Dear Friends,
The Govt of Kerala has done something that is worth congratulating. It, after being elected with the votes of the Citizen of Kerala, has effectively killed at least 4 infants, children of the Citizen of Kerala, with the Pentavalent vaccine which everyone had warned internationally would kill children. Then it has filed an counter affidavit stating that "we are not alone to blame, someone or something else could also have been responsible". It also says that only 4 children have died, so the vaccine should be allowed to continue and "save lives".
The person responsible for this astounding feat is Sri Rajeev Sadanandan who is the Principal Secretary, Health & Family Welfare, Govt of Kerala, who has filed the above astounding
affidavit which is enclosed for your kind perusal.
If you kindly feel it worthy you may please call up Sri Rajeev Sadanandan at the number and address given below and show your solidarity with him. Please congratulate him for having de-populated Kerala so effectively by bumping of 4 innocent infants and then having placed such excellent excuses before the Hon'ble High Court of Kerala. Please tell him that we are recommending his name for the Padma Bhushan. We will also recommend his name for the Indira Gandhi Peace Prize. If Bill Gates can be awarded the Indira Gandhi Peace Prize then why not Sri Rajeev Sadanandan?
Kindly do so if you feel that we should at least congratulate him. Nobody is forcing you of course. Ask your conscience and if your conscience permits then go ahead. You can call him, mail him or write to him. He will most probably switch off his mobile phone, so call him up at his office
phone and also fax him. Flood him with congratulatory emails and also snail mail. Please continue till all vaccines are withdrawn from Kerala. After all we cannot recommend the Padma Bhushan for the entire Govt is it not? So they should stop "saving lives" by bumping off our children.
Actually we do not have money otherwise we would have awarded him gold and diamond studded bangles, anklets, necklace, nose ring and ear rings. Maybe if you all want we can donate to a common fund and suitably award this extraordinary gentleman.
Sh. Rajeev SadanandanPrincipal Secretary (Health & Family Welfare) Department of Health & Family Welfare,Government of Kerala,Secretariat Building,Thiruvananthapuramm-695001,Kerala
Tele office : 0471- 2518255,Fax No : 0471-2327865,Mob : 09446480365E Mail : secy@health.kerala.gov.in,
Thanks!
With Immense Love & PeaceJagannath
THE
AFFIDAVIT
This is the counter
affidavit filed by the Kerala Government to the High Court in Ernakulum , to a case filed by the Human
Rights Law Network (HRLN)on behalf of parents of Ancy who died after receiving
Pentavalent vaccine. The plea is to stop vaccinating other kids as there is
risk of death in them
The papers below were retyped from the
Government affidavit for ease in sending by email (not scanned documents).
There are some typos. The original can be had from the HRLN advocate
Sandhya Raju
47 Subhash Nagar
Edappally Cochin 24
# 09847032397
Please see
paragraph 12
4 kids
died after pentavalent vaccine according to the Governments own affidavit in
the 2 months after starting the programme in the small State of Kerala .
1. Ancy.
Post mortem report says that due to hypersensitivity to injection
(because there was severe swelling of the injection site and in the breathing
tubes of the baby) The Govt says it may be hypersensitivity to Paracetamol
syrup given because of the high fever caused as reaction to the vaccine. BUT
paracetamol was syrup not injection. Post mortem report says reaction was to
injection.
2. Case 2
died but post mortem examination not allowed by parents.
But post
mortem examination is not needed by Brighton
to classify the cause of adverse effect following immunization. If the reaction
occurred after the injection and there was no other cause for the reaction it
must probably be due to vaccine.
In this
case child had reaction on way home from Govt hospital after vaccination. They
went back to same Govt hospital. Child died there. The hospital asked to do
post mortem which the parents declined. The hospital got them to sign saying
they were not willing for post mortem and they will not file a case.
3. Case 3
and 4 Government says died of Co morbid condition. It does not explain what the
co morbid condition was nor why the doctors gave Pentavalent vaccine to two
children who were so sick, that they were anyway going to die that day!!!
Typed copy
of Government affidavit is below. Please contact Advocate Sandhya for
originals.
1.
The above writ petition is filed
mainly with the prayer to issue a writ of mandamus directing the respondent not
to introduce the Hib vaccine as Pentavalent vaccine under the universal
immunization programme in the state of kerala. Wpc 4099/12 is also filed
interalia mainly with the prayer to direct the immediate cessation of the use of
pentavalent vaccine and also to set up an expert committee to look into the
matter. It is respectfully submitted that the without prejudice to the right of
the respondents to file detailed counter affidavits in both cases at later
stage refuting all the averments raised by the writ petition s this preliminary
statement is being filed as directed by this hon'ble court so as to bring to
the notice of the hon'ble court that the apprehensions raised by the writ
Petitions with regard to the use of penatvalent vaccine as part of the
Universal immunization programme is ill founded and without any basis.
2.
It is submitted that the govt of india implemented the expanded programme of
immunization in 1978 and subsequently in 1985 extended the same to the entire
country under the UIP. Currently under the UIP vaccination is provided against
Diphtheria , Pertusis tetanus tuberculosis (BCG) measles polio, hepatitis B,
Japanese Encephalitis ( in selected areas) and Hemophilus Influenza b in
selected states. When the Govt of india
decided to implement the use of pentavalent vaccine for a better coverage of
immunization programme the state of kerala and T.N were chosen as pilot states
considering the fact of high standards of health care and literacy prevalent
therein. How ever when apprehensions were raised from different corners with
regard to the use of this vaccine the government of kerala appointed an expert
committee to examine the controversies relating to the use of vaccine. The
Committee headed by Noel Narayanan former HOD pediatrics, Tvm Medical college ,
Dr lila HOD dept community Medicine Amritha institute of medical sciences as
members and Dr P.K Jameela director of health services, Tvm as convener. The
committee after considering the various pros and cons of the use of Pentavalent
vaccine submitted its report in November
2011 wherein it was recommended that the use of vaccine outweigh the risks.
