Here's some important news (below), although you wouldn't know it
from the headline--
or the lede, which makes it seem as if the issue here is swine flu's
toll "in other countries."
The issue, rather, is our susceptibility to H1N1, and the safety of
the vaccine that our
government is urging (and may be requiring) us to take.
It's actually good news: that the government--"for now"--will not
allow the use of
adjuvants in the vaccine. This represents the confirmation of a shift
in policy that they
announced a few weeks back, since, prior to that, they'd bought a
large supply of squalene,
an adjuvant that (like all the other adjuvants out there) has not
been adequately tested.
So they decided not to let the manufacturers use squalene (or any
adjuvants); and the
manufacturers pushed back, because using it is in their interests.
(It stretches the available
supply, and therefore makes them more money.) And since the
manufacturers have not
stopped pushing (see below), it's good news that the Times got Jesse
Goodman and
Anthony Fauci to confirm the government's anti-squalene position on the record.
This doesn't mean that the vaccine is A-OK. The fact is that we don't
yet know it's safe,
because it hasn't been properly tested (although we keep on hearing
that it has). But at
least the government has ("for now") been receptive to the argument
that adjuvanted
vaccines are just too risky.
So, if you're interested in learning more, and/or in telling the
government that you approve
of their new policy (so that "for now" becomes "for good"), here's
some useful info:
For excellent coverage, by an expert, of all this, read Dr. Meryl
Nass's blog, at
http://anthraxvaccine.blogspot.com/. She's on top of this, and really
knows her stuff.
And, at CDC, the man in charge of vaccine safety is one John
Iskander. His e-mail
address is <mailto:[email protected]>[email protected].
MCM
Benefit and Doubt in Vaccine Additive
By ANDREW POLLACK
http://www.nytimes.com/2009/09/22/health/22vacc.html?hp
Are Americans obligated to use an unproven vaccine to help protect
people in other countries from the flu pandemic?
That is the crux of a debate over adjuvants - a class of substances
that somewhat mysteriously increase the potency of vaccines. Early
studies suggest that adjuvants (pronounced AD-joo-vants) could allow
four times as many people to be immunized against the H1N1 pandemic
influenza with a given amount of vaccine. So with the world facing
possibly severe shortages of vaccine, the World Health Organization
and some health experts have been calling for the use of adjuvants to
stretch the vaccine supply.
"We have always argued that using adjuvanted vaccine would leave more
vaccine for poor people," said Marie-Paule Kieny, director of the
World Health Organization's initiative for vaccine research.
Wealthy nations have contracted for much of the expected pandemic
vaccine production, leaving little for poorer countries. But while
Canada and some European nations will use vaccines containing
adjuvants, American officials have decided against it for now. They
say that they have enough vaccine and that the safety of the
additives has not been proved.
"These are products that potentially can be given to millions of
healthy people," said Dr. Jesse Goodman, chief scientist at the Food
and Drug Administration. "There is not a known, specific safety
danger or issue" with the adjuvants, Dr. Goodman acknowledged.
"There's just more uncertainty."
Officials also fear that using an adjuvant would raise public fears
about vaccine safety at a time when their challenge might be about to
shift from procuring enough vaccine to persuading people to use it.
"If you add what the public would perceive as another unknown there,
there's a concern that people would be reluctant to get vaccinated,"
said Dr. Anthony S. Fauci, director of the National Institute of
Allergy and Infectious Diseases.
Furthermore, officials say, one reason to use adjuvants is that they
can increase a vaccine's potency against a virus to which it is
poorly matched. But the swine flu vaccine is well matched to the
virus, which has not mutated.
In the last two weeks, new data has lifted some of the pressure on
the government to use adjuvants. Early studies suggest that even
without an adjuvant, a single injection of swine flu vaccine - rather
than the two anticipated - will confer adequate protection on adults
and children at least 10 years old. That effectively doubles the
number of people who can be immunized, and last week the government
said it would make 10 percent of its roughly 200 million vaccine
doses available to other countries. Eight other nations are also
releasing some vaccine.
Still, Dr. Tadataka Yamada, president of the global health program at
the Bill and Melinda Gates Foundation, said that most of the world's
population of six billion people, mostly in poorer countries, would
still be without vaccine, especially early in the pandemic.
Less vaccine than expected has been produced so far because of
manufacturing problems. "Over all, there is still clearly a shortage
of vaccine supplies," said Dr. Andrin Oswald, chief executive of the
vaccine business at Novartis. Except for the United States, Dr.
Oswald said, most countries ordering from Novartis have taken vaccine
with adjuvant.
Dr. Kieny, of the W.H.O., said as many as three billion doses of
vaccine could be produced in a year. But she said governments that
had ordered adjuvant vaccines should not abandon them. "There's no
reason to think these vaccines will not be safe," she said.
Even if adjuvants do not save the day in this pandemic, experts say
they will become increasingly important for vaccines against all
manner of diseases.
