Meningitis C Vaccine

Meningitis Vaccine Blamed For Rise In Deaths

(Independent, September 20, 2004)


The success of a vaccination campaign against meningitis is being
blamed for a sudden rise in the number of deaths.

Cases of meningitis and septicaemia have fallen from about 4,000 a
year in the late 1990s to 2,446 last year following the introduction
of a vaccine against meningitis C in November 1999. But in a bizarre
twist the number of deaths rose last year by 17 per cent from 317 to
370 and is not far below the level before the vaccine was introduced.

Specialists say one reason for the rise in deaths is the mistaken
belief that the vaccine protects against all forms of meningitis. The
vaccine is only effective against meningitis C, cases of which have
fallen by 90 per cent, but offers no protection against the equally
deadly meningitis B.

The Meningitis Research Foundation is to launch a campaign this week
to alert the public to the risks. A spokes-woman said: "We are
extremely concerned about the rise in deaths. With cases declining
this is the last thing we want to see. We don't know why deaths are
rising but anecdotal evidence suggests many people think that since
the introduction of the meningitis C vaccine the problem is solved."

The vaccine is given routinely to all babies in the first months of
life and has also been administered in catch-up exercises to older
children and young adults.

But the foundation says this has generated a false sense of security
among the public and led parents and individuals to ignore symptoms,
leading to delays in getting help.

"In a survey of students we found that half thought that, because they
had been vaccinated, they couldn't get meningitis. They thought they
were OK and didn't have to worry any more. Callers to our helpline
said the same thing. So many mums said they didn't think their child
could get the disease because they had been vaccinated."

Meningitis is dangerous because of the speed and ferocity with which
it strikes. It can strike at any age but mostly affects infants and
students in their late teens and urgent medical attention is essential
to save lives.

Throughout the 1990s the death rate remained at about 10 per cent of
cases. But in 2002 it rose to 12 per cent and last year to 15. "We
hoped the rise to 12 per cent in 2002 was a blip. But when we saw it
had gone up again last year, we were alarmed," the spokeswoman said.
The foundation is launching its campaign, called "Race against time", tomorrow.

Despite Vaccine, Meningitis Takes Teens Life

Despite vaccine, meningitis takes teen's life
Strain of bacterial disease kills immunized Bentley freshman

By Tania deLuzuriaga, Globe Staff | October 10, 2007

When Bentley College freshman Erin M. Ortiz went home sick last weekend,
her mother did what any mother might do. She cooked comfort foods - corned
beef, rice, and plantains - reflecting her daughter's Puerto Rican and
Irish heritage.

"It was her favorite meal," said Brenda Rivera, a family friend.

But just hours after complaining of a headache and going to bed to sleep it
off, Ortiz, 18, was dead of bacterial meningitis, a disease against which
she had been vaccinated. Now, Ortiz's family hopes others will learn from
their story.

"I'm all cried out," said her father, Raymond Ortiz. "I've got a hole in my
heart. I don't think I'll ever be the same."

"We thought she'd be covered," he said. "They don't tell you that even if
you get the vaccine, you're still susceptible."

Like most incoming freshmen, Ortiz was vaccinated last summer.
Massachusetts law requires all college students to receive the vaccine. But
it protects only about 85 percent of recipients and is not effective
against all strains of the bacteria that cause infection in the brain and
spinal fluid, which can result in brain damage, hearing loss, learning
disability, or death.

"I wish we had a vaccine that worked 100 percent of the time," said Dr.
Richard A. Moriarty, a professor of clinical pediatrics at the University
of Massachusetts Medical School. "But this is certainly better than not
being immunized."

Editor's Comment: how does he know the vaccine didn't CAUSE meningitis rather than simply failing to protect?

Meningitis C vaccine, Mutations And Superbugs

A meningitis C vaccine was developed way back in the 1970's when I was a baby but scientists found that it caused a massive leap in the number of meningitis B cases so they abandoned the vaccine until an effective B vaccine could also be produced.

However, in 1999 a new meningitis C vaccine was introduced into the childhood vaccination programme despite the fact that we still don't have a meningitis B vaccine and they knew from prior research that a possible effect of the vaccine would be to increase other strains of meningitis.