While taking into account the five adverse reactions to the vaccine, the committee recommended
that the introduction of the said vaccine would be beneficial to the poor children in the state. A true
copy of the report dated submitted by the committee before the government is produced herewith and
marked as Exhibit R3(a).TEH committee while submitting the report had also
taken note of the fact that no adverse reaction has been reported from any of
the hospitals in the state by eth use of pentavalent vaccine.
3.
It is pertinent to point out that it
is accepting the recommendations at Ext R3 (a) that the government decided to
proceed with the implementation of the pentavalent vaccine in the UIP. It is
relevant to bring to the notice of this honble court that the pentavalent
vaccine is available in the Indian
market since 2004 in various combinations. This vaccine is freely administered
by private practitioners and paediatricians at an exorbitant rate per dose. On
the other hand vaccines under UIP are given to one and all absolutely fee of
cost. Not only is the pentavalent vaccine available in the private sector for
more than 7 years, nearly 1.67 crore doses of pentavalent vaccine have been
supplied to the Indian private market by the 5 indian manufacturer alone, as
per information supplied by them. Supplies made by foreign vaccine manufacturer
are over and above this figure. Out of 1.67 crore doses, 1.56 crore doses have
been supplied during 2007 to 2011,indicating a surge in teht demandin the
country leading to high profit margins on the part of the private service
providers. Sensing this market opportunity the number of Indian manufacturers
of Pentavalent vaccine has also increased from 1 in 2004 to 5 in 2009. It is pertinent to submit that
the issues of need cost efficacy and safety of pentavalent vaccine have not
been called into question by the petitioner so far as its use by the private
sector is concerned, which poses a doubt as to the real intention of the
Petitioner which can be understood as only to prevent the government from
providing the same vaccine free of charge so that the commercial interest of
private sector are protected. It would also be important to apprise the Hon'ble
court that the costs charged by private practitioners for Pentavalent vaccine
ranges from 2000 per dose thus
translating into a total charge of up to Rs 6000 for a 3 dose complete course.
At this enormous cost charged by the private practitioner the poor and the most
needy are the ones whose children are deprived of protection against illness,
death and disability. The Petitioner is trying to create unnecessary scare
through misinformation only to block introduction of penatavalent vaccine in
the public health programme so as to protect and promote the exploitative
practices of the private practitioners.
4.
It is submitted that core committee
constituted by the ICMR for Hib has indicated that the two most common case of
pyogenic Meningitis are Hib and Streptococcus pneumonia. Of the children with
pyogenic meningitis, a third of each cases die, recover with sequelae or
recover fully. In 8 hospital based studies, a median of 39% (range 29-88%) of
etiologically characterized meningitis cases confirmed by culture or identification
of a bacterial pathogen ( 5 studies ) are due to Hib. Mortality due to hib
meningitis in India (Minz et al 2008)
which showed an incidence of Hib Meningitis of 7.1 per 100,000children under 5
years of age ,19 per 100,000 children in children less than 2 years of age had
32 per 100,000 infants( Minz et al 2008) . It is however important to note that
the state of Goa has been
implementing pentavalent vaccination under their routine immunization through
state initiative since 2008 and 28000
pentavalent vaccines have been administered till 2011 without any reported
adverse events. The core committee constituted by Indian council of medical
research on Hib and pentavalent vaccine noted the following issues for
recommending Hib Vaccine:
·
Pyogenic meningitis cases are commonly
seen in pediatric wards and constitute 2-4% of all pediatric admissions. Most
of the children affected are less than 2 years of age. The Two most common
causes of Pyogenic meningitis is hemophilus influenza B and streptococcus
Pneumonia. Of the children with Pyogenic meningitis , a third each of cases die
recover with sequel or recover fully .
·
Hospital based studies show that a
median of 17 % of probable meningitis (bases on CSF cell count and /or elevated
protein or decreased glucose range(9-35%). A median of 39% ( range 29-88% ) of etiologically
characterized meningitis cases confirmed by culture or identification of a
bacterial pathogen ( 5 studies) are due to Hib. Mortality due to Hib meningitis
has been observed to range from 13 to 67%. There has been no major change in
these rates over the years. Age groups most affected are children less than 2
yr. Antibiotic use prior to LP is high
and is the cause for low sensitivity to culture and gram stain.
·
Overall available evidence from hospital
based studies in India shows Hib to be
an important cause of bacterial meningitis and pneumonia. The estimates above
are likely underestimates as all children with disease reach hospitals late or
after antibiotic have been consumed.
·
In another study of the ICMR ( Part A
– site preparation for a vaccine probe study) showed an incidence of severe
pneumonia ranging from 2717 to 7890 per 100,000 child years of observation and
suspected meningitis ranged from 1971 to 2433 per 100,00 child years of observation.
In the hospital based study arm in a total of 269 physician diagnosed
meningitis,7.9%, 29.6% and 21.0% of CSF samples with cell count more >
100 wbc's /mm3 were purulent. Of these Purulent meningitis 16.7%,22.7% and 29%
were hib positive by culture or antigen at Chandigarh, kolkatta and vellore
respectively considering all sites together 24% of purulent meningitis were hib
. Nasopharynagal carriage rate varied from 6 to 7.6% across the three sites.