That is because many vaccines now being developed "simply don't work
that well without an adjuvant," said Dr. Thomas Monath, acting chief
medical officer of Juvaris BioTherapeutics, a company developing
adjuvants.
Vaccines once typically contained a weakened or killed pathogen to
spur an immune response. Some newer vaccines consist of only proteins
or protein fragments from a pathogen, which makes them purer, safer
and quicker to produce. But it turns out that the missing parts of
the pathogens help to jolt the immune system; without them, an
adjuvant is needed. Companies and academic laboratories are racing to
develop adjuvants, "mainly because everyone recognizes the adjuvant
could be the make-or-break component of a vaccine," Dr. Monath said.
Intercell, an Austrian company, is developing an adjuvant for flu
shots in a patch worn on top of the injection site for a few hours.
Scientists are also learning how adjuvants work and how to devise
them rationally rather than by trial and error.
"For the longest time, adjuvants were sort of a witch's brew of
substances, empirically designed," said Bali Pulendran, a professor
of pathology at Emory University. "What was once a black box is now
being illuminated at the mechanistic level by new advances in
immunology."
The term adjuvant, from a Latin word meaning "to help," was coined in
the 1920s by Gaston Ramon, a veterinarian at the Pasteur Institute in
France, who observed that horses given diphtheria toxin had a
stronger immune response if they had some inflammation at the
injection site. Among his first adjuvants were bread crumbs and
tapioca.
Within a few years, scientists discovered that aluminum salts could
prompt an immune response. Alum, as this adjuvant is often called, is
now used in various vaccines, including those for tetanus and
hepatitis B. It is a relatively weak adjuvant. But about 80 years
after its discovery, it is still the only one used in vaccines the
United States.
That could soon change. An advisory committee to the F.D.A. recently
recommended approval of Cervarix, a vaccine against the virus that
causes cervical cancer. The vaccine, made by GlaxoSmithKline, uses an
adjuvant containing a bacterial lipid. (Gardasil, the Merck cervical
cancer vaccine already in use, has an aluminum adjuvant.)
Alum is not used in flu shots because it has little effect. But
Novartis and GlaxoSmithKline are selling pandemic flu vaccines
containing newer adjuvants they have developed. They are oil-in-water
emulsions of squalene, a lipid that is found in the body. Glaxo's
also contains vitamin E.
A seasonal flu vaccine containing Novartis's MF59 adjuvant has been
used in Europe since 1997. Glaxo's adjuvant, called AS03, is in a
vaccine approved in Europe for use against the H5N1 bird flu, which
spurred fears of a pandemic a few years ago.
For the bird flu, an adjuvant was crucial because vaccines without
adjuvants did not work well in tests and required huge doses. Glaxo's
vaccine required only one twenty-fourth as much antigen, the viral
component of the vaccine, as another company's vaccine that did not
contain an adjuvant.
Thinking the swine flu might pose the same problem, federal officials
ordered $700 million worth of adjuvant from Novartis and Glaxo.
If the adjuvants were used, they would have to be combined with the
vaccine before the injection was given. And because the adjuvants
have not been approved by the F.D.A., they would fall under a
so-called emergency use authorization.
But in the last two weeks it has been learned that the vaccines
against the H1N1 virus stimulate a strong response on their own. A
single shot containing 15 micrograms of antigen - the same amount
used for each strain in a seasonal flu vaccine - should confer
adequate protection for most people.
Preliminary data from GlaxoSmithKline show that a vaccine with an
adjuvant might use only one-fourth as much antigen. But federal
officials say the savings are not large enough to offset the possible
risks and extra complexity of using the adjuvants.
While adjuvants tend to increase the temporary pain, swelling or
fatigue caused by a vaccine, the main concern is whether they might
cause an autoimmune disease, like rheumatoid arthritis, in which the
immune system attacks the body's own tissues. Some animal studies
have suggested that possibility.
Last year, the F.D.A. halted a clinical trial of a hepatitis B
vaccine containing a novel adjuvant after one participant developed a
type of blood-vessel inflammation that is considered an autoimmune
disease. But the agency lifted its hold this month, apparently
satisfied that the vaccine, made by Dynavax Technologies, was not the
cause.
Adjuvant makers say there is no cause for concern with the flu
vaccines. Dr. Bruce Innis, head of the clinical flu vaccine team at
GlaxoSmithKline, said the immune response spurred by his company's
adjuvant was directed only at the antigen in the vaccine. "There is
not a general upregulation of immune responses across the body,"
which would be needed for an autoimmune disease, Dr. Innis said.
Novartis says more than 40 million doses of vaccine with its adjuvant
have been used in Europe, with no signs of problems. But Dr. Fauci,
of the National Institute of Allergy and Infectious Diseases, said
Novartis's adjuvant had been used mainly among the elderly, who
tended to have weaker immune systems. There is less data, he said, on
its use among children, younger adults and pregnant women.
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