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Whooping cough (pertussis) and influenza vaccination for pregnant women

Video message to health professionals

Transcript: Pertussis video message for GPs from Dr Sonya Bennett, Executive Director, Communicable Diseases Branch, Department of Health, October 2016

Voice over: Pertussis, also known as whooping cough, is a highly contagious respiratory infection caused by Bordetella pertussis bacteria.

In Australia, outbreaks of pertussis typically occur every three to four years. The last major outbreak was prolonged - from late 2008 through to 2012. Pertussis is an ongoing issue and our data shows there were 1,860 cases of pertussis reported in 2015.

Concern about the risk of whooping cough and the threat it presents to pregnant women and unborn babies is a priority for Queensland Health.

Whooping cough can be a very serious and life threatening disease, especially for young children who can't be fully vaccinated against it until six months old.

Most hospitalisations and deaths occur in infants under this age.

In Queensland, there have been more than 23,000 notifications of pertussis in children and adults over the past five years and, tragically, six Queensland babies have died from pertussis between 2000-2015.

The Queensland Department of Health provides the whooping cough vaccine free for women in the third trimester of each pregnancy, to protect them and their newborn baby against whooping cough. The vaccine is a combined diphtheria, tetanus and pertussis vaccine and can be ordered from the Queensland Health Immunisation Program through the usual processes.

Some people may have concerns about the safety of administering dTpa vaccine to pregnant women.

Use in pregnancy is not contraindicated and dTpa vaccine is safe and well tolerated in pregnant women.

The Australian Immunisation Handbook strongly recommends vaccination in the third trimester, between 28–32 weeks, to provide maximum protection to infants.

It's recommended for every pregnancy, including those which are closely spaced.

Discussions at the Pharmaceutical Benefits Advisory Committee recommended the inclusion of dTpa on the National Immunisation Program, which is under consideration by the Commonwealth Department of Health.

Research carried out for the Queensland Department of Health found pregnant women place great importance on advice from their GP, obstetrician or other health professional in relation to vaccinations during pregnancy - particularly vaccination against whooping cough.

The research also showed that not enough women know they can access the funded vaccine and the importance of being immunised.

I urge all health professionals to advise pregnant women:

  • on the aetiology of whooping cough and the significance of the disease in infants
  • on the benefits of the vaccination in pregnancy
  • that the vaccine is safe to have during pregnancy

    • and

  • to take advantage of the free vaccine by scheduling a vaccination appointment to get the vaccine at 28 weeks of pregnancy.

Vaccination for household members and carers of infants is also encouraged, however is not funded by the Queensland Department of Health.

Vaccination of pregnant women is the most effective method of protecting infants against whooping cough.

The flu vaccination is also important for pregnant women.

As flu vaccinations can be given at any time during pregnancy, women need not wait until 28 weeks to have it. They should be advised to have it early in their pregnancy, as possible, depending on the timing of the flu season.

Where flu vaccination has not occurred early in pregnancy, vaccinations for whooping cough and flu can be given at the same time.

Let's work together to improve the coverage of pertussis and influenza vaccination in pregnant women.

Thank you.

Authorised by the Queensland Government Brisbane.

Research

This summary of research provides an overview of some key findings from research and statements from international public health  authorities. Key points of note include:

  • the whooping cough (pertussis) vaccine is safe for pregnant women and there is no evidence of an increased risk of adverse events related to pregnancy and no evidence of an increased risk of stillbirth (Donegan et al., Zheteyeva YA et al., WHO Strategic Advisory Group of Experts: pertussis working group 2014, Sukumaran L. et al, Munoz FM et  al., Morgan J., Centres for Disease Control, Morbidity and Mortality  Weekly Report, 2011, Vol. 60, No. 41., Public Health Agency of Canada www.publichealth.gc.ca, New Zealand Ministry of Health http://www.health.govt.nz, Australian Immunisation Handbook, Chapter 3, 10th Edition 2013, Updated  version., Loving S., Pollard, A. Vaccine Knowledge Project, UK)
  • the vaccine is effective in offering protection for babies against whooping cough (Amirthalingam G, et al., Dabrera G et al., Munoz FM et al., Centres for Disease Control, MMWR 2013;62(07):131-135., Centres for Disease  Control, Morbidity and Mortality Weekly Report, 2011, Vol. 60, No. 41.  New Zealand Ministry of Health http://www.health.govt.nz,  Australian Immunisation Handbook, Chapter 3, 10th Edition 2013, Updated version., Loving S., Pollard, A. Vaccine Knowledge Project, UK)

The pertussis vaccine is available to pregnant women in a number of countries including Australia, the United Kingdom, United States, Canada and New Zealand. The following table summarises relevant key international literature on the safety, efficacy and acceptability of a pertussis vaccination program for pregnant women.

Note: In Australia the diphtheria, tetanus, pertussis vaccine is referred to as dTpa. Other countries may use a different acronym for the vaccine, for example in the US ‘Tdap’ is used. They are the same vaccine.