·
The above estimates have remained
generally stable over a long period of time ranging from 1976 to 2009.
·
A population based study on incidence
of hib Meningitis in India (Minz et al) showing an incidence of hib meningitis
of 7.1 Per 100,000 children under 5 year of age , 19 per 100,000 children in
children less than two years of age and 32 per 100,000 infants(Minz et al
2008).
·
Data on disease surveillance in kerala
for 1999-2000( john et al.2004) showed 75 meningitis cases of which at least 27
were bacterial meningitis . Assuming that 1/3 of this is due to Hib for a 26
million birth cohort , the estimated hib meningitis is 52000 per year. Using
the validated Hib rapid assessment tool estimates , that allows pneumonia
burden estimates based on Meningitis data, the estimated Hib Pneumonia cases
would be 260000 per year( WHO 2001)
·
A study on the community effect of Hib
Vaccination carried out in Vellore (
verghese VP et al 2009 ) showed that for less that 4500 infants immunized , 7
cases of Hib meningitis was prevented which works out to approximately 166 per
100000 infants and 33 per 100000 under five children immunized per year.
5.
It is submitted that Pyogenic meningitis is a medical emergency to be
diagnosed and treated within 8 hours . Health care system is unable to provide
prompt equitable health care and rehabilitation of assured quality to rural ,
peri urban, and urban poor. Hence prevention is ethical . It has been
demonstrated that Hib vaccine is associated with high herd immunity and
therefore greater levels of population
level protection , effective even when the immunization coverage is 50%.
Pentavalent vaccine is a combination vaccine consisting of DPT, Hepatatis B and
Hib Vaccine. DPT vaccine reduced the
number of injections per child from 9 to 3 and provides protection against
Hepatatis B, Diptheria, pertusis , Tetanus and Hib in one go. This also
translates into additional benefits by way of savings of AD syringes and cold
chain space better management of logistics and easy monitoring beside better
scope for improved coverage of children. Pentavalant vaccine is being supplied
by GAVI a reputed international agency free of cost. As a matter of fact it
Penatavlent vaccine is not introduced as part of UIP, patients are forced to
pay up to rs 2000 per dose in private hospitals, which cannot be borne by a
major section of the society. When the government has introduced this vaccine
to be administered to the poorer sections without charging any amount, there is
no reason why this vaccine which is administered by the private sector at an
exorbitant rate, should not be administered by the government as part of the UIP.
6.
It is begged to submit that the
petitioner is misleading this honorable court by indicating pentavalent vaccine
introduction as a clinical trial. Penatvalent vaccine has already been licenses
by drugs controller general of India in the year 2004 after it has passed all
the necessary safety and efficacy tests and is in extensive use in the Private
sector. The Government of India has decided to roll out the Pentavalent vaccine
as per NTG report in Immunisation recommendations in two states at the initial
stage so that a system of scalability can be framed and the
fear of use of such vaccine , which is created among public is dispelled.
7.
As a
matter of fact , trial of the said vaccine is already done before the
product is licenses. Adverse event following Immunisation ( AEFI) does not
imply only adverse event related to vaccination , but actually is a mechanism
to track all kinds of adverse events that may occur following vaccination ,
whether related or unrelated. It signals zero tolerance on the part of the govt
for missing out even a single case of vaccine relate adverse event. Government
of india has taken steps to strengthen Adverse event following immunization (
AEFI ) monitoring)including revision of guidelines for AEFI 2010, their
dissemination to all the programme officers in the states and districts and
training of various categories of primary health care staff with a view to
improve reporting. The District /State / national AEFI committees have been
constituted to regularly review and analyze all the reported AEFI cases.
Besides , supervisory visits are made to ensure regular reporting and to minimize
programmatic errors. All these initiatives are part of an overall effort by the
central govt to improve the quality of
immunization programme and enhance public confidence. AEFI monitoring is
already being done for all vaccines introduced in UIP and is not restricted to
penatvalent vaccine.
8.
The decision of the government to
introduce Pentavalent vaccine is intended to provide better health care to the
under privileged as a social welfare measure. The government while introducing
the pentavalent vaccine have constituted AEFI committee at block level and
state level and had even appointed a committee prior to the introduction of eth
same to study about the effects and after effects of its use. The pentavalent
vaccine is better that the vaccines in existence since combined vaccines which
are already used for many diseases have the advantages of decreased number of
injections. Instead of giving DPT hepatitis B and hib separately , use of
Combined Pentavalent vaccine needs only 3 injections . Avoidance of multiple
injections would also save both time and cost.
9.
With regard to the unfortunate demise
of a 56 days old female baby ancy daughter of the petitioner in Wp ( c) no:
4099/12. It is submitted that on an enquiry conducted into the incident, it is
revealed that the baby was a brought to the community health center Vithura for Vaccination on 14 .2.2011 and the
baby was administered the first dose of pentavalent vaccine. On the same day at
4.00 pm the bay developed fever which is usual after immunization and was given
paracetamol syrup at home and was left to sleep in the cradle. Since the baby
had high fever, she administered another dose of paracetamol by the mother,
after which also the baby went to sleep. However on 15.12.11 when the mother
tried to breast feed the baby she refused and as such the mother left the baby
in the bed and pursue her household works. Since the baby was noticed lying
still in the bed at about 8.30 am, she was rushed to the hospital by the
grandfather at about 9.30 am when the death was confirmed by the duty doctor.
Though an enquiry was conducted by a team constituted by the GOI, the linkage
between the death of the child and the administration of Pentavalent vaccine is
not yet conclusively proven and appears to be only extremely remote. No other
child who was vaccinated from the same container or from any other container on
that day had adverse consequences. A true copy of the report dated 18t.02.12.
submitted by the director of health
service before the 3rd Respondent in this regard is produced
herewith and marked as Exhibit R 3(b)
10.
