Re: [AVN] Meningococcal vaccine - help please?

[Guest guest]

At 08:58 AM 03/06/2002 +1100, you wrote:

>I have had a mother ask me about the ingredients and documented adverse

>effects for this particular vaccine. Does anyone have access to a product

>insert?

>

>Thanks,

>Bronwyn

Is it the Wyeth one

http://www.doh.gov.uk/meningitis-vaccine/keypharm.htm

Wyeth one in UK ( & Chiron one)

USE OF MENINGOCOCCAL GROUP C CONJUGATE VACCINE

KEY PHARMACEUTICAL/TECHNICAL ISSUES

(UPDATED AUGUST 2000)

Q1: What are the details of presentations and pack sizes?

A: The vaccine is available in the following presentations:

1.Wyeth Vaccines (Brand name: Meningitec): A single pack containing 1 x 1

dose in glass vial (0.5ml suspension) and a multipack containing 10 x 1

dose in glass vials (0.5ml suspension).

The dimensions are:

(1 x 1 dose pack) 36 mm long x 25 mm deep x 52 mm high

(10 x 1 dose pack) 76 mm long x 52 mm deep x 45 mm high

The product is not shrink-wrapped.

2. Chiron Vaccines (Brand name: Menjugate): A single pack containing 1 x 1

dose glass vial of lyophilised powder and a glass vial containing 0.5ml

diluent for reconstitution. There is also a single pack containing 1 x 10

dose glass vial of lyophilised powder and 1 glass vial of diluent.

The dimensions are:

(1 x 1 dose pack) 141 mm long x 41 mm deep x 22 mm high

(1 x 10 dose pack) 56 mm long x 36 mm deep x 70 mm high (shrink wrapped in

outers of 5)

3. North American Vaccine (Brand name: NeisVac-C): A multipack containing

20 x 1 dose in pre-filled syringes (0.5ml liquid suspension) without needle.

The dimensions are: 223 mm long x 107 mm deep x 52 mm high.

The product is not shrink-wrapped.

The Wyeth brand is licensed for use in children and older people of any age

and is being supplied through primary care in a single dose presentation.

The Chiron brand is currently licensed only for use in children over 12

months of age and the initial supply is mostly in a multi dose presentation

and will be used only in the schools programme.

The North American Vaccine brand is currently licensed only for use in

children over 12 months of age and is in a single dose syringe presentation

and the initial supply will be used only in the schools programme.

We are advised that the marketing authorisation holder, North American

Vaccine (UK) Ltd has recently been acquired by Baxter Healthcare Ltd.

Further information is available from the Hyland Immuno division of Baxter

Healthcare Ltd.

Q2: Is there an overage in the presentations?

A: There is adequate vaccine in each presentation to provide at least the

full quantity of recommended dose/doses.

Q3: Will the vaccines need to be transported under cold chain conditions?

A: The meningococcal group C conjugate vaccine should be stored at

temperatures of 2o -8oC at all times. It should be discarded if frozen, or

if it is suspected to have been exposed to temperatures less than 2oC. In

addition it should be kept away from sources of direct heat, such as a

radiator and out of direct sunlight.

When the vaccine is transported to, and used in a school, it may not always

be practical to keep it stored between temperatures of 2o-8oC.

For the Wyeth product we have data to suggest that the stability of the

vaccine will not be impaired if it is kept at temperatures not exceeding

25oC for no longer than 24 hours.

On the basis of the above data, we would advise that for the Wyeth product,

unrefrigerated vaccine does not have to be discarded on the day of issue

but can be returned to appropriate refrigeration provided that:

Vaccine stored outside of the 2o-8oC recommended range is appropriately

marked before being returned to refrigeration to ensure that when next

issued it is used on that occasion.

Vaccine is only subjected to re-refrigeration on one occasion.

Total exposure time to temperatures between 8o and 25oC does not exceed 24

hours.

For the Chiron product we have data which demonstrates that the lyophilised

vaccine is stable when held for 3 months at 30oC, after storage at 2o-8oC

for 18 months. The diluent is stable for 18 months at 30oC.

On the basis of the above data for the Chiron product we would advise that

unrefrigerated vaccine does not have to be discarded on the day of issue

but can be returned to appropriate refrigeration provided that:

Vaccine stored outside of the 2o-8oC recommended range is appropriately

marked before being returned to refrigeration to ensure that when next

issued it is used on that occasion.

Total exposure time of the vaccine to temperatures between 8oC and 30oC

does not exceed 3 months.

The Department of Health is advising that any multi-dose vaccine once

reconstituted should be used within 4 hours.

For the North American Vaccine product we have data to suggest that the

stability of the vaccine will not be impaired if it is kept at temperatures

not exceeding 40oC for no longer than 30 days.

