Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis

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 investigations. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Jacob Puliyel [verfasserIn] Jaspreet Kaur [verfasserIn] Ashish Puliyel [verfasserIn] Visnubhatla Sreenivas [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	Adverse events following immunization pentavalent vaccine TOKEN study

Übergeordnetes Werk:	In: Medical Journal of Dr. D.Y. Patil Vidyapeeth - Wolters Kluwer Medknow Publications, 2019, 11(2018), 2, Seite 99-105
Übergeordnetes Werk:	volume:11 ; year:2018 ; number:2 ; pages:99-105

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc Journal toc

DOI / URN:	10.4103/MJDRDYPU.MJDRDYPU_188_17

Katalog-ID:	DOAJ076302245

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245	1	0	\|a Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis
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520			\|a 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 investigations.
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allfields	10.4103/MJDRDYPU.MJDRDYPU_188_17 doi (DE-627)DOAJ076302245 (DE-599)DOAJ2fe790e1448d4dd5a2282d7adc14651d DE-627 ger DE-627 rakwb eng Jacob Puliyel verfasserin aut Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 investigations. Adverse events following immunization pentavalent vaccine TOKEN study Medicine R Jaspreet Kaur verfasserin aut Ashish Puliyel verfasserin aut Visnubhatla Sreenivas verfasserin aut In Medical Journal of Dr. D.Y. Patil Vidyapeeth Wolters Kluwer Medknow Publications, 2019 11(2018), 2, Seite 99-105 (DE-627)1760594458 25898310 nnns volume:11 year:2018 number:2 pages:99-105 https://doi.org/10.4103/MJDRDYPU.MJDRDYPU_188_17 kostenfrei https://doaj.org/article/2fe790e1448d4dd5a2282d7adc14651d kostenfrei http://www.mjdrdypv.org/article.asp?issn=2589-8302;year=2018;volume=11;issue=2;spage=99;epage=105;aulast=Puliyel kostenfrei https://doaj.org/toc/2589-8302 Journal toc kostenfrei https://doaj.org/toc/2589-8310 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_206 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4305 GBV_ILN_4338 AR 11 2018 2 99-105
spelling	10.4103/MJDRDYPU.MJDRDYPU_188_17 doi (DE-627)DOAJ076302245 (DE-599)DOAJ2fe790e1448d4dd5a2282d7adc14651d DE-627 ger DE-627 rakwb eng Jacob Puliyel verfasserin aut Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 investigations. Adverse events following immunization pentavalent vaccine TOKEN study Medicine R Jaspreet Kaur verfasserin aut Ashish Puliyel verfasserin aut Visnubhatla Sreenivas verfasserin aut In Medical Journal of Dr. D.Y. Patil Vidyapeeth Wolters Kluwer Medknow Publications, 2019 11(2018), 2, Seite 99-105 (DE-627)1760594458 25898310 nnns volume:11 year:2018 number:2 pages:99-105 https://doi.org/10.4103/MJDRDYPU.MJDRDYPU_188_17 kostenfrei https://doaj.org/article/2fe790e1448d4dd5a2282d7adc14651d kostenfrei http://www.mjdrdypv.org/article.asp?issn=2589-8302;year=2018;volume=11;issue=2;spage=99;epage=105;aulast=Puliyel kostenfrei https://doaj.org/toc/2589-8302 Journal toc kostenfrei https://doaj.org/toc/2589-8310 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_206 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4305 GBV_ILN_4338 AR 11 2018 2 99-105
allfields_unstemmed	10.4103/MJDRDYPU.MJDRDYPU_188_17 doi (DE-627)DOAJ076302245 (DE-599)DOAJ2fe790e1448d4dd5a2282d7adc14651d DE-627 ger DE-627 rakwb eng Jacob Puliyel verfasserin aut Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 investigations. Adverse events following immunization pentavalent vaccine TOKEN study Medicine R Jaspreet Kaur verfasserin aut Ashish Puliyel verfasserin aut Visnubhatla Sreenivas verfasserin aut In Medical Journal of Dr. D.Y. Patil Vidyapeeth Wolters Kluwer Medknow Publications, 2019 11(2018), 2, Seite 99-105 (DE-627)1760594458 25898310 nnns volume:11 year:2018 number:2 pages:99-105 https://doi.org/10.4103/MJDRDYPU.MJDRDYPU_188_17 kostenfrei https://doaj.org/article/2fe790e1448d4dd5a2282d7adc14651d kostenfrei http://www.mjdrdypv.org/article.asp?issn=2589-8302;year=2018;volume=11;issue=2;spage=99;epage=105;aulast=Puliyel kostenfrei https://doaj.org/toc/2589-8302 Journal toc kostenfrei https://doaj.org/toc/2589-8310 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_206 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4305 GBV_ILN_4338 AR 11 2018 2 99-105
