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Thursday, July 30, 2009

Swine Flu Vaccine Priorities

A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

In this update:
(1) Pregnancy
(2) ACIP meeting
[3] Adjuvants

[1] Pregnancy
Date: Tue 28 Jul 2009
Source: CIDRAP NEWS, Associated Press report [edited]

Pregnancy likely to be swine flu shot priority
Swine flu [influenza pandemic (H1N1) 2009 virus infection] has been
hitting pregnant women unusually hard, so they are likely to be among
the 1st group advised to get a new swine flu shot this fall. Pregnant
women account for 6 percent of U.S. swine flu deaths since the
pandemic began in April [2009], even though they make up just 1
percent of the U.S. population.

On Wednesday [28 Jul 2009] a federal vaccine advisory panel is
meeting to take up the question of who should be 1st to get swine flu
shots when there aren't enough for everyone. At the top of the list
are health care workers, who would be crucial to society during a bad
pandemic. But pregnant women may be near the top of the list because
they have suffered and died from swine flu at disproportionately high rates.

"Are they more at risk for severe disease? That's the issue," and it
appears they are, said Dr. Denise Jamieson, an epidemiologist with
the U.S. Centers for Disease Control and Prevention (CDC).

Pregnant women's risk from swine flu has been a raging topic in
Europe, following the contentious suggestion this month by British
and Swiss health officials that women should consider delaying
pregnancy if they can. Most health officials call that advice
unwarranted, but have agreed that the health risks are significant.
In a recent report, World Health Organization (WHO) experts found
that pregnant women appear to be "at increased risk for severe
disease, potentially resulting in spontaneous abortion and/or death,
especially during the 2nd and 3rd trimesters of pregnancy." However,
so far, WHO has not recommended that pregnant women get priority vaccinations.

Now doctors are waiting to see what's decided by the Advisory
Committee on Immunization Practices {ACIP, see below], whose guidance
usually is accepted by the CDC and influences doctors and insurance
coverage. For more than a decade, the committee has recommended that
pregnant women get vaccinated for seasonal flu, which is considered a
serious threat even to pregnant women who are young and healthy.
Pregnant women are unusually vulnerable -- especially in the 3rd
trimester -- due to changes in the lungs and immune system that make
it harder for them to shake off respiratory infections, said Dr.
Kevin Ault, an Emory University obstetrician.

CDC data indicate swine flu is at least as dangerous. Of 302 U.S.
deaths attributed to swine flu to date, the CDC has detailed
information on 266 of them. The agency has found that 15 of the 266
were pregnant women -- or about 6 percent. The 1st American with
swine flu to die was a 33-year-old pregnant woman in Texas. She died
5 May 2009 after slipping into a coma and giving birth to a healthy
baby girl, delivered by Cesarean section.

Some infected pregnant women have other health problems. The Texas
woman, for example, also had asthma and the skin condition psoriasis.
But many of the pregnant women who died were considered relatively
healthy, suggesting pregnancy itself is a significant risk, Jamieson said.

"I think the whole concept that this flu only affects pregnant women
with underlying medical conditions is incorrect," Jamieson said.

Experts believe an effective vaccine would benefit not only a
pregnant woman but also her unborn child. Infants, whose immune
systems are weak, should not get a flu shot until they are at least 6
months old. So whatever immunity they have is passed on to them by
their mothers, doctors say. The belief in the protective powers of a
mother's vaccination on their unborn children was demonstrated in a
study of women in Bangladesh published last year [2008] in the New
England Journal of Medicine. It found that flu shots given to
pregnant women reduced flu in infants by 63 percent.

Only about 15 percent of pregnant women get seasonal flu shots,
experts noted, so it's not clear how many will get the new shot. Some
women avoid regular flu shots, worried about possible risks to the
fetus, but studies have not shown any increased dangers from the
shot. Until recently, many obstetricians haven't offered them,
choosing to avoid the expense of buying and storing vaccine and the
hassle of trying to convince reluctant patients, said Dr. William
Schaffner, a Vanderbilt University flu expert. "Obstetricians are
only now getting with the program and are growing comfortable with
administering flu vaccine," he said.

