[NVIC] Hep A Vaccine Mandates Coming Soon

[Guest guest]

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

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

* * * * * * * * * * * * * * * * * * * * * * *

UNITED WAY/COMBINED FEDERAL CAMPAIGN

#8122

* * * * * * * * * * * * * * * * * * * * * * *

" Protecting the health and informed consent rights of children since 1982. "

============================================================================

==============

BL Fisher Note:

Every time federal health agencies approve a vaccine for use in children,

drug companies, public health officials and doctors press states to add the

vaccine to the mandatory vaccination laws. Look for hepatitis A vaccine to

be added to the list of 39 doses of 12 vaccines children already are

getting, with more vaccines in the vaccine development pipeline on the way.

Vaccine development and availability is not in question. But forced

vaccination with no liability for vaccine makers and givers is unacceptable.

No liability? No mandates.

http://www.eurekalert.org/pub_releases/2005-10/cw-gha101805.php

EurekaAlert

GlaxoKline's Havrix® now approved for use in children aged 12 months

and older

FDA grants expanded indication to protect younger children against hepatitis

A

Philadelphia, PA - October 18, 2005 - GlaxoKline announced today that

the U.S. Food and Drug Administration (FDA) approved the expanded use of

Havrix® (hepatitis A vaccine, inactivated) for the prevention of hepatitis

A in children aged 12 months and older. Havrix was previously approved by

the FDA for use in children ages two through 18 years. This expanded

indication will allow healthcare practitioners to vaccinate younger children

against hepatitis A with Havrix and may help to further reduce the incidence

of hepatitis A in the United States, particularly among young children who

often transmit the disease.

" The expanded indication of Havrix marks an important milestone in the fight

against hepatitis A in the United States, " said P. Hitchcock, M.D.,

of the American Board of Pediatrics, La Jolla, California. " Immunizing

children under age two helps protect a very vulnerable population that often

does not show symptoms of the disease but frequently spreads it to other

children and family members. "

Havrix for the Prevention of Hepatitis A in Children Aged 12 Months and

Older

The FDA approved the expanded use of Havrix in children to 12 months and

older on the basis of a pivotal trial which studied the administration of

Havrix in children in the United States and Australia. The prospective,

open, comparative, multi-center clinical trial involved over 1,000 healthy

children and showed Havrix given to children down to the age of 11 months to

be comparable to Havrix given to children approximately two years of age

with regard to safety and immunogenicity. The study also showed that Havrix

can be given concomitantly with OMNIHIBTM [Haemophilus b Conjugate Vaccine

(Tetanus Toxoid Conjugate)], also called Hib conjugate vaccine (PRP-T).

Each subject was enrolled in one of five groups according to their age and

previous vaccination history and vaccinated with either Havrix alone or

Havrix with Infanrix® (Diphtheria and Tetanus Toxoids and Acellular

Pertussis Vaccine Adsorbed) and Hib conjugate vaccine (PRP-T). The

administration of two doses of Havrix (720 EL.U/0.5 mL on a 0, 6-month

schedule) starting at 11-13 months of age or 15-18 months of age was safe

and immunogenic compared to two doses administered to children at

approximately two years of age. One hundred percent of children demonstrated

a positive immune response against hepatitis A. The study also showed the

immune response of both Havrix and Hib conjugate vaccine (PRP-T) was

comparable when given together or separately. Havrix was shown to be well

tolerated. Solicited local and general side effects with the use of Havrix

alone were comparable across all age groups.

About Hepatitis A

Hepatitis A is a serious liver disease caused by the hepatitis A virus. This

virus is found in the stool of persons with hepatitis A and is spread by

close personal contact and by eating food or drinking water contaminated

with the hepatitis A virus. Hepatitis A can be easily passed by those

infected with the disease to others within the same household.

About one in five people with the disease has to be hospitalized and up to

100 people with the disease may die each year in the U.S. Symptoms of the

disease can be debilitating and include fever, fatigue, loss of appetite,

nausea, abdominal discomfort, jaundice and dark urine.

According to the Centers for Disease Control and Prevention, hepatitis A

incidence rates in children have been among the highest reported because

they often come in close contact with other children.

Later this month, the Advisory Committee on Immunization Practices (ACIP)

will convene to determine if hepatitis A vaccination requirements should be

expanded to all children 12 months of age or older - helping reduce the

burden of one of the most commonly reported vaccine-preventable diseases in

the country.