A detailed enquiry was conducted by a
team of officers of the Drugs control department, consisting of Chief Inspector
( Drugs intelligence squad), Drugs inspector ( Special intelligence branch) and
Drugs inspector, Thiruvananthapuram. The following vaccine was reported to be
administered from community health center Vithura on 14.2.11 to the baby.
Pentavalent
vaccine : batch no: 124 L, 1028 A( UNICEF supply –mfg date not mentioned)
Expiry date July 2013
Mfd
by Serum institute of india Ltd 212/2, Hadapsar , Pune 411028, India.
11.
As per the hospital records a single
dose vaccine from a multi-dose vial( 5 ml -10 doses ) was administered to eth
baby along with other babies as part of the immunization programme. The vaccine
manufacturer has supplied 59304 vials out of the 72500 vials manufactured by
them to the state of Kerala. 20,000 vials each has been supplied to Tvm and ekm
districts and 19304 vials to Kozhikode District. As per the information
received from this office, no major incidents of adverse effects have been
reported either from the community health center Vithura or from any other
hospital in Kerala. In the CHC, vithura two babies were administered vaccine
from the same container out which only one baby , who is now no more is
reported to be affected. The Vaccine was found to be stored in Ice lined
refrigerator of the hospital under the prescribed storage conditions mentioned
in the label. Out of the 50 vials supplied
to the CHC vithura, 26 vials were seen redistributed to the Primary health
centers at Peringammala and tholicode. Enquiry has been conducted at eth above
Primary health centers also and noted that no complaints were reported out of
the said batched of the vaccine administered to children. No other adverse
reports of any sort have been received
either from other districts of Kerala or from the state of Tamil nadu. There
was a balance stock of 1457 Vials of the vaccine at the Family welfare store,
tvm. Details were collected regarding the vaccine from the manufacturer and it
is seen that the said batch has been
released after obtaining the release certificate from the central Drugs
Laboratory, Kasauli, Himachal Pradesh which is the apex laboratory in the govt
of india. Regarding the disposable syringe with the needle bearing Batch LLC,
Post box 30485 , Abu Dhabi ( UAE) reported to be used for the administration of
the said vaccine for the baby, the batch o f the syringe has been sampled for
analysis at the drug testing Laboratory of the drug control dept for testing
it's quality and its report is awaited. It is relevant to submit that despite
the above action taken to have the samples of vaccine and syringe tested the
committees on AEFI had decided to test the use of Penatvalent vaccine at the central Drug Laboratory , Kasauli H.p so
as to rule out possibilities of any adverse effect of the same. Statutory sampling of the vaccine
has been done as per rule by the drug inspector Tvmm and delivered personally
maintaining cold chain at the central drugs laboratory, Kasuali, Himachal
Pradesh on 18.1.2012. The Test reports expected to be received
after 2 months from the date of receipt
of the samples at Kasauli.
12.
It is respectfully submitted that the
Postmortem report of the baby has only
indicated that hypersensitivity reaction is a probable cause of death . It does
not indicate any direct reaction of the vaccine to the death of the child.
Apart from the vaccine any other foreign material including paracetamol could
have caused hypersensitivity to the child which has resulted in death. Since
the date of Introduction, the pentavalent vaccine is being routinely
administered as part of the UIP. Out of the
4 adverse instances reported after the administration of the this
vaccine, including that of the deceased Ancy , no case is reported having
direct connection with eth administration of the vaccine. While two children
are reported dead due to co-morbidity, another case could not be investigated
due to refusal of parents to have autopsy conducted on the dead child. The
vaccine has been implemented in the private sector for a long time before
introduction of the Pentavalent vaccine in the govt sector. Pentavalent vaccine
is certified as safe by WHO also. The possibility of adverse reaction due to
the use of pentavalent vaccine is no more than what is seen in other vaccines.
Since hypersensitivity occurs through unique reaction between the recipients
body and the allergen, administration of pentavalent vaccine cannot be said to
be universally bad since the allergic
reaction depends on the acceptability of the foreign element within the body of
every and any individual. As the relationship between vaccine and hypersensitivity is not
established and as almost 20 hours had
elapsed between vaccination and death of the child no reactions were seen
during the intervening period, administration of pentavalent vaccine cannot be
said to be the sole cause of the child's death.
13.
It is submitted that the Govt of
Kerala have taken ample care and issued guidelines for the implementation of the pentavalent
vaccine. The Vaccination Programme was introduced on 14.2.11 for a period of 1
year with a committee to watch and report regarding its utility and safety. The
govt has introduced this vaccine as part of UIP with the best of interest
except to promote better health care to the under privileged. All other
averments and allegations in the writ petition against the introduction of the
pentavalent vaccine as part of UIP are made without any bonafided and as such
the prayer of the Petitioner is to be rejected.
Rajeev
Sadanandan , Principal Secy H& Fw department.==================================================================MOKSH: (Monitoring Knowledge & Social Health)An International Network of Eminent Scientists Questioning the Science Behind "Science"1st Floor, N-3/409, IRC Village,Nayapalli, Bhubaneswar - 15Odisha,
IndiaPhone: +91-9337102146http://www.facebook.com/jagannath.chatterjeehttp://www.facebook.com/pages/Information-on-Vaccine-Risks/211069518950053http://pecangroup.org/educate-yourself/vaccination/50-reasons-not-to-vaccinate-infantsDisclaimer: Views expressed in my mails are my own and may not represent that of the organisation.===================================================================
\
The Govt of Kerala has done something that is worth congratulating. It, after being elected with the votes of the Citizen of Kerala, has effectively killed at least 4 infants, children of the Citizen of Kerala, with the Pentavalent vaccine which everyone had warned internationally would kill children. Then it has filed an counter affidavit stating that "we are not alone to blame, someone or something else could also have been responsible". It also says that only 4 children have died, so the vaccine should be allowed to continue and "save lives".