The bacteria in the vaccine is killed, but studies of various vaccines have shown that killed bacteria and viruses are capable of mutating and can change from C strain to B strain, so if a person is vaccinated against C strain meningitis and then comes down with B strain afterwards, it may have been caused by his vaccine.

For instance, as reported in the New England Journal of Medicine (Volume 342:219-220, January 20, 2000, number 3), a 16 year old girl died of meningitis B after contracting meningitis from her boyfriend's meningitis C vaccine. It mutated into B strain and killed her:

Rapid Serogroup Switching in Neisseria meningitidis

To the Editor: In Neisseria meningitidis, the horizontal transfer of siaD genes encoding polysialyltransferases has been shown to result in capsular serogroup switching in vitro.1 The presence of closely related clones with different serogroups suggests that serogroup switching also occurs in vivo.2,3 However, the time course of the transfer of siaD genes in humans is unknown.

We describe a case of unexpectedly rapid serogroup switching in virulent meningococci. A 16-year-old girl died of fulminant serogroup B meningococcal septicemia. Examination of nasopharyngeal swabs from close contacts revealed massive colonization with serogroup C meningococci in the girl's boyfriend.

Meningitec Manufacturer's Information

. NAME OF THE MEDICINAL PRODUCT To the top of the page


Meningitec suspension for injection in pre-filled syringe

Meningococcal serogroup C oligosaccharide conjugate vaccine (adsorbed).

2. QUALITATIVE AND QUANTITATIVE COMPOSITION To the top of the page


One dose (0.5ml) contains:

Neisseria meningitidis (strain C11)

Serogroup C oligosaccharide……………… 10 micrograms

Conjugated to Corynebacterium diphtheriae

CRM197 carrier protein…………approximately 15 micrograms

Adsorbed on aluminium phosphate … 0.125 mg Al3+

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM To the top of the page


Suspension for injection, in pre-filled syringe. After shaking, the vaccine is a homogeneous, white suspension.



4. CLINICAL PARTICULARS To the top of the page



4.1 Therapeutic indications To the top of the page


Active immunisation of children from 2 months of age, adolescents and adults for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.

The use of Meningitec should be determined on the basis of official recommendations.




4.2 Posology and method of administration To the top of the page


Posology

There are no data on the use of different Meningococcal serogroup C conjugate vaccines within the primary series or for boosting. Whenever possible, the same vaccine should be used throughout.

Primary immunisation

Infants up to the age of 12 months: two doses, each of 0.5 mL, the first dose given not earlier than 2 months of age and with an interval of at least 2 months between doses.

Children over the age of 12 months, adolescents and adults: a single dose of 0.5 mL.

The timing of the doses should be in accordance with official recommendations.

Booster doses

It is recommended that a booster dose should be given after completion of the primary immunisation series in infants. The timing of this dose should be in accordance with available official recommendations. Information on responses to booster doses and on co-administration with other childhood vaccines is given in sections 5.1 and 4.5, respectively.

The need for booster doses in subjects primed with a single dose (i.e. aged 12 months or more when first immunised) has not yet been established.

Method of administration

Meningitec is for intramuscular injection, preferably in the anterolateral thigh in infants and in the deltoid region in older children, adolescents and adults. Meningitec should not be injected in the gluteal area.

Avoid injection into or near nerves and blood vessels.

The vaccine must not be administered intradermally, subcutaneously or intravenously (see section 4.4).

Separate injection sites should be used if more than one vaccine is being administered (see section 4.5). This vaccine must not be mixed with other vaccines in the same syringe.




4.3 Contraindications To the top of the page


• Hypersensitivity to the active substances or to any of the excipients.

• Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein.

• Hypersensitivity after previous administration of Meningitec.

• As with other vaccines, the administration of Meningitec should be postponed in subjects suffering from an acute severe febrile illness.




4.4 Special warnings and precautions for use To the top of the page


As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactoid/anaphylactic event following the administration of the vaccine (see section 4.8 Undesirable effects).

As with any intramuscular injection, the vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder or to those receiving anticoagulation therapy.

Meningitec will only confer protection against serogroup C of Neisseria meningitidis and may not completely prevent meningococcal serogroup C disease. It will not protect against other groups of Neisseria meningitidis or other organisms that cause meningitis or septicaemia. In the event of petechiae and/or purpura following vaccination (see section 4.8), the aetiology should be thoroughly investigated. Both infective and non-infective causes should be considered.

