MMR news

27-Jan-03: 16 January 2003 Press Release: Ban on import of Pavivac mumps vaccine extended

As a precautionary measure the Medicines Control Agency has extended the importation ban on Pavivac mumps vaccine on safety grounds. Full press release with Questions and Answers

STATEMENT FROM THE COMMITTEE ON SAFETY OF MEDICINES

ADVICE THAT UNLICENSED PAVIVAC MUMPS VACCINE SHOULD NOT BE IMPORTED OR USED

As a precautionary measure, the Committee on Safety of Medicines (CSM) has advised that the Medicines Control Agency (MCA) should continue to object to the importation of an unlicensed single mumps vaccine, Pavivac, manufactured in the Czech Republic.

The CSM met on January 15 2003 to review the information obtained by the Medicines Control Agency following concerns raised over the manufacture, testing and storage of the vaccine at its meeting on 13 November 2002. The independent scientific advisory body reviewed the most up to date data available on Pavivac. The CSM said that it remained concerned that there was insufficient information to be able to offer any firm assurances on its safety, quality or efficacy.

The key concerns surround the use of dog kidney cells in the manufacture of this vaccine. There are no other vaccines in the Department of Health's vaccination programme which use this method of manufacture. As a result there are a number of additional questions not all of which have been satisfactorily answered.

All methods of manufacture using materials of animal origin for making medicines for human use may present a risk from unknown infections. The answers provided by the manufacturer do not yet provide sufficient information to be able to understand fully the risks in this particular case.

The CSM is to ask clinics who have provided Pavivac to ensure that a record is maintained of those children who received this vaccine so that any adverse reaction can be quickly and thoroughly investigated.

Professor Alasdair Breckenridge, Chairman of the Committee on Safety of Medicines, said:

"There are a number of outstanding questions about the manufacture and testing of the unlicensed vaccine Pavivac which are not answered by the information currently available. Because of this lack of information, we are continuing to advise that its importation and use should be prevented as a precautionary measure.

"Information supplied by the manufacturer shows that this vaccine is effective in protecting children against mumps provided that the child receives a second dose of a mumps containing vaccine. The interval recommended by the Czech authorities is six to ten months after the first dose was administered. Only about two-thirds of children will receive protection from one dose of the vaccine.

"Parents of children who have received one dose of Pavivac should contact their GP or clinic to arrange for a second dose of a licensed mumps containing vaccine."

Notes:

The Committee on Safety of Medicines (CSM) is an independent expert scientific committee, which advises the Government on medicines. The CSM has a responsibility to monitor the safety of medicines, including vaccines, used in UK practice. It achieves this through assessment of data on suspected adverse drug reactions, received predominantly via the Yellow Card Scheme, and data from scientific studies published in the medical literature.

The Medicines Control Agency is an Executive Agency of the Department of Health. The MCA, with expert advice from the CSM, is responsible for safeguarding public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy.

Pavivac is a single mumps vaccine manufactured by Sevapharma in the Czech Republic. It is licensed by the Czech Regulatory Authority but it is not licensed in the UK, or any other EU country. Sevapharma also manufactures a single measles vaccine, Movivac. Information is also being sought on Movivac although there have been no imports of this unlicensed product for use in the UK.

The CSM will reconsider this matter should any new information come to light.

In accordance with medicines legislation, unlicensed medicines may be imported into the UK by licensed importers following notification to MCA. Such unlicensed medicines may only be imported to meet the special needs of individual patients, which an equivalent licensed product cannot meet. As such, unlicensed single Jeryl Lynn mumps vaccines have been imported by licensed importers following notification to MCA.

[ENDS]

