Cervical Cancer Jabs Suspended After Girl, 14, Dies

[TrueScotsman]

http://news.sky.com/skynews/Home/UK...es_After_Having_Cervical_Cancer_Jab_At_School

The cervical cancer vaccination programme in Coventry has been suspended following the sudden death of a 14-year-old girl who had received the HPV1 Cervarix jab.

Coventry Health Authority has made the announcement a day after Natalie Morton died in hospital shortly after being given the vaccine.

She apparently suffered a "rare but extreme reaction" after being given the injection.

Natalie was a pupil at Blue Coat Church of England School in Coventry.

Counselling has been offered to traumatised fellow pupils at the school, some of whom broke down in tears after finding out about Natalie's death.

On a tribute site to Natalie set up on social networking site Facebook, Ellen Elizabeth Slack, from Blue Coat, said: "I'm so shocked by what has happened today.

"It feels so wrong that something that should help to avoid an illness could cause this."

Headteacher Julie Roberts told Sky News that bereavement counsellors were on hand and special assemblies would be held.

"We have all the chaplains in today to talk to the children," she said.

"We have made provision for counselling and we have a school chaplain for every year."

Sky News correspondent David Crabtree said that while some children were voicing fears and concerns the message from teachers and authorities was "not to panic".

"Understandably, children are shocked and scared. There has been talk of children bursting into tears in the school classrooms and corridors, hugging each other and leaving flowers," he said.

"But the message to parents is to be vigilant - to keep a close eye on their daughters to make sure everything is ok, but not to spread panic."

Health bosses in Coventry have launched an "urgent" investigation following the tragedy.

Natalie had had the vaccine as part of the national immunisation programme to protect women against the disease.

A small number of other girls at the school also reported mild symptoms, such as dizziness and nausea, but were not admitted to hospital.

 

[TrueScotsman]

Re: Cervical Cancer Jabs Suspended After Girl, 14, Dies

http://news.bbc.co.uk/1/hi/health/8279855.stm

Health chiefs have launched a "full and urgent" investigation into the death of a 14-year-old girl after she was given a cervical cancer vaccine at school.

Post-mortem tests into the exact cause are expected to be held on Tuesday.

The girl, named as Natalie Morton, died in hospital on Monday after receiving the Cervarix jab at the Blue Coat CofE School in Coventry.

There have been 4,657 suspected reactions to Cervarix from more than 1.4m doses, according to experts.

The Medicines and Healthcare Regulatory Agency added it had received 2,137 reports between 14 April 2008 and 23 September this year.

However, the risk of severe, potentially life-threatening reactions is estimated at no more than one per million doses of vaccine.

And it is possible that Natalie's death was due to an underlying health problem, or was a coincidence, and nothing directly to do with the vaccine.

Dizziness and nausea

The batch of the vaccine used has been placed into quarantine as a "precautionary measure".

The local NHS also confirmed the vaccination programme would continue, but after a "short pause".

Dr Caron Grainger, joint director of public health for NHS Coventry and Coventry City Council, said their sympathies were with the girl's family and friends.

She said: "The incident happened shortly after the girl had received her HPV vaccine in the school. No link can be made between the death and the vaccine until all the facts are known and a post-mortem takes place.

"We are conducting an urgent and full investigation into the events surrounding this tragedy."

The teenager died at the city's University Hospital on Monday lunchtime.

A small number of girls at the school had also reported mild symptoms such as dizziness and nausea but were not admitted to hospital.

In a statement posted on the school's website, headteacher Dr Julie Roberts said during the immunisation, "one of the girls suffered a rare, but extreme reaction to the vaccine".

"A number of other girls also reported being unwell and some were sent home," she said.

"If your daughter has received a vaccine today we ask that you are extra vigilant regarding any signs or symptoms."

She listed possible reactions as mild to moderate short-lasting pain at the injection site, headache, muscle pain, fatigue and a low-grade fever.

The injection - part of a national immunisation programme - protects against the human papilloma virus (HPV), a sexually transmitted disease linked to most cervical cancers.

A routine programme of vaccinating 12 and 13-year-old girls started in September 2008 across the UK using the Cervarix vaccine made by GlaxoSmithKline. A catch-up campaign is now under way for older girls.