Although symptoms of meningism such as neckpain/stiffness or photophobia have been reported there is no evidence that the vaccine causes meningococcal C meningitis. Clinical alertness to the possibility of co-incidental meningitis should therefore be maintained.

Consideration should be given to the risk of Neisseria meningitidis serogroup C disease in a given population and the perceived benefits of immunisation before the institution of a widespread immunisation programme.

No data on the applicability of the vaccine to outbreak control are available.

The safety and immunogenicity have not been established in infants below the age of two months (see section 5.1 pharmacodynamic properties).

There are limited data on safety and immunogenicity of the vaccine in the adult population and there are no data in adults aged 65 years and older (see section 5.1).

Limited data are available on the use of Meningitec in immunodeficient subjects. In individuals with impaired immune responsiveness (whether due to the use of immunosuppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes) the expected immune response to meningococcal serogroup C conjugate vaccines may not be obtained. The implications for the actual degree of protection against infection are unknown, since this will depend also on whether the vaccine has elicited an immunological memory response. Individuals with complement deficiencies and individuals with functional or anatomical asplenia may mount an immune response to meningococcal serogroup C conjugate vaccines; however, the degree of protection that would be afforded is unknown.

The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born LESS-THAN OR EQUAL TO (8804) 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Immunisation with this vaccine does not substitute for routine diphtheria vaccination.

Meningitec SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY.




4.5 Interaction with other medicinal products and other forms of interaction To the top of the page


Meningitec must not be mixed with other vaccines in the same syringe. Separate injection sites should be used if more than one vaccine is being administered.

Administration of Meningitec at the same time as (but, for injected vaccines, at a different injection site) the following vaccines did not reduce the immunological response to any of these other antigens in clinical trials:

Oral Polio vaccine (OPV); Inactivated Polio vaccine (IPV); Hepatitis B vaccine (HBV); diphtheria and tetanus vaccine alone (D or T), in combination (DT or dT), or in combination with whole cell or acellular Pertussis vaccine (DTwP or DTaP); Haemophilus influenzae type b conjugate vaccine (Hib alone or in combination with other antigens) or combined Measles, Mumps, and Rubella vaccine (MMR).

Minor variations in geometric mean antibody concentrations (GMCs) or titres (GMTs) were observed between studies; however, the clinical significance, if any, of these observations is not established.

Data that support concomitant administration of Meningitec and an acellular Pertussis vaccine (i.e. DTaP) or an Inactivated Polio vaccine (IPV) are derived from studies in which subjects received either Meningitec or the same meningococcal serogroup C conjugate as in Meningitec combined with an investigational pneumococcal conjugate vaccine and from a study of concomitant administration with a pediatric combination vaccine (DTaP-HBV-IPV/Hib).

In various studies with different vaccines, concomitant administration of meningococcal serogroup C conjugates with combinations containing acellular pertussis components (with or without inactivated polio viruses, hepatitis B surface antigen or Hib conjugates) has been shown to result in lower SBA GMTs compared to separate administrations or to co-administration with whole cell pertussis vaccines. The proportions reaching SBA titres of at least 1:8 or 1:128 are not affected. At present, the potential implications of these observations for the duration of protection are not known.

Data on concomitant administration of Meningitec with 7-valent pneumococcal conjugate vaccine (Prevenar) are not available. However, data from an investigational combination vaccine (9-valent pneumococcal-CRM197 protein conjugate vaccine and meningococcal serogroup C-CRM197 protein conjugate vaccine [9vPnC-MnCC]) containing amongst others the same 7 conjugated pneumococcal serotypes as Prevenar have shown that meningococcal serogroup C (MnC) serum bactericidal antibodies(SBA) titres were lower in recipients of this combination than those receiving Meningitec alone, although almost all subjects achieved a titre of at least 1:8.

One study using a 2, 3 and 4 month schedule showed that 75% and 79% of vaccinees in two groups that received Meningitec alone for the primary series still had SBA titres of at least 1:8 at 12 months of age compared to only 28% and 31% in the two groups primed with the 9vPnC-MnCC vaccine. One month following the twelve-month booster dose, 100% of the MnCC group and 100% of the 9vPnC-MnCC group had SBA titres of at least 1:8.

