It appears that a new vaccine is being slipped into private clinics via the back door without anyone noticing. Medi-Mumps is a single mumps vaccine that will be available for use in the UK from June 2012.
The new vaccine is cultured on canine kidney cells instead of chick embryos making it suitable for those children allergic to eggs; however, the new wonder vaccine may not be suitable for those allergic to dogs. To understand the reason why, please read on.
The Early Onset website (1) announcing the news states:
The availability of the single mumps vaccine will come as a huge relief to parents of children who have yet to be immunised against the virus due to the lack of supply of the vaccine in the UK over the last three years. (sic)
For those of you who are unaware, although the mumps vaccine was available in private clinics until 2009, it was only being offered as an unlicensed product. This was because if a parent specifically requests a single vaccine, a private clinic can apply to the MHRA for permission to use an unlicensed product in the patient’s name.
This was referenced in the Hansard document 4 Dec 2002 (2) by Ms. Blears:
Single mumps vaccines being prescribed and administered, as part of single measles, mumps and rubella vaccination programmes such as MMR SepVax, are unlicensed imported medicines. Medicines legislation allows a doctor or dentist to prescribe an unlicensed medicine to meet the special clinical needs of his individual patients, on his direct personal responsibility.
So where did the vaccine Medi-Mumps originate from?
It is difficult to say exactly where this vaccine has come from or indeed why the UK needs a separate mumps vaccine if the MMR is as successful as it is made out to be. The true situation in respect of this new product Medi-Mumps has been somewhat obscured with one report stating that the new vaccine is to be manufactured on British soil and another reporting that neither Almac Pharma Services Ltd or Medical Imports Ltd the two companies associated with the vaccine are manufacturing it.
It has been reported on the ruleof6ix (3) website by Connor Bamford that he was advised by a representative of Almac Pharma Services Ltd that they were not manufacturing the vaccine but merely importing and packaging it.
He states:
“So when I got in contact with Almac Pharma Services Ltd, the quality care guy there assured me that they nor Medical Imports Ltd. were not in fact manufacturing it but only importing and packaging it for the UK market; it was being made in a facility in the Czech Republic. He noted that it’s importation was being held up by some regulatory issues to do with the way the vaccine was produced. ” (sic)
Medi-Mumps is said to be a vaccine suitable for children suffering from an allergy to eggs. This is because the vaccine is cultured on canine kidney cells instead of the usual chick embryo fibroblast (CEF) cell cultures, enabling the vaccine to be administered to babies who are allergic to eggs. The vaccine has been proven to be clinically safe in Europe and approved by the WHO.(1)
Is An Increase In Egg Allergies The Real Reason For Medi-Mumps?
I have to wonder if Medi-Mumps being introduced to private clinics has anything to do with an increase in the numbers of children suffering from egg allergies.
In 2010 an article in the Guardian (4) stated that:
The number of people at risk from severe and fatal allergic reactions has increased sharply every year for the past 15 years, according to new NHS figures. The number of adults developing potentially lethal new allergies for the first time has also accelerated dramatically.
The CNN Website (5) states that ‘Eggs are one of the most common allergy-causing foods in children’.
Interestingly Medi-Mumps is extremely similar to the banned vaccine Pavivac. The Pavivac vaccine was also manufactured in the Czech Republic and cultured on canine kidney cells but this vaccine was rejected by the CSM (Committee on the Safety of Medicines) in 2002 because of safety concerns. (6)
As a precautionary measure, the Committee on the Safety of Medicines (CSM) has advised that the use of an unlicensed single mumps vaccine, Pavivac, should be suspended, pending further investigations by the Medicines Controls Agency (MCA).
The MCA should also continue to oppose further imports of this product.
The CSM met following concerns raised over the manufacture, testing and storage of the vaccine. At its meeting yesterday (13 November 2002), the independent scientific advisory body reviewed the most up to date data available on Pavivac. The CSM said that it had insufficient information.
The CSM (7) also expressed further concerns in another paper stating:
The activities of clinics and private practitioners offering single dose measles and mumps vaccine gives rise for concern. The Committee on Safety of Medicines (CSM) had to intervene to advise against the importation of unlicensed “Pavivac” mumps vaccine due to concerns surrounding the use of dog kidney cells in its manufacture and the risk from unknown infections.
Of course the Medi-Mumps vaccine could in fact be the Pavivac vaccine with a new name, after all this would not be the first time that a rogue vaccine has been brought into the UK boasting a brand new identity. If we cast our minds back to 1988 the JCVI (Joint Committee for Vaccinations and Immunizations) introduced Canada’s banned MMR vaccine Trivirix to the UK with the new name Pluserix causing a huge number of children to suffer horrendous side effects including encephalitis, seizures and deafness.
Do the UK authorities now have the missing data on safety and efficacy to argue allowing the importation of this similar type vaccine in June/July 2012 into the UK? I am sure parents will be keen for some answers on this especially if they have children with egg allergies who have suffered a severe adverse reaction to the MMR vaccine.
As we all know governments want as many children vaccinated as possible. If parents with children suffering from egg allergies are refusing the MMR vaccine, then it makes sense to have an alternative to hand. It could explain this sudden change of heart and why a vaccine similar to a previously refused vaccine is now entering the UK market.
