RABIES VACCINE, SERIOUS ADVERSE EVENTS - INDIA: REQUEST FOR
INFORMATION
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[There is an error in this post which incorrectly says in the moderator comment that the WHO states that nerve tissue rabies vaccines are more immunogenic when in fact the WHO position paper on rabies vaccines clearly states: "Nerve tissue vaccines induce more severe adverse reactions and are less immunogenic than CCEEVs; therefore their production and use is not recommended by WHO."
This error has been corrected in a followup post archive number 20110922.2872. ProMED-mail apologizes for this error.]
Date: 21 Sep 2011
Source: Times of India [edited]
<
http://timesofindia.indiatimes.com/city ... 059274.cms>
Two persons suffered severe respiratory problems and cardiac arrest
after they were injected with an anti-rabies vaccine at the New Delhi
Municipal (NDMC)-run Charak Palika hospital in Moti Bagh on Monday [19
Sep 2011]. [A 45-year-old male] and a [52-year-old female] are in
critical condition and have been shifted to Safdarjung hospital's ICU
ward at present. According to NDMC spokesperson Amit Prasad, all
vaccine vials have been sealed, and a 4-member committee has been
formed to inquire into the matter.
"Prima facie, it appears that an allergic reaction to the drug led to
sudden cardiac arrest and respiratory attack, said a hospital doctor,
who requested not to be named.
Sources said [the 45-year-old male] is an NDMC employee, and [the
52-year-old female] is a housewife living in Moti Bagh. Soon after
being administered the injections, they complained of severe chest
pain and were admitted to the emergency unit of the hospital. A team
of doctors, including cardiologists and anesthetists, tried to revive
them, but when their condition deteriorated further, they were shifted
to Safdarjung hospital.
"My mother had gone to NDMC hospital for the 3rd dose of anti-rabies
vaccine. The vaccine caused sudden cardiac arrest, and her condition
is critical. She is in coma and has been put on a life support
system," claimed Harish, Chandra Devi's son who works with the Delhi
Police. He said that they have filed an FIR against the hospital in
this case.
[The 45-year-old male's] condition is also serious, and he is on
ventilator support. His cousin said that [he] was perfectly fine when
he left the home. "We were informed about his condition almost an hour
later," he said.
According to Dr P K Sharma, the NDMC health officer, anti-rabies
vaccines were given to 12 patients on Monday [19 Sep 2011] including
[the above mentioned individuals]. "All the other patients are fine.
The 2 patients who suffered chest pain and cardiac arrest were given
injections from a new vial. As a preventive measure, we have sealed
all vaccines, and a committee has been formed to inquire into the
matter. Drug reaction from rabies vaccines is extremely rare," he
said.
Sharma added that the expiry date of the vaccines is the year 2013.
NDMC gives anti-rabies vaccines to more than 500 patients every month.
The Municipal Corporation of Delhi (MCD) gives over 10 000 anti-rabies
vaccines monthly. Said Dr V K Monga, Chairman of the MCD health
committee, "I have never come across a case where anti-rabies vaccine
causes such a fatal reaction. Let the committee report come, and if
any problem is found with the particular batch of vaccine, we will
also review our injections."
Another expert said, "The various minor side effects that may develop
during and after a course of anti-rabies treatment includes fever,
headache, insomnia and diarrhoea. Sensitization to proteins contained
in older vaccines can cause a sudden shock-like collapse, usually
towards the end of the course of treatment." He added that no comment
can be passed in this case without further examination.
--
Communicated by:
ProMED-mail <
promed@promedmail.org>
[According to the WHO 2010 position paper on rabies vaccines, there
are an estimated 20 000 deaths annual attributable to rabies in
India.
There are 2 types of rabies vaccines for humans, nerve tissue and cell
culture vaccines. WHO recommends all countries replace the use of
nerve tissue vaccines with the use of the more efficacious, safer
vaccines developed through cell culture as soon as possible. In the
past, India had been using the neural tissue vaccines but has changed
over to the use of the cell culture vaccines.
The concentrated and purified cell-culture (CCV) and embryonated
egg-based (EEV) rabies vaccines (jointly referred to as CCEEVs) have
proved to be safe and effective in preventing rabies. Nerve tissue
vaccines have been associated with more severe adverse reactions and
are generally more immunogenic than the CCEEVs and are no longer
recommended for use by WHO. CCEEVs contain rabies virus that has been
propagated in cell substrates such as human diploid cells (embryonic
fibroblast cells), fetal rhesus diploid cells, Vero cells (African
green monkey kidney cells), primary Syrian hamster kidney cells,
primary chick embryo cells or embryonated duck eggs. The more recently
developed vaccines that are based on chick embryo cells and Vero cells
have safety and efficacy records comparable to those of the human
diploid cell vaccines and are less expensive.
Following growth in the respective cell cultures (or embryonic egg),
the viral harvest is concentrated, purified, inactivated and
lyophilized. Some of the CCEEVs use human albumin or processed gelatin
as a stabilizer. WHO prequalified rabies vaccines do not use
preservatives such as thimerosal.
Recommendations for post-exposure depend on the type of contact with
the suspected rabid animal. For category I exposure (touching or
feeding animals, licks on intact skin), no prophylaxis is required;
for category II (nibbling of uncovered skin, minor scratches or
abrasions without bleeding), immediate vaccination; and for category
III (single or multiple transdermal bites or scratches, contamination
of mucous membrane with saliva from licks, licks on broken skin,
exposures to bats), immediate vaccination and administration of rabies
immunoglobulin are recommended.
According to WHO data on post rabies vaccines adverse events,
approximately 35-45 percent of recipients develop minor and transient
erythema (redness), pain and/or swelling at the vaccination site,
especially following intradermal booster administration. Mild systemic
events such as transient fever, headache, dizziness and
gastrointestinal symptoms have been observed in 5-15 percent of
vaccinees. More serious adverse events -- mainly allergic or
neurological -- have been noted to rarely occur
(<
http://www.who.int/wer/2010/wer8532.pdf>).
The above description of the serious adverse events in 2 individuals
vaccinated from the same newly opened vial of vaccine is suggestive of
the possibility of an additive substance used in that vial of vaccine
prior to administration that led to the apparently rapid onset of
chest pain and respiratory distress. As the rabies vaccines are
lyophilized, the possibility of a contaminant or incorrect solution
used in the reconstitution of the vaccine needs to be considered as
well. It is noteworthy that there were other individuals vaccinated
the same day in the same clinic, presumably using the same substance
for reconstitution of the lyophilized vaccine. The possibility of 2
consecutive rare serious allergic reactions is there, but the
probability of that occurring due to chance seems very low (this
moderator was not able to easily find data on the incidence of
post-vaccine allergic reactions; most documents just mention "very
rare").
More information on findings of the investigations into these events
from knowledgeable individuals would be greatly appreciated.
For the HealthMap/ProMED map of India highlighting New Delhi, the
capital city, see <
http://healthmap.org/r/1gpL>. - Mod.MPP]
