could there be another option when it comes to building a defense against each year’s influenza virus?

In 2014, the Centers for Disease Control and Prevention (CDC) recommended the use of FluMist Quadrivalent, an intranasal live attenuated influenza vaccine, for children ages 2 to 8 years. Basing its recommendation on a 2004 randomized controlled trial that found a 55% reduction in the number of flu cases among children who had used the spray, the CDC concluded that the spray was more effective in these children than traditional, injectable forms of the vaccine.1

According to the FluMist website, the nasal spray acts in a manner similar to traditional flu vaccines, by introducing a person’s immune system to weakened influenza viruses to build defense. Unlike traditional vaccines, FluMist does not require a person to receive an injection, and instead a single spray in each nostril. The medication “works in three ways—in your nose, your cells and your bloodstream—to help provide flu protection,”2 the website states. The website also states that this nasal delivery of the vaccine can benefit patients between the ages of 2 and 49.

However, in 2015, the CDC did not renew its preference for FluMist, although it was still considered a viable alternative to traditional vaccines. In 2016, the CDC determined that FluMist was essentially ineffective as a flu vaccine, eliminating the nasal spray from its recommendations altogether.1

Why?

It’s difficult to determine exactly why the effectiveness of FluMist seemed to vanish between 2014 and 2016. However, the apparent results—or lack thereof—that accompanied the use of the vaccine gave the CDC little choice but to retract its recommendation.

During the 2013–2014 flu season, the healthcare world was combatting the H1N1 virus, better known as the “swine flu.” While most influenza vaccines performed well against the virus, FluMist showed no measurable effectiveness.1

The flu season of 2014–2015 proved difficult for the country as a whole. H3N2 viruses dominated, and many of the vaccines in circulation proved ineffective. While versions of H3N2 were present in the nasal spray and injectable vaccines, 80% of the H3N2 viruses circulating in the United States were different from the recommended H3N2 vaccine virus.3

Because the CDC makes its recommendations prior to flu season, it’s always a bit of a guessing game, which is why so many vaccines used in 2014–2015 proved ineffective. However, when examining the nasal spray’s effectiveness from 2013 to 2016, the CDC determined that it should not be used at all: FluMist was strikingly less effective than traditional vaccines, protecting only 3% of children as opposed to the 63% protected by traditional vaccines.4

A Devastating Loss?

While many parents and healthcare providers alike are surprised by the shift in CDC recommendations, the absence of FluMist in flu clinics this year won’t necessarily be a dramatic change. “Those willing to immunize their children or themselves will do so no matter how it is dispensed,” said Cathy Carrico, DNP, APRN-NP, FNP, an assistant professor at Creighton University College of Nursing.

Although FluMist gave people an option to get vaccinated without an injection, in Carrico’s experience, the spray wasn’t necessarily a huge improvement from traditional flu vaccines, even before its effectiveness was questioned.

“There were more restrictions with FluMist. Children with asthma couldn’t use it, adults over the age of 50 couldn’t use it, and it was more expensive,” she said. “Plus, in my practice, I noticed that some of the children really didn’t like the FluMist. It stings a little bit, and it’s a funny feeling in their nose. They didn’t like it any more than getting a shot.”

Still, Carrico stressed the importance of telling patients in advance about the new recommendations. “I’ve been seeing patients and reminding them that FluMist isn’t going to be available so that they’re prepared before they come in.”

No matter how unpleasant FluMist might be, children who have grown accustomed to the spray may need some encouragement before being presented with the traditional form of the vaccine. “Healthcare providers need to know how to reduce the fear and anxiety in kids that comes with needles,” Carrico said. “They need to know effective techniques that don’t take a lot of time, such as breathing exercises or distraction techniques. Also, be honest. Don’t say it won’t hurt. Say it’ll hurt a little, but it’ll be quick.”

Boosting Vaccination Rates

A University of Pittsburgh-developed program successfully boosts vaccination rates in adult patients seen at primary care offices, as demonstrated in two recent studies.Physician offices participating in the 4 Pillars Practice Transformation Program had nearly three times the increase in patients getting the Tdap vaccine for protection against pertussis compared to non-participating offices, according to research published in the journal Vaccine.Another study, published in the Journal for Healthcare Quality, demonstrated that certain characteristics already embedded into some primary care practices, such as open leadership and staff communication, organizational flexibility and experience with quality improvement, predicted which practices would garner the most vaccination rate improvement from the 4 Pillars program.