The potential for immune interference in the antibody response between Prevenar and Meningitec should be taken into consideration before concomitant administration of these vaccines as a 2, 3, and 4 month or another primary series schedule. Consideration should also be given to the age at which the booster dose is administered following priming with concomitant Meningitec and Prevenar.




4.6 Pregnancy and lactation To the top of the page


Pregnancy

There are no clinical data on the use of meningococcal serogroup C conjugate vaccine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonal/foetal development, parturition and postnatal development (see 5.3. Preclinical safety data). The potential risk for humans is unknown.

Nevertheless, considering the severity of meningococcal serogroup C disease, pregnancy should not preclude vaccination when the risk of exposure is clearly defined.

Lactation

The risk-benefit relationship should also be examined before making the decision as to whether immunise during lactation.




4.7 Effects on ability to drive and use machines To the top of the page


No studies on the effects on the ability to drive and use machines have been performed.

Some of the effects mentioned under section 4.8 (Undesirable effects) such as dizziness and somnolence may affect the ability to drive or operate machinery.




4.8 Undesirable effects To the top of the page


Note: the following descriptions of frequency have been defined as: Very common (GREATER-THAN OR EQUAL TO (8805)10%); Common (GREATER-THAN OR EQUAL TO (8805)1% and <10%); Uncommon (GREATER-THAN OR EQUAL TO (8805)0.1% and <1%); Rare (GREATER-THAN OR EQUAL TO (8805)0.01% and <0.1%); Very rare (<0.01%), not known (cannot be estimated from the available data).

Adverse Reactions from Clinical Trials

Adverse reactions reported across all age groups are provided below. Adverse reactions were collected on the day of vaccination and the following three days. The majority of reactions were self-limiting and resolved within the follow-up period.

In all age groups injection site reactions (including redness, swelling and tenderness/pain) were very common. However, these were not usually clinically significant. Redness or swelling of at least 3 cm and tenderness interfering with movement for more than 48 hours was infrequent where studied. Transient injection site tenderness was reported in 70% of adults during clinical trials.

Fever of at least 38.0°C was common in infants and toddlers and very common in pre-school children, but did not usually exceed 39.1°C, particularly in older age groups.

In infants and toddlers crying was common after vaccination while drowsiness, impaired sleeping, anorexia, diarrhoea and vomiting were very common. Irritability was very common in infants and in toddlers and common in children aged between 3.5 and 6 years. There was no evidence that these were related to Meningitec rather than concomitant vaccines, particularly DTP.

In trials that evaluated three-dose schedules (2, 3 and 4 months or 2, 4 and 6 months) in infants, rates of adverse events did not increase with successive doses with the exception of fever GREATER-THAN OR EQUAL TO (8805)38°C. However, it should be noted that infants received other scheduled vaccines concomitantly with Meningitec in these studies.

Myalgia was common in adults. Somnolence was commonly reported in children between 3.5 and 6 years of age and in adults. Headache was common in children between 3.5 and 6 years of age and was very common in adults.

Adverse reactions reported across all age groups are provided below.

General Disorders and Administration Site Conditions:

Very common: Injection site reactions (e.g. redness, swelling, pain/tenderness)

Common: Fever GREATER-THAN OR EQUAL TO (8805) 38 °C

Additional reactions reported in infants (first year of life) and toddlers (second year of life) are provided below.

Metabolism and Nutrition disorders:

Very common: Anorexia

Psychiatric Disorders:

Very common: Irritability

Common: Crying

Nervous System Disorders:

Very common: Drowsiness, impaired sleeping

Gastrointestinal Disorders:

Very common: Vomiting, diarrhoea

Additional reactions reported in older age groups including adults (4 to 60 years) included:

Psychiatric Disorders:

Common: Irritability (children between 3.5 and 6 years of age)

Nervous System Disorders:

Very common: Headache (adults)

Common: Somnolence, headache (children between 3.5 and 6 years of age)

Musculoskeletal, Connective Tissue and Bone Disorders:

Common: Myalgia (adults)

Adverse Reactions from Post Marketing Surveillance (for all age groups)

These frequencies are based on spontaneous reporting rates and have been calculated using number of reports and number of doses distributed.

