Academy reviewing possible return of nasal spray flu vaccine
MelissaJenco, News Content Editor
The Academy is reviewing a federal health committee’s recommendation to bring back
a nasal spray flu vaccine next season.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization
Practices (ACIP) voted on Wednesday to add the quadrivalent live attenuated influenza
vaccine (LAIV4, FluMist) as an option for the 2018-’19 season after pulling it for
the past two influenza seasons due to poor effectiveness, especially during H1N1 seasons.
However, the CDC director still needs to approve ACIP’s recommendation in order for
it to be CDC policy.
The AAP Committee on Infectious Diseases (COID) will make its own recommendations
at the spring meeting based on how COID views the evidence on LAIV effectiveness.
“AAP values the importance of vaccines and influenza vaccine especially given the
high rate of hospitalizations and deaths in children from this disease, and we are
always very thoughtful regarding improving the benefit of influenza vaccines as well
as the uptake of these vaccines,” said Yvonne A. Maldonado, M.D., FAAP, vice chair
of COID. “COID looks forward to considering the return of a recommendation for LAIV
use once we have an opportunity to carefully review all of the data on the newly reformulated
LAIV, which is given by intranasal spray to healthy patients ages 2 through 49 years,
was a popular option for those reluctant to get a shot. However, in 2016, ACIP reviewed
data showing no effectiveness, especially against H1N1 strains, and did not recommend
it for the 2016-’17 or 2017-’18 seasons.
On Wednesday, Raburn Mallory, M.D., senior director of clinical development for FluMist
manufacturer MedImmune, told the committee it had changed to a new H1N1 strain (A/Slovenia)
that is producing better antibody responses than the previous strain (A/Bolivia).
He also presented data on shedding of the vaccine strain and on seroconversion. However,
because there has been little circulation of influenza A/H1N1 in the past two years,
there are no efficacy data for the new formulation against H1N1 which was the strain
for which LAIV performed poorly in the 2013-’14 and 2015-’16 seasons.
“The studies showed the new strain induced significantly higher seroconversion rates
than the old strain,” Dr. Mallory said. “These results validate the changes and improvements
we’ve made to our strain selection process, and this improved process is being applied
to all future LAIV strains.”
The CDC also presented new analyses of LAIV effectiveness data from several studies.
Given the available data, ACIP felt that adding a non-injectable option might improve
influenza immunization rates since some individuals would prefer to avoid a shot.
Use of LAIV during an influenza season will allow evaluation of efficacy of the new
“I think the evidence is pretty clear this vaccine is better than not being vaccinated
and there are kids who will not be vaccinated without this option, so let’s put it
out there as an option, let’s give clinicians and parents a chance to talk it over
and figure out what they want to give their kids,” said ACIP member Cynthia Pellegrini,
senior vice president of public policy and government affairs for March of Dimes.
But Henry H. Bernstein, D.O., M.H.C.M., FAAP, Red Book Online associate editor, said influenza vaccination rates haven’t gone down since
LAIV was removed, and he questioned whether MedImmune’s data on shedding was a sufficient
indicator it would be effective.
“The part that really worries me the most is the fact if we reinstate LAIV4 without
knowing its vaccine effectiveness during an H1N1 season and then we have an H1N1 season
and it results in increased morbidity and mortality … that is likely to undermine
administration of flu vaccine for the public, potentially lowering all coverage rates
and negatively impacting the country’s overall flu vaccine program,” said Dr. Bernstein,
who voted against the recommendation.
ACIP ultimately voted 12-2 to recommend using any age-appropriate vaccine — inactivated
influenza vaccine, LAIV, or recombinant influenza vaccine. There was significant discussion
among the committee related to how to message the reinstatement of LAIV. The group
acknowledged the Vaccines for Children program already has placed orders and likely
would not have LAIV available for VFC vaccine recipients for 2018-’19.
If the CDC director approves ACIP’s recommendation, it will be published as an official
recommendation in the Morbidity and Mortality Weekly Report. The Academy typically releases its own influenza policy in September.
The current influenza season has been widespread and severe with high hospitalization
rates and 84 pediatric deaths to date. Despite a 36% vaccine effectiveness rate, influenza
immunization prevents millions of influenza-like illnesses and many cases of severe
influenza disease and hospitalizations. The Academy and CDC continue to recommend
everyone 6 months and older be vaccinated as the virus may continue to spread for
several more weeks.