NEWBORNS TO BE PROTECTED AGAINST WHOOPING COUGH

Pregnant women will be offered whooping cough vaccinations to protect their newborn babies following a rise in cases and deaths amongst young infants, Chief Medical Officer Professor Dame Sally Davies has announced. Due to begin next week, the programme aims to boost the short-term immunity passed on by pregnant women to protect their newborn babies – who normally cannot be vaccinated until they are two months old.

The move comes as the latest figures for England and Wales, released today by the Health Protection Agency, show a large increase in cases in young infants. The figures show:

– In the first eight months of this year 302 cases were reported in infants under 12 weeks of age – more than double the 115 cases reported in the same period in 2011;

– There were nine deaths of young children in the same period – up from seven in the whole of 2011; and
– From January to August 2012, 4,791 cases in all ages were reported – three times more than the whole of 2011 which saw 1118 cases.

The decision to introduce the temporary programme was made after the Joint Committee on Vaccination and Immunisation – the Government’s independent vaccine experts – reviewed the available evidence and agreed that the vaccine should be offered to the approximate 650,000 women a year who are between 28 and 38 weeks of pregnancy.

The vaccine will be offered to pregnant women during routine antenatal appointments with a nurse, midwife or GP.

Even if women have previously been immunised they will be encouraged to be vaccinated again to boost their immunity, as it helps protect their babies before they can start their own immunisations.


The temporary programme will start next week and will be monitored by the Health Protection Agency (HPA) and Medicines and Healthcare products Regulatory Agency (MHRA).

Chief Medical Officer Dame Sally Davies said:

“Whooping cough is highly contagious and newborns are particularly vulnerable. Nine infants have died as a result of whooping cough this year and there have been 302 cases of the disease in children under three months old. It’s vital that babies are protected from the day they are born – that’s why we are offering the vaccine to all pregnant women.”

Professor David Salisbury, Director of Immunisation said:

“Over the last year we have seen a large rise in the number of whooping cough cases with the most serious cases being in children too young to be protected by routine vaccinations. The vaccine that we are offering to pregnant women has been recommended by experts and a similar vaccine is already given to pregnant women in the US. If you are pregnant, getting vaccinated is the best way you can protect your baby against whooping cough.”

Dr Mary Ramsay, Head of Immunisation at the HPA, said:

“We have been very concerned about the continuing increase in whooping cough cases and related deaths. We welcome the urgent measure from the Department of Health to minimise the harm from whooping cough, particularly in young infants, and we encourage all pregnant women to ensure they receive the vaccination to give their baby the best protection against whooping cough.

“It’s also important we continue to remind all parents to ensure their children are vaccinated against whooping cough to continue their protection through childhood. Parents should also be alert to the signs and symptoms – which include severe coughing fits accompanied by the characteristic “whoop” sound in young children but as a prolonged cough in older children or adults. It is also advisable to keep their babies away from older siblings or adults who have the infection.”

All children are already vaccinated against the infection when they are a few months old, as part of the Childhood Immunisation Programme. The new programme will mean that newborns are given protection through their mother until the main vaccination programme begins two-three months after birth.

The vaccine, Repevax, is similar to one currently used in the US and protects against whooping cough, diphtheria, tetanus and polio.

There is experience from the US that shows that this type of vaccine can be given to pregnant women. The JCVI had no concerns about the safety of this vaccine for pregnant women and their babies.

Symptoms

Whooping cough, also known as pertussis, can be a serious illness, especially in the very young.

The main symptoms are severe coughing fits which, in babies and children, are accompanied by the characteristic “whoop” sound as the child gasps for breath after coughing.

Very young children have the highest risk of severe complications and death.

Whooping cough in older people can be an unpleasant illness, but does not usually lead to serious complications.

The infection can be treated with a course of antibiotics to prevent the infection spreading further but young infants may need hospital care due to the risk of severe complications.


Image: Whooping cough cases 2011/12


WHAT YOU NEED TO KNOW ABOUT WHOOPING COUGH

The number of cases of whooping cough has been increasing across age groups in the UK and is higher in 2012 than at any other time in more than a decade.

So far this year, nine babies have died from whooping cough. Up to the end of August 2012, there have been 302 cases of the infection in children under 12 weeks old this year – more than double the number during the same period in 2011 (115).