On the basis of the above data for the NAVA product we would advise that

unrefrigerated vaccine does not have to be discarded on the day of issue

but can be returned to appropriate refrigeration provided that:

Vaccine stored outside of the 2o-8oC recommended range is appropriately

marked before being returned to refrigeration to ensure that when next

issued it is used on that occasion.

Total exposure time of the vaccine to temperatures between 8oC and 40oC

does not exceed 30 days.

Q4: What is the shelf life of the vaccine?

A: The Wyeth and Chiron vaccines have a shelf life of 18 months.

The North American Vaccine product has a shelf life of 12 months.

Q5: What are the possible side effects? eg headaches

A: Meningococcal Group C conjugate vaccines are well tolerated in all age

groups. The rates of local reactions and systemic reactions are similar to

those seen previously with Hib vaccines. Further information is available

in the CMO Update 27 (August 2000), the joint CMO/CNO/CPhO Letter

(PL/CMO/99/4, PL/CNO/99/8,PL/CPHO/99/3 issued in October 1999), the

replacement chapter on Meningococcal Group C conjugate vaccine for

" Immunisation against Infectious Disease 1996 " , the leaflet 'Reduce the

risk: Your guide to the new meningitis vaccine' and in the Fact Sheet for

health professionals on Meningitis C conjugate vaccine.

The following side effects sometimes happen one to three days after

immunisation in the age groups shown below.

Babies Some redness or swelling where the injection was given.

One in two babies may become irritable.

One in 20 babies may have a mild fever.

Toddlers

(over 12 months)

Some redness or swelling where the injection was given.

One in five toddlers may become irritable.

One in 20 toddlers may have a mild fever.

Pre-school children

One in 10 children may have redness or swelling where the injection was

given.

About one in 100 children may have a mild fever.

One in 25 children may become irritable.

Children and

young people

About one in three may have some redness or swelling where the injection

was given and one in 100 may have a very sore arm from the injection which

may last a day or so.

About one in 50 may have a mild fever.

About one in 20 primary school children and one in seven secondary school

children may have a headache.

These side effects also occur at similar levels after other routine

immunisations given to babies, children and young people.

Following injections some young people may experience nausea, vomiting,

minor skin rashes, dizziness and tiredness and some young people may faint

at the time of the injection.

There have been very rare reports of people having fits: these have usually

been febrile or associated with fainting and recovery has usually been very

quick. Fits have not been shown to be caused by the vaccine.

Q6: How should any suspected adverse reactions be reported?

A: As this vaccine is a new product, it carries a 'black triangle' symbol.

If a doctor or pharmacist suspects any adverse reaction (ADRs) to the

vaccine, however minor, he/she should report this to the Medicines Control

Agency through the Yellow Card spontaneous reporting scheme in the normal

manner.

Reports of suspected ADRs will now be accepted by MCA directly from nursing

staff who are involved in administering the vaccine or involved in the care

of individuals receiving the vaccine, for the period of the meningitis

vaccine campaign. Nursing staff should complete and sign the Yellow Card

and include the doctor's name and address. When including the name and

address of the doctor the nurse does not need to obtain the doctor's

signature.

As there are now three suppliers of the vaccine it is important to identify

both the brand and the batch number of the vaccine when reporting an

adverse reaction.

Q7: Does the vaccine contain thiomersal, human albumin, bovine components

or human fetal material?

A: Manufacturers have been asked for answers to these points.

According to Wyeth, one of the components used in the manufacture of the

vaccine is derived from cow's milk but no bovine material is added to the

final product. The milk-derived components used in the production of the

vaccine comes from countries where no BSE has ever been reported. The

vaccine does not contain any thiomersal, human albumin or human fetal

material.

Chiron have stated that one of the components used in the manufacture of

the vaccine is derived from cow's milk but no bovine material is added to

the final product. The milk-derived component used in the production of the

vaccine comes from countries where no BSE has ever been reported (Australia

and/or New Zealand). The finished product does not contain thiomersal,

human albumin or human fetal material.

North American Vaccine has confirmed that the finished product does not

contain thiomersal, human albumin or human fetal material. Semi-solid

special agar containing beef broth is used for the initial propagation of

the Clostridium tetani seed cultures prior to inoculation of the fermentor.

No bovine material used in the early stages of the production is present in

the final product. A component derived from cow's milk is also used in the

vaccine manufacture, but not added to the final product.

Bovine materials used in production comply with the European CPMP

recommendations and are sourced from 'BSE-free' countries according to the

current criteria.

Q8: Is the vaccine genetically modified?

A: Two of the vaccines are manufactured using a natural genetic variant as

a carrier protein.

This component has been used for many years in other vaccines.

Q9: Are the different brands of Meningitis C vaccine interchangeable?

A: The new meningococcal C vaccines use the same technology as that

applied to the development of Hib conjugate vaccines. Experience from the

use of Hib vaccines suggests that different brands of the Meningitis C

vaccine are interchangeable.

