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[e-drug] Expensive Rabies Vaccine In India

Dear All
 
Rabies is endemic in India, approximately more than 30,000 deaths are reporting 
per year and most of the cases reporting from rural areas.
 
Majority of the victims are treated by nerve/sample tissue vaccine up to now. 
Now the drug authorities in India have banned the Nerve Tissue Rabies Vaccine, 
which was available in government hospitals free of cost. WHO seems to be 
recommending tissue culture vaccines (Vero/Human diploid, chick embryo etc), 
which are available for high cost (RS 2000 or $45 per course)? 
 
All modern tissue culture vaccines are available in India but they are not 
affordable to middle, low class income people who have more proximity to rabies 
bites.
 
Already 90% of the dog bite cases reporting from India now. Due to the above 
situation Governments Should take necessary action for availability of these 
modern tissue culture vaccines at affordable prices.
 
I also like to know what is the situation of Rabies in Europe and Africa. 
Please let us Share. What are the types of vaccine available at present in your 
countries? What is the procurement process? Etc.
 
Thanks in advance
 
Sincerely
 
Tirumala
Pharmacist
Chirala, Prakasam dist
Andhra Pradesh
India

[Moderator comment:
WHO is right - newer vaccines are much safer than the old nerve tissue vaccine, 
and people should get access to the safer versions. But no access to a safe 
vaccine is worse than access to an unsafe vaccine... 

What is the policy of the Indian Government? 

The WHO recommendations on rabies vaccine are found at 
http://www.who.int/vaccines/en/rabies.shtml#vaccines

An extract:

"Rabies vaccines 

More than 100 years ago, Louis Pasteur and his colleagues developed the first 
crude rabies vaccine based on attenuated virus from desiccated nerve tissue. 
Unfortunately, the majority of post-exposure immunizations against rabies are 
still performed with vaccines of crude nerve tissue origin. Although 
continuously improved over the years, inactivated vaccines produced in sheep or 
goat brains (Semple) or suckling mouse brain (Fuenzalida) may be associated 
with serious adverse events. Possible post-vaccinal neurological reactions may 
include meningoencephalitis, meningoencephalomyelitis, mononeuritis multiplex, 
dorsolumbar transverse myelitis and ascending paralysis of the Landry type, 
usually occurring between one and two weeks after the first injection. With the 
Semple-type vaccines, the incidence of neurological reactions varies between 1 
in 200 and 1 in 1600 recipients, with a lethality of up to 14%. Vaccines of the 
Fuenzalida type are associated with neurological complications in about 1 in 
8000 to 1 in 27 000 courses. Furthermore, in terms of protective potency these 
vaccines are inferior to modern cell-derived vaccines. A complete post-exposure 
treatment using nerve tissue vaccines involves a prolonged and painful 
immunization course of up to 23 injections. Obviously, these vaccines are not 
recommended for pre-exposure immunization.

The human diploid cell rabies vaccine was introduced in 1967 and is regarded as 
the gold standard for rabies vaccines. However, the more recently developed and 
less expensive purified chick embryo cell vaccine and purified Vero cell rabies 
vaccine have comparable characteristics. They are all lyophilized and must be 
reconstituted. The potency of all cell-derived vaccines is assessed using a 
National Institutes of Health test and the WHO requirement is a potency of at 
least 2.5 IU per intramuscular dose. 

Human diploid cell rabies vaccines are based on the Pitman-Moore L503 strain 
or, in one case, the Flury strain of rabies virus. Human diploid cell rabies 
vaccines have been given to more than 1.5 million people worldwide. Its 
protective efficacy in situations of heavy exposure has been shown in the 
Islamic Republic of Iran where none of 45 persons who received post-exposure 
treatment with this vaccine developed rabies following severe bites by rabid 
dogs or wolves. 

The purified Vero cell rabies vaccine contains the Wistar strain of the virus, 
but with the Vero cell line as substrate. Clinical studies with the purified 
Vero cell vaccine show neutralizing antibody responses both after primary and 
secondary immunizations that are fully comparable to those seen after 
vaccination with the human diploid cell vaccines. In Thailand, post-exposure 
treatment using purified Vero cell vaccine and rabies immune globulin has been 
shown to be protective. 

