[NVIC] Where is the Vaccine Safety Data?

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E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

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BL Fisher Note:

There were only 694 children in this study. Where is the safety data for

injecting measles, mumps, rubella, varicella, HIB and pneumococcal vaccines

on one day into large numbers of 12 to 15 month old children with diverse

personal and family medical histories and ethnic backgrounds? How many

children, after receiving 6 vaccines on one day, were evaluated for

pathological changes in immune or brain function or effects on chromosomal

integrity? How many of the children studied were sick at the time of

vaccination or had suffered previous reactions prior to getting 6 vaccines

on one day or had a family history of autoimmune disease as do many children

vaccinated at 12 to 15 months in America? How many children, within six to

12 months following vaccination, regressed into autism? Or were all the

health problems following vaccination written off as " coincidentally "

associated with vaccination?

And why should parents have blind faith in the results of ANY vaccine study

conducted by a vaccine maker profiting from vaccines or an HMO, which is a

paid partner of the vaccine policymaking Centers for Disease Control?

Pediatr Infect Dis J. 2006 Apr;25(4):306-311.

Immunogenicity and Safety of Measles-Mumps-Rubella, Varicella and

Haemophilus influenzae Type b Vaccines Administered Concurrently With a

Fourth Dose of Heptavalent Pneumococcal Conjugate Vaccine Compared With the

Vaccines Administered Without Heptavalent Pneumococcal Conjugate Vaccine.

Black SB, Cimino CO, Hansen J, E, Ray P, Corsaro B, Graepel J, Laufer

D.

From the *Kaiser Permanente Vaccine Study Center, Oakland, CA; daggerGlobal

Medical Affairs and double daggerVaccines, Wyeth Pharmaceuticals,

Collegeville, PA.

BACKGROUND: Prevnar [heptavalent pneumococcal conjugate vaccine (PCV7)] is

licensed in the United States for routine administration in infants and may

be coadministered with other infant vaccines. Safety and immunogenicity data

on the coadministration of the fourth dose of PCV7 with

measles-mumps-rubella (MMR), varicella and Haemophilus influenzae type b

Hib) vaccines are limited.

METHODS: Children 12-15 months of age received

either MMR with PCV7 (group 1) or MMR without PCV7 (group 2). All subjects

received Hib and varicella vaccines. Group 2 received PCV7 6-9 weeks after

MMR vaccination. Sera for analysis of all non-PCV7 antibodies were collected

just before administration of MMR vaccine and 6 weeks later. Optimal antigen

responses were assessed with the use of predetermined antibody titers. The

primary end point was >90% response rate (all antigens). Noninferiority was

defined as <10% difference between groups. Local and systemic reactions and

postvaccination adverse events were monitored and compared between groups.

RESULTS: A total of 694 subjects (347 per group) were enrolled. After

immunization with MMR plus PCV7 concurrently, or MMR followed 6 weeks later

by PCV7, the percentages of subjects seroconverting were significantly

greater than 90% for all antigens. The difference between the 2 groups was

significantly less than 10%.

CONCLUSION: The immune response to MMR, Hib

and varicella vaccines, when administered concurrently with a 4th (booster)

dose of PCV7, was noninferior to that of these vaccines when given without

PCV7. These results support concomitant administration of PCV7 with MMR,

varicella and Hib as part of the recommended immunization schedule for

children 12-15 months of age.

Pediatric Infectious Disease Journal. 25(4):287-292, April 2006.

Safety and Immunogenicity of a Measles, Mumps, Rubella and Varicella Vaccine

Given With Combined Haemophilus influenzae Type b Conjugate/Hepatitis B

Vaccines and Combined Diphtheria-Tetanus-Acellular Pertussis Vaccines.

Shinefield, Henry MD *; Black, Steve MD +; Thear, Marci MPH ++; Coury,

MD ; Reisinger, MD [//]; Rothstein, MD [P]; Xu, Jin

MS ++; Hartzel, PhD ++; , Barbara BS ++; Digilio, MD ++;

Schodel, Florian MD ++; Brown, L. Hoffman BS ++; Kuter, Barbara

MPH, PhD ++; The 013 Study Group for ProQuad

Abstract:

Background: A study was conducted to assess administration of a combination

measles, mumps, rubella and varicella vaccine (MMRV) with other childhood

vaccines.

Methods: In this open, multicenter trial, 1915 healthy children ages 12-15

months were randomized into 3 groups: group 1, MMRV, combined Haemophilus

influenzae type b conjugate-hepatitis B vaccines (Hib/HepB) and combined

diphtheria-tetanus-acellular pertussis vaccines (DTaP) concomitantly; group

2, MMRV followed by Hib/HepB and DTaP 42 days later; group 3, MMR and

varicella vaccine followed by Hib/HepB and DTaP 42 days later.

Results: Antibody responses to measles, mumps, rubella, varicella, Hib,

HepB, diphtheria and tetanus were similar between groups 1 and 2 (all >95%,

except varicella, 89.7% in group 1 and 90.9% in group 2). Pertussis toxin

and filamentous hemagglutinin responses were significantly lower in group 1

than in group 2 (group 1, 74.1 and 67.1%; group 2, 90.4 and 86.8%,

respectively). An exploratory analysis suggested that the difference in and

pertussis toxin and filamentous hemagglutinin responses was likely the

result of study design rather than interference among vaccine components

because the groups differed in age of receipt of DTaP (group 1, ~12 months;

group 2, ~13.5 months). When the groups were matched for age, sample size

was sufficient for comparison only in children >=13.5 months old. Pertussis

toxin and filamentous hemagglutinin responses were similar in these

children. The safety profiles for each vaccination regimen were comparable.

Conclusions: The immunogenicity data support concomitant administration of

MMRV with Hib/HepB. Limited data from an exploratory analysis indicate that

MMRV can be administered concomitantly with DTaP. Concomitant administration

of MMRV, Hib/HepB and DTaP is well-tolerated.

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