Medi-Mumps May Not Be Suitable For Children Allergic To Dog Hair
Whilst the Medi-Mumps vaccine may be good news for parents of children suffering an egg allergy, it may not be so good if they are also allergic to dog hair. Like Pavivac, Medi-Mumps is cultured on canine kidney cells therefore; it could also have the same contraindications. On the Pavivac product sheet (8) in the section marked contraindications it clearly states that any person with an allergy to proteins of canine hair should not receive the vaccine. It says:
hypersensitivity to any components of the vaccine (e.g. neomycin, proteins of canine hair)
Whatever the reasons behind the introduction of this new vaccine I am beginning to suspect foul play, or could it be simply a case of dogged determination in a bid to have all children vaccinated come what may? Let’s face it neither chick eggs nor the kidney cells from dogs are desirable products to be adding to children’s vaccinations in the first place.
So How Do Vaccine Manufacturers Obtain Canine Kidney Cells?
The answer to the above question is simple, they breed their own supply. When the CSM originally rejected the Pavivac vaccine they rejected it because kidney cells from dogs were used to make it. The CSM felt that there was a possible risk of infection by using materials of animal origin in vaccinations.
To reassure the CSM the export director for Sevapharma, Miroslav Reinhardt, said that the vaccine was safe and that his company had cooperated with UK officials. He told the Prague Post (9)
“The kidney cells were taken from dogs bred at farms that follow laws regulating such practices.”
Adding
“We cooperated with the Medicines Control Agency (MCA) intensely — we provided them with our documentation and we hope they will reconsider their decision.”
It rather looks as if they have doesn’t it? However, I have to wonder if the real reason for this sudden change of heart is that egg allergy sufferers ARE ACTUALLY AT RISK if they receive the MMR vaccine. If this is so then why do the AAP (American Academy of Pediatrics) and the ACIP (Advisory Committee on Immunization Practices) both state that the MMR is entirely safe for children allergic to eggs?
Several studies have documented the safety of measles and mumps vaccine (which are grown in chick embryo tissue culture) in children with severe egg allergy. Neither the AAP’s “Red Book” Committee nor ACIP consider egg allergy as a contraindication to MMR vaccine. ACIP recommends routine vaccination of egg-allergic children without the use of special protocols or desensitization procedures. (10)
This is all very strange because the first MMR license issued on the 17th August 1972 by Merck Sharpe and Dohme Ltd in the UK did NOT advocate the MMR for anyone with so much as a feather allergy let alone an egg allergy!! (11)
This license was changed in August 1987 to accommodate a switch in the rubella strain and became MMR II. On the information sheet for the MMR11, Merck (12) quote the AAP and state that it is safe to give children the MMR even if they suffer from an egg allergy. Merck’s says:
M-M-R® II
(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)
The AAP (American Academy of Pediatrics) has stated,
“Most children with a history of anaphylactic reactions to eggs have no untoward reactions to measles or MMR vaccine. Persons are not at increased risk if they have egg allergies that are not anaphylactic, and they should be vaccinated in the usual manner. In addition, skin testing of egg-allergic children with vaccine has not been predictive of which children will have an immediate hypersensitivity reaction…Persons with allergies to chickens or chicken feathers are not at increased risk of reaction to the vaccine.” (my emphasis)
I wish they would all make up their minds because whatever is going on it is all very suspicious and I have to wonder if the UK is now going to see the return of the single vaccines due to more and more parents boycotting the MMR due to safety concerns.
References
- Early Onset Mumps Vaccine to be Made Available in UK from June 2012 http://earlyonset.com/mumps-vaccine-to-be-made-available-in-uk-from-june-2012.html
- Hansard 4 Dec 2002, Column 904W http://www.parliament.the-stationery-office.co.uk/pa/cm200203/cmhansrd/vo021204/text/21204w28.htm
- Connor Bamford Ruleof6ix A virologist’s take on the black death genome #microtwjc 2 http://ruleof6ix.fieldofscience.com/view/classic
- Guardian Sharp Rise in the Number of People With Allergies http://www.guardian.co.uk/society/2010/feb/07/allergies-sharp-rise-anaphylaxis
- CNN Egg Allergy http://edition.cnn.com/HEALTH/library/egg-allergy/DS01021.html
- CSM STATEMENT FROM THE COMMITTEE ON SAFETY OF MEDICINES ADVICE THAT UNLICENSED PAVIVAC SINGLE MUMPS VACCINE SHOULD NOT BE IMPORTED OR USED November 2002 http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con2031109.pdf
- CSM Paper http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1194947371225
- Pavivac Product sheet – contraindications Page 2 http://www.sevapharma.cz/file/pavivac_EN_new.pdf
- Mindy Kay BrickerStaff Writer, The Prague Post (January 22, 2003) Mumps vaccine suspended in UK http://www.whale.to/a/pavivac1.html
- Ask the Experts http://www.immunize.org/askexperts/experts_mmr.asp
- Medicines Act 1972 Product License No. 0025/0078 Schedule Part 1 – Particulars of The Products Of Which The License Relates. Name of the product MMR Vaccine (paper given to me by a colleague)
- MMR 11 Product information http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf
Extra research
- From The Chief Medical Officer: URGENT COMMUNICATION HSS(MD)33/2002 http://www.dhsspsni.gov.uk/hssmd33-02.pdf
- Joint Committee on Vaccination and Immunization Minutes of the Meeting held on Friday 7 February 2003 at 10.30 http://www.advisorybodies.doh.gov.uk/JCVI/mins7feb03.htm