It's not clear that the demand for swine flu shots would be much
greater. Pregnant patients haven't expressed much concern about swine
flu, said the CDC's Jamieson, who is also an obstetrician seeing
inner-city patients at Atlanta's Grady Memorial Hospital. "It hasn't
been a major concern," viewed as a relatively mild illness. They
worry more about economic concerns -- "how to take care of the baby,
how to get food to eat and how to get safe and secure housing," Jamieson said.

So far, swine flu has likely infected more than 1 million Americans,
the CDC believes, with at least 300 deaths. The United States expects
to begin testing swine flu vaccines on some volunteers in August
[2009], and predicts 160 million doses may be ready by October.

[Byline: Mike Stobbe]

Communicated by:

[2] ACIP meeting
Date: Wed 29 Jul 2009
Source: The New York Times [edited]

Swine Flu Vaccine Priorities Outlined
Anticipating that not enough swine flu [influenza pandemic (H1N1)
2009 virus] vaccine will be available to immunize every American in
time for the expected surge of cases this fall and winter, health
experts recommended on Wednesday [29 Jul 2009] that certain people
should be vaccinated 1st. The top priority group, 150 million
Americans in all, or about half the population, would include health
care workers and emergency medical responders, because their jobs are critical.

It would also include people with the highest risk of complications
and severe illness from the new H1N1 virus: pregnant women [see
above]; people caring for infants under 6 months; children and young
adults from 6 months to 24 years; and people aged 25 to 64 with
medical problems like asthma, diabetes or heart disease.

The recommendations were issued at a meeting of the Advisory
Committee on Immunization Practices (ACIP), a panel of medical
experts from around the country that advises the Centers for Disease
Control and Prevention. The group has 14 members who voted on the
recommendations, and the disease centers [CDC] usually take their
advice in issuing guidelines for state and local health officials.

But once the panel made its initial recommendation, members struggled
and argued about what to do if there was a severe shortage of the
vaccine and the eligibility requirements had to be drawn even
tighter. The deliberations left some shaking their heads in confusion
and dismay. As the meeting dragged on past its deadline, one member,
looking piqued, left before the final vote.

Ultimately, the group decided that if the shortage was severe,
healthy children over 4 would not be vaccinated, nor would any adults
except pregnant women, health and emergency workers and people caring
for infants. Those cuts would reduce the number of vaccinations
needed in the 1st round to about 40 million.

The last to be eligible for vaccine will be healthy people over 65,
who are least likely to contract swine flu but most likely to suffer
complications when they do become ill. The group recommended that
they not be offered vaccine until all the other groups had received it.

Some argued that any efforts to restrict vaccination, based on fears
of a shortage, inevitably confuse the public, discourage people from
being immunized and result in vaccine going to waste. "Tight
prioritization will result in vaccine being unused," said Dr. William
Schaffner, a nonvoting member of the group and an infectious disease
expert at Vanderbilt University. "When you have vaccine, just give it."

The decisions are being made against a backdrop of uncertainty and in
real time, as the pandemic continues to unfold in this country and
around the world. Health officials expect a surge of new cases when
schools open in the fall, but they cannot be sure.

The vaccine has not yet been tested for either safety or efficacy.
Government officials have projected that 120 million doses of vaccine
will be available by October [2009], but a number of participants at
the conference said they thought that was overly optimistic. "I think
the virus is beating us to the tape, and it will be the virus itself
that will immunize us in the fall," said Dr. Schaffner. He said he
feared a "double-barreled flu season," with many cases of swine flu
in the fall and early winter, and then a seasonal outbreak starting
later and peaking in February as it usually does.