The person responsible for this astounding feat is Sri Rajeev Sadanandan who is the Principal Secretary, Health & Family Welfare, Govt of Kerala, who has filed the above astounding
affidavit which is enclosed for your kind perusal.
If you kindly feel it worthy you may please call up Sri Rajeev Sadanandan at the number and address given below and show your solidarity with him. Please congratulate him for having de-populated Kerala so effectively by bumping of 4 innocent infants and then having placed such excellent excuses before the Hon'ble High Court of Kerala. Please tell him that we are recommending his name for the Padma Bhushan. We will also recommend his name for the Indira Gandhi Peace Prize. If Bill Gates can be awarded the Indira Gandhi Peace Prize then why not Sri Rajeev Sadanandan?
Kindly do so if you feel that we should at least congratulate him. Nobody is forcing you of course. Ask your conscience and if your conscience permits then go ahead. You can call him, mail him or write to him. He will most probably switch off his mobile phone, so call him up at his office
phone and also fax him. Flood him with congratulatory emails and also snail mail. Please continue till all vaccines are withdrawn from Kerala. After all we cannot recommend the Padma Bhushan for the entire Govt is it not? So they should stop "saving lives" by bumping off our children.
Actually we do not have money otherwise we would have awarded him gold and diamond studded bangles, anklets, necklace, nose ring and ear rings. Maybe if you all want we can donate to a common fund and suitably award this extraordinary gentleman.
Sh. Rajeev SadanandanPrincipal Secretary (Health & Family Welfare) Department of Health & Family Welfare,Government of Kerala,Secretariat Building,Thiruvananthapuramm-695001,Kerala
Tele office : 0471- 2518255,Fax No : 0471-2327865,Mob : 09446480365E Mail : secy@health.kerala.gov.in,
Thanks!
With Immense Love & PeaceJagannath
THE
AFFIDAVIT
This is the counter
affidavit filed by the Kerala Government to the High Court in Ernakulum , to a case filed by the Human
Rights Law Network (HRLN)on behalf of parents of Ancy who died after receiving
Pentavalent vaccine. The plea is to stop vaccinating other kids as there is
risk of death in them
The papers below were retyped from the
Government affidavit for ease in sending by email (not scanned documents).
There are some typos. The original can be had from the HRLN advocate
Sandhya Raju
47 Subhash Nagar
Edappally Cochin 24
# 09847032397
Please see
paragraph 12
4 kids
died after pentavalent vaccine according to the Governments own affidavit in
the 2 months after starting the programme in the small State of Kerala .
1. Ancy.
Post mortem report says that due to hypersensitivity to injection
(because there was severe swelling of the injection site and in the breathing
tubes of the baby) The Govt says it may be hypersensitivity to Paracetamol
syrup given because of the high fever caused as reaction to the vaccine. BUT
paracetamol was syrup not injection. Post mortem report says reaction was to
injection.
2. Case 2
died but post mortem examination not allowed by parents.
But post
mortem examination is not needed by Brighton
to classify the cause of adverse effect following immunization. If the reaction
occurred after the injection and there was no other cause for the reaction it
must probably be due to vaccine.
In this
case child had reaction on way home from Govt hospital after vaccination. They
went back to same Govt hospital. Child died there. The hospital asked to do
post mortem which the parents declined. The hospital got them to sign saying
they were not willing for post mortem and they will not file a case.
3. Case 3
and 4 Government says died of Co morbid condition. It does not explain what the
co morbid condition was nor why the doctors gave Pentavalent vaccine to two
children who were so sick, that they were anyway going to die that day!!!
Typed copy
of Government affidavit is below. Please contact Advocate Sandhya for
originals.
1.
The above writ petition is filed
mainly with the prayer to issue a writ of mandamus directing the respondent not
to introduce the Hib vaccine as Pentavalent vaccine under the universal
immunization programme in the state of kerala. Wpc 4099/12 is also filed
interalia mainly with the prayer to direct the immediate cessation of the use of
pentavalent vaccine and also to set up an expert committee to look into the
matter. It is respectfully submitted that the without prejudice to the right of
the respondents to file detailed counter affidavits in both cases at later
stage refuting all the averments raised by the writ petition s this preliminary
statement is being filed as directed by this hon'ble court so as to bring to
the notice of the hon'ble court that the apprehensions raised by the writ
Petitions with regard to the use of penatvalent vaccine as part of the
Universal immunization programme is ill founded and without any basis.
2.
It is submitted that the govt of india implemented the expanded programme of
immunization in 1978 and subsequently in 1985 extended the same to the entire
country under the UIP. Currently under the UIP vaccination is provided against
Diphtheria , Pertusis tetanus tuberculosis (BCG) measles polio, hepatitis B,
Japanese Encephalitis ( in selected areas) and Hemophilus Influenza b in
selected states. When the Govt of india
decided to implement the use of pentavalent vaccine for a better coverage of
immunization programme the state of kerala and T.N were chosen as pilot states
considering the fact of high standards of health care and literacy prevalent
therein. How ever when apprehensions were raised from different corners with
regard to the use of this vaccine the government of kerala appointed an expert
committee to examine the controversies relating to the use of vaccine. The
Committee headed by Noel Narayanan former HOD pediatrics, Tvm Medical college ,
Dr lila HOD dept community Medicine Amritha institute of medical sciences as
members and Dr P.K Jameela director of health services, Tvm as convener. The
committee after considering the various pros and cons of the use of Pentavalent
vaccine submitted its report in November
2011 wherein it was recommended that the use of vaccine outweigh the risks.