It is thought about a million girls have already safely received the jab.

Dr David Elliman, a consultant in community paediatrics at Great Ormond Street Hospital, told the BBC it was important to investigate "very quickly" to allay people's fears about the safety of the jab.

He said: "Once in a while you will expect someone to have a severe allergic reaction to a vaccine, just as with food or any medication.

"At this stage we don't know what was the tragic cause of this child's death, so whether or not it's linked we cannot say, but these are the sort of things one would look for - a severe allergic reaction or more likely a coincidence."

When the national immunisation project was announced, there was some controversy about the selection of Cervarix over Gardasil, which is used by the majority of vaccination programmes worldwide.

Dr Pim Kon, medical director at GlaxoSmithKline UK, which makes Cervarix, said: "Our deepest sympathies are with the family and friends of the young girl.

"We are working with the Department of Health and MHRA (Medicines and Healthcare products Regulatory Agency) to better understand this case, as at this stage the exact cause of this tragic death is unknown."

The global pharmaceutical company added that the vast majority of suspected adverse reactions have related either to the symptoms of recognised side-effects or were due to the injection process and not the vaccine itself.

Safety record

Public Health Minister Gillian Merron said: "Our deepest sympathies are with the family. It is important we have the results of further investigations as soon as possible to establish the cause of this sad event."

Public Health Minister Gillian Merron said: "Our deepest sympathies are with the family. It is important we have the results of further investigations as soon as possible to establish the cause of this sad event."

In the UK, about 3,000 women are diagnosed with cervical cancer every year and about 1,000 die from it.

The department said Cervarix had a strong safety record.

Shadow health secretary Andrew Lansley said the tragedy needed to be investigated "as a matter of urgency".

There are more than 100 types of HPV but only 13 of them are known to cause cancer.

Cervarix protects against two strains of HPV that cause more than 70% of cases of cervical cancer in women.

Vaccination is not compulsory and consent is required before it is administered to the under-16s.

 

[TrueScotsman]

Cancer Jab 'Unlikely To Have Killed' Teen

Cancer Jab 'Unlikely To Have Killed' Teen

Source : http://news.sky.com/skynews/Home/UK...en_Most_Unlikely_To_Have_Died_After_Injection

A 14-year-old girl who died shortly after being given a cervical cancer vaccine had a "serious underlying medical condition".

Natalie Morton collapsed at Coventry's Blue Coat Church of England School on Monday and died in hospital.

Preliminary results from post-mortem tests indicated it was "most unlikely" the HPV jab caused her death.

Dr Caron Grainger, of NHS Coventry and Coventry City Council, said: "We are awaiting further test results which will take some time.

"However, indications are that it was most unlikely that the HPV vaccination was the cause of death.

"We would again like to reiterate our sincere sympathies to the family and friends of Natalie Morton during this difficult time."

The post-mortem examination was carried out at University Hospital in Coventry and Natalie's family have been informed of the initial results.

Meanwhile, the NHS quarantined the batch of Cervarix vaccine and schools and primary care trusts temporarily suspended the immunisation programme.

Manufacturer GlaxoSmithKline recalled the specific batch of vaccine for further testing.

But health officials sought to reassure parents of the safety of the jab amid growing confusion and said the vaccination programme should continue using fresh supplies.

A Department of Health spokesman said: "As a purely precautionary measure, we have asked the NHS to quarantine all stocks of HPV vaccine from the batch related to this case.

"No link can be made between the death and the vaccine until all the facts are known."

Natalie's headteacher earlier spoke of the school's shock and sadness at her death and said children have been offered counselling.

Bishop of Coventry the Rt Rev Dr Christopher Cocksworth visited Blue Coat to speak to pupils, many of whom left personal messages for Natalie at a wooden cross near the school gates.

The impromptu remembrance garden also featured flowers left by friends of the teenager and messages weighed down with candles.

