The great donkey  remark

” Congratulation Lorenzin and Siliquini (Italian superior health council)

 

di Giuseppe R,Brera

Dati inconfutabili mostrano il raddoppio del rischio da mortalità infantile (fino a 2,7 per il vaccino Hexavac) nel periodo successivo a vaccinazione esavalente ( dopo la prima dose). (dati 1999-2004) Dato che il lavoro è del 2011, come mai l’ex ministro Lorenzin e il Consiglio superiore della sanità diretto dalla prof. Siliquini non li hanno considerati prima della legge ?

I dati grezzi mostrano 52 decessi entro i 14 gg dalla vaccinazione

Rate ratio of sudden unexpected deaths in infants of age 31–729 days by risk period (following any vaccination) and dose, Italy 1999–2004.
Risk period: 0–1 days Risk period: 0–7 days Risk period: 0–14 days
N RR adj1 (95% CI) N RR adj1 (95% CI) N RR adj1 (95% CI)
All doses 8 1.2 (0.4–2.1) 34 1.3 (0.9–1.9) 52 1.1 (0.8–1.5)
1st dose 5 1.2 (0.4–2.5) 24 1.5 (1.0–2.3) 34 1.2 (0.8–1.6)
2nd – 3rd dose 3 1.2 (0.3–3.0) 10 1.0 (0.4–1.9) 18 1.0 (0.6–1.6)
N: Number of deaths; RR adj: adjusted Rate Ratio; CI: Confidence Interval.
1RRs are estimated according to the self controlled case-series method for censoring, perturbed or curtailed post-event exposures [19] and adjusted by age group (31–80; 81–100; 101–120; 121–180; 181–360; 361–729).

Table 4

Rate ratio of sudden unexpected deaths in infants of age 31–729 days by risk period and type of vaccine, Italy 1999–2004.
Vaccine groups Risk period: 0–1 days Risk period: 0–7 days Risk period: 0–14 days
N P-d RR adj1 (95% CI) N P-d RR adj1 (95% CI) N P-d RR adj1 (95% CI)
Any vaccine 8 864 1.1 (0.5–2.4) 34 3355 1.4 (0.9–2.1) 52 6104 1.1 (0.8–1.6)
All concomitant administration of six antigens 7 593 1.5 (0.7–3.5) 30 2276 1.8 (1.1–2.8) 44 4112 1.5 (1.0–2.2)
Hexavalent products2 4 322 1.5 (0.6–4.2) 18 1231 2.0 (1.2–3.5) 25 2228 1.5 (0.9–2.4)
Hexavac 1 160 0.7 (0.1–5.5) 12 599 2.8 (1.4–5.3) 13 1075 1.6 (0.8–3.1)
Infanrix hexa 3 160 2.3 (0.8–7.7) 6 624 1.4 (0.6–3.1) 12 1138 1.5 (0.8–2.7)
Other concomitant administration of six antigens 3 271 1.4 (0.4–4.8) 12 1045 1.6 (0.8–3.0) 19 1884 1.4 (0.8–2.3)
Others 1 271 0.5 (0.1–3.4) 4 1079 0.5 (0.2–1.4) 8 1978 0.6 (0.3–1.1)
Control period 192 29875 1 192 29875 1 192 29875 1
N: Number of deaths; P-d: Person-days at risk; RR adj: adjusted Rate Ratio; CI: Confidence Interval.
1RRs are estimated by the Poisson regression model and adjusted by age group (31–80; 81–100; 101–120; 121–180; 181–360; 361–729).
2The information of the brand name of the hexavalent product was missing for 1 infant (the event occurred in the control period).

Table 5  30 Morti dopo la prima dose del vaccino con rischi tra 1,6 e 2,7

Rate ratio of sudden unexpected deaths in infants of age 31–729 days for the risk period 0–14 days following vaccination with a combination of six antigens by dose, Italy 1999–2004.
First dose Second and third dose
N P-d RR adj1 (95% CI) N P-d RR adj1 (95% CI)
Any administration of six antigens 30 2457 1.9 (1.0–3.4) 14 1655 1.2 (0.7–2.1)
Hexavalent products 2 18 1263 2.2 (1.1–4.4) 7 965 1.0 (0.5–2.1)
Hexavac 10 580 2.7 (1.1–6.9) 3 480 0.8 (0.3–2.6)
Infanrix hexa 8 668 1.9 (0.8–4.2) 4 485 1.1 (0.5–2.9)
Other concomitant administration of six antigens 12 1194 1.6 (0.8–3.2) 7 690 1.4 (0.6–3.0)
Control period 192 29875 1 192 29875 1

dati dal lavoro

Sudden Unexpected Deaths and Vaccinations during the First Two Years of Life in Italy: A Case Series Study

Giuseppe Traversa, 1 Stefania Spila-Alegiani, 1 , * Clara Bianchi, 1 Marta Ciofi degli Atti, 2 Luisa Frova, 3 Marco Massari, 1 Roberto Raschetti, 1 Stefania Salmaso, 1 Gianpaolo Scalia Tomba, 4 and and the Hera Study Group
Yang Yang, Editor
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Abstract

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Background

The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy.

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Methodology/Principal Findings

The reference population comprises around 3 million infants vaccinated in Italy in the study period 1999–2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1–23 months were identified through the death certificates. Vaccination history was retrieved from immunisation registries. Association between immunisation and death was assessed adopting a case series design focusing on the risk periods 0–1, 0–7, and 0–14 days after immunisation. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR = 1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0–7 and 0–14 were 2.0 (95% CI 1.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR = 2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined.

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Conclusions

The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates in Germany. The limited increase in RRs found in Italy appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age.