Blood and Lymphatic System Disorders:

Very rare: Lymphadenopathy

Immune System Disorders:

Very rare: Anaphylactoid/anaphylactic reactions including shock, hypersensitivity reactions including bronchospasm, facial oedema and angioedema

Nervous System Disorders:

Very rare: Dizziness, faints, seizures (convulsions) including febrile seizures and seizures in patients with pre-existing seizure disorders, hypoaesthesia, paraesthesia and hypotonia (including hypotonic-hyporesponsive episode [HHE])

There have been very rare reports of seizures following Meningitec vaccination; individuals have usually rapidly recovered. Some of the reported seizures may have been faints. The reporting rate of seizures was below the background rate of epilepsy in children. In infants seizures were usually associated with fever and were likely to be febrile convulsions.

There have been very rare spontaneous reports of hypotonic-hyporesponsive episode (HHE), a condition characterised by hypotonia and reduced responsiveness in association with pallor or cyanosis, in temporal association with the administration of meningococcal serogroup C conjugate vaccine. In most cases, meningococcal serogroup C conjugate vaccine was administered concomitantly with other vaccines, the majority of which were pertussis-containing vaccines.

Gastrointestinal Disorders:

Very rare: Vomiting, nausea, abdominal pain

Skin and Subcutaneous Tissue Disorders:

Very rare: Rash, urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome

Musculoskeletal, Connective Tissue and Bone Disorders:

Very rare: Arthralgia

Renal and Urinary Disorders:

Relapse of nephrotic syndrome has been reported in association with Meningococcal serogroup C conjugate vaccines.

Very rarely, petechiae and/or purpura have been reported following immunisation (see also section 4.4).

Apnoea in very premature infants (LESS-THAN OR EQUAL TO (8804) 28 weeks of gestation) (see section 4.4).




4.9 Overdose To the top of the page


There have been reports of overdose with Meningitec, including cases of administration of a higher than recommended dose at one visit, cases of subsequent doses administered closer than recommended to the previous dose, and cases in which the recommended total number of doses has been exceeded. Most individuals were asymptomatic. In general, adverse events reported with overdosage have also been reported with recommended single doses of Meningitec.



5. PHARMACOLOGICAL PROPERTIES To the top of the page



5.1 Pharmacodynamic properties To the top of the page


Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH07

Immunogenicity

No prospective efficacy trials have been performed.

Serological correlates for protection have not been definitively established for conjugated meningococcal C vaccines; these are under study.

The serum bactericidal antibody (SBA) assay referenced in the text below, used rabbit serum as a source of complement.

Primary Series in Infants

Two doses in infants provided SBA antibody titres (using baby rabbit complement) GREATER-THAN OR EQUAL TO (8805)1:8 in 98-99.5% of infants, as shown in the Table below. A two-dose infant schedule primed for a memory response to a booster dose given at 12 months of age.

% of subjects achieving GREATER-THAN OR EQUAL TO (8805)1:8 SBA titres (GMT)

STUDY with Meningitec given at age


AFTER 2ND DOSE


AFTER 12-MONTH booster

2, 3, 4 months with concomitant DTwP-Hib and OPV


98% (766)

n=55


(Not studied)

3, 5, 7 months given alone



99.5% (1591)#

n=214


(Not studied)

2, 4, 6 months with concomitant

DTaP-HBV-IPV/Hib*


99.5% (1034)#

n=218


(Not studied)

3, 5 months administered as 9vPnC-MnCC with concomitant DTaP-IPV/Hib


98.2% (572)

n=56


100% (1928)

n=23 (9vPnC-MnCC booster)

100% (2623)

n=28 (Meningitec+23vPnPS booster)

* See section 4.5

# measured at two months after the second dose

MnCC = meningococcal serogroup C conjugate vaccine (which is the active component in Meningitec)

DTwP = whole cell pertussis vaccine with diphtheria and tetanus toxoids

OPV = oral polio virus vaccine

DTaP-IPV/Hib = acellular pertussis components, diphtheria and tetanus toxoids, inactivated polioviruses and a Hib conjugate (tetanus toxoid carrier protein)

DTaP-HBV-IPV/Hib = as above plus recombinant hepatitis B surface antigen in a hexavalent formulation

9v-PnC-MnCC = investigational 9-valent pneumococcal conjugate vaccine (not licensed) formulated with meningococcal serogroup C conjugate vaccine (which is the active component in Meningitec)

23vPnPS = 23-valent pneumococcal polysaccharide vaccine

Immunogenicity of a single primary dose in toddlers

91% of 75 toddlers of 13 months of age developed SBA titers GREATER-THAN OR EQUAL TO (8805) 1/8 and 89% of these 75 subjects showed a four-fold increase over their pre-vaccination antibody titre after receiving a single dose of Meningitec.

