Archive for October, 2010

Cruise Ship Hygiene Safety Study

Friday, October 29, 2010 // Uncategorized

11/5/2009 10:59:00 PM

Contemplating a cruise?  The following article from Journal Watch may have some helpful information.

Cruise Ship Restrooms: An Exposé

Some are very clean, but most are not . . . until an outbreak of gastroenteritis occurs.

Cruise ships are plagued by outbreaks of acute gastroenteritis, almost always caused by norovirus. This hardy virus can survive on stainless steel surfaces for weeks and is relatively resistant to alcohol-based hand rubs. Thus, good manual scrubbing of restrooms is extremely important in limiting norovirus transmission.

In a 3-year covert operation, a team of 46 medical professionals evaluated the cleanliness of public restrooms on 56 ships. At the start of each cruise, a team member applied a colorless fluorescent gel to standardized objects in several restrooms; the gel — visible under ultraviolet light — is removed easily by light scrubbing with water. Daily evaluations (and reapplications of gel, if it had been cleaned off) were conducted.

Cleanliness scores varied widely by ship, from 100% to <5%. Overall, toilet seats were the best-cleaned objects, but they were cleaned only 50% of the time. Baby changing tables were the least-cleaned objects (cleaned only 30% of the time). Handholds next to toilets often were overlooked as well. Serendipitous outbreaks of gastroenteritis occurred on 16 evaluated ships. Before the outbreaks, affected vessels had significantly worse cleaning scores than unaffected ships had, but significantly better cleaning scores were recorded after outbreaks.

Comment: Not too surprisingly, given outbreak frequency, bathroom surfaces with a high likelihood of contamination by gastrointestinal pathogens are not cleaned well on most cruise ships. But here’s a new travel safety tip: Book a cruise on a ship that’s just recovered from an outbreak — the staff will be newly sensitized to the importance of sanitation.

Abigail Zuger, MD

Published in Journal Watch General Medicine November 5, 2009


Carling PC et al. Cruise ship environmental hygiene and the risk of norovirus infection outbreaks: An objective assessment of 56 vessels over 3 years. Clin Infect Dis 2009 Nov 1; 49:1312.

hygiene, cruise ships, cruise ship, ship cruise, cruise, cruises, health, safety,

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Bad News About Seasonal Flu Vaccine

Friday, October 29, 2010 // Uncategorized

11/5/2009 10:12:17 PM

We’re expecting a little more seasonal flu vaccine to come in.  The outlook for more is not good.  This article is from The New York Times.

November 5, 2009

Nation Is Facing Vaccine Shortage for Seasonal Flu

Even though the regular flu season has yet to start, the nation is facing a severe shortage of seasonal flu vaccine as well as swine flu vaccine.

Federal officials and independent flu experts have said the situation was unavoidable, given that the global swine flu pandemic had raised demand for all flu shots far beyond what manufacturers can make in a year.

The shortage does not mean there will be an increase in seasonal flu deaths, which average about 36,000 a year. The same amount of vaccine was made this year as last, and there is no reason to believe any of the three strains of seasonal flu will be worse this winter. In parts of the Southern Hemisphere, swine flu seemed to “crowd out” seasonal flu this winter, experts said, but whether it will do so here is impossible to predict.

Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, told a House subcommittee on Wednesday that officials were “very frustrated” by the shortages but unable to prevent them.

Dr. Anthony S. Fauci, director of the National Institute for Allergy and Infectious Diseases, said it showed “the inexorable connection between preparedness for pandemic flu and preparedness for seasonal flu.”

In New York, the shortage is so acute that the city health department on Wednesday asked doctors to stop giving seasonal vaccines to healthy adults under 65.

“Some additional supplies of vaccine are expected during November,” said Dr. Thomas Farley, the city’s health commissioner. “But the demand may continue to exceed the supply.”

Shortages are being reported across the country. Based on recent telephone surveys and health insurer billing data, the C.D.C. believes that up to 85 million Americans have already had seasonal flu shots, said David Daigle, a C.D.C. spokesman. Last year at this time, only about 61 million had.