Authors and Citation Title and summary of findings
Donegan K, King B, Bryan P. British Medical Journal 2014; 349: p4219

Safety of pertussis vaccination in pregnant women in UK: observational study

  • Analysis of 20,074 pregnant women vaccinated in the UK during the first 6 months of their pertussis vaccination campaign.
  • Uptake of vaccination program approx. 60%.
  • Study found no evidence of an increased risk of adverse events related to pregnancy, in particular, no evidence of an increased risk of stillbirth.
  • There was no increased risk of maternal or neonatal death, (pre-) eclampsia, haemorrhage, foetal distress, uterine rupture, placenta or vasa praevia, caesarean delivery, low birth weight, or child renal failure.
  • These initial data provide evidence for health professionals and the public to balance against the benefits of the vaccine and can help to inform international vaccination policy making.

Amirthalingam G, Andrews N, Campbell H, Riberio S, Kara E, Donegan K, Fry NK, Miller E, Ramsay M. Lancet, published online 16 July 2014

Effectiveness of maternal pertussis vaccination in England: an observational study

  • Assessment of maternal vaccination program in England shows a high point estimate for vaccine effectiveness of 91% and suggests that the protection was mainly due to placental transfer of antibodies and reduced maternal exposure.
  • Vaccine effectiveness was 90% when the analysis was restricted to children younger than 2 months.
Sukumaran L, McCarthy NL, Kharbanda EO, McNeil MM, Naleway AL , Klein NP, Jackson ML, Hambidge SJ, Lugg MM, Li R, Weintraub ES , Bednarczyk RA, King JP, DeStefano F, Orenstein WA, Omer SB Journal American Medical Association. 2015;314 (15):1581-1587.

Association of Tdap Vaccination with acute events and adverse birth outcomes among pregnant women with prior tetanus-containing immunizations

  • A retrospective cohort study in 29,155 pregnant women from 2007 – 2013 using data from 7 vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington and Wisconsin
  • Study sought to determine whether women receiving Tdap vaccine during pregnancy given in close intervals from prior tetanus containing vaccinations, is associated with acute adverse events in mothers and adverse birth outcomes in neonates.
  • Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before.
  • Findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.

Dabrera G, Amirthalingam G, Andrews N, Campbell H, Ribeiro S , Kara E, Fry NK, Ramsay M. Clin Infect Dis. 2015 Feb 1;60(3):333-7.

A case-control study to estimate the effectiveness of maternal pertussis vaccination in protecting newborn infants in England and Wales, 2012-2013.

  • The objective of this study was to estimate the effectiveness of maternal pertussis vaccination in protecting infants against laboratory-confirmed pertussis infection.
  • This research was a case-control study undertaken in England and Wales between October 2012 and July 2013. Cases where infants aged <8 weeks at onset with pertussis infection tested by real-time polymerase chain reaction or culture.
  • Family doctors of each case were asked to identify healthy infants born consecutively after the case in each practice, to act as controls. Fifty-eight cases and 55 controls were included in this study. Odds ratios (ORs) were calculated for the association between maternal vaccination and infant pertussis infection. The vaccine effectiveness (VE) was calculated as 1 - OR. This was adjusted for sex, geographical region, and birth period.
The research found that maternal pertussis vaccination is effective in preventing pertussis infection in infants aged <8 weeks and may be considered in other countries experiencing high levels of pertussis notifications.

Munoz FM, Bond NH, Maccato M, et al.. JAMA 2014;311:1760-9.

Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunisation during pregnancy in mothers and infants: a randomized clinical trial

  • The study sought to evaluate the safety and immunogenicity of Tdap immunisation during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.
  • This was a clinical trial conducted from 2008 to 2012. Forty-eight pregnant women aged 18 to 45 years received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks’ gestation, with crossover immunisation postpartum.
  • This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants. For secondary outcomes, maternal immunisation with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunisation during pregnancy.

Top G and Paeps A Flemish Agency for Care and Health, Poster presentation

Pertussis vaccination and epidemiology in Flanders: the need for future alternative vaccination strategies

  • Following the Belgian Superior Health Council (National Immunisation Technical Advisory Group-NITAG) recommendation that all pregnant women between 24–32 weeks gestation receive pertussis vaccination, the city of Flanders will add pertussis vaccination of pregnant women in each pregnancy to their vaccination program from 1 July 2014.

Zheteyeva YA, Moro PL et. al.
American Journal of Obstetrics and Gynaecology 2012; 207: 59. e1-7.

Adverse event reports after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines in pregnant women

  • Analysis of 132 adverse event reports to the Vaccine Adverse Event Reporting System (VAERS) from pregnant women who received acellular pertussis vaccine.
  • In a time when pertussis vaccination was not routinely recommended for pregnant women, the study found no concerning patterns in maternal, infant or foetal outcomes.

American College of Obstetricians and GynaecologistsObstetrics and Gynaecology 2013; 121: 1411-4.

Update on immunisation and pregnancy: tetanus, diphtheria and pertussis vaccination.  Committee Opinion No. 566.