Immunogenicity of a single primary dose in adults

All the 15 adults of 18-60 years who received a single dose of Meningitec achieved SBA titers GREATER-THAN OR EQUAL TO (8805) 1/8 and a four-fold rise in antibody titre.

There are no data in adults aged 65 years and older.

Post-marketing surveillance following an immunisation campaign in the UK

Estimates of vaccine effectiveness from the UK's routine immunisation programme (using various quantities of three meningococcal serogroup C conjugate vaccines) covering the period from introduction at the end of 1999 to March 2004 have demonstrated the need for a booster dose after completion of the primary series (three doses administered at 2, 3 and 4 months).

Within one year of completion of the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% CI: 67, 99). However, more than one year after completion of the primary series, there was clear evidence of waning protection. Estimates of effectiveness based on a small number of cases to date indicate that there may also be waning protection in children who received a single priming dose as toddlers. Effectiveness in all other age groups (up to 18 years) primed with a single dose has so far remained around 90% or more within and more than one year after vaccination.


5.2 Pharmacokinetic properties To the top of the page


Evaluation of pharmacokinetic properties is not required for vaccines.


5.3 Preclinical safety data To the top of the page


Female mice were immunised intramuscularly with twice the clinical dose of meningococcal serogroup C conjugate vaccine, either prior to mating or during the gestation period. Gross necropsy of viscera was performed on each mouse. All mice survived to either delivery or caesarean-section. No adverse clinical signs were present in any mouse and no parameters that were evaluated were affected by administration of the vaccine, in either the adult or foetal mice.

6. PHARMACEUTICAL PARTICULARS To the top of the page



6.1 List of excipients To the top of the page


Sodium chloride

Water for injections.


6.2 Incompatibilities To the top of the page


In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.




6.3 Shelf life To the top of the page


2 years.


6.4 Special precautions for storage To the top of the page


Store in a refrigerator (2°C – 8°C).Do not freeze. Discard if the vaccine has been frozen.

Store in the original package.


6.5 Nature and contents of container To the top of the page


0.5 ml of suspension in a pre-filled syringe (type I glass) and a plunger stopper (gray butyl rubber). Pack sizes of 1 and 10pre-filled syringes with or without needle.

Not all pack sizes may be marketed.


6.6 Special precautions for disposal and other handling To the top of the page


Upon storage, a white deposit and clear supernatant can be observed.

The vaccine should be well shaken in order to obtain a homogeneous white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. If this is observed, discard the vaccine.

Any unused product or waste material should be disposed of in accordance with local requirements.



7. MARKETING AUTHORISATION HOLDER To the top of the page


John Wyeth & Brother Limited

Huntercombe Lane South

Taplow, Maidenhead

Berkshire SL6 0PH

United Kingdom

MENINGITIS C VACCINE ALERT!

Two batches of Meningitis C vaccine which were distributed in January and February of 2009 are being recalled as they were found to contain Staphylococcus aureus, a potientially dangerous bacteria.

Hundreds, if not thousands of babies could have already been injected with vaccines from the bad batches. The batch numbers are 235012A and 236011.

Novartis Vaccines have stated:

'Novartis Vaccines and Diagnostics S.r.l. are recalling the above batches of Menjugate Kit as a precaution following an initial failure of a sterility test carried out as part of a shipping validation study of the batch of aluminium hydroxide solvent used in them, batch number 088902. This batch passed its sterility test at the time of release.

The tested samples were of one batch of solvent used in two batches (235012A and 236011) of Menjugate Kit, and were identified positive for the bacteria Staphylococcus aureus.

Novartis are investigating the root cause for the non-conforming sterility result. We have no evidence that any other lots of Aluminum-hydroxide solvent would be impacted.

