MERCK PACKAGE INSERT FOR HEP B COMVAX VACCINE

July 19, 2001

See last paragraph........

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http://www.merck.com/product/usa/comvax/pi.html#adverse

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COMVAX [haemophilus b conjugate (meningococcal protein conjugate)

and Hepatitis B (recombinant) vaccine]

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.... Among 856 infants from combined clinical trials who were monitored

for both serious and non-serious adverse experiences, the following

serious events were reported to occur in 13 infants during a 14-day

period following vaccination with COMVAX (usually coadministered with

other pediatric vaccines). These adverse experiences are grouped by

case: viral infection; febrile seizure; asthma; diarrhea, vomiting,

acidosis, dehydration, hypoglycemia, and seizure disorder; bacterial

infection; bronchiolitis and reflux esophagitis; dehydration and fever;

asthma, respiratory congestion, and tachypnea; asthma and upper

respiratory infection; urinary tract infection and vomiting; pneumonia

and asthma; apnea and reflux esophagitis; and vitreous hemorrhage. A

causal relationship to the vaccine is unknown; however, these serious

adverse events were judged not to be related to vaccination with COMVAX

by the investigator.

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Among 1756 infants who received COMVAX concomitantly with either an

investigational pneumococcal polysaccharide protein conjugate vaccine or

an investigational preparation of diphtheria, tetanus, pertussis, and

inactivated poliovirus vaccine, the following serious events were

reported to occur in 9 infants during a 14-day period following

vaccination with COMVAX. These adverse experiences are grouped by case:

respiratory syncytial virus; respiratory distress and otitis media;

bronchiolitis in two vaccinees; viral gastroenteritis; skull fracture;

bronchiolitis, respiratory syncytial virus, and pneumonia; respiratory

syncytial virus and bronchiolitis; and upper respiratory infection,

viral (see CLINICAL PHARMACOLOGY ). A causal relationship to the vaccine

is unknown; however, these serious events were judged not to be related

to vaccination with COMVAX by the investigator.

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In a group of infants (n=3D126) given a three-dose course of COMVAX after

previously receiving a dose of Hepatitis B Vaccine (Recombinant) at or

shortly after birth, the type, frequency, and severity of adverse

experiences did not appear to be greater or different from those

observed in infants given only COMVAX.

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As with any vaccine, there is the possibility that broad use of COMVAX

could reveal adverse experiences not observed in clinical trials.=20

Potential Adverse Effects

In addition, a variety of adverse effects have been reported with

marketed use of either PedvaxHIB or RECOMBIVAX HB in infants and

children through 71 months of age. These adverse effects are listed

below.

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PedvaxHIB

Hypersensitivity

Rarely, angioedema

Hematologic/Lymphatic

Lymphadenopathy

Nervous System

Febrile seizures

Skin

Sterile injection-site abscess; pain at the injection site

RECOMBIVAX HB

Hypersensitivity

Anaphylaxis and symptoms of hypersensitivity including reports of rash,

pruritus, urticaria, edema, angioedema, arthralgia, dyspnea,

hypotension, erythema multiforme, and ecchymoses=20

Cardiovascular System

Tachycardia; syncope

Digestive System

Elevation of liver enzymes

Hematologic

Increased erythrocyte sedimentation rate; thrombocytopenia

Musculoskeletal System

Arthritis

Nervous System

Bell's Palsy; Guillain-Barr=E9 Syndrome

Psychiatric/Behavioral

Agitation; somnolence; irritability

Skin

s- Syndrome; alopecia

Special Senses

Conjunctivitis; visual disturbances

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Vaccine Information & Awareness (VIA)

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Any information obtained here should not be construed as

medical OR legal advice. The decision whether to vaccinate

and how you implement that decision is yours and yours alone.

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Sheri Nakken, R.N., MA=09

Vaccination Information & Choice Network, Nevada City CA & UK

530-478-1242 Voicemail in US

http://www.nccn.net/~wwithin/vaccine.htm

" All that is necessary for the triumph of evil is that good men ( &

women) do nothing " ...Edmund Burke=20

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. THE=

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October 11, 2002

From Meryl@AVN:

MERCK PACKAGE INSERT FOR HEP B COMVAX VACCINE

Belkin wrote:

This is the from the Merck package insert for their new COMVAX vaccine.

Comvax is combination HIB/Hep B. Recombivax is hep B only. Last part is

observed adverse reactions from marketing Recombivax. I'm sure it's a

big relief to everyone that " these serious events were judged not to be

related to vaccination with COMVAX by the investigator. "

Notice in the testing the control group gets another vaccine -- not a

true placebo. Total junk science.