Vaccino pentavalente in India

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Vaccino pentavalente in India


Messaggio da Eva.Martini » 20 mar 2018, 20:00

A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases

Date: Thu 15 Mar 2018
Source: The Week [edited]
< ... ktail.html>

A new study claims that pentavalent vaccine (PV), introduced in the
country's immunisation programme six years ago, has doubled the deaths
of children (soon after vaccination) as compared to DPT
(Diphtheria-Pertussis- Tetanus) vaccine. The study, published in the
peer-reviewed journal, Wolters Kluwer Health's journal, Medical
Journal of Dr D Y Patel University, calls for a "rigorous review of
the deaths following vaccination with PV [1]."

The pentavalent [vaccine] is a combination of DPT vaccine and two more
vaccines, [one] against Haemophilus Influenza type B (Hib) and
[another against] Hepatitis B. In December 2011, the [PV] vaccine was
introduced in India's immunisation programme to replace DPT vaccine in
a staged manner with a view to add protection against Hib and
Hepatitis B, without increasing the number of injections given to
infants. At that time too, several public health experts had
questioned the rationale behind introducing the vaccine and its
adverse effects.

In their latest paper, Jacob Puliyel, head of Pediatrics, St Stephens
Hospital in New Delhi, and V. Sreenivas, professor of Biostatistics at
the All India Institute of Medical Sciences, say sporadic reports of
"unexplained deaths" following immunisation with PV had been a matter
of concern. To investigate the issue, Puliyel, Sreenivas, and their
colleagues undertook a study to find out if these deaths were merely
coincidental or vaccine induced. The authors obtained data of all
deaths reported from April 2012 to May 2016 under the Right to
Information Act.

Data on deaths within 72 hours of administering DPT and PV from
different states were used. For the study, the authors say they
assumed that all deaths within 72 hours of receiving DPT are "natural
deaths". Using this figure as the baseline, they presumed that any
increase in the number of deaths above this baseline among children
receiving PV must be caused by the vaccine. "If a state introduced PV
in 2014, then data on DPT doses, PV doses, and deaths following
vaccination were noted from that year on. This ensured that the deaths
were all reported from the state using the same surveillance system,"
they said.

The analysis of the data provided by the government revealed that
there were 237 deaths within 72 hours of administering the PV - twice
the death rate among infants who received DPT vaccine. Extrapolating
the data, the authors say they estimated that vaccination of 26
million children each year in India would result in 122 additional
deaths within 72 hours, due to the switch from DPT to PV. "There are
likely to be 7,020 to 8,190 deaths from PV each year if data from
states with better reporting, namely Manipur and Chandigarh, are
projected nationwide," their report says.

The authors, however, say while the study looks at the short-term
increase in deaths (within three days of vaccination) it does not
calculate the potential benefits of PV on infant mortality, for
example by protection against lethal diseases like _Haemophilus
influenzae_. In spite of the data presented in this paper (from a
large cohort) the authors point out that the evidence is merely
circumstantial and "not conclusive". "These findings of differential
death rates between DPT and PV do call for further rigorous
prospective population-based investigations," the study concludes.

[1. Puliyel J, Kaur J, Puliyel A, Sreenivas V. Deaths reported after
pentavalent vaccine compared with death reported after
diphtheria-tetanus-pertussis vaccine: An exploratory analysis. Med J
DY Patil Vidyapeeth 0;0:0. DOI: 10.4103/MJDRDYPU.MJDRDYPU_188_17.
Available at: <>.]

Communicated by:
ProMED-mail from Healthmap Alerts

[The following is the abstract from the journal article referenced

"Introduction: Immunization is one of the most effective public health
tools available to prevent death and disease. Serious adverse events
following immunization (AEFI) are rare. However, coincidental
sudden‐infant‐death‐syndrome (SIDS) deaths do occur temporally
associated with vaccination. In 2010, the Government of India (GoI)
introduced a new standard operating procedure (SOP) to report AEFI.
There have been stray newspaper reports of deaths soon after the
administration of the pentavalent vaccine (PV) which was introduced by
the GoI in December 2011. This study was conducted to examine if there
is an epidemiological signal from the data collected passively under
the new SOP. Materials and Methods: We used data provided by the GoI
on the number children who received three doses of
diphtheria‐tetanus‐pertussis vaccine (DTP), the number receiving
PV and the number of deaths in the vaccinated within 72 h. Results:
After PV was introduced in the states, 45 million infants received DTP
vaccination and 25 million received PV. There were 217 deaths within
72 h after DTP was administered and 237 following PV. There were 4.8
deaths per million vaccinated with DTP (95% confidence interval [CI]:
4.2-5.5) and 9.6 deaths (95% CI: 8.4-10.8) per million vaccinated with
PV (odds ratio 1.98 (95% CI 1.65‐2.38) There were 4.7 additional
deaths (95% CI: 3.5-5.9), per million, vaccinated with PV instead of
DTP (P < 0.0001). Discussion: Deaths following DTP vaccination would
include the natural rate of deaths within that window period, plus
deaths if any, caused by DTP. For purposes of this study, we assumed
that all the deaths associated with DTP are coincidental SIDS deaths.
Taking that as the base rate of SIDS, we look for any increase in the
death rate after PV. This study demonstrated an increase in reports of
sudden unexplained deaths within 72 h of administering PV compared to
DTP vaccine. Whether improvements in AEFI surveillance system or other
factors contributed to this increase cannot be ascertained from this
study. Conclusion: These findings do not warrant deviation from
current vaccination schedule, but the differential death rates between
DTP and PV do call for further rigorous prospective population‐based

Pentavalent vaccine (PV) is a combined vaccine that protects against 5
diseases, namely diphtheria, tetanus, pertussis plus hepatitis B and
_Hemophilus influenzae_ type B (Hib) infections. PV is at present
recommended by WHO and its introduction is supported by Global
Alliance on Vaccines and Immunisation (GAVI) funds. PV carries several
different brand names (e.g., ComBE Five, Pentavac PFS, Easyfive,
Pentaxim (DTaP), Shan5, and Quinvaxem) as a consequence of being
manufactured by different companies.