Last year was the previous record: 113 million doses of vaccine were made and about 103 million Americans took them. This year, from February to May, manufacturers had grown virtually the same amount — 114 million doses — before they were asked to switch to swine flu vaccine. They have shipped about 90 million doses of seasonal flu vaccine, Mr. Daigle said.

Unless there is a sudden loss of interest, a shortage seems inevitable even after the remaining 24 million doses are shipped. Exactly when shipping will finish is unknown. One company that had problems growing one of the three seasonal flu strains has not even filled its vials yet, said a flu expert who spoke on condition of anonymity.

A sudden drop in demand seems unlikely. In New York, children and teenagers have had 258,000 doses, twice the number given last year, and frustrated parents are looking for more. The city’s public clinics have already vaccinated more people than they did all last year, the health department said.

“Most of my colleagues in Manhattan ran out of injectable vaccine two or more weeks ago and are faced with dwindling stocks of FluMist,” said Dr. Mark Horowitz, a family practitioner with offices near Wall Street and Carnegie Hall. “And none of the manufacturers are going to retool to make more.”

The University of Minnesota, which last year set the record — 11,810 — for most seasonal flu shots given in one day, had to cancel this year’s clinic because it could not get vaccine, said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy there.

The current problems began years ago, experts said, when vaccine companies started abandoning the American market.

Vaccines, which involve living viruses, are much harder to make than most drugs. Profits are lower and unused flu vaccine expires after a few months. Also, vaccines are primarily intended for children, and Americans frequently sue when a child is injured.

Little was done to lure companies back until bioterrorism fears emerged after the anthrax attacks of 2001 and the H5N1 avian flu virus, which kills about 60 percent of humans infected with it, emerged in 2003, Dr. Fauci said.

In 2004, only two companies were licensed to sell flu vaccine in the United States; now there are five, but only one, Sanofi-Pasteur, has a domestic plant. The others — GlaxoSmithKline, Novartis, CSL Ltd. and Medimmune — use plants in England, Germany and Australia.

The drawback of relying on foreign plants was made clear recently when the Australian government pressured CSL to keep its vaccine at home instead of fulfilling its contract for 36 million doses of swine flu vaccine for the United States.

Bush administration officials repeatedly pressed Congress for money for vaccine technology, sometimes as part of bioterrorism-preparedness budgets, but never got as much as they asked for, said William Hall, a spokesman for the Department of Health and Human Services.

Trying to place blame for the current shortages “is inappropriate,” said Dr. William Schaffner, director of preventive medicine at Vanderbilt University medical school. “It was decisions by the manufacturers, and it was only recently, after the bioterrorism threat, that people woke up and started trying to reverse that.”

Although the government itself ordered and paid for all this year’s swine flu vaccine, about 90 percent of each year’s seasonal vaccine is made for the private sector.

Some of it is ordered directly by pharmacies, hospitals and other big users, and some is ordered by distributors who sell to individual doctors.

There is no way for vaccine makers to make more seasonal vaccine now, several experts said. They have already committed their factories to making nearly 200 million doses of swine flu vaccine for the United States and unknown amounts for other markets. It is growing in eggs much more slowly than was predicted.

They are under pressure to make more to donate or sell to the World Health Organization. Even optimistic predictions say the world’s poorest countries will get only 10 percent of the vaccine they need by winter’s end.

Also, it takes longer to make seasonal vaccine because it contains three strains.

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H1N1 Flu vaccine 10/30/2009

Friday, October 29, 2010 // Uncategorized

10/31/2009 11:28:55 PM

Don’t Hold Your Breath Revisited:

News Release October 30, 2009

Texas H1N1 Vaccine Update

The Texas Department of State Health Services continues to order the state’s full allocation of the H1N1 vaccine as quickly as possible, with more than 1.5 million doses ordered as of yesterday. More orders and shipments will follow as doctors and clinics confirm their orders with DSHS.

The U.S. Centers for Disease Control and Prevention has allocated about 2 million H1N1 vaccine doses to Texas. Some three-quarters of a million of those doses were allocated Monday, Tuesday, Thursday and today and are in the process of being allocated to Texas providers. A CDC report issued today on national shipments does not include orders processed after Wednesday afternoon and currently on the way to Texas.