 

[Vibrant62]

Re: Cervical Cancer Jabs Suspended After Girl, 14, Dies

1. NAME OF THE MEDICINAL PRODUCT
Cervarix suspension for injection in pre-filled syringe

Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)



Go to top of the page2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:

Human Papillomavirus1 type 16 L1 protein2,3,4 20 micrograms

Human Papillomavirus1 type 18 L1 protein2,3,4 20 micrograms

1Human Papillomavirus = HPV

2adjuvanted by AS04 containing:

3-O-desacyl-4'- monophosphoryl lipid A (MPL)3 50 micrograms

3adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+ in total

4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.

For a full list of excipients, see section 6.1.

SPC Information

 

[german-docter]

Re: Cervical Cancer Jabs Suspended After Girl, 14, Dies



related links:

http://jama.ama-assn.org/cgi/content/abstract/302/7/750

JAMA Vol. 302 No. 7, August 19, 2009

Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

Barbara A. Slade, MD, MS; Laura Leidel, RN, FNP-C, MPH; Claudia Vellozzi, MD, MPH; Emily Jane Woo, MD, MPH; Wei Hua, MD, PhD; Andrea Sutherland, MD, MSc, MPH; Hector S. Izurieta, MD, MPH; Robert Ball, MD, MPH; Nancy Miller, MD; M. Miles Braun, MD, MPH; Lauri E. Markowitz, MD; John Iskander, MD

JAMA. 2009;302(7):750-757.
Context In June 2006, the Food and Drug Administration licensed the quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine (qHPV) in the United States for use in females aged 9 to 26 years; the Advisory Committee on Immunization Practices then recommended qHPV for routine vaccination of girls aged 11 to 12 years.

Objective To summarize reports to the Vaccine Adverse Event Reporting System (VAERS) following receipt of qHPV.

Design, Setting, and Participants Review and describe adverse events following immunization (AEFIs) reported to VAERS, a national, voluntary, passive surveillance system, from June 1, 2006, through December 31, 2008. Additional analyses were performed for some AEFIs in prelicensure trials, those of unusual severity, or those that had received public attention. Statistical data mining, including proportional reporting ratios (PRRs) and empirical Bayesian geometric mean methods, were used to detect disproportionality in reporting.

Main Outcome Measures Numbers of reported AEFIs, reporting rates (reports per 100 000 doses of distributed vaccine or per person-years at risk), and comparisons with expected background rates.

Results VAERS received 12 424 reports of AEFIs following qHPV distribution, a rate of 53.9 reports per 100 000 doses distributed. A total of 772 reports (6.2% of all reports) described serious AEFIs, including 32 reports of death. The reporting rates per 100 000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barr? syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease. Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.

Conclusions Most of the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events. The significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system.

Author Affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia (Drs Slade, Vellozzi, Markowitz, and Iskander and Ms Leidel); US Food and Drug Administration,Washington, DC (Drs Woo, Hua, Sutherland, Izurieta, Ball, Miller, and Braun).


http://www.cdc.gov/vaccinesafety/vaers/HPV_JAMA.htm
CDC: Summary of HPV Adverse Event Reports Published in JAMA

 

[hermit]

Re: Cervical Cancer Jabs Suspended After Girl, 14, Dies

Autopsy has shown that the girl had a "serious underlying health problem" and that it is unlikely that the death was due to the vaccine.

 

[TrueScotsman]

Cancer Vaccine 'Not A Factor' In Teen's Death

Cancer Vaccine 'Not A Factor' In Teen's Death

Source : http://news.sky.com/skynews/Home/UK..._Natalie_Mortons_Death:_Teen_Had_Chest_Tumour

The cervical cancer vaccine did not contribute to 14-year-old Natalie Morton's death, an inquest has been told.

The teenager died from a malignant tumour in her chest which affected her heart and lungs, the deputy coroner for Coventry said.

The inquest heard the tumour was so severe, Natalie could have died at any time.

Outside court, the girl's stepfather said she was a "kind and fun-loving teenager with a beautiful smile".

Andrew Bullock added: "We now know that Natalie's death was the result of a serious underlying medical condition and most probably nothing to do with the vaccine that she had at school."

The girl collapsed at the Blue Coat Church of England School on Monday shortly after receiving the cervical cancer jab.

She died later that day in hospital.

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