Newborns are particularly vulnerable to complications, hospitalisation and death from whooping cough.

The Department of Health has announced that all pregnant women will be offered the whooping cough vaccine to help protect newborns against the disease. It will also protect mothers from getting infected and passing it on to their infant.

Immunising pregnant women against the disease may help provide their newborns with protection until they can receive their routine immunisations from two months of age.

The latest figures released by the Health Protection Agency show the biggest monthly increase in cases this year – 1,230 cases were reported during August.

The programme will begin next week and aims to boost the short-term immunity passed on by pregnant women to protect their newborn babies – who normally cannot be vaccinated until they are two months old.

Plans to extend the vaccine programme were endorsed by the UK’s independent panel of immunisation experts – the Joint Committee on Vaccination and Immunisation (JCVI) at a specially convened meeting at the end of last month.

The vaccine, Repevax, is similar to one that’s been used by pregnant women in the US since 2011. It will be offered to pregnant women during routine antenatal appointments with a nurse, midwife or GP.

Experience shows that this type of vaccine can be given safely to pregnant women. The JCVI has no concerns about the safety of this vaccine for pregnant women and their babies.

FURTHER INFORMATION


The disease

What is whooping cough and what are the symptoms?

Whooping cough (also known as pertussis) is an infection that causes an irritating cough that often develops into long periods of coughing. In children, the coughing is commonly followed by a characteristic ‘whoop’ sound (except in babies) and may be accompanied by vomiting. In young people and adults, the symptoms may only be a prolonged cough.

How is whooping cough spread?

Whooping cough is spread from person to person through during coughing or sneezing. The bacteria can also be spread indirectly, through contact with respiratory droplets on another person or object and then transfer to the mouth or nose.

How serious is whooping cough?

In young babies, whooping cough can be very serious and complications are most severe in infants under six months of age. Infection can lead to pneumonia, weight loss (due to repeated vomiting), hypoxia (inadequate oxygen supply) which can result in brain damage, and death. Less serious complications include bloodshot eyes, nosebleeds, facial swelling, mouth ulcers and ear infections.

Who can catch whooping cough?

Anyone at any age can get whooping cough.

Immunisation provides protection against whooping cough, but immunity (even after natural infection) is not life long. Whooping cough is being seen in young people who received all their routine whooping cough immunisations when they were younger, although the infections in previously immunised individuals tend to be milder.

The UK childhood immunisation programme offers primary immunisations against whooping cough at two, three and four months of age. The level of protection provided by the first primary immunisation is not complete but improves following the second and third primary immunisations. A booster immunisation is given pre-school at three years and four months of age or soon thereafter.

How severe is the current outbreak?

The current outbreak is much larger than has been seen for over a decade. There have been 4,791 confirmed cases of whooping cough in England and Wales to the end of August 2012 compared with 525 cases in the same period in the last outbreak in 2008. In infants under three months of age there have been 302 cases up to the end of August 2012 compared with 115 cases in the same period in 2011. There have been nine whooping cough-related deaths in infants (all unimmunised) reported during 2011.

More and updated information on the outbreak is available at the Health Protection Agency website: www.hpa.org.uk

IMMUNISING PREGNANT WOMEN – A TEMPORARY PROGRAMME

Why offer pregnant women immunisation against whooping cough?

Independent experts on immunisation – the Joint Committee on Vaccination and Immunisation (JCVI) – has advised that pregnant women should be vaccinated in response to the current whooping cough outbreak. This will help protect their infants when born and before they can receive their routine immunisations.

How does immunising pregnant women protect babies?

Antibodies are produced in response to vaccination and these help the body to fight infections and reduce the severity of infections.

By immunising pregnant women against whooping cough, the antibodies produced will cross the placenta to the foetus so that when the infant is born it will have these antibodies to help protect it against whooping cough from birth. However, this protection is short-lived and diminishes over a few months so infants should continue to get vaccinations as part of the routine childhood immunisation schedule.

Why not immunise infants at birth?

There is evidence to suggest that this approach may result in poorer immune responses to subsequent routine doses of vaccine, which may leave older infants more vulnerable to infection.

When should pregnant women receive the vaccine?