Purified chick embryo cell rabies vaccine is prepared from inactivated rabies 
virus of the Flury LEP-25 strain. No clinically important differences were 
observed when this vaccine was evaluated together with human diploid cell 
vaccines in studies on post-exposure protection of animals and humans and in 
pre-exposure immunogenicity studies. More than 30 million doses of the purified 
chick embryo cell vaccine have been administered worldwide.

Purified duck embryo rabies vaccine showed similar qualities to the other 
cell-derived rabies vaccines, but is no longer manufactured. 

Despite applying potent, modern, cell-derived vaccines, about one "failure" in 
1 million post-exposure treatments does occur. Careful analyses show that such 
failures are almost always associated with severe lesions on or near the head 
and/or inappropriate administration of the treatment.

There are no contraindications to any of these vaccines being used for 
post-exposure treatment. Should an allergic reaction occur, the modern vaccines 
of different cell substrate origin may replace each other. Pregnancy is not a 
contraindication to post-exposure treatment.

Although associated with mild and transient reactions, all the cell-derived 
rabies vaccines are considered safe. With human diploid cell vaccines, which 
are most thoroughly investigated, pain, erythema and swelling or itching at the 
injection site occur among 30%–74% of the recipients. Systemic reactions 
involving headache, nausea, abdominal pain, muscle aches or dizziness are 
reported among 5%–40% of vaccinees, and allergic oedema in 0.1%. One 
study reports fever among 3.6% of recipients of the human diploid cell vaccine. 
Systemic allergic reactions characterized by generalized urticaria accompanied 
in some cases by arthralgia, angiooedema, fever, nausea and vomiting have been 
reported. They are uncommon in persons receiving primary vaccination, but have 
occurred in up to 6% of persons receiving a booster dose, with onset after 
2–21 days. These reactions have been shown to follow the development of 
IgE antibodies to b-propiolactone altered human serum albumin in the vaccine 
(b-propiolactone is used as an inactivating agent). According to the 
manufacturers of purified Vero cell rabies vaccine and purified chick embryo 
cell vaccine, allergic reactions are very rare after both primary and booster 
doses with these vaccines. Studies on the purified Vero cell rabies vaccine 
report local and general reactions in 10.6% of post-exposure treatment patients 
and complaints of mild to moderate reactions in 7%. Also, among intradermal or 
intramuscular recipients of this vaccine, low-grade fever was the only 
significant systemic event, occurring in 8% of all subjects and most frequently 
following intramuscular vaccination. In the same study, pruritus at the 
injection site was the only significant local reaction. Among 88 healthy adults 
receiving a total of 292 doses of purified chick embryo cell vaccine, 16.4% 
reported local side-effects, whereas 15.1% reported general symptoms. 

Other cell-derived vaccines are available on a national scale only. For 
example, in the United States the Kissling rabies strain has been adapted to 
replication in lung fibroblasts of fetal rhesus monkeys. The resulting vaccine, 
which is given according to the same pre- and post-exposure schedules as the 
human diploid cell vaccine, is considered equally effective and may less often 
cause allergic reactions. In Japan, a vaccine type similar to the purified 
chick embryo cell vaccine, but based on the Flury HEP strain, has reached 
limited distribution. A primary hamster kidney-cell rabies vaccine is mainly 
used in China where it was licensed in 1989. Each year more than 5 million 
doses of this vaccine are administered in China, where it has now completely 
replaced the Semple-type rabies vaccine. A chromatographically purified version 
of the purified Vero cell rabies vaccine is about to be licensed in Europe."

...

"WHO position on rabies vaccines

All the above internationally available cell-derived rabies vaccines are of 
assured quality. If used properly, when necessary in combination with rabies 
immune globulin and immediate wound treatment, they are regarded as 100% 
effective in preventing death from rabies. 

Despite development of less expensive vaccines against rabies and less 
vaccine-consuming administration schedules, many of the countries particularly 
affected by this disease can afford only the less efficacious and relatively 
dangerous nerve tissue vaccines. Due to their high rates of adverse effects, it 
is imperative that these vaccines be replaced by the more potent and safe 
cell-derived products. Veterinary rabies vaccines should not be used for 
humans."
]

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