To:

NHS Trusts - Medical Directors (England)
Primary Care Trusts - Directors of Public Health
Primary Care Trusts - Medical Directors
Public Health Link

Cc (Groups):

Chairman - Professional Executive Committee of PCT
Consultants in Communicable Disease
DHSC - Directors of Public Health
Strategic Health Authorities (England) - Directors of
Public Health
Territorial CMOs

Fax To:

From:
Dr David Salisbury - Immunisation and communicable
disease team - Department of Health

Date:
8 July 2003

Reference
CEM/CMO/2003/10

Category:
URGENT (cascade within 24 hours)


Title:
PRIVATE IMMUNISATION CLINICS AT ELSTREE AND SHEFFIELD

------------------------------------------------------------------------

Broadcast Content:

The message pasted in below is also attached as a word
document.

To: Directors of Public Health of PCTs to forward to:


- All GENERAL PRACTITIONERS - please ensure this
message is seen by all practice nurses and
non-principals working in your practice and retain a
copy in your `locum information pack'. Please pass to
health visitors in your practice
- Deputising services
- PCT lead nurses to pass to health visitors
- PCT employed community nurses
- Project manager/Nurse lead in Walk in Centres
- PCT pharmaceutical advisers to forward to community
pharmacists
- PCT Prescribing Advisers
- PCT Prescribing Leads
- Chief Executives of private hospitals
- Chief Executives of private pathology laboratories

Medical Directors of NHS Trusts to forward to:
- Trust chief pharmacists to forward to Medicines
Information Pharmacists
- Medical microbiologists
- Nurse Executive Directors

Cc: - Regional Directors of Public Health
- Consultants in communicable disease control
- Immunisation coordinators
- Directors of Public Health of Strategic Health
Authorities to forward to SHA pharmaceutical advisers
- UK CMOs
- Chairmen of Professional Executive Committee

PRIVATE IMMUNISATION CLINICS AT ELSTREE AND SHEFFIELD

Dear colleagues

BACKGROUND
Earlier this year a problem was identified at
immunisation clinics held by Lifeline Care Limited at
Elstree Aerodrome and Hillsborough Arena, Sheffield.
These clinics have now closed as they were not
registered with the National Care Standards
Commission. The clinics had been offering measles
and/or mumps and/or rubella vaccines on a private
basis to children from a large catchment area in the
south and also the north of England. At the time the
understanding was that just over 1000 children among
those immunised during the period 3 June-22 December
2002 had received vaccines which had not been
reconstituted and administered in accordance with the
data sheets of the manufacturers. This included a
method of making up multiple doses of vaccine in
advance. We therefore recommended that this group of
just over 1000 children should be given MMR vaccine.

THE UPDATED SITUATION
Further information has become available that aberrant
reconstitution and administration practices were
undertaken at these clinics before June 2002. Also
anyone who was immunised at these clinics could have
been immunised by a non standard procedure. The advice
now is that all previous patients who received measles
and/or mumps and/or rubella vaccine/s at these clinics
should be immunised with MMR vaccine. This should be
given according to current national recommendations.
The present estimate is that this could involve up to
40,000 immunisations going back over a 10 year period.


ONGOING SITUATION
From July 9th, we intend to use regional advertising
and the media to announce our advice to parents about
getting MMR. Parents can get advice by telephoning a
dedicated NHS Direct helpline number (telephone 0845
850 9850). Lines are open Monday- Friday 9am-6.30pm
and Saturday 9am-midday.
We are asking GPs, if they are aware a patient
registered with them has attended immunisation clinics
at Elstree Aerodrome or the Hillsborough Arena, to
advise the parents of these patients about our
concerns and to offer MMR vaccine.

A Q & A brief is attached and should be read in
conjunction with this message.

If you require further information contact: Dr David
Salisbury (Tel: 020 7972 1519, Fax: 020 7972 5758) or
Dorian Kennedy (Tel: 020 7972 1523, Fax: 020 7972 5758
Immunisation and Communicable Disease Team, Department
of Health, 606A Skipton House, 80 London Road, SE1
6LH.

8 July 2003.
Questions and answers. Elstree and Hillsborough advice
line.

Q1. What exactly has happened?
A. The private vaccine clinics that had been offering
single antigen vaccines had not been following the
correct procedures recommended by the manufacturer for
making up and administering the vaccines. Also the
clinic made up batches of vaccines in advance for an
unknown number of its vaccination clinics. This is not
normal practice and might have led to the vaccines
being less effective than normal (and therefore not
offering the child proper protection) as well as
producing contamination and risking bacterial
infection from the injection.

The clinics in question have been reported to the
National Care Standards Commission. See also answer to
Q14.

Q.2 Over what period of time were there problems at
the clinics?
A. It was thought originally that the problem occurred
only during 3 June – 22 December 2002. However new
information has come to light that problems with the
vaccine had been occurring over a longer period.
Unfortunately we have been unable to find out exactly
when these problems started. Thus anyone who was
vaccinated at either of these clinics could be at
risk.

Q3. Which clinics have been affected?
A. As far as we are aware, only the single antigen
vaccine clinics run by Lifeline Care Ltd at Elstree
Aeromedical Centre and Hillsborough Arena Sheffield.
All sessions at these clinics could have been
affected.

Q4. What does this mean for my child? Could my child
have been harmed?
A. Our two greatest concerns are that:

1) The clinics had not followed the correct procedure
recommended by the manufacturer for making up and
administering the vaccines. Also the clinic made up
batches of vaccines in advance for an unknown number
of its vaccination clinics. This is not normal
practice and might have led to the vaccines being less
effective than normal. This means that some children
who have been vaccinated may not be adequately
protected against one or more of the diseases for
which they received the vaccine.

