FLU NEWS SCAN: Preparedness goal comments, H1N1 in newborns, H5N1 VLP vaccine

Aug 25, 2011

Deadline approaches on National Preparedness Goal draft comments
The deadline for submitting comments on a draft version of a new national preparedness goal is drawing near, with comments due by Sep 2. On Mar 30 President Barack Obama issued a policy directive ordering federal agencies to develop a National Preparedness Goal designed to define core capabilities and a national preparedness system. The goal is also intended to serve as a benchmark to help officials gauge progress on improving the nation's preparedness. A 58-page draft of the goal is posted on the Federal Emergency Management Agency (FEMA) Web site, along with instructions on how to submit comments. The draft goal covers core capabilities in 33 different areas, such as community resilience, transportation, and mass care services. It is geared toward threats that are human made (including bioterror attacks), technology related (which includes "accidental" food contamination), and natural, including pandemics and animal diseases. It also suggests 151 performance objectives that are organized by five areas: prevention, protection, response, recovery, and mitigation. The first of a proposed annually updated preparedness report is due to the president by Mar 30, 2012.
Mar 30 Presidential Policy Directive 8 on national preparedness
Draft National Preparedness Goal
FEMA Presidential Policy Directive 8 Web site

Newborns seldom contract H1N1 from mom: Japanese study
Pandemic 2009 H1N1 influenza in Japan was seldom passed from mother to newborn, according to a report yesterday in Emerging Infectious Diseases. Scientists contacted 522 hospitals nationwide about whether any children who had been born in their facilities to women who had 2009 H1N1. Of those, 327 facilities (63%) responded, with 47 (16%) reporting such cases. Of the 37 hospitals that could provide detailed information, the researchers were able to identify 42 women who gave birth to 43 infants (29 full-term and 14 preterm). Of those newborns, only one was confirmed to have 2009 H1N1 flu. That infant became lethargic at 4 days of age and received oseltamivir (Tamiflu) and recovered the next day. The authors write, "Because onset occurred 4 days after birth, the possibility of horizontal infection from the mother cannot be excluded." They conclude, "Our results show that pandemic (H1N1) 2009 virus infection in mothers seldom occurred in their neonates, i.e., vertical transmission was rare," which is consistent with other reports.
Aug 24 Emerg Infect Dis report

H5N1 virus-like particle vaccine shows cross-reactivity in clinical trials
A virus-like particle (VLP) H5N1 vaccine was shown to be immunogenic and cross-reactive to other subtypes, according to results of a phase 1/2 human trial published yesterday in the Journal of Virology. Researchers from the Food and Drug Administration and Novavax, the vaccine's maker, conducted a two-stage clinical trial. In the first stage, 70 volunteers age 18 to 40 received 15 or 45 micrograms (mcg) of the H5N1 VLP vaccine or placebo (7:3 ratio) at days 0 and 28. In stage two, after assessing for safety, the researchers administered 15-, 45-, or 90-mcg doses or a placebo (1:1:1:1 ratio) to 160 volunteers. The authors write, "Two doses of H5N1 VLPs at 15, 45 or 90 mcg HA/dose [hemagglutinin/dose] resulted in seroconversion and production of functional antibodies. Moreover, cross-reactivity against other clade 2 subtypes was demonstrated using virus neutralization assays." Serocoversion was defined as either a pre-vaccination HA inhibition (HAI) titer of <1:10 and post-vaccination titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum fourfold rise in serum HAI titer. The researchers conclude, "These findings represent the first report describing the quality of the antibody responses in humans following [avian flu] VLP immunization and support further development of such vaccines against emerging influenza strains."
Aug 24 J Virol abstract

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