Several of the brands have been withdrawn temporarily: Shan5,
manufactured by Shanta Biotechnic in India, was temporarily withdrawn
in 2010 because of the presence of a white sediment sticking to glass
vials containing Shan5 vaccine
(< ... july10.pdf>).
Easyfive, manufactured by Panacea, was temporarily withdrawn in 2011
due to deficiencies in quality systems found at the company's Lalru
manufacturing site in India
(< ... l_list/en/>).

Unexplained deaths have been noted to be associated with PV in the
past. The authors of the referenced study above cite a study by WHO
that investigated sudden unexplained deaths associated with PV in Sri
Lanka and Vietnam (Quinvaxem) and serious AEFI in Bhutan (Easyfive):
WHO found the AEFI were unlikely to be related to the vaccine
(< ... l_2013/en/>).
For some cases, additional clinical information (e.g., autopsies)
allowed another cause of death to be identified.

PV (Pentavac), manufactured by the Serum Institute of India, when
introduced in India to replace DTP in 2011
(< ... l_2013/en/>)
was also associated with sudden unexplained deaths following its use
(< ... -ii-haiti/>).
It is apparent that several of the PV brands have been associated with
sudden unexplained deaths, as some of the referenced study's authors
said in an open letter to WHO in 2012, "The reactions in India suggest
that the cause of the problem is unrelated to the brand or
manufacturer or lot of the vaccine"
(< ... -ii-haiti/>).
The brand or brands of PV used in the referenced study above in India
are not specified in the journal article.

In the Universal Immunization Programme (UIP) by the Government of
India, the pentavalent vaccine comes in a liquid form in a vial that
contains 10 doses. Each dose is 0.5 ml to be given by intramuscular
(< ... o_FAQs.pdf>).
Reconstitution with a diluent is not required with this pentavalent
vaccine; use of an incorrect or contaminated diluent has led to
adverse reactions with other types of vaccines.

The referenced study above compared the rate of sudden unexplained
death within 72 hours following PV versus that following
diphtheria‐tetanus‐pertussis (DTP) vaccine from 2012 to 2016 in
different states in a large cohort, based on adverse effects following
immunization (AEFI) data from the Indian government surveillance
system. Deaths associated with DPT were accessed after PV was
introduced in a particular Indian state to ensure that all deaths
following vaccination were investigated and reported using the same
type of protocol. The referenced study found unexplained deaths within
72 hours following PV to significantly exceed deaths following DTP
and, although rare, the 4.7 excess deaths per million vaccinated
following PV require a detailed medical explanation. - Mod.ML]

[While the article in question (abstracted above) presents the summary
data findings, it would be nice to see the actual data tables,
disaggregated by year and State (in India) to see if there are State
associations or annual associations. For example, was there an
increase reporting in years or locations (States) following previous
press announcements? Clearly there is a need to conduct more formal
analyses which will address potential confounding variables. It took
multiple studies to "clear dpt" as a contributing factor for SIDS
following the beginning of the USA adverse events following
vaccination surveillance efforts back in the late 70s and early 80s
following reports of a cluster of SIDS deaths following receipt of DPT
in Tennessee USA. At present it is too early to conclude that the
pentavalent vaccine is responsible for the increase in unexplained
mortality (as the author of the above paper concludes as well). -

A HealthMap/ProMED-mail map can be accessed at:

[See Also:
Yellow fever - Africa (79): Uganda, vaccine adverse effects, comment
Yellow fever - Africa (77): Uganda, adverse vaccine effects
Vaccine adverse event, fatalities - Syria (02): (ID, DY) muscle
Vaccine adverse event - Syria (ID, DY): muscle relaxant, fatalities
Rabies vaccine, serious adverse events - India: (PB) fatality, RFI
Brucella vaccine adverse reactions, human - Russia: (Buryatia)
Rabies vaccine, serious adverse events - India (02): fatality, RFI
Rabies vaccine, serious adverse events - India: corr.
Rabies vaccine, serious adverse events - India: RFI
Pediatric influenza vaccine - Australia (03): adverse reactions
Pediatric influenza vaccine - Australia (02): adverse reactions
Pediatric influenza vaccine - NZ, Australia: adverse reactions
Pediatric influenza vaccine - Australia: adverse reactions
Strep. pneumoniae, vaccination adverse events - Netherlands: alert
Smallpox vaccination, adverse events - USA: prog. vaccinia
Hepatitis A vaccine - China: (Beijing), adverse events, RFI
Hepatitis A vaccination deaths - China: (Beijing), adverse events, RFI
Measles vaccine - India: (Maharashtra), adverse events, RFI
MMR vaccination adverse events - Canada: RFI]
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