[Byline: Denis Grady]

Communicated by:

[3] Adjuvants
Date Wed 29 Jul 2009
Source: Bloomberg.com [edited]

Swine Flu Shot May Rely on Emergency Use of Additives (Update1)
Swine flu vaccine makers may rely on a U.S. emergency declaration to
use experimental additives made by GlaxoSmithKline Plc and Novartis
AG to boost a limited supply of shots that will be available to fight
the pandemic. The ingredients, known as adjuvants, may be added for
the 1st time to flu shots in the U.S. Health officials today are
meeting to discuss the additives at the U.S. Centers for Disease
Control and Prevention (CDC) in Atlanta, and to recommend who should
receive the limited amount of vaccines drug makers say they will
begin delivering in September or October [2009].

The U.S. Health and Human Services Department (DHHS) declared a
public health emergency over swine flu in April [2009], and the Food
and Drug Administration (FDA) has the power to allow the use of
unapproved medical products during such a crisis. The U.S. has been
slow to approve the use of adjuvants because of safety concerns, and
for fear of giving Americans an excuse to avoid getting the shots,
said John Treanor, a University of Rochester researcher. "The
question is, do you really feel comfortable throwing this new thing
into the mix and do you really need to?" said Treanor, a professor of
medicine, microbiology and immunology at the school in Rochester, New
York. "I myself, if I had to do it, would really wrestle with that decision."

The CDC agreed to pay London-based Glaxo and Novartis, based in
Basel, Switzerland, more than USD 415 million for adjuvants that
could be added to the swine flu vaccines, according to a 13 Jul 2009
statement. Adjuvants may not be necessary if enough shots can be
produced without them, according to Health and Human Services. That
possibility got a boost today from authorities at the CDC, who said
40 million shots of unadjuvanted vaccine may be available in
September [2009], earlier than previously reported, with 80 million
more doses ready in October. A safety concern was raised in 2004 when
researchers at the University of Florida in Gainesville reported that
mice injected with oils used in the adjuvants developed conditions of
the type that occur when the body's immune system produces an
excessive protective reaction. Similar reactions haven't been seen in humans.

MF59, made by Novartis and sold in Europe, has been given to more
than 40 million people, mostly adults, to prevent seasonal flu,
according to the company. Glaxo's adjuvant has proven safe and
effective in clinical trials with 39 000 people, said Lisa Behrens, a
spokeswoman for the company, in an e-mail message. Glaxo will conduct
more studies and continue to monitor safety after the vaccines are in
use, she said. Under the U.S. health emergency, the FDA may authorize
the use of unlicensed vaccines, according to Peper Long, an agency
spokeswoman. The FDA convened an advisory committee 23 Jul 2009 to
consider what trials are necessary for the vaccines' approval.
Advisory committees consist of medical experts who provide guidance
to the agency.

Swine flu's [influenza pandemic (H1N1) 2009 virus infection] full
force may reach the U.S. earlier than the typical flu season,
according to the CDC. Vaccine makers are racing to make shots by
mid-October, when cases are expected to rise in the northern
hemisphere, fueled by cooler temperatures and the return of pupils to
close quarters of classrooms. The World Health Organization, based in
Geneva, has said the H1N1 influenza, as the pandemic flu is known, is
moving with "unprecedented speed." The flu spread farther globally in
less than 6 weeks than previous pandemics have in more than 6 months,
the Geneva-based agency said on its Web site on 17 Jul 2009. Global
health authorities have stopped counting the number of cases and the
CDC says more than 1 million people Americans have been sickened by the virus.

The vaccine makers have found it difficult to cultivate the
quantities of virus needed for vaccine, as the strain yields 50
percent to 75 percent less antigen, the substance that induces
immunity, compared with a typical seasonal flu strain, according to
the WHO. The virus didn't initially grow well in eggs, the principal
medium used by the industry, vaccine makers said. In the last week,
scientists have been able to improve yields in eggs for the 1st time,
which should ease pressure on manufacturers, Robin Robinson, chief of
the Biomedical Advanced Research Development Authority, the U.S.
agency in charge of buying the vaccine, said today [29 Jul 2009]. A
decision on adjuvant use hasn't been made, he said.

