FLU NEWS SCAN: High-dose flu vaccine safety, H1N1 and pregnancy, IOM on crisis care standards

Mar 23, 2012

Adverse-events surveillance finds high-dose flu vaccine safe
Investigators monitoring adverse events after the introduction of high-dose trivalent inactivated influenza vaccine (TIV-HD) found no new serious safety concerns, but some reported that serious events were higher for TIV-HD than for the standard trivalent inactivated vaccine (TIV), according to a report in Clinical Infectious Diseases. TIV-HD was licensed for adults 65 and older in December 2009. The authors, from the US Food and Drug Administration and the Centers for Disease Control and Prevention, analyzed data from the Vaccine Adverse Event Reporting System (VAERS) in that age-group from Jul 1 through Dec 31, 2010, and found 606 reports for TIV-HD and 1,227 reports for TIV. Of those, 51 (8.4%) in the TIV-HD group were serious, compared with 123 (10.0%) in the TIV group. Among the serious events reported, recipients of TIV-HD had higher rates of gastrointestinal (9.8% vs 0.8%; 5 cases vs 1 case) and cardiac (17.6% vs 4.9%; 9 vs 6 cases) events. However, TIV-HD recipients had a lower incidence of Guillain-Barre syndrome (9.8% vs 31.7%; 5 vs 39 cases) and neurologic events as a whole (13.7% vs 43.9%; 7 vs 54 cases). The authors conclude, "During the first year after US licensure of TIV-HD, no new serious safety concerns were identified in VAERS. Our analyses suggested a clinically important imbalance between the reported and expected number of gastrointestinal events after TIV-HD receipt. Future studies should assess this potential association." They also note that any finding from VAERS data should be interpreted with caution because of the inherent limitations of passive surveillance.
Mar 22 Clin Infect Dis abstract

H1N1 vaccination, infection yield similar antibody response during pregnancy
Antibody response in pregnant women was the same whether they were vaccinated against pandemic 2009 H1N1 (pH1N1) or contracted the disease, and both routes conferred immunity to the women's newborns, according to a small study in PLoS One yesterday. Researchers from the University of Colorado and vaccine maker Novartis analyzed blood from 16 women with confirmed pH1N1 infection, 14 women who received the pH1N1 vaccine, and 10 women without infection or vaccination. They performed hemagglutination inhibition (HAI) assays and linear regression analyses and determined that vaccination did not differ from infection during pregnancy with respect to (1) HAI titers at delivery, (2) HAI antibody decay slopes over time, and (3) HAI titers in cord blood. They conclude, "Vaccination against pH1N1 confers a similar HAI antibody response as compared to pH1N1 infection during pregnancy, both in quantity and quality. Illness or vaccination during pregnancy confers passive immunity to the newborn."
Mar 22 PLoS One study

IOM offers guidance for providing healthcare in catastrophes
The Institute of Medicine (IOM) this week published a resource manual to help healthcare organizations and other stakeholders determine how to make healthcare decisions in emergencies that overwhelm normal medical capacity, such as widespread epidemics and devastating earthquakes. The report, titled Crisis Standards of Care: A Systems Framework for Catastrophic Disaster Response, recommends a systems-based approach to allocating resources and provides templates and tools to help different stakeholders identify their core functions and responsibilities, the IOM said in a press release. It explained that a systems-based approach underscores the importance of coordination and integration across the full spectrum of stakeholders, such as healthcare organizations, public health agencies, first responders, and other government agencies. To be ready to shift quickly and effectively to crisis standards of care, the IOM said, each organization needs to identify in advance the core functions it must carry out in a crisis and who will be responsible for each task. The report's templates are designed to help stakeholders define these responsibilities and to guide them in defining their criteria and process for shifting from usual to crisis standards of care. Also included are tools to help agencies get public input on crisis planning and disaster response. The report was sponsored by the US departments of Health and Human Services, Transportation, and Veterans Affairs.
IOM report home page
"Report at a glance"
Mar 21 IOM press release

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