http://www.vaccineinfo.net/issues/meningococcal/under_scrutiny.htm
taken from http://www.chiroweb.com/archives/18/22/05.html
by Michael Devitt,
Associate Editor
Last November, the British
government instituted a mass national immunization program designed to
vaccinate all children under 18 against meningitis C, a rare but potentially
fatal brain disease. A series of government documents obtained by The
Observer, a British newspaper, has revealed that more than 16,000 adverse
reactions possibly linked to two vaccines have been reported in the past 10
months, including 12 deaths that occurred in people after being vaccinated.
The vaccines in question, Meningitec and Meninjugate, are designed to offer protection from meningitis C, which
strikes approximately 1,500 people in the
Since the immunization program
began in November 1999, it has been under review by the Medicines Control
Agency (MCA) and the Committee on Safety of Medicines (CSM), which use a system
called the Yellow Card Scheme to report possible adverse reactions to drugs and
vaccines. Under the scheme, doctors, pharmacists, coroners and dentists are
advised to submit suspected adverse reactions to pharmaceuticals or new
vaccines to the MCA or CSM - even if they are not completely sure whether the
vaccine caused the reaction. The MCA and CSM, in turn, investigate all causes
of death and assess Yellow Card reports to determine any safety issues that may
be associated with a new drug or vaccine.
According to the Committee on
Safety of Medicines, more than 15 million doses of the vaccines have been
distributed in the U.K. Statistical analyses conducted by the British
Department of Health, claim the vaccine has reduced the number of meningitis
cases by as much as 85 percent, particularly among children aged 15-17 and
infants less than a year old.
Figures compiled by The Observer,
however, appear to contradict those published by the government. According to
their statistics, there has been only an 18 percent drop in the total number of
meningitis cases, from 713 cases during the first eight months of 1999 to 587
through the same time frame this year. Moreover, in parts of
The Observer also reported that as of August 29, MCA and
CSM had received 7,742 Yellow Card reports associated with the meningitis C
vaccine, with symptoms ranging from headaches and dizziness to vomiting and
convulsions. Although each report corresponded to one patient, many reports
listed more than one reaction (for instance, nausea and headache), bringing the
total number of adverse reactions that may have been caused by the vaccine to
16,527 - approximately one reaction for every 907 doses given.
In addition to the adverse
reactions, 12 deaths occurring in people who had been recently vaccinated have
been reported to the CSM. Seven of the deaths were a result of sudden infant
death syndrome (SIDS); one patient died of a convulsion 10 days after being
vaccinated.
While those numbers are high, the actual numbers may be much higher. The
Department of Health estimates that only 10-15 percent of reactions are
reported using the Yellow Card Scheme. Based on that estimation, the actual
number of people experiencing adverse reactions to the meningitis vaccine could
be in the tens of thousands.
Health officials have downplayed
those numbers, insisting that the vaccine has saved lives and prevented
disabilities. A statement released by CSM and the Joint Committee on Vaccination
and Immunisation in August said that "the
balance of risk and benefit is overwhelmingly favourable"
and that "there is no suggestion that this vaccine has led to any
deaths."
As worried parents and lawmakers
seek a peaceful conclusion, the situation has angered parents across the
"I am not convinced by
government reassurances," said Isabella Thomas, a member of Justice
Awareness Basic Support, a vaccination support group. "We are receiving
daily calls from parents whose children have had serious reactions. We believe
the government introduced it far too quickly."
Adam Finn, a pediatric expert at
Sheffield Children's Hospital, added that the vaccine was safe, but that it had
induced adverse reactions in a number of children. Finn also said that the
government has a duty to give the public all relevant information about the
vaccine. "The public has sufficient intelligence to make the decision for themselves," he said. "The way to get them to
accept it is to tell the whole story."
The situation
regarding the safety of the meningitis program was further called into question
in September, when it was learned that four of the medical experts responsible
for advising the government on the meningitis vaccine's safety had financial
ties to one or more of the vaccine's manufacturers.
Professor Janet Barbyshire,
a member of the Committee on Safety of Medicines and director of the Medical
Research Council, was found to have received support for academic research from
Wyeth and Chiron, the makers of the Meningitec and Meninjugate
vaccines currently used in the
In addition, three members of the
government's Joint Committee on Vaccination and Immunisation
were shown to have declared interests in vaccine manufacturers. One member, Dr.
David Goldblatt of the Institute of Child Health, was
found to have served on an advisory panel for Wyeth
and to have received research grants from both Wyeth
and North American Vaccines, which produces a third meningitis vaccine (Neisvac). Another, Professor Keith Cartwright, received
funding to "evaluate candidate meningicoccal
vaccines" for use in the
"This is a question of
propriety," said Norman Baker, the Liberal Democrat party's consumer
affairs spokesman, who has tabled parliamentary questions about the financial
interests of the committee members. "There must be enough independent
people around to give advice without turning to those who clearly have a
conflict of interests. I am not questioning their academic credentials, but
with the best will in the world, their judgments must be looked at in that
context."
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MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR
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MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN
IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN
CONSULTATION WITH YOUR HEALTH CARE PROVIDER.