The adjuvants are mixes of oil and water that -- by stimulating the
immune system -- offer a way to boost the body's response to antigen.
Adjuvants, whose effectiveness vary by flu strain, may boost the
strength of the antigen as much as 10-fold, as was the case with a
bird flu vaccine approved in Europe, said Treanor, of the University
of Rochester. By adding an adjuvant the same amount of antigen can be
used to treat more people, he said.

"Until GlaxoSmithKline and Novartis can show me it won't harm a rat
or guinea pig, I think it's a bad idea to give it to humans," Vicky
Debold, a registered nurse with a Ph.D. in public health, who is a
member of the FDA's advisory committee for reviewing vaccines, said
27 Jul 2009 in an interview. The U.S. never had to consider the risks
of an adjuvant because regular flu vaccines were deemed to have
"worked so tremendously well," said Lone Simonsen, research director
in the department of global health at George Washington University in
Washington. "We have had a safe experience with the MF59-adjuvanted
vaccine in Italy and Spain for many years now," Simonsen said. "That
experience we can lean on. Those are going to be the best data we
have in time for using adjuvanted vaccines."

CSL Ltd., which has a USD 180 million order to supply bulk H1N1
antigen to the U.S. government, decided against boosting its vaccine
with an adjuvant, preferring to use a formulation more closely
resembling the seasonal flu shot, said Mary Sontrop, general manager
of the Melbourne-based company's biotherapies unit. The U.S. has
contracts with 5 companies to provide flu shots. Novartis, based in
Basel, Switzerland, is responsible for 45 percent of the supply,
while Sanofi will provide 26 percent and CSL will make 19 percent,
said Anthony Fauci, director of the National Institute of Allergy and
Infectious Diseases in Bethesda, Maryland, in an interview last week.
The remaining doses will be made by Glaxo and London-based drug maker
AstraZeneca Plc.

[Byline: Tom Randall and Gary Matsumoto]

Communicated by:
ProMED-mail Rapporteur Mary Marshall

[An official statement on these issues from the the Advisory
Committee on Immunization Practices (ACIP) is awaited. - Mod.CP]

[See also:
Influenza pandemic (H1N1) 2009 (20): Peru, 33 percent
asymptomatic 20090730.2668
Influenza pandemic (H1N1) 2009 (19): Viet Nam, H1N1, H5N1 (susp) 20090728.2655
Influenza pandemic (H1N1) 2009 (18): 1st case? 20090725.2631
Influenza pandemic (H1N1) 2009 (17): neurologic complications 20090723.2606
Influenza pandemic (H1N1) 2009 (16): Argentina, sequencing 20090723.2604
Influenza pandemic (H1N1) 2009 (15): Canada (AB) swine workers 20090723.2603
Influenza pandemic (H1N1) 2009 (14): case count 20090722.2599
Influenza pandemic (H1N1) 2009 (13): comments 20090722.2598
Influenza pandemic (H1N1) 2009 (12): antivirals 20090722.2597
Influenza pandemic (H1N1) 2009 (11): vaccine issues 20090722.2595
Influenza pandemic (H1N1) 2009 (10): vaccine 20090720.2577
Influenza pandemic (H1N1) 2009 (09): UK, pig stockman 20090718.2560
Influenza pandemic (H1N1) 2009 (08): pandemic origins 20090718.2559
Influenza pandemic (H1N1) 2009 (07): Argentina, swine, alert 20090718.2557
Influenza pandemic (H1N1) 2009 (06): case reporting 20090717.2553
Influenza pandemic (H1N1) 2009 (05): vaccine 20090716.2540
Influenza pandemic (H1N1) 2009 (04): pandemic origins 20090715.2527
Influenza pandemic (H1N1) 2009 (03): vaccine 20090713.2505
Influenza pandemic (H1N1) 2009 (02): obesity risk factor 20090711.2482
Influenza pandemic (H1N1) 2009 - Viet Nam: patient data 20090708.2450]

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