Given the limited national supply, Texas is allocating vaccine to private practice providers, public and private hospitals, local health departments and DSHS regional offices to vaccinate those most at risk – pregnant women, children and health care workers who provide direct patient care.

The national supply still isn’t adequate to meet the public demand. Texas will allocate more vaccine to other groups as it becomes more widely available. About 12,000 Texas providers have registered to receive the vaccine.

health, hospital, h1n1, medical, flu

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Seasonal Flu Vaccine Update

Friday, October 29, 2010 // Uncategorized

10/28/2009 8:44:05 PM

Good news!  We’ve received our second shipment of seasonal flu vaccine.  It was delayed due to efforts to ship H1N1 vaccine.  We will begin calling patients to set up a time to vaccinate you.  WE WILL CALL YOU.  YOU DON’T NEED TO CALL US UNLESS YOU DON’T HEAR FROM US WITHIN THE NEXT WEEK.  We have yet to receive any H1N1 vaccine.  I have heard of some pediatricians who have received some.  When we received that vaccine AND we have immunized high risk individuals, we will open it up to those who wish to receive the vaccine.  While the present outbreak appears to be peaking, I don’t think it will disappear and it may be around at a lower level for an extended period of time.
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H1N1 Vaccine 10/20/2009

Friday, October 29, 2010 // Uncategorized

10/20/2009 10:08:19 PM

Read the second to last sentence, first.

News Release October 20, 2009

Texas H1N1 Vaccine Update

The U.S. Centers for Disease Control and Prevention allocated an additional 454,200 H1N1 vaccine doses to Texas last week bringing the total vaccine allocation for Texas to 960,400.

Last week’s allocation of doses included 233,100 of the injectable, or shot, form and 221,100 doses of the mist form.

Texas’ allocation for the week that ended Oct. 9 was 363,800 and included 235,000 doses of the injectable form and 128,800 doses of the mist form.

Texas’ allocation for the week that ended Oct. 2 was 142,400 doses, all of it the nasal mist form of the vaccine.

Using a strategic approach to reach priority vaccine groups and subsets of those groups, DSHS has allocated the limited supply of vaccine to providers who serve pregnant women, children 2 years through 4 years of age, children 5 years through 18 years of age who are at higher risk of serious consequences should they get the flu and health care workers who provide direct patient care.

The 960,000 doses have been allocated to some 5,053 providers, with some of it distributed to local health departments as a safety net to meet special needs in communities. Some 12,000 Texas providers have registered to receive the vaccine.

The H1N1 vaccine distribution steps are:

  • CDC allocates vaccine to the various state health departments each week.
  • DSHS accepts the entire allocation and further apportions it to registered providers in Texas based on vaccine formulation, priority vaccination groups, geography and other factors.
  • DSHS then notifies those providers to go online to confirm that they still want the vaccine, giving them a few days to confirm.
  • Once confirmation is received, DSHS issues shipping instructions to a distributor to send the vaccine to the provider.

DSHS officials expect the weekly availability of the vaccine to be low for the next few weeks, adding that initial vaccine quantities are not high enough for public vaccination clinics to be held. They are urging providers and the public to be patient.

Texas expects to receive 15 million doses of the vaccine by the end of January.

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"Just The Flu", Not Exactly

Friday, October 29, 2010 // Uncategorized

10/20/2009 10:01:03 PM

I referred to H1N1 in a previous blog as “just the flu”.  For the most part that is true, but it may be more severe in certain situtations which distinguishes it from seasonal flu.  It is more likely to cause viral pneumonia.   Also, vaccine production is slower than anticipated.  That comes as no suprise to many of us.