2) Due to the way in which the vaccines were prepared,
they may have become contaminated. This could have
increased the risk of children suffering bacterial
infections from the immunisation or greater side
effects to the vaccines.

If your child has been well since the immunisation, it
is very unlikely that any problems will now occur
directly as a result of the injection.

If you are concerned about your child's health please
see your GP. If your child did experience infection or
adverse reactions after receiving the vaccine, you
should inform your GP so that the reaction can be
reported to the Committee on Safety of Medicines in
the usual way.

Q5. How will I know if my child was affected?
A. Any child vaccinated in the single antigen vaccine
clinics held at Elstree Aeromedical Centre and
Hillsborough Arena, Sheffield could have been
affected.

Q6. Can I have my child tested to see if they have
responded to the vaccine?
A. Although blood (and, in some cases, saliva) tests
are available to detect antibodies to the illnesses,
it is very difficult to interpret the results of
antibody tests to the vaccines. Even if we did an
antibody test, we would not be able to reassure you
confidently that your child has been protected. It is
much better to be sure by vaccinating them. The safest
and most effective way to do this is with the MMR
vaccine. (See Questions 8, 9 and 10).

Q7. What should I do now?
A. We are recommending that all children who were
vaccinated with single antigen vaccine for measles or
mumps or rubella should be properly vaccinated, with
MMR . This applies whatever age your previously
vaccinated child is now. You should see your GP about
arranging this.

Q8. What if my child has, in fact, been given an
effective vaccine?
A. There is no harm from having a second or even a
third dose of vaccine if you are already immune. The
body would recognise that it had met the vaccine virus
before, and respond by eliminating it promptly. This
is exactly what would happen if your body encountered
the virus naturally.

If you require further information, please see your GP
or the websites below.

Q9. If my child did respond to the vaccine, surely
revaccination will overload their immune system?
A. The immune system is designed to deal with repeated
exposure to many different antigens, from birth.
Recent studies have also shown that the immune system
of young children can deal with thousands of different
antigens at the same time. Repeating a vaccination
will boost any existing immunity. It will not damage
the immune system. In fact, the immune system is
designed to work this way.

If you require further information, please see your GP
or the websites below.

Q10. If my child is revaccinated, will they be more
likely to get side effects?
A. No. In fact, research has shown that side effects
are LESS likely to occur and are less pronounced after
a second or further dose of vaccine, than they are
after the first dose.

If you require further information, please see your
GP.

Q11. I would like my child to be revaccinated with
single antigen vaccine instead of MMR. What should I
do now?
A. We cannot recommend single antigen vaccine be used.
MMR is the safest and most effective way to protect
children against all three diseases. Some of the
single antigen vaccines are not readily available.

If you choose to take your child to a private clinic,
either for single vaccines or for a blood test, you
should exercise caution. You should ensure that the
clinic is registered with the National Care Standards
Commission. The clinic should be able to demonstrate
that they follow the manufacturer's requirements
exactly on transport, storage, reconstitution and
administration of the vaccine. The clinic should
provide support in the weeks following each
vaccination in case of any adverse events.

Q12. What if I do not get my child revaccinated?
A. Your child may have responded to the vaccine and
may be protected. We cannot guarantee this so we
recommend that your child is revaccinated with MMR.
This will give them protection against all three
diseases.

Q13. Where can I get more information?
A. For more information about what has happened, for
information about MMR vaccine, or information about
immunisation in general, you should speak to your GP
or health visitor.
For detailed information about MMR you may visit the
following websites: http://www.immunisation.nhs.uk
http://www.mmrthefacts.nhs.uk
http://www.HPA.org.uk
http://www.nhsdirect.nhs.uk

Q14. I have heard the clinics at Elstree and Sheffield
have been shut down. What is the situation there?
A. The National Care Standards Commission registers
and inspects private health care services. The NCSC
ordered that the clinics operated by Lifeline Care
Limited at Elstree and at Sheffield stop practising
from 5pm on 20 February 2003. The clinics were not
registered with the NCSC and as such were operating
outside the law.

Q15. Should my child have blood tests?
A. We are not recommending that blood tests be done
which are often unreliable. We recommend
revaccination.

Q16. Can you not tell which vaccines were contaminated
from the batch numbers?
A. This would only be useful if a particular batch of
vaccine was responsible for a problem. In this case,
because our concerns are related to the way vaccine
doses were handled, any batch number could be
affected. The vaccines themselves were not
contaminated when they arrived at the clinics. The
problem was that they might have become contaminated
because of the way they were prepared in the clinics.

Q17. I want to have my child revaccinated. How long
should I wait?
A. As it is now more than six weeks since the last
child was vaccinated using the non-standard procedure,
children may be revaccinated now.

Q18. Can I get my money back from the clinic?
A. Your child is a private patient of Lifeline Care
Limited. Patients must approach the clinics directly
about this.

Q19. I would like to make a formal complaint against
the clinic . Who do I complain to?
A. The National Care Standards Commission on 0191 233
3556.

Q20. I have more questions. Who can I contact?
A. You can phone the dedicated helpline number
telephone 0845 850 9850. Also you can contact your GP
or health visitor in the usual way.

Q21. My child had vaccines at the clinic but not
vaccines for measles or mumps or rubella. What shall I
do?
A. Contact your GP for advice.


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"A doctor can bury his mistakes but an architect can only advise his clients
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