While taking into account the five adverse reactions to the vaccine, the committee recommended
that the introduction of the said vaccine would be beneficial to the poor children in the state. A true
copy of the report dated submitted by the committee before the government is produced herewith and
marked as Exhibit R3(a).TEH committee while submitting the report had also
taken note of the fact that no adverse reaction has been reported from any of
the hospitals in the state by eth use of pentavalent vaccine.
3.
It is pertinent to point out that it
is accepting the recommendations at Ext R3 (a) that the government decided to
proceed with the implementation of the pentavalent vaccine in the UIP. It is
relevant to bring to the notice of this honble court that the pentavalent
vaccine is available in the Indian
market since 2004 in various combinations. This vaccine is freely administered
by private practitioners and paediatricians at an exorbitant rate per dose. On
the other hand vaccines under UIP are given to one and all absolutely fee of
cost. Not only is the pentavalent vaccine available in the private sector for
more than 7 years, nearly 1.67 crore doses of pentavalent vaccine have been
supplied to the Indian private market by the 5 indian manufacturer alone, as
per information supplied by them. Supplies made by foreign vaccine manufacturer
are over and above this figure. Out of 1.67 crore doses, 1.56 crore doses have
been supplied during 2007 to 2011,indicating a surge in teht demandin the
country leading to high profit margins on the part of the private service
providers. Sensing this market opportunity the number of Indian manufacturers
of Pentavalent vaccine has also increased from 1 in 2004 to 5 in 2009. It is pertinent to submit that
the issues of need cost efficacy and safety of pentavalent vaccine have not
been called into question by the petitioner so far as its use by the private
sector is concerned, which poses a doubt as to the real intention of the
Petitioner which can be understood as only to prevent the government from
providing the same vaccine free of charge so that the commercial interest of
private sector are protected. It would also be important to apprise the Hon'ble
court that the costs charged by private practitioners for Pentavalent vaccine
ranges from 2000 per dose thus
translating into a total charge of up to Rs 6000 for a 3 dose complete course.
At this enormous cost charged by the private practitioner the poor and the most
needy are the ones whose children are deprived of protection against illness,
death and disability. The Petitioner is trying to create unnecessary scare
through misinformation only to block introduction of penatavalent vaccine in
the public health programme so as to protect and promote the exploitative
practices of the private practitioners.
4.
It is submitted that core committee
constituted by the ICMR for Hib has indicated that the two most common case of
pyogenic Meningitis are Hib and Streptococcus pneumonia. Of the children with
pyogenic meningitis, a third of each cases die, recover with sequelae or
recover fully. In 8 hospital based studies, a median of 39% (range 29-88%) of
etiologically characterized meningitis cases confirmed by culture or identification
of a bacterial pathogen ( 5 studies ) are due to Hib. Mortality due to hib
meningitis in India (Minz et al 2008)
which showed an incidence of Hib Meningitis of 7.1 per 100,000children under 5
years of age ,19 per 100,000 children in children less than 2 years of age had
32 per 100,000 infants( Minz et al 2008) . It is however important to note that
the state of Goa has been
implementing pentavalent vaccination under their routine immunization through
state initiative since 2008 and 28000
pentavalent vaccines have been administered till 2011 without any reported
adverse events. The core committee constituted by Indian council of medical
research on Hib and pentavalent vaccine noted the following issues for
recommending Hib Vaccine:
·
Pyogenic meningitis cases are commonly
seen in pediatric wards and constitute 2-4% of all pediatric admissions. Most
of the children affected are less than 2 years of age. The Two most common
causes of Pyogenic meningitis is hemophilus influenza B and streptococcus
Pneumonia. Of the children with Pyogenic meningitis , a third each of cases die
recover with sequel or recover fully .
·
Hospital based studies show that a
median of 17 % of probable meningitis (bases on CSF cell count and /or elevated
protein or decreased glucose range(9-35%). A median of 39% ( range 29-88% ) of etiologically
characterized meningitis cases confirmed by culture or identification of a
bacterial pathogen ( 5 studies) are due to Hib. Mortality due to Hib meningitis
has been observed to range from 13 to 67%. There has been no major change in
these rates over the years. Age groups most affected are children less than 2
yr. Antibiotic use prior to LP is high
and is the cause for low sensitivity to culture and gram stain.
·
Overall available evidence from hospital
based studies in India shows Hib to be
an important cause of bacterial meningitis and pneumonia. The estimates above
are likely underestimates as all children with disease reach hospitals late or
after antibiotic have been consumed.
·
In another study of the ICMR ( Part A
– site preparation for a vaccine probe study) showed an incidence of severe
pneumonia ranging from 2717 to 7890 per 100,000 child years of observation and
suspected meningitis ranged from 1971 to 2433 per 100,00 child years of observation.
In the hospital based study arm in a total of 269 physician diagnosed
meningitis,7.9%, 29.6% and 21.0% of CSF samples with cell count more >
100 wbc's /mm3 were purulent. Of these Purulent meningitis 16.7%,22.7% and 29%
were hib positive by culture or antigen at Chandigarh, kolkatta and vellore
respectively considering all sites together 24% of purulent meningitis were hib
. Nasopharynagal carriage rate varied from 6 to 7.6% across the three sites.
