What Happened to the FluMist Nasal Spray Vaccine?

Now that it is almost fall, it is time to start thinking about flu shots. According to the American Academy of Pediatrics, all children older than six months of age should get shots this year and bypass the painless nasal spray vaccine.

Initial Enthusiasm for FluMist Nasal Spray Vaccine:

What child likes to get a shot? None that we know. That’s why there was such enthusiasm for a nasal spray vaccine that did not hurt. FluMist nasal spray vaccine was first marketed in 2003 against three flu viruses. In 2012 a quadrivalent (four different viral strains) FluMist product was approved. Many assumed it was as effective or better than the traditional flu shot.

An article by Liz Szabo in USA Today (November 3, 2012) describes the attitude four years ago:

“When it comes to flu vaccines, most kids clearly and loudly prefer the nasal spray over the traditional shot in the arm.

“As it turns out, those instincts are right on the nose.

“With mounting evidence that the FluMist nasal spray works much better in kids than an injection, flu experts are considering whether the Centers for Disease Control and Prevention should actually steer young children toward the less painful alternative…

“In a study of children published in The New England Journal of Medicine, Belshe found kids who got FluMist were half as likely to get influenza than those given an injection.

“FluMist offered broader protection than the shot, even when the strain of flu virus in circulation wasn’t a good match to the strain used in the vaccine, his study found.

“In that study, about 5% of children vaccinated with FluMist came down with influenza, compared with 10% of those given an injection.”

What Went Wrong with FluMist?

For reasons that remain somewhat mysterious, data from the CDC revealed that last season’s FluMist nasal spray was barely effective. According to the Advisory Committee on Immunization Practices (ACIP), the nasal spray vaccine (with a live attenuated flu virus) was only about 3 percent effective. The Committee actually went further:

“This 3 percent estimate means no protective benefit could be measured. In comparison, IIV (flu shots) had a VE [vaccine effectiveness] estimate of 63 percent (with a 95 percent CI of 52 percent to 72 percent) against any flu virus among children 2 years through 17 years.”

As a result of these dismal results the American Academy of Pediatrics discourages the use of FluMist nasal spray flu vaccine this season. Instead, this esteemed group of pediatricians recommends that children and their parents and caregivers receive injections with either three or four strains of inactivated influenza virus. Pregnant women and mothers who are breast feeding also can and should be vaccinated according to the American Academy of Pediatrics.

Pediatrics, Sept. 6, 2016

How Good Is the Flu Shot?

Many people assume that flu shots are extremely effective, protecting anywhere from 80 to 100 percent of those vaccinated. Here are the actual numbers from the CDC’s analysis of “Seasonal Influenza Vaccine Effectiveness, 2005-2016.”

2004-2005:    Adjusted Vaccine Effectiveness = 10%
2005-2006:    Adjusted Vaccine Effectiveness = 21%
2006-2007:    Adjusted Vaccine Effectiveness = 52%
2007-2008:    Adjusted Vaccine Effectiveness = 37%
2009-2010:    Adjusted Vaccine Effectiveness = 56%
2010-2011:    Adjusted Vaccine Effectiveness = 60%
2011-2012:    Adjusted Vaccine Effectiveness = 47%
2012-2013:    Adjusted Vaccine Effectiveness = 49%
2013-2014:    Adjusted Vaccine Effectiveness = 51%
2014-2015:    Adjusted Vaccine Effectiveness = 23%
2015-2016:    Adjusted Vaccine Effectiveness = 47%

That means that over the last decade the vaccine effectiveness rate was roughly 41%. Put another way, nearly 60 percent of people who got a shot did not achieve significant benefit against the flu. We find such numbers disappointing.

What About Side Effects:

The CDC downplays vaccine side effects:

“Most people who get a flu shot do not have any problems with it.”

“Minor problems following a flu shot include:

• soreness, redness, or swelling where the shot was given
• hoarseness
• sore, red or itchy eyes
• cough
• fever
• aches
• headache
• itching
• fatigue

If these problems occur, they usually begin soon after the shot and last 1 or 2 days.”

“Some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.”

Sore Shoulder May Not Be So Rare:

Over the last couple of seasons we have received increasing numbers of reports of severe shoulder pain after people got a flu shot. They say the pain does not go away in a day or two. Here are links to some articles on this topic. You will find a great many stories of woe and intrigue regarding the recent flu vaccine injections.

Is My Lasting Shoulder Pain Due to the Flu Shot?

Why Does My Shoulder Still Hurt So Much After a Flu Shot?

Can Flu Shots Cause Long-Lasting Arm Pain?

The Bottom Line on Flu Shots:

We do not understand why there has suddenly been such a crop of adverse reactions to flu shots. We are tempted to link these reports to the relatively new quadrivalent flu shots that protect against four influenza strains, but we do not have enough data to make that connection.

Clearly, many people are protected from influenza with a vaccine. Those who have chronic health conditions are especially vulnerable to the flu and may benefit from an annual flu shot.

We only wish the vaccines were more effective. Perhaps someday we will have better ways of preventing influenza. Until then, it looks like we are stuck with the shot. The nasal spray vaccine does not appear to be a viable alternative this year, especially for children.