Here is the latest from ProMed Digest:

Viral pneumonia commoner with swine flu than common flu
– ——————————————————-
The World Health Organization (WHO) on Friday [16 Oct 2009] urged doctors
to treat suspected swine flu cases as quickly as possible with antiviral
drugs, warning that the virus can cause potentially life-threatening viral
pneumonia much more commonly than the typical flu, sometimes in relatively
young, otherwise healthy people. “It’s not like seasonal influenza,” said
Nikki Shindo, a medical officer in the WHO’s Epidemic and Pandemic Alert
and Response Department. “It can cause very severe disease in previously
healthy young adults.” Shindo’s comments came at the conclusion of a
special 3 day meeting in Washington of more than 100 experts from around
the world. WHO called the meeting to review the latest research on the new
H1N1 virus [the pandemic (H1N1) 2009 virus] and to revise guidelines for
treating the infection [see part [2] below}.

Unlike the seasonal flu, Shindo said, the virus appears more likely to
travel deep into the lungs, where it can cause viral pneumonia. Such a
condition can cause severe lung damage and a life threatening condition
known as acute respiratory distress syndrome. “Remarkably different is this
small subset of patients that presents very severe viral pneumonia,” Shindo
said. Shindo noted that some hospitals in Australia and New Zealand were
severely strained by seriously ill swine flu patients during their recently
ended winter.

“This disease overwhelmed emergency rooms and especially intensive care
units because of the very severe patients that required special care,”
Shindo said, urging hospitals to prepare for the possibility of a
significant number of patients requiring intensive care. “We can expect
more severe disease during the upcoming influenza season,” she said. Shindo
noted that, although a few cases have been reported of people who have been
infected with virus that is resistant to antiviral drugs, the medications
remain highly effective for most patients if administered quickly. “Do not
delay treatment,” Shindo said. “Do not miss this opportunity for early

WHO’s warnings came as US health officials announced that the number of
states reporting widespread flu had increased from 37 to 41 and regional or
local outbreaks were being reported in the remaining parts of the country.
The number of deaths from pneumonia and flu-like illnesses had surpassed
what the federal Centers for Disease Control and Prevention (CDC) considers
an epidemic level, said Anne Schuchat of CDC. About 6 per cent of all
doctor visits are for flu-like illnesses, she said. “It’s unprecedented for
this time of year to see the whole country seeing such high level of
activity,” she said.

CDC also reported that vaccine production was proceeding slower than
officials had hoped, meaning less vaccine was probably going to be
available by the end of the month than originally projected. While
officials had hoped about 40 million doses would be available by the end of
October [2009], that would probably fall short by about 10 million to 12
million doses, Schuchat said. “We do still expect to have the large number
of doses,” Schuchat said. “Eventually anyone who wants to be vaccinated
will be able to be vaccinated. But it’s a slow start. We unfortunately
won’t have as much by the end of this month as we had hoped.” So far 11.4
million doses have become available and states have ordered about 8 million
doses, but large amounts of vaccine will not become available until
November [2009], she said.

The number of children and teenagers who have died from the disease
continued to mount, Schuchat said. At least 86 Americans younger than 18
have died from the disease, including 11 deaths that have been reported in
the past week. About half of the deaths that have occurred in the past
month were among teenagers, she said. Since 30 Aug 2009, 43 pediatric
deaths have been reported, including 3 in those younger than age 2; 5 among
those ages 2 to 4, 16 in those ages 5 to 11; and 19 among those ages 12 to
17, she said. “These are very sobering statistics,” Schuchat said, noting
that only about 40 or 50 children die during an entire flu season. While
many of the deaths occurred among those with other health problems, some
occurred in children who were otherwise healthy, she said. “Every death we
take seriously, but as a society the deaths of children are very hard to
take,” she said.

[byline: Rob Stein]


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Red Yeast Rice Revisited

Friday, October 29, 2010 // Uncategorized

10/20/2009 9:58:07 PM

There is a lot of interest in red yeast rice by those who are intolerant of cholesterol lowering medicines called statins.  This is a recent summary from The Medical Letter which is a nonprofit organization which publishes unbiased analyses of pharmaceuticals.