Immunisation should be offered at a routine antenatal visit in weeks 28 to 38 of pregnancy. Immunisation in weeks 28 to 38 of pregnancy is likely to maximise the transfer of antibodies across the placenta.

Pregnant women who are now beyond week 38 of pregnancy should be offered immunisation up to the onset of labour so that some direct protection may still be provided to the infant. In addition, immunisation of pregnant women, even after 38 weeks, will reduce the risk of the mother contracting pertussis in the post-partum period and therefore prevent her from infecting her infant.

When will the temporary programme stop?

This temporary immunisation programme has been introduced in response to the current outbreak of whooping cough and will continue for the time being. The immunisation programme will be evaluated by JCVI.

Which vaccine should be used and how many doses should be given?

A single dose of Repevax® vaccine (produced by Sanofi Pasteur MSD). This is a combination vaccine that provides protection against diphtheria, tetanus, and polio in addition to whooping cough. There are no single whooping cough vaccines available. Repevax® is the only vaccine against whooping cough that is authorised for use in adults and currently available in the UK.

How safe is this vaccine for pregnant women?

Repevax® is a combined inactivated viral, bacterial and toxoid vaccine. There is no evidence of risk to the pregnant women or unborn child with inactivated viral or bacterial vaccines or toxoids.

Millions of doses of Repevax® have been sold worldwide, and its safety has been well established.

In those countries where Repevax® is routinely recommended in adults, there has been some use in pregnant women, and this has not shown any risks to pregnancy. Also, a very similar vaccine from the same manufacturer (but which does not provide protection from polio) has been routinely recommended for use in pregnant women in the United States since last year. This has shown no evidence of risk.

Repevax® has been used in the childhood immunisation programme in the UK since 2004 as well as in other countries and has an excellent safety record.

What side effects may be seen from the vaccination?

The most common side effects in adults include headache, nausea, vomiting, diarrhoea, joint and muscle pain, weakness, mild fever and injection site reactions (redness and inflammation).

As with all vaccines, there is a very rare possibility (approximately one in a million doses) of this vaccine causing a severe allergic reaction called anaphylaxis. All health professionals responsible for immunisation should be trained to recognise and treat anaphylaxis.

The possible known side effects are not expected to be any different in pregnant women compared with other adults, and the benefits outweigh these possible reactions.

A full list of possible side effects is available in the Patient Information Leaflet (PIL) that is provided with the vaccine.

Does the vaccine need to be given with every pregnancy?

Women who become pregnant again while the programme is in place should be offered immunisation during each pregnancy to maximise the level of antibodies that they pass on to their infants. Pregnant women who have received immunisation against pertussis, tetanus, diphtheria and/or polio relatively recently should be offered immunisation. Cumulative doses may increase the likelihood of injection site reactions or fever, this is far outweighed by the expected benefits.

Experience from other countries

Similar increases in whooping cough have occurred in other countries. Immunisation of pregnant women against whooping cough was recommended in the United States of America in June 2011 using an almost identical vaccine (without the polio component). It is too early to know what the impact of this recommendation has been.

When should the vaccine be given?

The vaccine should ideally be given at a routine antenatal appointment in the period week 28 to 38 of pregnancy with week 28 to 32 optimal.

Why does the Patient Information Leaflet state that Repevax® is not recommended in pregnancy?

This says that the vaccine is not recommended for use in pregnancy because of the routine exclusion of pregnant women from clinical trials, and not because of any specific safety concerns or evidence of harm in pregnancy. Use in pregnancy is not contraindicated.

The Department of Health Green Book states that recommendations from the Joint Committee on Vaccines and Immunisation (JCVI) should be followed instead of the information supplied by the manufacturer.

www.wp.dh.gov.uk

What about pregnant women carrying more than one child?

The same amount of antibodies should be passed on to each baby after immunisation. Only one dose of Repevax® should be given during a pregnancy.

Can Repevax® be given at the same time as flu vaccine?

There are no reasons why Repevax® can’t be given at the same time as the flu vaccine. However, flu immunisation should not be delayed until week 28 or after of pregnancy in order to give Repevax® at the same time as pregnant women are at risk of severe illness at any stage of pregnancy from influenza.

Is there an alternative way of protecting babies from whooping cough?

Immunising pregnant women is likely to be the most effective approach to providing protection against pertussis to infants from birth and until they can receive their routine immunisations.

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