allfieldsGer	10.4103/MJDRDYPU.MJDRDYPU_188_17 doi (DE-627)DOAJ076302245 (DE-599)DOAJ2fe790e1448d4dd5a2282d7adc14651d DE-627 ger DE-627 rakwb eng Jacob Puliyel verfasserin aut Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 investigations. Adverse events following immunization pentavalent vaccine TOKEN study Medicine R Jaspreet Kaur verfasserin aut Ashish Puliyel verfasserin aut Visnubhatla Sreenivas verfasserin aut In Medical Journal of Dr. D.Y. Patil Vidyapeeth Wolters Kluwer Medknow Publications, 2019 11(2018), 2, Seite 99-105 (DE-627)1760594458 25898310 nnns volume:11 year:2018 number:2 pages:99-105 https://doi.org/10.4103/MJDRDYPU.MJDRDYPU_188_17 kostenfrei https://doaj.org/article/2fe790e1448d4dd5a2282d7adc14651d kostenfrei http://www.mjdrdypv.org/article.asp?issn=2589-8302;year=2018;volume=11;issue=2;spage=99;epage=105;aulast=Puliyel kostenfrei https://doaj.org/toc/2589-8302 Journal toc kostenfrei https://doaj.org/toc/2589-8310 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_206 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4305 GBV_ILN_4338 AR 11 2018 2 99-105
allfieldsSound	10.4103/MJDRDYPU.MJDRDYPU_188_17 doi (DE-627)DOAJ076302245 (DE-599)DOAJ2fe790e1448d4dd5a2282d7adc14651d DE-627 ger DE-627 rakwb eng Jacob Puliyel verfasserin aut Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 investigations. Adverse events following immunization pentavalent vaccine TOKEN study Medicine R Jaspreet Kaur verfasserin aut Ashish Puliyel verfasserin aut Visnubhatla Sreenivas verfasserin aut In Medical Journal of Dr. D.Y. Patil Vidyapeeth Wolters Kluwer Medknow Publications, 2019 11(2018), 2, Seite 99-105 (DE-627)1760594458 25898310 nnns volume:11 year:2018 number:2 pages:99-105 https://doi.org/10.4103/MJDRDYPU.MJDRDYPU_188_17 kostenfrei https://doaj.org/article/2fe790e1448d4dd5a2282d7adc14651d kostenfrei http://www.mjdrdypv.org/article.asp?issn=2589-8302;year=2018;volume=11;issue=2;spage=99;epage=105;aulast=Puliyel kostenfrei https://doaj.org/toc/2589-8302 Journal toc kostenfrei https://doaj.org/toc/2589-8310 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_206 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4305 GBV_ILN_4338 AR 11 2018 2 99-105
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source	In Medical Journal of Dr. D.Y. Patil Vidyapeeth 11(2018), 2, Seite 99-105 volume:11 year:2018 number:2 pages:99-105
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title	Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis
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title_sort	deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: an exploratory analysis
title_auth	Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis
abstract	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 investigations.
abstractGer	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 investigations.
abstract_unstemmed	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 investigations.
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container_issue	2
title_short	Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis
url	https://doi.org/10.4103/MJDRDYPU.MJDRDYPU_188_17 https://doaj.org/article/2fe790e1448d4dd5a2282d7adc14651d http://www.mjdrdypv.org/article.asp?issn=2589-8302;year=2018;volume=11;issue=2;spage=99;epage=105;aulast=Puliyel https://doaj.org/toc/2589-8302 https://doaj.org/toc/2589-8310
remote_bool	true
author2	Jaspreet Kaur Ashish Puliyel Visnubhatla Sreenivas
author2Str	Jaspreet Kaur Ashish Puliyel Visnubhatla Sreenivas
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doi_str	10.4103/MJDRDYPU.MJDRDYPU_188_17
up_date	2024-07-03T19:44:07.975Z
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Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis

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