The Medical Letter®

On Drugs and Therapeutics

Published by The Medical Letter, Inc. • 1000 Main Street, New Rochelle, NY 10801 • A Nonprofit Publication

Volume 51  (Issue 1320)

September 7, 2009

Red Yeast Rice

Red yeast rice is a food product that has been used in Chinese cooking and medicine for centuries.  It is available in the US in a capsule formulation and is often used by patients who want a “natural” product to lower cholesterol.

THE PRODUCT — Red yeast rice is formed when rice is fermented with the yeast Monascus purpureus. The fermented product usually contains numerous monacolins, which are naturally occurring HMG-CoA reductase inhibitors. One of these, monacolin K, also known as mevinolin, became lovastatin (Mevacor, and others), the first statin approved in the US.

In one report analyzing the contents of 9 red yeast rice products on the market in the US, the total monacolin content varied by weight from 0% to 0.58% (REF 1). In another, among 10 such products, monacolin K content varied 100-fold (REF 2).

CLINICAL STUDIES —  In one study, the lipid-lowering effect of a red yeast rice product containing about 5 mg of monacolin K, 8 other monacolins, and other ingredients was equivalent to that of 20-40 mg of lovastatin (REF 3). A 24-week randomized double-blind study in 62 previously statin-intolerant patients found that LDL cholesterol decreased 21.3% (from 163.3 to 128.3 mg/dL) with 1800 mg of red yeast rice (about 13 mg of monacolin K) twice daily and 8.7% (from 165.1 to 149.8 mg/dL) with placebo (REF 4).

A double-blind, multicenter trial in China randomized 4870 patients with a previous myocardial infarction (MI) and total cholesterol >170 mg/dL to twice-daily treatment with 600 mg of a red yeast rice preparation (each 300-mg capsule contained 2.5-3.2 mg monacolin K) or placebo. After a mean of 4.5 years, the incidence of major coronary events, including nonfatal MI and death from coronary heart disease, was 5.7% with the supplement compared to 10.4% with placebo, a statistically significant difference (REF 5).

ADVERSE EFFECTS — As with lovastatin and other statins, myopathy can occur with red yeast rice (REF 6-8). Rhabdomyolysis was reported in a patient taking red yeast rice concurrently with cyclosporine, which is a moderate inhibitor of CYP3A4 (lovastatin is a substrate of CYP3A4) (REF 9). Hepatitis has been reported with red yeast rice (REF 10-11). Some of these products contain citrinin, a mycotoxin that can cause kidney failure in animals (REF 12). Statins are teratogenic in animals and should not be taken during pregnancy.

DIETARY SUPPLEMENTS — As with other dietary supplements, red yeast rice products do not require FDA approval and may contain unlabeled ingredients. Most labels for these products contain no information on their active ingredients. The FDA has tried, apparently unsuccessfully, to remove red yeast rice products from the US market as unapproved formulations of an approved drug (lovastatin).

DOSAGE AND COST — Most red yeast rice supplements are marketed as 600-mg capsules. The dosage suggested on their labels is two 600-mg capsules twice daily. The cost of one month’s treatment at the maximum dose is $16-$37 (REF 13). A month’s supply of generic lovastatin costs $4 at some discount pharmacies.

CONCLUSION — Red yeast rice products, which may contain one or more compounds that lower cholesterol by inhibiting HMG-CoA reductase, have been effective in lowering LDL-C in some studies, but the ingredients in these products are not standardized. Some contain mevinolin, which is lova-statin. Some contain citrinin, a mycotoxin that may cause renal failure. Generic lovastatin would be safer and could cost less.

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Patience Urged for H1N1 Vaccine

Friday, October 29, 2010 // Uncategorized

10/13/2009 10:05:53 PM

News Release October 13, 2009

Texas H1N1 Vaccine Update

A total of 506,200 doses of the H1N1 vaccine have been allotted to Texas by the U.S. Centers for Disease Control and Prevention during the first two weeks of national allocation of the vaccine supply.

Texas’ allocation for the week that ended Oct. 2 was 142,400 doses, all of it the nasal mist form of the vaccine.

Texas allocation for the week that ended Oct. 9 was 363,800 and included 235,000 doses of the injectable, or shot, form and 128,800 more doses of the mist form.

