14 THERAPY

World s first hepatitis A vaccine

The world's rllst vaccine against viral hepatitis A, 'Havrix', was presented at the International Symposium 01

"Active Immunisation Against Hepatitis A." More than 500 medical specialists from over

30 countries gathered in Vienna on 27-29 Jan 1992, to discuss hepatitis A and its prevention. The Symposium focused on the hepatitis A vaccine, 'Havrix', developed by SmithKline Beecham Biologicals.

'Havrix' - the vaccine

'We, single-mJndedly, went for an inact1vated whole virus right from

the start.' Erik V'Hondt, Associate Director of Research and

Development, SmithKline Beecham Biologicals

Eight years of research and development will come to fruition in 1992 with the introduction 0 'Havrix'. The development of the vaccine, which ensures long term protection against hepatitis A, offers the first real hope for the prevention of this serious, and sometimes fatal, viral liver infection.

Until now, the only available form of protection against hepatitis A has been an injection of immunoglobulin (gammaglobulin) -a preparation of plasma-derived hepatitis A antibodies taken from donors who had already had the disease and who were immune to the infection. Unfortunately, this type of passive or 'borrowed' immunity has to be given in quite large injections and often painful volumes. The protection gained lasts for only a few months.

'Havrix' contains purified hepatitis A virus particles which have been inactivated. These 'killed' virus particles stimulate the body's own immune system to produce antibodies which will recognise and combat future assault from the live virus. The vaccine gives the same sort of long­term, active protection against the virus as contracting the disease itself - but since the virus in the vaccine is inactivated, protection is given without the symptoms of the disease.

So far, over 25,000 healthy volunteers have received 'Havrix' in more than 60 clinical studies. The results show that levels of

'SB has undertaken no fewer than 60 studies in over 25,000 individuals - and we have established beyond doubt that

the vacdne is safe. ' Dr FranciS Anclti:, Vice·President and Virector of Medical and Scientific Services, SmithKline Beecham Biologicals

hepatitis A antibody following completion of the vaccination course are about 100 times higher than the antibody levels immunoglobulins can provide, ensuring protection for up to 10 years or more - and the side effects are mild and generally limited to a slight soreness and reddening at the site of the injection. These

8 Feb 1992INPHARMAGD

studies confirm that the vaccine is both well tolerated and effective.

Who is set to benefit from the introduction of 'Havrix'? Since the hepatitis A virus is spread by

contaminated food and water, anyone who lacks immunity to the virus is at risk of infection in places where standards of sanitation and hygiene

Hepatiti me Key • The hepaLiti A iru cau a eriou. debilitating

infe lion of Ihe Ii er. ch y ar, over 10 milJion infections of hepalili ar occumng worldwide. at an e timated co I of

$ I .5-3.0 billion in medical car and working day 10 I.

!though mo t patient reco r completely. as many 20 per cent will uffer a relap . minority of palient will de elop life-threatenmg fulminant hepalui .

• The se ent of hepallti with age. Recent figure from the U ugge t that the Vlru kill about one m every thirty iCllm over the ag of 49.

• P ople infected with the lru are capable of preading the infection to olhers weeks before

they. lhemsel e . become iU with lhe di a . • The hepanti lru I Iran milted from person

to per on b the con umpllon of food or drink which ha been contaminated by particles of human w teo

are inadequate. Nursing and other health care professionals, the staff at children's day-care centres, food handlers and those living closely together in military barracks and institutions all carry an increased risk of exposure to hepatitis A. In addition, visitors from industrialised countries who have never encountered the virus put themselves at risk of prolonged and debilitating illness on every business trip or holiday to a hepatitis A high risk area. These groups can now be given long term protection with a vaccine against hepatitis A.

What is the risk? Hepatitis A is now thought to be the most

common preventable infection caught by travellers. Despite the availability of immunoglobulins, hepatitis A is now reported about 100 times more frequently than typhoid fever and at least 800 times more frequently than cholera.

'Using data reported to the WHO between 1975 and 1981 and projected for

the 1990 population, we now estimate that 1.4 million cases of hepatitis A are reported annually worldwide, with the highest disease burdens in Asia, Africa and Eastern Europe. Since reporting is incomplete, true disease incidence may

be 3 to 10 fold higher.'

ISSN 0156·2703/92/0208·0014/0$01.00/0 © Adis In!ematianal lid

Dr Srephen Hadler, Cencres for Disease Concrol, Arlanra, US

'With fulminant hepatitis in older people, almost all of these patients die.' Dr Blaine Hollinger, Professor of Medicine, Virology and

Epidemiology, Baylor College, Housron, USA

One possible explanation for the failure of immunoglobulin to control the hepatitis A problem is the short duration of protection (generally less than 3 months) which means several injections every year to maintain immunity - a fact often forgotten by the travellers themselves.

THERAPY

A primary course of 2 doses of 'Havrix' given 2-4 weeks apart provide protection against the virus for at least one year. A booster dOSe, given 6 to 12 months after the primary course, is expected to extend that protection for up to 10 years or more.

Availability 'Havrix' is currently registered in Belgium and

Switzerland; registration and availability for routine use in the prevention of hepatitis A in most other European countries can be expected

lover the next months. -Press release 9346

1

ISSN 0156·2703/92/0208-0015/0$01.00/0 © Adis International lid

.IS

INPHARMA® 8 Feb 1992