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New evidence on vaccine effectiveness and safety published alongside latest data on whooping cough cases. 

Public Health England (PHE) welcomes this weeks (16 July 2014) announcement from the Joint Committee on Vaccination and Immunisation (JCVI) advising the Department of Health (DH) that the whooping cough (pertussis) vaccination programme for pregnant women should continue for a further 5 years. The advice reflects new data on vaccine effectiveness and safety published by PHE and the Medicines and Healthcare Products Regulatory Agency (MHRA).

The DH announced the temporary vaccination programme for pregnant women in October 2012, in response to a national whooping cough outbreak that led to several infant deaths. Vaccinating women against whooping cough in pregnancy (between 28 and 38 weeks) means that the mother passes immunity on to her unborn child, protecting the baby until they receive their first whooping cough vaccination at 2 months old.

Deputy Chief Medical Officer, Professor John Watson said:

Babies too young to start their vaccinations are at greatest risk from whooping cough. It’s an extremely distressing illness that can lead to young babies being admitted to hospital and can potentially be fatal. TheJCVI’s advice will be welcomed by families and we will work with NHS England to ensure the programme continues to be offered to mums-to-be.

New PHE research published in The Lancet Infectious Diseases shows that vaccinating pregnant women against whooping cough has been highly effective in protecting young infants from this potentially fatal disease. Babies born to women vaccinated at least a week before delivery had a 91% reduced risk of becoming ill with whooping cough in their first weeks of life, compared to babies whose mothers had not been vaccinated.

These findings are supplemented by the first large study of the whooping cough vaccine safety in pregnancy, published by the MHRA in the British Medical Journal. Reviewing data from around 18,000 vaccinated women from the Clinical Practice Research Datalink (CPRD), the research found no evidence of risk from the vaccine to pregnancy or the developing baby, and rates of normal, healthy births were similar to those seen in unvaccinated women.

Dr Katherine Donegan, lead author of the MHRA study, said:

Coupled with the new evidence from Public Health England on the effectiveness of the vaccine, our research should provide further reassurance on the safety and benefits of the vaccine for expectant mothers and healthcare professionals who offer the vaccine.

The latest PHE data also show an overall decline in whooping cough cases since the pregnancy programme started in October 2012. The greatest decrease in disease seen has been in infants under 6 months old, who are targeted by the maternal vaccination programme, which provides good evidence it is working.

There were 14 deaths in infants diagnosed with whooping cough in 2012 and born before the vaccination in pregnancy programme started. Eight deaths have been reported in infants diagnosed with whooping cough in 2013 and so far this year. The mothers of 7 of these 8 babies were not vaccinated in pregnancy.

PHE’s head of immunisation, Dr Mary Ramsay, said:

We welcome JCVI’s advice that the vaccination programme for pregnant women is continued, particularly while whooping cough continues to circulate at elevated levels. It has been highly effective at preventing disease, and deaths in young babies.

The latest figures show that around 60% of pregnant women have received the whooping cough vaccination, which is a testament to the health professionals implementing this programme. However, these infant deaths reminds us how important it is that every pregnant woman is informed about the benefits of the vaccine, and given the opportunity to receive it at the right time so their babies are protected from birth.

Although we have also seen a decline in cases in older children and adults from the peak in 2012 the numbers still remain considerably higher than those in 2011, suggesting the infection has not fallen to background levels.

Today, we urge pregnant women to ensure they are vaccinated between 28 and 32 weeks of their pregnancy wherever possible, although vaccination may be given up to 38 weeks. We are also working with GPs, midwives and other health professionals to ensure they have the facts at hand, including the latest evidence from the PHE and MHRA studies, to help women take up this highly effective and safe vaccine.

Whooping cough affects all ages and is highly infectious. Young infants are at highest risk of severe complications and death from whooping cough as babies do not complete vaccination until they are 4 months old. In older children and adults whooping cough can be an unpleasant illness but it does not usually lead to serious complications.

Dr Ramsay, continues:

Parents should also be alert to the signs and symptoms of whooping cough – which include severe coughing fits which may be accompanied by difficulty breathing (or pauses in breathing in young infants) or vomiting after coughing and the characteristic ‘whoop’ sound in young children. In older children or adults it may present simply as a prolonged cough.

Parents must also ensure their children are vaccinated against whooping cough on time, even babies of women who’ve had the vaccine in pregnancy – this is to provide continued protection through childhood.

Notes to editors

• Read the Joint Committee on Vaccination and Immunisation minutes, July 2014
• The PHE effectiveness paper, Lancet Infection Diseases is available from the Lancet website
• The MHRA safety paper, BMJ 2014;349:g4219 is available from the BMJ website
• Read the PHE whooping cough data, end of May 2014 (Health Protection Report)
• Read the PHE whooping cough 2013 data (regional, age and sex breakdown)
• PHE exists to protect and improve the nation’s health and wellbeing, and reduce health inequalities. It does this through advocacy, partnerships, world-class science, knowledge and intelligence, and the delivery of specialist public health services. PHE is an operationally autonomous executive agency of the Department of Health www.gov.uk/phe Follow us on Twitter @PHE_uk
• The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.
• The Clinical Practice Research Datalink (CPRD) is the English NHS observational data and interventional research service, jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA). CPRD services are designed to maximise the way anonymised NHS clinical data can be linked to enable many types of observational research and deliver research outputs that are beneficial to improving and safeguarding public health.
• CPRD is considered by many as the gold standard and its usage has resulted in over 890 clinical reviews and papers. The team at CPRDprovides value-added services to the General Practitioners who contribute to the database and to the researchers who want to make use of this unique public health research tool.

MHRA press office

Telephone: 020 3080 7651 Out of hours telephone: 07770 446 189 Email:infections-pressoffice@phe.gov.uk