DSHS is providing the mist form to some registered providers to vaccinate 2- and 3-year-olds. The shot form supply is being provided to some registered providers to vaccinate pregnant women, 4-year-olds and children 4 years through 18 years of age who are at higher risk of serious consequences should they get the flu.

Some 12,000 Texas providers have registered to receive the vaccine.

CDC allocates vaccine to the various state health departments each week. DSHS apportions Texas’ based on vaccine formulation, priority vaccination groups, geography and other factors.

DSHS then notifies the providers to go online to confirm that they still want the vaccine. Once confirmation is received, DSHS issues shipping instructions to a distributor to send the vaccine to the provider.  The process can take from five to 14 days depending on volume and provider response time.

DSHS officials expect the weekly availability of the vaccine to be low for the first few weeks with volume predicted to increase later this month. They said initial vaccine quantities are not high enough for public vaccination clinics to be held.  They are urging providers and the public to be patient.

Texas expects to receive 15 million doses of the vaccine by the end of January.

DSHS will provide another vaccine allocation update early next week.

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H1N1 Vaccine Safety/ Seasonal Vaccine and H1N1

Friday, October 29, 2010 // Uncategorized

10/7/2009 6:03:36 PM

I’ve been at the annual meeting of the Texas Club of Internists in Toronto.  This has involved three days of meetings and has left little time for blogging.

Here are a couple of interesting news items on H1N1.

H1N1 Update: CDC Offers Reassurance on Vaccine Safety and Availability
The CDC addressed fears over 2009 H1N1 vaccine safety and availability at a press briefing Tuesday.
CDC Director Thomas Frieden addressed “three major concerns that people have” — that 2009 H1N1 is “just a mild illness”; that the vaccine may not be safe; and that it’s already too late to be vaccinated.
Dr. Frieden countered with a reminder that 2009 H1N1 has killed many people and will likely kill more. Regarding safety, he said that the vaccine is made in the same way and in the same facilities as seasonal vaccines, which have an excellent safety record. And as to the futility of vaccination, he said, we “don’t know what the rest of this long flu season is going to hold. We haven’t had a flu season like this in at least 50 years.”
He added: “We’re very confident that there will be plenty of vaccine for everyone who wants to be vaccinated. It won’t be available when everyone wants to be vaccinated.”

This is also encouraging:

H1N1 Update: Seasonal Flu Vaccine Seems to Offer Some Protection Against 2009 H1N1

Vaccination against seasonal strains of flu seems to offer some protection against 2009 H1N1 virus, particularly severe infections, according to a retrospective study published online in BMJ.
Researchers examined vaccination status in 60 laboratory-confirmed cases of 2009 H1N1 compared with that in 180 matched controls. All subjects were patients in a respiratory disease hospital in Mexico City during the early months of the pandemic. Cases had been admitted for influenza, and controls were treated for diseases other than influenza or pneumonia.
Cases were less likely than controls to have received the seasonal vaccine (13% vs. 29%). Among the cases, those who’d been vaccinated were less likely to die.
The authors urge caution in interpreting the results, which they say “in no way indicate that seasonal vaccine should replace vaccination against pandemic influenza.”

This report is at odds against a report from Canada that suggested that previous seasonal flu vaccine increased the risk of catching H1N1.  If you want to read more about the dicussion on that read further from Promed Digest:

No need to change vaccine policy based on Canadian flu data: WHO
– —————————————————————-
International influenza vaccine experts are apparently not convinced
that Canadian researchers have found a true link between getting a
seasonal flu shot and catching swine flu [see: ProMED-mail posting
“Influenza pandemic (H1N1) 2009 (59): Canada, vaccination
20090929.3400”]. The consensus that emerged from a World Health
Organization (WHO) teleconference Friday [2 Oct 2009] on the
controversial data seemed to be that the Canadian findings are likely
due to some confounding factor or factors in the data themselves and
may not reflect a real increased risk, according to a WHO official who
helped pull together the meeting.