·
The above estimates have remained
generally stable over a long period of time ranging from 1976 to 2009.
·
A population based study on incidence
of hib Meningitis in India (Minz et al) showing an incidence of hib meningitis
of 7.1 Per 100,000 children under 5 year of age , 19 per 100,000 children in
children less than two years of age and 32 per 100,000 infants(Minz et al
2008).
·
Data on disease surveillance in kerala
for 1999-2000( john et al.2004) showed 75 meningitis cases of which at least 27
were bacterial meningitis . Assuming that 1/3 of this is due to Hib for a 26
million birth cohort , the estimated hib meningitis is 52000 per year. Using
the validated Hib rapid assessment tool estimates , that allows pneumonia
burden estimates based on Meningitis data, the estimated Hib Pneumonia cases
would be 260000 per year( WHO 2001)
·
A study on the community effect of Hib
Vaccination carried out in Vellore (
verghese VP et al 2009 ) showed that for less that 4500 infants immunized , 7
cases of Hib meningitis was prevented which works out to approximately 166 per
100000 infants and 33 per 100000 under five children immunized per year.
5.
It is submitted that Pyogenic meningitis is a medical emergency to be
diagnosed and treated within 8 hours . Health care system is unable to provide
prompt equitable health care and rehabilitation of assured quality to rural ,
peri urban, and urban poor. Hence prevention is ethical . It has been
demonstrated that Hib vaccine is associated with high herd immunity and
therefore greater levels of population
level protection , effective even when the immunization coverage is 50%.
Pentavalent vaccine is a combination vaccine consisting of DPT, Hepatatis B and
Hib Vaccine. DPT vaccine reduced the
number of injections per child from 9 to 3 and provides protection against
Hepatatis B, Diptheria, pertusis , Tetanus and Hib in one go. This also
translates into additional benefits by way of savings of AD syringes and cold
chain space better management of logistics and easy monitoring beside better
scope for improved coverage of children. Pentavalant vaccine is being supplied
by GAVI a reputed international agency free of cost. As a matter of fact it
Penatavlent vaccine is not introduced as part of UIP, patients are forced to
pay up to rs 2000 per dose in private hospitals, which cannot be borne by a
major section of the society. When the government has introduced this vaccine
to be administered to the poorer sections without charging any amount, there is
no reason why this vaccine which is administered by the private sector at an
exorbitant rate, should not be administered by the government as part of the UIP.
6.
It is begged to submit that the
petitioner is misleading this honorable court by indicating pentavalent vaccine
introduction as a clinical trial. Penatvalent vaccine has already been licenses
by drugs controller general of India in the year 2004 after it has passed all
the necessary safety and efficacy tests and is in extensive use in the Private
sector. The Government of India has decided to roll out the Pentavalent vaccine
as per NTG report in Immunisation recommendations in two states at the initial
stage so that a system of scalability can be framed and the
fear of use of such vaccine , which is created among public is dispelled.
7.
As a
matter of fact , trial of the said vaccine is already done before the
product is licenses. Adverse event following Immunisation ( AEFI) does not
imply only adverse event related to vaccination , but actually is a mechanism
to track all kinds of adverse events that may occur following vaccination ,
whether related or unrelated. It signals zero tolerance on the part of the govt
for missing out even a single case of vaccine relate adverse event. Government
of india has taken steps to strengthen Adverse event following immunization (
AEFI ) monitoring)including revision of guidelines for AEFI 2010, their
dissemination to all the programme officers in the states and districts and
training of various categories of primary health care staff with a view to
improve reporting. The District /State / national AEFI committees have been
constituted to regularly review and analyze all the reported AEFI cases.
Besides , supervisory visits are made to ensure regular reporting and to minimize
programmatic errors. All these initiatives are part of an overall effort by the
central govt to improve the quality of
immunization programme and enhance public confidence. AEFI monitoring is
already being done for all vaccines introduced in UIP and is not restricted to
penatvalent vaccine.
8.
The decision of the government to
introduce Pentavalent vaccine is intended to provide better health care to the
under privileged as a social welfare measure. The government while introducing
the pentavalent vaccine have constituted AEFI committee at block level and
state level and had even appointed a committee prior to the introduction of eth
same to study about the effects and after effects of its use. The pentavalent
vaccine is better that the vaccines in existence since combined vaccines which
are already used for many diseases have the advantages of decreased number of
injections. Instead of giving DPT hepatitis B and hib separately , use of
Combined Pentavalent vaccine needs only 3 injections . Avoidance of multiple
injections would also save both time and cost.
9.
With regard to the unfortunate demise
of a 56 days old female baby ancy daughter of the petitioner in Wp ( c) no:
4099/12. It is submitted that on an enquiry conducted into the incident, it is
revealed that the baby was a brought to the community health center Vithura for Vaccination on 14 .2.2011 and the
baby was administered the first dose of pentavalent vaccine. On the same day at
4.00 pm the bay developed fever which is usual after immunization and was given
paracetamol syrup at home and was left to sleep in the cradle. Since the baby
had high fever, she administered another dose of paracetamol by the mother,
after which also the baby went to sleep. However on 15.12.11 when the mother
tried to breast feed the baby she refused and as such the mother left the baby
in the bed and pursue her household works. Since the baby was noticed lying
still in the bed at about 8.30 am, she was rushed to the hospital by the
grandfather at about 9.30 am when the death was confirmed by the duty doctor.
Though an enquiry was conducted by a team constituted by the GOI, the linkage
between the death of the child and the administration of Pentavalent vaccine is
not yet conclusively proven and appears to be only extremely remote. No other
child who was vaccinated from the same container or from any other container on
that day had adverse consequences. A true copy of the report dated 18t.02.12.
submitted by the director of health
service before the 3rd Respondent in this regard is produced
herewith and marked as Exhibit R 3(b)
10.