Questions & Answers- Pavivac and Movivac vaccines

Can you assure me that the single vaccine I gave my child was safe?
This vaccine is manufactured using dog kidney cells; there are no vaccines approved for use in the UK that use this method of manufacture. Sufficient details are not available to assure us that this vaccine is safe enough to be used in the UK. Therefore, we cannot give you any firm assurances about the safety of Pavivac.
But this vaccine has been used widely in the Czech Republic with no reports of serious reactions?
The reporting system used in the Czech Republic is limited and is not as well established as the system used in the UK to record adverse reactions.
How do you know it is not so good?
We know that some vaccines cause fairly common mild adverse reactions and we have good information on how often such reactions occur. The records for the Czech adverse reaction surveillance system show that they appear to pick up a smaller numbers of the events that would be expected to occur. We therefore cannot rely on this information for reassurance in the same way that we could for information collected in the UK. We are reminding clinics of the need to be vigilant and to report any suspected adverse reactions.
Does Pavivac protect against mumps?
Information supplied by the manufacturer suggests that vaccine may not be effective after only 1 dose. Protection is provided if a second dose is administered according to the schedule used in the Czech Republic (at 6-10 months after the first dose). We would expect excellent results when children who have had one dose of Pavivac receive a further dose of a licensed mumps vaccine; the interval can be any time from about 6 weeks after a dose of Pavivac.
What should I do if my child has had one dose of Pavivac?
You should contact your GP or clinic to arrange for your child to receive a second dose of a different licensed mumps containing vaccine. The recommendation of the Department of Health is that a child can complete a course of single vaccines with MMR, at whatever stage the child has reached.
There are supply problems with mumps vaccine, what should I do?
You should not use Pavivac for the reasons outlined above. You should use a licensed mumps containing vaccine, and MMR is the safest and most effective way to complete your child's immunisation.
What should I do if my child has received partial courses of mono-component vaccines, but no single mumps vaccine is available?
The Department of Health recommends that all children are protected against measles, mumps and rubella, because these are potentially serious diseases. The Department's advice remains that the best way to protect your child against these three diseases is through MMR. The recommendation of the Department of Health is that a child can complete a course of single vaccines with MMR, at whatever stage of the course of vaccines the child has reached.
What else should I know?
Pavivac has highly unusual storage requirements – it must be stored at between –20°C and –10°C. All of the clinics visited by MCA inspectors had appropriate storage facilities and information supplied by the manufacturer shows that it is stored and distributed under controlled conditions.
Concerns have been raised about TSE in relation to other vaccines; do the same concerns exist with this vaccine?
The MCA is still gathering information on this issue. However, the manufacturers have confirmed compliance with the requirements for a number of materials and have promised additional information (as yet unseen by the MCA) for the remainder.
Are Pavivac and Movivac licensed in the UK?
No – they are not licensed in the UK. They were only available through importation by a licensed wholesaler. Unlicensed vaccines have not been assessed for safety, quality and effectiveness, as is the case for medicines licensed in the UK.
How long have these vaccines been available for use in the UK?
From May 2002 until late September 2002.
How many doses of Pavivac and Movivac have been administered?
Only the clinics providing separate vaccines know how many doses have been used. What we know is that the maximum number of doses of Pavivac that have been supplied to clinics is 5,720. We believe that no Movivac has been used in the UK – the supplies that were imported were re-exported to Ireland. The authorities in Ireland have been alerted.
Why did the problems with this vaccine only come to light initially in September 2002?
This is because the MCA only became aware of potential concerns over the manufacturing of this vaccine in late September 2002. The information provided by the importer did not fully reflect the facts about these vaccines.
How can unlicensed medicines (including vaccines) be used in this country?
Where a doctor feels that their patient has a special clinical need, which is not met by a licensed medicine, they may use an unlicensed medicine. Where unlicensed medicines are imported, it must be via a licensed wholesaler. A doctor prescribes unlicensed medicines on his or her own personal responsibility. These vaccines are manufactured and licensed in the Czech Republic.
Shouldn't the MCA have blocked Pavivac at the outset?
The system of approving imports of unlicensed pharmaceuticals works on a process where the MCA does not object where there are no known safety concerns. The use of an unlicensed medicine is on the direct personal responsibility of the prescriber. The MCA will object to importation of an unlicensed medicine where there are known safety concerns.
Is there a safety issue for children who are hypersensitive to dog antigens?
Yes. The datasheet for this product warns specifically of the possibility of allergic reactions in individuals who are hypersensitive to dog protein (dog hair).
How come I wasn't advised about the presence of dog protein in Pavivac [or Movivac]?
The doctor giving the vaccine is responsible for talking you through these issues. If you have any concerns contact the doctor/clinic who administered the vaccine.
Should my child have an antibody test to see if the vaccine has worked?
The Department of Health does not recommend testing for antibodies. Unless mumps antibodies are tested in a specialist laboratory, you cannot be sure that the results do confirm that your child is protected.
But what can I do to protect my child?
The best thing you can do for your child is to have MMR. This vaccine has passed rigorous safety, effectiveness and quality testing. There remains no evidence that there are valid safety concerns over MMR. The present experience suggests that there can indeed be safety concerns over the use of certain single vaccines.
Isn't all this the Department's fault by blocking single vaccines and forcing clinics to use vaccines they cannot guarantee being safe?
No. The MCA has not blocked importation of any single vaccines that match the safety and effectiveness requirements of the vaccines that the NHS routinely provides. The MCA has only blocked importation of single vaccines where there are concerns about safety or level of protection. The MCA has blocked imports of Urabe mumps vaccine that has a known risk of causing aseptic meningitis, import of Leningrad-Zagreb Mumps vaccine for the same reason and Rubini Mumps vaccine because of concerns about level of protection.
But why doesn't the DoH give licenses to single vaccines, then there wouldn't be the problem?
Single mumps and single measles vaccines are licensed in the UK. However, the pharmaceutical companies that hold the product licences do not manufacture the vaccines for or market them in this country.

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