LAIV nasal syringe – Credit CDC PHIL
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Beyond the difficulties of producing billions of doses of an emergency pandemic influenza vaccine, one of the logistical nightmares is how to best deploy them. The standard solutions – where vaccination centers are set up in public venues, pharmacies, and clinics – have some serious downsides.
Queuing hundreds of people together for hours during a pandemic is a good way to spread a virus further. And there are likely to be crowd control and security issues in some places as well.
During the 1976 Swine flu scare (see Deja Flu, All Over Again), I was one of thousands of health care workers around the country who were dragooned into providing pandemic flu shots. The logistics of vaccinating millions of people – even without a pandemic raging – were daunting.
Yes, that’s me in 1976. I and swear to this very day, that lady was making that face before I gave her the shot.
One solution – made possible by the development of an LAIV (Live attenuated Influenza Vaccine) – would be to have people self inoculate themselves at home.
LAIV vaccines – unlike the standard flu shot - are delivered via a nasal spray, not a needle.
The CDC describes the major differences between the TIV (Trivalent Influenza Vaccine) shot, and the LAIV nasal spray as follows:
Major Differences Between TIV and LAIV
Influenza Prevention and Control Recommendations
Published for the 2010-11 Influenza Season; Adapted for the 2012-13 Influenza Season
Trivalent inactivated influenza vaccine (TIV) contains inactivated viruses and thus cannot cause influenza. Live-attenuated influenza vaccine (LAIV) contains live attenuated influenza viruses that have the potential to cause mild signs or symptoms related to vaccine virus infection (e.g., rhinorrhea, nasal congestion, fever, or sore throat). LAIV is administered intranasally by sprayer, whereas TIV is administered intramuscularly or intradermally by injection.
LAIV is licensed for use among nonpregnant persons aged 2-49 years; safety has not been established in persons with underlying medical conditions that confer a higher risk for influenza complications. TIV is licensed for use among persons 6 months and older, including those who are healthy and those with chronic medical conditions.
While not suitable for everyone, LAIVs could be used to inoculate a large segment of the population during an influenza pandemic, without the need of a Health care worker.
All of which brings us to a study, recently published in the journal Vaccine (abstract slightly reparagraphed for readability), which looks at:
The safety and effectiveness of self-administration of intranasal live attenuated influenza vaccine in adults.
Ambrose CS, Wu X.
Vaccine. 2012 Dec 19. pii: S0264-410X(12)01798-7. doi: 10.1016/j.vaccine.2012.12.028.
Source
MedImmune, LLC, Gaithersburg, MD, USA. Electronic address: ambrosec@medimmune.com.
Abstract
Intranasal live attenuated influenza vaccine (LAIV) has potential for self-administration (SA) by adults and adolescents, which could save time and cost in mass vaccination settings. Participants in a study of LAIV in adults (n=4561) selected either SA or health care provider (HCP) administration and were followed for febrile illness during the influenza season.
More LAIV recipients chose SA-LAIV (72%) than HCP-LAIV (28%). Overall, 97% of SA-LAIV and 98% of HCP-LAIV recipients had no problems with vaccine administration. Four of 13 study sites enrolled more than 50 subjects in both cohorts. Overall and for these 4 sites, illness incidence was similar with SA-LAIV and HCP-LAIV.
Solicited reactogenicity events and adverse events through 7 days post vaccination were comparable for SA-LAIV and HCP-LAIV recipients; both groups exhibited increased runny nose, sore throat, and cough relative to placebo recipients. SA-LAIV and HCP-LAIV appeared similarly effective against influenza-like illness and had comparable safety profiles.
CIDRAP NEWS summarized these findings last week in their Flu News Scan.
Study: Smooth sailing for self-administered LAIV flu vax
Self-administered intranasal live attenuated influenza vaccine (LAIV) is as safe and effective as that administered by health providers, according to recent analysis of data from a randomized, placebo-controlled study conducted in 1997 and 1998.The study, which explored differences in administration and was funded by MedImmune, the maker of Flumist, appeared in the Dec 20 online edition of Vaccine. Self-administered flu vaccines could be useful in a pandemic mass immunization setting and could be a tool for making vaccination more efficient and less costly, the authors say.
<SNIP>
The research group found no significant difference in illness incidence between the two groups and observed comparable levels of reactions and adverse events 7 days after vaccination.
Dec 20 Vaccine abstract
LAIVs are normally shipped and stored at 35°F--46°F (cite) - which makes mailing them problematic - but they could be easily distributed via drive thru windows or hand delivered to homes in neighborhoods.
LAIVs are particularly attractive during a pandemic because they can be produced in much larger quantities than Inactivated vaccines.
But there remain some questions regarding their effectiveness in adults, compared to the TIV (see Study: Nasal Flu Vaccines Generally Less Effective Than Shots In Adults).
Caveat: this study was based on seasonal flu vaccine strains used in the middle of the last decade, not on a newly emergent pandemic strain, and so the results may not be fully applicable.
Nevertheless, self-administered LAIVs have the potential to streamline vaccine delivery to a significant portion of the population during the next influenza pandemic. And with a novel flu, the quicker you can increase the levels of community immunity, the sooner the crisis will begin to abate.