Q10: Can this vaccine be given with other vaccines including travel vaccines?

A: As we have advised in the DH fact sheet for health professionals on

Meningitis C vaccine, studies have shown that this vaccine can be safely

given with routine childhood immunisations including DTP/Hib, MMR, DT, Td,

oral polio vaccine and IPV.

There are no studies to date on hepatitis B or BCG vaccine being given at

the same time although there is no reason to suspect an interaction. BCG

vaccine has been given within a month of meningococcal C conjugate vaccine

with no adverse effects.

Travel vaccines other than the meningococcal plain polysaccharide A and C

vaccine can be given at the same time as the meningococcal C conjugate

vaccine but as with other vaccines, it is preferable to administer them at

different sites.

Q11: Should the meningococcal C conjugate vaccine be given to patients who

have received the meningococcal plain polysaccharide A and C vaccine in the

past?

A: A gap of six months is suggested between the administration of the

meningococcal plain polysaccharide A and C vaccine and the subsequent

meningococcal C conjugate vaccine except in conditions of very high risk in

young children (under five years of age) who would not be expected to have

responded well to the earlier administration of the C component of the

polysaccharide vaccine. Such children may receive the meningococcal C

conjugate vaccine at least two weeks after the plain polysaccharide A and C

vaccine.

Q12: How long after the administration of the meningococcal C conjugate

vaccine can the meningococcal plain polysaccharide A and C vaccine be given?

A: A minimum of two weeks should be left after the administration of the

meningococcal C conjugate vaccine before the meningococcal plain

polysaccharide A and C vaccine is given.

Q13: Can the new meningococcal vaccine be given for travel purposes?

A: Meningococcal plain polysaccharide A & C vaccine (ACVax or Mengivac A +

C) is still recommended for people travelling to high risk countries.

Vaccine required for travel immunisation must be ordered from the

manufacturers in the usual way.

Q14: What advice do we give if asked about interactions between the

vaccine and drinking alcohol and the use of illicit drugs?

A: There are no known interactions with consumption of alcohol. We have no

information on any interactions between meningococcal C vaccine and illicit

drugs.

Q15: Are there adequate patient information leaflets supplied with

multidose presentations?

A. We understand that there are adequate patient information leaflets for

each dose of vaccine.

Q16: How are consumables supplied?

A: Consumables such as needles, syringes and 'sharps' bins are obtained

locally and distributed through the normal channels.

Q17: Are anaphylactic packs available?

A: These are provided locally as for any routine immunisations.

The advice on the management of anaphylaxis provided in 'Immunisation

against Infectious Disease 1996' remains current.

Q18: What funding is available?

A: Resources are allocated to Health Authorities, according to the school

aged target population, through a Cash Limit Adjustment. Across all English

Health Authorities a total of £1.8m last year and around £6.5m this

financial year has been allocated. This represents an allocation of £1 per

child aged 5 to 17 years and is used to support the schools' programme.

Trusts will need to contact Health Authorities to see how the money is

allocated within Health Authorities.

Q19: How is the input of pharmacy services to this campaign supported?

A: Trust Chief Pharmacists negotiate with Health Authorities/Trusts to

ensure that the programme is appropriately resourced.

Details of the additional activities which need to be resourced were given

in the joint professional letter from

CMO/CNO/CPhO(PL/CMO/99/2,PL/CNO/99/4,PL/CPHO/99/1) dated 20 July 1999.

Further information

For details of other questions which have been asked it would be best to

contact your local Drug Information Pharmacist.

There is a factsheet on meningococcal C vaccine as part of the HEA - now

Health Promotion England - series for health professionals. This was sent

directly to all health professionals on the HEA/HPE database. There is also

available a parent information leaflet 'Meningitis C Reduce the Risk. Your

guide to the new meningitis C vaccine' available through local suppliers or

from Health Promotion England. Details can be found on the HEA/HPE website

at www.immunisation.org.uk.

This Q and A is available on the Department of Health website at:

http://www.doh.gov.uk/meningitis-vaccine.htm.

DEPARTMENT OF HEALTH

AUGUST 2000

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

Sheri Nakken, R.N., MA

Vaccination Information & Choice Network, Nevada City CA & Wales UK

$$ Donations to help in the work - accepted by Paypal account

vaccineinfo@...

(go to http://www.paypal.com) or by mail

PO Box 1563 Nevada City CA 95959 530-740-0561 Voicemail in US

http://www.nccn.net/~wwithin/vaccine.htm

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. THE

DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

Well Within's Earth Mysteries & Sacred Site Tours

http://www.nccn.net/~wwithin

International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine Dangers

Education, Homeopathic Education

CEU's for nurses, Books & Multi-Pure Water Filters