http://www.usatoday.com/money/industries/health/drugs/2005-08-31-glaxo-flu-v
accine_x.htm
New flu vaccine, Fluarix, to be available for fall
By Anita Manning, USA TODAY
A new flu vaccine was approved Wednesday for sale in the USA this fall, and
a second manufacturer moved closer to getting the go-ahead, easing concerns
of a replay of last year's flu shot shortage.
GlaxoSmithKline's (GSK) Fluarix, which is widely used in Europe, got the
Food and Drug Administration's OK under an accelerated approval process.
"FDA's approval of Fluarix is a big step toward providing an adequate supply
of flu vaccine for the American public," Health & Human Services Secretary
Mike Leavitt said in a prepared statement.
Chiron, whose license was suspended last fall after its flu vaccine was
found to be contaminated with bacteria, got "favorable results" from the
FDA's July inspection of its plant in Liverpool, England, says Chiron
spokeswoman Alison Marquiss.
Full FDA clearance has not yet been achieved, but "there are no regulatory
hurdles except supplemental approvals and regular batch release," Marquiss
said, referring to FDA inspection of the final product, "and the fact that
we have to finish manufacturing (the vaccine)."
British regulators suspended Chiron's license in October. The FDA barred
U.S. distribution of the vaccine, which cut in half the nation's expected
supply of vaccine. That prompted rationing and prioritization of supplies
and distribution delays. At season's end, some doses went unused.
Sanofi Pasteur, the other major supplier of flu vaccine, has said it will
produce 60 million doses for the 2005-06 flu season, which generally begins
in late fall.
MedImmune has said it can make 3 million doses of its nasal spray vaccine,
FluMist, which is licensed for healthy people ages 5 to 49.
GlaxoSmithKline expects to distribute 8 million doses and "will begin
shipping immediately," spokeswoman Patty Seif says. Chiron, if approved, has
said it could supply 18 million to 26 million doses of Fluvirin.
http://www.ias.org.nz/thimerosal_and_formaldehyde.htm
Thimerosal and Formaldehyde
(Excerpted from Investigate Before You Vaccinate: making an informed
decision about vaccination in New Zealand, by Susan Claridge)
While the MoH claim that no scheduled childhood vaccines still contain
thimerosal, the “adult” Diphtheria-Tetanus vaccine which is administered at
11 years contains the controversial preservative, as does the Fluarix
vaccine that is currently recommended (although not scheduled) for children
six months of age and above. In addition, the adult hepatitis B vaccine
(H-B-VAXII) also contains thimerosal.
Thimerosal, also known as thiomersal, is an ethyl mercury sodium salt (49%
mercury); mercury is a heavy metal that is extremely toxic. Concerns about
the toxicity of mercury in vaccines and links between thimerosal and a vast
number of illnesses and disabilities, including neurotoxicity and
nephrotoxicity, led to calls for thimerosal to be removed from childhood
vaccines. It had already been banned by the US FDA in over-the-counter drug
preparations because of questions over safety. In the past some babies have
been exposed to cumulative levels of mercury that exceed US Environmental
Protection Agency recommendations.
Various international agencies agreed in 1999 that thimerosal should be
removed from vaccines although existing stocks of vaccines containing the
preservative continued to be injected into babies and children. It was
revealed in March 2002 that pharmaceutical company, Eli Lilly, knew as far
back as 1930 that thimerosal was hazardous to people exposed to, or injected
with, the compound.
Recent studies show that it inhibits phagocytes, one of the bodies most
vital immune defenses in blood. Van’t Veen states that “the ethylmercury
radical of the thiomersal molecule appears to be the prominent sensitiser.
The prevalence of thiomersal hypersensitivity in mostly selected populations
varies up to 18%, but higher figures have been reported.” Mercury
sensitivity, developed through repeated exposure from vaccines is one cause
of serious reactions to vaccines.
High-dose exposure to mercury is known to cause catastrophic developmental
effects. However, recent research has shown that even low dose exposure can
cause developmental problems including impairments in attention, memory,
learning, social behavior, and IQ. Bernard at al. write that “exposure to
mercury can cause immune, sensory, neurological, motor, and behavioral
dysfunctions similar to traits defining or associated with autism.” They
conclude that a review of the medical literature suggests that “many cases
of idiopathic autism are induced by early mercury exposure from thimerosal.”
It has also been linked to Alzheimer’s disease.
It is recognised that the individuals most sensitive to thimerosal toxicity
are the developing foetus and infants. The danger is greatest when the brain
is undergoing its most rapid devolpment (in utero and in infancy), yet the
Medical Establishment still recommends that pregnant women and babies should
be vaccinated with flu vaccines, all of which contain thimerosal. Research
published in the Journal of Pediatrics showed that there was a significant
increase in total mercury levels after vaccination in both pre-term and full
term babies, but that pre-term infants had the highest post-vaccinal levels.
Mercury is a known developmental toxicant and is suspected to be a
cardiovascular or blood toxicant, endocrine toxicant, gastrointestinal or
liver toxicant, immunotoxicant, kidney toxicant, neurotoxicant, reproductive
toxicant, respiratory toxicant, and skin or sense organ toxicant. It is more
hazardous than most chemicals in eight out of nine ranking systems and it is
ranked as one of the most hazardous compounds (worst 10%) to human health.