For the past two flu seasons, the Advisory Committee on Immunization Practices
, a panel of immunization experts, has not recommended the needleless option.
However, the panel voted 12-2 this week to include FluMist as an option for doctors to use during next year's flu season, CDC spokesman Ian Branam said. The CDC is expected to go along with the recommendation of the committee.
"The nasal spray flu vaccine is licensed for use in otherwise healthy, non-pregnant people ages 2 through 49 years," he said.
FluMist is a live attenuated influenza vaccine. Though the viruses in FluMist are live, they have been weakened (attenuated, in medical terms) and work by stimulating the immune system. By contrast, the flu shot is an inactivated influenza vaccine.
MedImmune, a subsidiary of London-based AstraZeneca PLC, produces FluMist, which was first approved
by the US Food and Drug Administration in 2003. By all accounts, it worked well in the early years. However, a 2015-16 influenza vaccine effectiveness study found FluMist to be overall 46% effective -- with zero effectiveness against one strain of flu -- compared with the flu shot's overall 65% effectiveness.
Beginning with the 2016-17 season, then, the Advisory Committee on Immunization Practices decided to not recommend the spray because of its poor performance compared with the flu shot, and that decision was repeated for this season.
Before voting in favor of the vaccine on Wednesday, the committee "heard data from the vaccine manufacturer about a possible root cause of poor effectiveness against the influenza A H1N1 virus in the past and a potential solution to address this," Branam said. This solution includes using a different type of influenza A H1N1 virus in the vaccine.
AstraZeneca presented positive results from a US study in children between 2 and 4 years old that evaluated their responses to the H1N1 strain in the quadrivalent formula of the spray which protects against four different influenza viruses. The pediatric study results showed that the H1N1 strain in the 2017-18 vaccine "performed significantly better" than the H1N1 strain in the 2015-16 vaccine, according to a statement released Wednesday
The children's response was comparable to what was seen before the 2009 H1N1 flu pandemic season. FluMist is popular among those who hate needles -- including most children.
Along with FluMist, immunization providers may choose to give their patients one of two types of flu shots: either the inactivated influenza vaccine (known as IIV) or the recombinant influenza vaccine (RIV), CDC spokeswoman Kristen Nordlund said.
This year's 2017-18 seasonal flu shot has been just 36% effective against both A and B virus strains, the CDC estimated in a midseason report
. However, it still offers some protection. "Getting the flu shot is the same kind of sensible precaution as buckling your seat belt. If you got the flu shot but you end up catching the flu, it could be less severe and less likely to land you in the hospital," Health and Human Services Secretary Alex Azar said last week.
Even though FluMist has not been recommended for the past two flu seasons, the Food and Drug Administration has still approved it, Nordlund noted. That means immunization providers could still give patients the nasal spray instead of the flu shot if requested although most physicians have not offered it. It has also remained available and recommended in both Canada and the European Union.
FluMist quadrivalent will be available in the US for the 2018-19 influenza season, pending annual strain approval from the FDA, the company noted in its statement.