FOCUS
New Hepatitis vaccine
HEPATITIS B
Composition of Hepatitis B Virus
Hepatitis B virus infects liver cells. where it multiplies. The virus consists of a core component. made in the nucleus of the liver cell, and a surface component. which is made outside of the nucleus. As you can see in the diagram on the right, the complete hepatitis B virus particle is formed when the core material leaves the
from virus to vaccine
nucleus and is then coated by the surface component. This surface component, called "hepatitis B surface antigen." is produced in much greater quantities than the core. As a result. many extra surface antigen particles pass out of the liver cell, along with the complete virus particles, into the bloodstream.
BLOOD VESSEL
LIVER CHIL
Vi Patw
CC
Complete Hepatitis B Virus Particle
Contains an antigen which is the
infectious part of the hepatitis B virus
Surtare Constr
Non-infections
Coats core material
Induces protective antibody aga future hepatitis B infection
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Production of H-B-VAX® On the right is an electron micrograph of the blood of a person infected with hepatitis B. virus. You can see complete virus particles and many excess particles of surface antigen. The "infectious" part of the virus. which allows it to multiply, is contained in the core material. The surface antigen, which coats the core and floats freely in the blood
The major objectives in the preparation of H-B-VAX are to extract hepatitis B surface antigen in order to formulate a vaccine that is as safe, potent and effective as possible. A carefully controlled. ten-step manufacturing process includes 3 special steps designed to destroy the infectious core of the hepatitis B virus and remove all other impurities in the starting
plasma, is not itself infectious. This antigen stimulates the production of antibodies which then protect against subsequent hepatitis B infection.
Carriers of hepatitis B have blood such as that pictured on the right. This type of blood plasma, rich in surface antigen, is the source material for hepatitis B vaccine.
plasma. At the end of the purification process, only the spherical particles of hepatitis B surface antigen remain, as can be seen in the electron micrograph on the right. Note that in contrast with the previous photo of the starting plasma, there are no complete infectious hepatitis B virus particles.
Electron Micrograph of HBV Carrier Plasma
Electron Micrograph of B-B-VAX
Surface Augenproduces protective antibodies
contains infectious component of
Virus
The entire manufacturing process for H-B-VAX takes 65 weeks. As an added precaution, each lot of vaccine is safety tested in chimpanzees before it is released for sale.
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FEDERAL Government inaction on the prohibitive cost of Hep-B-Vax seems likely to lead to limitations on the effectiveness and availability of the vaccine. At the moment a [complete vaccination programme of three shots could cost over $200. Hep-B-Vax, though in use for some time in the United States has only just been released on the Australian market.
Hepatitis B is one of the two classified strains of viral Hepatitis and in about 2 percent of cases can be life-threatening. It tis often communicated by mucous membrane to mucous membrane contact and is -now classed by the medical profession as Pan STD a sexually transmitted disease.
Due to the fact that it is a serum virus (carried in the blood) and is readily transImitted by sexual contact, male homosexuals, along with a number of other groups, are considered "at risk". The Sydney STD clinic estimates that 20 percent of young homosexuals contract Hepatitis B in their first year of particiipating in the urban gay community. Other "at risk" groups include health professionals, prostitutes, South East Asians and intravenous drug users.
Detection and prevention of the disease is complicated by the fact that a large number of those who get the disease may exhibit little or no symptoms, and the "carriers". Without regular blood screenings sexually active carriers may transmit the disease to many other people, some of whom become chronically ill or could even die.
The work on finding a safe and effective vaccine for Hepatitis B began in 1965 with the discovery of the "Australian antigen". Through a series of technological discoveries the American and French teams of scientists solved the problem of "de-activating" the blood serum used for the vaccine so that it did not cause infection, while retaining its immunityconferring properties. Tests on chimpancees began in 1975, on people in 1977,
and final field tests in 1980.
The blood serum. from which the vaccine is made comes largely from the New York male homosexual population.
The
company producing Hep-B-Vax, Merke, Sharpe and Dohme, paid tribute to the co-operation and organisation of the New York community, at the launching of the vaccine at the Sydney Opera House last month. As well as providing the blood for the production of the vaccine, homosexual men also volunteered for testing and survey work. Some subjects have been followed for up to seven years in a study at the long-term effects of Hep-B-Vax.
Some concern has been expressed over the possibility that Hep-B-Vax may transmitt AIDS given that the New York donors are also the most at risk from that syndrome. However, medical authorities appear convinced that the exhaustive "de-activation" procedures used in producing the vaccine would effectively kill any possible "AIDS virus". This opinion has been backed up by the extensive testing that has been done both with humans and animals.
The Gay Men's Health Crisis in New York has advised, in their latest bulletin, "Since Hepatitis B remains the most serious and widespread disease problem in the gay community, sexually active men who have never had Hepatitis B but who are currently at highest risk for this disease are being advised to undergo vaccination."
The main problems associated with the use of Hep-B-Vax appear to be screening and cost. A substantial and expensive effort needs to be made to inform "at risk" groups of the necessity for blood tests at regular intervals. STD clinics in Australia have been advising sexually active homosexuais to have a test every six months. However, they are unable to widely advertise this information.
In the United States the main dis-
tributor of the vaccine, the American Liver Foundation, has been taking fullpage paid advertisements in almost all
the gay press to advise people of the need for screening and the availability of the vaccine. Advertising regulations in Australia may prohibit such a course here. A Government funded education and screening programme would be necessary to achieve anything like the same effect here.
The cost of the vaccine is the other major problem. Hep-B-Vax is not cheap to produce. The cost price, through the Commonwealth Serum Laboratory, is around $40 per dose. However, with a mark-up by pharmacists, that cost rises to between $60 and $75 per dose. Uniess the Federal Government places Hep-VaxB on the National Health list, then this cost must be borne by the patient.
There has been some discussion of the fact that STD clinics, set up and funded by State Health Departments, are required to provide a free service. However, the administrator of the Sydney clinic, Dr Rod Jones, told Campaign that to provide Hep-B-Vax to the clients who would require the vaccine would involve "quadrupling the Clinic's budget". As a consequence the Sydney Clinic will not be providing the vaccine, but giving patients a script to purchase it themselves at a pharmacist.
Dr Jones went on to point out that a special allocation of funds from the Health Commission would be necessary it the Clinic were to be able to supply the vaccine free. Campaign understands that the situation is similar in all States of Australia.
A number of organisations nationally are working to resolve this funding crisis. In Sydney the Gay Solidarity Group has written to Federal Health Minister Neil Blewitt requesting a deputation.
Spokesperson Max Pearce told Campaign that "Hepatitis B is a major health problem for many sectors of the Australian population. If real progress is going to be made in eliminating this serious disease we can't just vaccinate those who are well off. We will be asking the Minister to place Hep-B-Vax on the National Health immediately it is a social problem and the costs should not be borne by individuals.""
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