Feature Article: What You Should Know — Lessons from FluMist

• Do you or your children usually get the nasal spray influenza vaccine, called FluMist?
• Have you heard that the Centers for Disease Control and Prevention (CDC) does not recommend using this version of the vaccine during the 2016-17 influenza season?
• Are you aware that your doctor might have that version of the vaccine anyway?

If these questions seem confusing, you are not alone. Read on to find out more about this story and see what this situation can teach us about vaccines and parental concerns.

Why did the CDC recommend against using the nasal spray influenza vaccine this year?

Historically, the nasal spray influenza vaccine provided equal or better protection from influenza than the shot. However, in recent years, protection following receipt of the intranasal vaccine has not been as robust, and last year (2015-16), the nasal spray version only protected about 3 of every 100 people who were vaccinated (compared with 63 of 100 people who got the influenza shot). Faced with these data, experts at the CDC recommended against using the nasal spray influenza vaccine during the 2016-17 season.

The nasal spray influenza vaccine was popular because of the method by which it was delivered; and researchers are working to understand why the vaccine stopped working effectively. However, until that happens, the nasal spray version is not likely to be recommended for use.

Read more about the ACIP’s decision and watch a video of Dr. Paul Offit, Director of the Vaccine Education Center discussing the decision. 

Why might healthcare providers still have the vaccine?

Despite the poor data related to the nasal spray influenza vaccine last year, this version of the vaccine is still being sold. So, how can that be?

Vaccines are tested in a variety of ways before they are available to the public. Two important hurdles in this process are licensure by the Food and Drug Administration (FDA) and recommendation by the CDC. Once the FDA licenses a vaccine, it may be sold by the company that makes it. Only after licensure does the CDC make recommendations related to its use.

It is important to understand that the roles of the FDA and the CDC in this process are different. The FDA focuses on the safety and quality of the product, whereas the CDC also focuses on its use; specifically, who should get the vaccine and when. Both are important and necessary to the process; both review much of the same information about a vaccine; and in some cases, both are looking at the data simultaneously, such as in the case of the Vaccine Adverse Events Reporting System (VAERS), which is co-sponsored by the two groups. However, realizing the different roles of these two agencies provides a basis for understanding how the two may differ in their view of a product, such as is currently the case with the nasal spray influenza vaccine.

For more information about the role of these groups when it comes to vaccines, visit their websites:

• FDA website
• CDC website

What did each group say about the FluMist situation?

The statements of each group related to FluMist reflect their different focus. FDA’s statement specifically discusses regulatory action (licensing) and mentions manufacturing and clinical data supporting licensure, whereas CDC’s statement focuses on public health:

• FDA statement  — “FDA continues to find that the benefits of FluMist Quadrivalent outweigh any potential risks. As such, the agency has determined that specific regulatory action is not warranted at this time. This determination is based on FDA’s review of manufacturing and clinical data supporting licensure noted above, the totality of the evidence presented at the ACIP meeting, taking into account the inherent limitations of observational studies conducted to evaluate influenza vaccine effectiveness, as well as the well-known variability of influenza vaccine effectiveness across influenza seasons. FDA continues to work closely with MedImmune, the manufacturer of FluMist, to determine the cause of the lower than expected effectiveness of FluMist Quadrivalent observed in recent years.”
• CDC statement  — “CDC conducts vaccine effectiveness (VE) studies each season to estimate flu vaccine effectiveness. Today’s ACIP vote highlights the importance of measuring and evaluating the effectiveness of public health interventions, which can have significant implications for public health policy. The change in the ACIP recommendation is an example of using newly available data to ensure public health actions are most beneficial. Influenza is a serious disease that causes millions of illnesses, hundreds of thousands of hospitalizations, and thousands or tens of thousands of deaths each year. While the protection offered by flu vaccines can vary, the flu shot’s overall VE estimate of 49 percent suggests that millions of people were protected against flu last season.”

What should a parent or patient do about FluMist?

Information from both the FDA and CDC is important so that parents know the product is both safe and of quality, and will protect individuals and the community. And, it is important to realize why these groups, looking at the same data, may come to different conclusions. It does not mean that one is wrong and one is right; it shows that understanding and context are important.

It is expected that most healthcare providers will follow the guidance of the CDC and not offer the nasal spray influenza vaccine this year. However, if you happen to be offered the choice of receiving the nasal spray or the shot, you should get the shot — even if you are scared of needles.

If you are the parent of a child who typically gets the nasal spray version, prepare your child before the appointment by letting him know that this year the vaccine will be given as a shot, and remind him that even though it may hurt a little, it is better than getting sick from influenza. Remember that your children will take their lead from you. If you are positive and comfortable with the decision, they will be as well.

For other tips to help make your children comfortable during immunizations, see these age-related pages:

• Birth to 2 years
• 4 to 6 years
• Adolescents
• Teens/college

What can we learn from this?

Parents are concerned about vaccines, and some spend a significant amount of time working to learn as much as possible about the vaccines recommended for their families. The current situation with FluMist shows why it is good for parents to approach vaccines with a questioning attitude. Indeed, parents and the public need to know something about the science of and recommendations for vaccines. In this case, it is important to know that if FluMist is offered, it should be declined.

However, this situation also shows a few other things. First, when an issue arises, different groups of experts will review the data through a variety of lenses; disagreement and conversation among these groups does not mean two sides. These academic discussions and evaluations keep everyone safer and provide more understanding. Second, parents can be reassured that when concerns arise, those evaluating the data will act on it. Finally, it shows why, as individuals, it is important to understand the process. Only when parents understand why the FDA and the CDC could come up with different conclusions and what their respective roles are in the process, does this situation make sense and enable parents to make a satisfying and informed decision to ensure their families are getting the best care.