“From a WHO point of view, the fact that the findings are not
replicated in other countries I think is reassuring for us that this
is an outlier, if you like, the unexpected findings that are coming
out of Canada,” said David Wood, coordinator of the quality, safety,
and standards team of WHO’s department of immunization, vaccines, and
biologicals. “Most people are still looking at this as some sort of
undetected confounding in the data, that for some reason is giving the
results that are there.”

In an interview from Geneva, Wood was diplomatic. But when pressed, he
did admit most experts on the call didn’t seem to believe that the
unpublished study, based on data from British Columbia, Quebec, and
Ontario, had found a true link between getting a seasonal flu vaccine
and having an increased risk of coming down with a mild case of H1N1
flu. “Well, yeah,” he said. “It’s a totally unexpected finding.” “So I
think people do then try to think: ‘Well, why is this happening? Are
there some effects that are just not being detected that are really
behind this?’ Because it is an unexpected finding. That’s the way
people tend to think.”

The work, which is [reportedly] being considered for publication by a
medical journal, contributed to decisions by most provinces and
territories to stagger or delay their seasonal flu shot efforts this
fall [2009]. Instead of launching full-fledged seasonal flu vaccine
programs in October [2009], most have announced they will offer
seasonal shots in October only to seniors — who aren’t currently at
high risk from the pandemic H1N1 virus — and residents of long-term
care facilities. After pandemic vaccination efforts are completed,
most of those provinces plan to offer seasonal vaccine more broadly.

A couple of jurisdictions — Quebec and Nunavut — will wait until
after they’ve completed their pandemic vaccination efforts before
offering seasonal flu shots. At the other end of the spectrum, New
Brunswick is going ahead with its regular seasonal flu shot campaign
before offering pandemic flu shots.

The Canadian findings, which are reportedly mirrored in data from
Manitoba as well, suggest that people who got a flu shot last fall
[2008] were twice as likely as people who didn’t to contract swine
flu. But the association, if it is real, is to mild disease. There is
no evidence that people who got seasonal flu shots are more prone to
develop severe illness if they catch the new H1N1 virus.

Scientists from the United States, Britain, and Australia have looked
at their data but didn’t see the same effect. A number of scientists
have speculated that the Canadian data may have some built-in
confounders — factors that can produce false results. For instance,
if people who get flu shots are also more likely to seek a diagnosis
of swine flu if they get sick, that could make it seem like more of
them got the illness when in fact what happened is that more of their
illnesses were recorded.

But if the Canadian results are due to some statistical flaws or
selection biases, no one on the 4 1/2-hour teleconference was able to
put a finger on what exactly the problem is, Wood acknowledged. And he
admitted there may not be a satisfactory answer to that puzzle in the
foreseeable future. “It didn’t seem very likely that we’re going to be
able to ….. suddenly come up with the magic explanation as to why
the Canadian data are different to others,” Wood said. “In the short
term, this is really probably as far as we’re going to get.”

New studies will likely be needed to get a definitive answer, he said.
Experts say there will need to be prospective studies — following
people who get a flu shot forward — rather than the retrospective
studies that produced the unusual findings. The evidence from
retrospective studies isn’t considered as high quality as that
garnered from prospective studies.

In the meantime, a summary of the situation will be presented to the
WHO’s Strategic Advisory Group of Experts on immunization, also known
as SAGE. The group, which meets later this month [October 2009], makes
recommendations for the WHO on vaccination policy. Wood said he
couldn’t prejudge what the committee will decide, but said for the
moment it doesn’t seem like the WHO needs to ask countries to change
their vaccination programs for this fall [2009]. “The fact that it’s
just been seen in Canada at the moment, I don’t think that that’s
going to force global policy changes,” he said.

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H1N1 Vaccine: The Latest

Friday, October 29, 2010 // Uncategorized

10/1/2009 8:29:33 PM

Here is the latest news on H1N1 vaccine from two sources.  The first is from The Medical Letter:

The Medical Letter®

On Drugs and Therapeutics

Published by The Medical Letter, Inc. • 1000 Main Street, New Rochelle, NY 10801 • A Nonprofit Publication

Volume 51  (Issue 1322)

October 5, 2009

H1N1 Vaccine for Prevention of Pandemic Influenza

The FDA has licensed 4 new monovalent vaccines for prevention of respiratory illness caused by a new influenza A H1N1 virus that appears to be derived from a swine strain. The 5th vaccine should be licensed soon. All of these vaccines are expected to become available in October. An intranasal formulation is expected in the first week of October.

