Tyson Gustin, son of Stacy and U.S. Air Force Staff Sgt. Michael Gustin, 23d Logistics Readiness Squadron, receives flu mist from a 23d Medical Operations Squadron allergy and immunization technician, Jan. 21, 2016, at Moody Air Force Base, Ga. During fiscal year 2015, the clinic administered approximately 17,000 vaccinations with an estimated 5,500 of those being flu vaccinations. (U.S. Air Force photo by Airman 1st Class Greg Nash/Released)

Urgent care centers across the US might be re-adding the intranasal FluMist® vaccine back in their flu prevention arsenals in the near future. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has voted in favor of renewing the recommendation to use the FluMist quadrivalent (LAIV) for the 2018-2019 flu season. Is this recommendation premature, or does the data back up its re-entry into the market?

This would reverse the CDC’s current recommendation not to use the nasal spray flu vaccine, a recommendation the CDC renewed for the 2017-2018 flu season out of concern for the nasal spray vaccine’s ineffectiveness.

This new recommendation comes as a result of AstraZeneca’s findings from a pediatric clinical study showing that a new strain of the nasal spray vaccine might be more effective than past strains. The study included 200 children between the ages of 2-4 that evaluated the shedding and antibody responses of the new 2017-2018 H1N1 FluMist vaccine and the 2015-2016 H1N1 FluMist vaccine. Results showed:

First Dose

Second Dose

2017-2018 FluMist Vaccine23 percent of children developed a four-fold antibody rise45 percent of children developed a four-fold antibody rise
2015-2016 FluMist Vaccine5 percent of children developed four-fold antibody rise12 percent of children developed a four-fold antibody rise

The data also indicate that the new FluMist vaccine resulted in an increased vaccine virus replication in vaccinated children. AstraZeneca says it will present the full results of its study at a “forthcoming medical meeting,” though the company has not provided specific details on which medical meeting.

Concerns over FluMist Recommendation

ACIP’s 12-2 vote does not come without some concerns, however. Although AstraZeneca’s MedImmune, the developers of FluMist, says it has identified the problem with the original formula, making the new vaccine more effective, there are some within the medical community who have concerns about recommending the vaccine based solely on AstraZeneca’s data.

ACIP panel member Henry Bernstein, a pediatrics professor at the Zucker School of Medicine at Hofstra/Northwell, who voted against the recommendation, said, “I’m a little concerned about whether it would be interpreted that we’re compromising our interpretation of the science.”

STAT News noted that one of the primary concerns is that the only way to test the vaccine’s efficacy against H1N1 on a large scale is to use it, which would require ACIP approval and a flu season involving sufficient H1N1 activity, which we haven’t seen over the past few flu seasons.

The CDC’s Lisa Grohskopf told the ACIP committee, “The effectiveness of this formulation against (H1N1) is not known and is likely to remain unknown until the next H1N1 predominant season, presuming adequate uptake of vaccine. We can’t predict when this will occur.”

The Advisory Board reports that others on the committee expressed concerns that if the FluMist is recommended but is ineffective yet again, it could damage the already-poor reputation attached to flu vaccines.

Urgent care centers may not have to worry about the implications just yet. According to the CDC, the vote most likely came too late for next flu season as most providers have already ordered their vaccinations for next year.

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