  • Overview of the Centres for Disease Control and Preventions Advisory Committee on Immunisation Practices recommendation a dose of Tdap for pregnant women during each pregnancy, irrespective of prior Tdap vaccination history.
  • The American College of Obstetricians and Gynaecologists support the revised recommendations.

World Health Organisation (WHO)
WHO, 14 March 2014

WHO Strategic Advisory Group of Experts (SAGE) pertussis working group: background paper, SAGE April 2014

  • Summarises key conclusions based on data from 15 high income and 4 middle income countries (where relevant):
    • UK experience indicates a high impact of vaccination with an overall reduction in infant mortality.
    • Vaccine is safe and effective to use in pregnant women (acellular pertussis).
    • Some evidence of reduced response to pertussis antigens in infants of vaccinated women (to date there is no evidence of increased risk of pertussis in infants aged 3–11 months).
    • “Vaccination of pregnant women is considered likely to be the most cost-effective complementary strategy to prevent pertussis associated infant mortality, more effective than cocooning”.
Morgan J. Baggari S, McIntire D, Sheffield J.  Obstetrics & Gynaecology 2015:125(6)1433-1438

Pregnancy outcomes after antepartum Tetanus, Diphtheria and acellular pertussis vaccinations.

  • This study evaluated pregnancy outcomes of 7,152 women who received tetanus, diphtheria, and acellular pertussis (Tdap) vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed.
  • No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error.

Centres for Disease Control
Morbidity and Mortality Weekly Report, 21 October 2011, Vol. 60, No. 41.

Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months-Advisory Committee on Immunisation Practices (ACIP), 2011

  • Since June 2011, ACIP has recommended use of Tdap in unvaccinated pregnant women in the third trimester.
  • ACIP reviewed pregnancy registry data from Vaccine Adverse Event Reporting System (VAERS), Sanofi Pasteur and GlaxoSmithKline (manufacturers of Tdap vaccine).
ACIP concluded 'data did not suggest any elevated frequency or unusual patterns of adverse events in pregnant women who received Tdap and that the few serious adverse events were unlikely to have been caused by the vaccine'.

Centres for Disease Control. MMWR. 2013;62(07):131–135.

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine in Pregnant Women -- Advisory Committee on Immunization Practices (ACIP), 2012

  • In October 2011, in an effort to reduce the burden of pertussis in infants, the Advisory Committee on Immunization Practices (ACIP) recommended that unvaccinated pregnant women receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap).
  • New data indicate that maternal antipertussis antibodies are short-lived; therefore, Tdap vaccination in one pregnancy will not provide high levels of antibodies to protect newborns during subsequent pregnancies.
  • ACIP concluded that experience with tetanus-toxoid containing vaccines suggests no excess risk for severe adverse events for women receiving Tdap with every pregnancy.
  • Tdap may be administered any time during pregnancy, but vaccination during the third trimester would provide the highest concentration of maternal antibodies to be transferred closer to birth.
  • ACIP recommends that providers of prenatal care implement a Tdap immunisation program for all pregnant women.
  • Health-care personnel should administer a dose of Tdap during each pregnancy, irrespective of the patient's prior history of receiving Tdap.

New Zealand Ministry of Health, (NZMoH),Immunisation Handbook 2014, 2nd edition, April 2016

New Zealand Ministry of Health: Immunisation Handbook 2014

  • The NZ MoH website states 'The whooping cough vaccine is safe for use in pregnancy'.
  • The NZ MoH states vaccination with Tdap should be offered in every pregnancy (currently funded between 28 and 38 weeks gestation to protect the mother).
Public Health Agency of Canada

Immunisation in Pregnancy and Breastfeeding

  • There is no theoretical reason to suspect that adverse events will occur in the fetus or infant following maternal vaccination with inactivated vaccines during pregnancy.
  • There are no published data indicating that currently authorized inactivated vaccines are teratogenic or embryotoxic, or have resulted in specific adverse pregnancy outcomes.
  • Immunisation with Tdap to date has been shown to be safe in pregnant women and allows high levels of antibody to be transferred to newborns during the first two months of life when the morbidity and mortality from pertussis infection is the highest.
  • All pregnant women at 26 weeks of pregnancy or later who have not received a dose of pertussis-containing vaccine in adulthood, should be encouraged to receive Tdap vaccination. Immunisation should not be delayed until close to delivery since this may provide insufficient time for optimal transfer of antibodies and direct protection of the infant against pertussis.
Australian Immunisation Handbook.

Vaccination of women who are planning pregnancy, pregnant or breastfeeding, and preterm infants

  • Studies have found no evidence of an increased risk of adverse pregnancy outcomes related to pertussis vaccination during pregnancy.
  • Pertussis vaccination during the third trimester of pregnancy has been shown to be more effective in reducing the risk of infant pertussis than maternal vaccination post partum.
Sarah Loving, Professor Andrew Pollard, Vaccines in Pregnancy: Pertussis (whooping cough), 2016

Vaccine Knowledge Project
University of Oxford, England United Kingdom

There are no safety concerns about the use of the vaccine in pregnancy, and there is considerable experience of its use both in the UK and the United States.
Last updated: 28 October 2016

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