" Expanding childhood vaccination is a strategy that could reduce the burden

of hepatitis A in our country, " said Barbara Howe, Vice President of

Clinical and Medical Affairs at GlaxoKline.

GlaxoKline: A Leader in Vaccines

GlaxoKline, with U.S. operations in Philadelphia, PA, and Research

Triangle Park, N.C., is one of the world's leading research-based

pharmaceutical and healthcare companies and is committed to improving the

quality of human life by enabling people to do more, feel better and live

longer. For full prescribing information related to Havrix, go to

www.havrix.com.

Forward-Looking Statements

Under the safe harbor provisions of the US Private Securities Litigation

Reform Act of 1995, the company cautions investors that any forward-looking

statements or projections made by the company, including those made in this

Announcement, are subject to risks and uncertainties that may cause actual

results to differ materially from those projected. Factors that may affect

the Group's operations are described under 'Risk Factors' in the Operating

and Financial Review and Prospects in the company's Annual Report on Form

20-F for 2004.

http://www.fda.gov/cber/approvltr/havgsk101705L.htm

FDA CBER

Product Approval Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration

1401 Rockville Pike

Rockville MD 20852-­1448

October 17, 2005

Our Submission Tracking Number (STN): BL 103475/5090

Judith A. Magner, M.S.

GlaxoKline Biologicals

2301 Renaissance Blvd.

P.O. Box 61540

King of Prussia, PA 19406-2772

Dear Ms. Magner:

We have approved your request to supplement your biologics license

application for Hepatitis A Vaccine, Inactivated (Havrix), to include

package insert labeling changes to support lowering the age indication for

Havrix from two years to 12 months of age. We will include information

contained in the above-referenced supplement in your biologics license

application file.

We acknowledge the post-marketing clinical commitments outlined in your

submission dated October 14, 2005 as follows:

You have agreed to evaluate the safety of administering two doses of Havrix

six months apart in at least 3000 children 12 to 23 months of age.

You have agreed to conduct an open, randomized, controlled study to evaluate

safety and immunogenicity of concurrent administration of Havrix (720

EL.U./0.5 mL dose) with Prevnar in healthy children 12 to 15 months of age.

The safety data for children administered two doses of Havrix in this study

may be included as part of your commitment to assess safety in at least 3000

children 12 to 23 months of age. We acknowledge that the study has been

initiated, and the final study report will be submitted to CBER by December,

2006.

You have agreed to conduct an open, randomized, controlled study to evaluate

safety and immunogencity of concurrent immunization of Havrix (720 EL.U./0.5

mL dose) with MMRII and Varivax in healthy children 12 to 15 months of age.

The safety data for children administered two doses of Havrix in this study

may be included as part of your commitment to assess safety in at least 3000

children 12 to 23 months of age. We acknowledge that the study has been

initiated and the final study report will be submitted to CBER by March,

2008.

You have agreed to conduct an open, randomized, controlled study to evaluate

safety and immunogencity of concurrent immunization of Havrix (720 EL.U./0.5

mL dose) with Infanrix and ActHIB in healthy children 12 to 15 months of

age. The safety data for children administered two doses of Havrix in this

study may be included as part of your commitment to assess safety in at

least 3000 children 12 to 23 months of age. We acknowledge that the study

has been initiated and discussions are ongoing with CBER regarding potential

revisions to the study protocol. The final study report will be submitted to

CBER by September, 2011.

The status of the required post-marketing commitments should be reported

annually according to 21 CFR 601.70.

All applications for new active ingredients, new dosage forms, new

indications, new routes of administration, and new dosing regimens are

required to contain an assessment of the safety and effectiveness of the

product in pediatric subjects unless this requirement is waived or deferred.

The data provided in this supplement are sufficient to assess the safety and

effectiveness of Havrix for the claimed indication in individuals 12 months

of age and older. Studies demonstrating safety and effectiveness of Havrix

in individuals less than 12 months of age are

deferred -------------------------------------------------------------------

------------------------------------------------------------

Please submit all final printed labeling and implementation information on

FDA Form 356h. Please provide a PDF-format electronic copy as well as one

original paper copy.

Sincerely yours,

--- signature ---

L. Goldenthal, M.D.

Director

Division of Vaccines and Related Products Applications

Office of Vaccines Research and Review

Center for Biologics Evaluation and Research

=============================================

News@... is a free service of the National Vaccine Information

Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed consent rights

http://www.nvic.org

Become a member and support NVIC's work

https://www.nvic.org/making%20cash%20donations.htm

To sign up for a free e-mail subscription http://www.nvic.org/emaillist.htm