Source: http://www.mhra.gov.uk/Publications/Safetywarnings/Drugalerts/CON038882 25th February 2009.

Antibodies From Meningitis C Vaccine Only Last 3 to 5 Years

Serogroup C meningococcal conjugate vaccines were introduced in Greece in 2001, and although no cases of serogroup C meningococcal disease were recorded in 2004, a steady increase was observed since 2005. In this study, serum bactericidal activity was assessed in sera of 269 vaccinated children at a mean time of about 5 years after vaccination. Non-protective antibody titers were observed in most children vaccinated at age <6 years (85.9%), followed by those between 6 and 10 years (62.2%). This percentage was considerably lower in adolescents vaccinated at an age >10 years (37.8%) (p < 0.01). Geometric mean concentrations of serum IgG antibodies against serogroup C showed a similar variation. The results indicate that serum bactericidal antibody titers significantly correlate with age of vaccination; most children do not have protective antibody titers few years after immunization in infancy and childhood.

Source: Vaccine,
Volume 27, Issue 33, 16 July 2009, Pages 4408-4411

Meningitis C Vaccine Wears off - only 25% of Teens show Antibodies

Three-quarters of children vaccinated against meningitis C lose their protection against the disease by their early teens, research suggests.

The Oxford team which did the work says its findings fuel calls for a booster jab to be offered to adolescents.

The study of 250 children aged six to 12, presented to a European conference, looked at immunity seven years after the jab was given.

UK experts agreed a booster may be needed in the future.

The research was carried out by the Oxford Vaccine Group at Oxford University.

By giving each teenager a booster dose of meningococcal vaccine as they are entering adolescence, we can ensure that they are protected when they most need it
Dr Jamie Findlow, Health Protection Agency

The group tested the children, who had all been vaccinated against meningitis C, for levels of antibodies against the bacteria in their bloodstream.

It was found that just 25% of the children had sufficiently high levels of the antibodies to give them protection against the disease.

Source: BBC News, 7 May 2010.

Teen Dies of Meningitis after Failing to Go to the Doctor Because She Thought She was Vaccinated

When Ohio University freshman Andrea Robinson felt sick in February, she and her father thought it was the flu.

They had heard about several cases of meningitis on campus, but she reminded her father that she was vaccinated against the disease so he didn't have to worry, ONN's Cristin Severance reported on Wednesday.

"I talked to her at the end of the day Monday and I said 'How are you feeling?'" Joe Robinson said. "She said that she was feeling a lot better and that her fever broke. She said that she was just going to lay down for a nap. Those were the last words I spoke to her, ever."

Andrea Robinson had contracted the "B-Strain" of bacterial Meningitis, which is a strain with no vaccine.

Joe Robinson said that all the warnings from Ohio University about the disease never mentioned the fact there was no vaccine.

"We were told to get these kids vaccinated," Joe Robinson said. "Every time one of these alerts came out that there is Bacterial Meningitis at OU, it said to get your kids vaccinated. That's what we were told, which did not give myself the comfort, but the kids comfort. They thought we are protected, we were vaccinated."

Joe Robinson said a week after his daughter's death was the first time the university sent an alert warning about the B-strain.

"Right at the time that Andrea passed, the dean of the school reassured me that they were going to do everything they could to get to this," Joe Robinson said.

He said that he never heard from Ryan Lombardi, dean of students, or anyone from the school again.

Then at the end of October, the family received a letter.

It was addressed to Robinson asking her why she hadn't returned to OU and wanting her to fill out a brief survey.

"This just goes to show you, the impersonal attitude that they have towards the kids at the school, and the families," Joe Robinson said. "I mean, what more extreme can you have? You lost a kid at your school and nine months later you don't even remember why they left your school?"

He said that he fired off a letter back to the school sharing his frustrations ( click here to read both letters ). He didn't even want a reply and said he would have never even talked publicly about these issues, until now.

"The letter just said to me, that they didn't care or they are incompetent," Joe Robinson said. "To me those are the same answers on why we weren't told about the B-strain. Either they don't care or they are incompetent. Neither one of those are a good answer for an education system."

Now, all he wants is the college to educate not just about the disease, but about the strain that killed his daughter.

Source: newsnet5.com, 18 November 2010.