MF59-adjuvant influenza vaccine appears effective in infants, young children

October 13, 2011

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MF59-adjuvant influenza vaccine appears effective in infants,

young children

Vesikari T.

N

Engl J Med. 2011;365:1406-1416.

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Influenza vaccine with the MF59 adjuvant is efficacious against

laboratory-confirmed influenza in infants and young children, according

to results of a new study published online today.

Results of the study by Timo Vesikari, MD, and colleagues indicate

that MF59-adjuvant vaccine (ATIV) was efficacious against influenza

(confirmed by polymerase chain reaction) caused by all circulating

influenza strains during two separate study periods (86% efficacy rate),

with higher efficacy against vaccine-matched strains (89%).

The researchers investigated the effect of ATIV, an oil-in-water

emulsion, on the efficacy of trivalent inactivated influenza vaccine

(TIV) in 4,707 healthy children aged 6 months to younger than 72 months

who were previously unimmunized with influenza vaccine.

During the 2007 to 2008 season, 654 children were enrolled in Germany,

and 2,104 children in Finland were enrolled during the 2008 to 2009

season. Participants were stratified according to age (aged 6 months to

younger than 36 months and aged 36 months to younger than 72 months) and

were randomly assigned to one of three study groups.

In year 1, patients were assigned to ATIV, subunit TIV or control

(non-influenza) vaccine in a ratio of 2:1:1. In the second year of the

study, the children were assigned to ATIV, split

TIV

or control vaccine in a ratio of 2:2:1.

“The subunit influenza vaccine consisted of purified hemagglutinin and

neuraminidase viral-surface proteins. The split vaccine consisted of

purified disrupted virions. Vaccines were administered in two doses, 28

days apart, with or without concomitant routine vaccines,” according to

the researchers.

Attack rates of influenza-like illness across

both

influenza seasons were 0.7%, 2.8% and 4.7% in the ATIV, TIV and

control vaccine groups, respectively. The absolute vaccine efficacy rates

against all influenza strains (94 of 110 cases were caused by

vaccine-matched H3N2 viruses) were 86% (95% CI, 74-93) for ATIV and 43%

(95% CI, 15-61) for TIV.

The relative vaccine efficacy rate for ATIV vs. TIV was 75% (95% CI,

55-87). Among children aged 6 months to younger than 36 months, the

efficacy rates for ATIV was 79% (95% CI, 55-90) vs. 40% (95% CI, –6 to

66) for TIV.

For children aged 36 months to younger than 72 months, efficacy rates for

ATIV was 92% (95% CI, 77-97) vs. 45% (95% CI, 6-68) for TIV. Antibody

responses were higher with ATIV and remained high through day 181,

according to the study results.

Regarding adverse events, “The rates of systemic and local reactions to

the influenza vaccines with and without the adjuvant were similar in the

younger age group (RR=1.04; 95% CI, 0.98-1.09), but systemic events in

the older age group were more frequent after administration of ATIV (63%)

than after administration of TIV (44%) or the control vaccine (50%),” the

researchers wrote, adding that these events were generally mild and of

short duration.

Serious adverse events were distributed evenly across the three vaccine

groups.

Disclosure: This study was funded by Novartis Vaccines and

Diagnostics.

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

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