A detailed enquiry was conducted by a
team of officers of the Drugs control department, consisting of Chief Inspector
( Drugs intelligence squad), Drugs inspector ( Special intelligence branch) and
Drugs inspector, Thiruvananthapuram. The following vaccine was reported to be
administered from community health center Vithura on 14.2.11 to the baby.
Pentavalent
vaccine : batch no: 124 L, 1028 A( UNICEF supply –mfg date not mentioned)
Expiry date July 2013
Mfd
by Serum institute of india Ltd 212/2, Hadapsar , Pune 411028, India.
11.
As per the hospital records a single
dose vaccine from a multi-dose vial( 5 ml -10 doses ) was administered to eth
baby along with other babies as part of the immunization programme. The vaccine
manufacturer has supplied 59304 vials out of the 72500 vials manufactured by
them to the state of Kerala. 20,000 vials each has been supplied to Tvm and ekm
districts and 19304 vials to Kozhikode District. As per the information
received from this office, no major incidents of adverse effects have been
reported either from the community health center Vithura or from any other
hospital in Kerala. In the CHC, vithura two babies were administered vaccine
from the same container out which only one baby , who is now no more is
reported to be affected. The Vaccine was found to be stored in Ice lined
refrigerator of the hospital under the prescribed storage conditions mentioned
in the label. Out of the 50 vials supplied
to the CHC vithura, 26 vials were seen redistributed to the Primary health
centers at Peringammala and tholicode. Enquiry has been conducted at eth above
Primary health centers also and noted that no complaints were reported out of
the said batched of the vaccine administered to children. No other adverse
reports of any sort have been received
either from other districts of Kerala or from the state of Tamil nadu. There
was a balance stock of 1457 Vials of the vaccine at the Family welfare store,
tvm. Details were collected regarding the vaccine from the manufacturer and it
is seen that the said batch has been
released after obtaining the release certificate from the central Drugs
Laboratory, Kasauli, Himachal Pradesh which is the apex laboratory in the govt
of india. Regarding the disposable syringe with the needle bearing Batch LLC,
Post box 30485 , Abu Dhabi ( UAE) reported to be used for the administration of
the said vaccine for the baby, the batch o f the syringe has been sampled for
analysis at the drug testing Laboratory of the drug control dept for testing
it's quality and its report is awaited. It is relevant to submit that despite
the above action taken to have the samples of vaccine and syringe tested the
committees on AEFI had decided to test the use of Penatvalent vaccine at the central Drug Laboratory , Kasauli H.p so
as to rule out possibilities of any adverse effect of the same. Statutory sampling of the vaccine
has been done as per rule by the drug inspector Tvmm and delivered personally
maintaining cold chain at the central drugs laboratory, Kasuali, Himachal
Pradesh on 18.1.2012. The Test reports expected to be received
after 2 months from the date of receipt
of the samples at Kasauli.
12.
It is respectfully submitted that the
Postmortem report of the baby has only
indicated that hypersensitivity reaction is a probable cause of death . It does
not indicate any direct reaction of the vaccine to the death of the child.
Apart from the vaccine any other foreign material including paracetamol could
have caused hypersensitivity to the child which has resulted in death. Since
the date of Introduction, the pentavalent vaccine is being routinely
administered as part of the UIP. Out of the
4 adverse instances reported after the administration of the this
vaccine, including that of the deceased Ancy , no case is reported having
direct connection with eth administration of the vaccine. While two children
are reported dead due to co-morbidity, another case could not be investigated
due to refusal of parents to have autopsy conducted on the dead child. The
vaccine has been implemented in the private sector for a long time before
introduction of the Pentavalent vaccine in the govt sector. Pentavalent vaccine
is certified as safe by WHO also. The possibility of adverse reaction due to
the use of pentavalent vaccine is no more than what is seen in other vaccines.
Since hypersensitivity occurs through unique reaction between the recipients
body and the allergen, administration of pentavalent vaccine cannot be said to
be universally bad since the allergic
reaction depends on the acceptability of the foreign element within the body of
every and any individual. As the relationship between vaccine and hypersensitivity is not
established and as almost 20 hours had
elapsed between vaccination and death of the child no reactions were seen
during the intervening period, administration of pentavalent vaccine cannot be
said to be the sole cause of the child's death.
13.
It is submitted that the Govt of
Kerala have taken ample care and issued guidelines for the implementation of the pentavalent
vaccine. The Vaccination Programme was introduced on 14.2.11 for a period of 1
year with a committee to watch and report regarding its utility and safety. The
govt has introduced this vaccine as part of UIP with the best of interest
except to promote better health care to the under privileged. All other
averments and allegations in the writ petition against the introduction of the
pentavalent vaccine as part of UIP are made without any bonafided and as such
the prayer of the Petitioner is to be rejected.
Rajeev
Sadanandan , Principal Secy H& Fw department.==================================================================MOKSH: (Monitoring Knowledge & Social Health)An International Network of Eminent Scientists Questioning the Science Behind "Science"1st Floor, N-3/409, IRC Village,Nayapalli, Bhubaneswar - 15Odisha,
IndiaPhone: +91-9337102146http://www.facebook.com/jagannath.chatterjeehttp://www.facebook.com/pages/Information-on-Vaccine-Risks/211069518950053http://pecangroup.org/educate-yourself/vaccination/50-reasons-not-to-vaccinate-infantsDisclaimer: Views expressed in my mails are my own and may not represent that of the organisation.===================================================================
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