“Vaccination is the single best way to prevent communicable diseases,” said Richard K. Zimmerman, MD, MPH, professor in the Pitt School of Medicine’s Department of Family Medicine, and senior or coauthor on the two studies. “In recent years, we’ve seen surges in cases of whooping cough, which can be deadly in newborns who can contract it from unvaccinated adults. And we recently learned from federal health officials that the rate of people getting vaccinated against the flu—another virus that kills hundreds annually—fell last season. We need to find ways to get more people immunized.”

The 4 Pillars program is a step-by-step guide, backed by decades of research, for increasing adult immunizations at primary care clinics by using an online tool that tracks vaccination rates. It’s based on four key pillars: convenient vaccination services; communication with patients about the importance of immunization; enhanced office systems to facilitate immunization; and motivation through an office “Immunization Champion” who is charged with implementing the strategies and maintaining the program.

In the first-ever study to focus on increasing Tdap immunization rates since it was universally recommended for all adults by the federal Advisory Committee on Immunization Practices in 2012, the researchers enrolled 25 primary care practices in Pittsburgh and Houston. Half received the 4 Pillars program in the first year, while the other half acted as a control group and didn’t receive the program until the second year.

At the beginning of the study, the practices had Tdap immunization rates ranging from a low of 6.8 percent to a high of 79.5%. With the 4 Pillars program, the practices increased their immunization rates by an average of 7.6% in the first year compared to a national increase of about 3 percent. One practice increased by 17% in the first year.

In a different analysis using the same enrolled practices, Mary Hawk, DrPH, assistant professor of behavioral and community health sciences at Pitt’s Graduate School of Public Health, examined factors that made the 4 Pillars program more effective at some practices.

Those that had the highest implementation of the 4 Pillars program strategies, resulting in the best immunization rate improvement, were those with:

  • Extensive experience with previous quality improvement initiatives.
  • Two-way communication in which information between physicians and staff members flowed in both directions, reflecting a mutual respect for ideas.
  • An Immunization Champion who was respected for his or her leadership and was able to guide and motivate staff in making office systems changes.
  • An organizational flexibility that was nimble and amenable to embracing positive changes.

 

“The ability to implement change within primary care settings requires more than simply intent to participate, especially when it comes to improving immunization rates,” said Dr. Hawk. “Even with a proven, research-backed program like 4 Pillars, practices also may need to make internal adjustments for the program to work to its full ability.”

 

A Future for Alternative Vaccines

Despite the CDC’s retraction of its recommendation, many healthcare professionals still question whether or not FluMist is truly ineffective. In fact, certain studies appear to contradict the CDC’s findings on the quadrivalent altogether: A Canadian study conducted from October 2012 to May 2015 followed 1,185 children ages 3 to 15 and found that trivalent intranasal live attenuated influenza vaccines were as effective as trivalent inactivated influenza vaccines.5

Even if FluMist stays off of the market permanently, Carrico expects that other alternative vaccines will emerge soon enough. “There are already some in research,” she said. “Some are using intradermal methods. Some needle-free injections are being explored. There’s also a microneedle patch. There are always new things out there.”


References

  1. Appleby J. The FluMist mystery: why was it effective one year but not now? The Washington Post. 2016.
  2. FluMist Quadrivalent. About FluMist quadrivalent.
  3. Centers for Disease Control and Protection. What you should know for the 2014-2015 influenza season. 2016.
  4. Crawford C. ACIP: Don’t use LAIV during 2016-2017 flu season. 2016.
  5. Loeb M, et al. Live attenuated versus inactivated influenza vaccine in Hutterite children: a cluster randomized blinded trial. Ann Intern Med. 2016. DOI: 10.7326/M16-0513
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Sarah Sutherland
Sarah Sutherland

Sarah Sutherland is a staff writer at ADVANCE. Contact: ssutherland@advanceweb.com

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