THE DISEASE — The signs and symptoms of this  H1N1 infection have been similar to those of the usual seasonal disease, except that diarrhea and vomiting have been more common and most hospitalizations have been in persons <65 years old (REF 1).

SUSCEPTIBILITY — Serologic evidence suggests that the majority of the population less than 60 years old is susceptible to infection with this H1N1 strain (REF 2). Trivalent seasonal vaccination is unlikely to provide protection (REF 3).

FORMULATIONS — The manufacturers of the pandemic vaccine are the same as those of the seasonal vaccine. The H1N1 monovalent vaccine is being prepared using the same manufacturing process used to prepare the seasonal vaccine. Like the trivalent seasonal influenza vaccine, the monovalent pandemic influenza vaccine will be available in an inactivated intramuscular and a live attenuated intranasal formulation. Both the inactivated and live monovalent vaccines will contain antigens from the A/California/07/2009-H1N1 strain. According to the CDC, this strain is antigenically similar to the currently circulating virus.

PRIORITY GROUPS — The US Advisory Committee on Immunization Practices (ACIP) recommends prioritizing available doses of the monovalent vaccine to 5 groups identified as being at highest risk for infection or complications: pregnant women (who should receive inactivated vaccine); persons who live with or provide care for infants <6 months of age; healthcare and emergency medical services personnel; children and young adults aged 6 months-24 years; and persons aged 25-64 years old with medical conditions that put them at risk for complications. After these groups have been vaccinated, the vaccine should be offered to healthy persons 25-64 years old before those >65 years old (REF 4).

In the event that the vaccine supply is not sufficient to cover even the priority groups, vaccine campaigns should preferentially target pregnant women (REF 5) and care providers of infants <6 months of age; healthcare and emergency medical services personnel who have direct contact with patients or infectious materials; children 6 months-4 years old; and children and adolescents 5-18 years old with medical conditions that put them at risk for complications (REF 4). As with seasonal vaccination, the new vaccine is not recommended for infants <6 months old, but infants born to immunized women may be protected by maternal antibodies.

EFFICACY — In one study in adults, a single IM dose of H1N1 vaccine produced antibody levels expected to be protective within 14 days (REF 6). In an unpublished study in children, according to Medical Letter consultants, one IM dose produced antibody levels expected to be protective in a majority (76%) of children aged 10-17 years old, but in fewer of those <9 years old (36% of 3-9 year-olds; 25% of those 6-35 months old).

ADVERSE EFFECTS — The adverse effects of the H1N1 vaccine are expected to be similar to those of the seasonal trivalent vaccine (REF 7).

DOSAGE AND ADMINISTRATION — The dose of the inactivated H1N1 vaccine for patients >3 years old is 0.5 mL IM. Children 6-35 months old should receive 0.25 mL IM. The dose of the live, attenuated intranasal vaccine, which is recommended only for patients 2-49 years old, is 0.2 mL. Patients >10 years old need only one dose of either vaccine; those <9 years old should receive 2 doses about a month apart. Although studies are incomplete, either the live or inactivated H1N1 vaccine can probably be given at the same time as the inactivated seasonal vaccine without loss of efficacy. The live seasonal vaccine can also be given with the inactivated H1N1 vaccine. The two live vaccines should not be given together until studies are completed that demonstrate immunogenicity when both are given at the same time.

CONCLUSION — The monovalent H1N1 vaccine for prevention of pandemic influenza is prepared in the same way by the same manufacturers as the usual seasonal vaccine. Pregnant women, people who live with and provide care for infants <6 months old, all persons 6 months-24 years old, persons 25-64 years old with illnesses that increase their risk of influenza complications, and healthcare workers should receive it first.

And from the Texas Department of  State Health Services:

News Release
September 30, 2009

Initial H1N1 Flu Vaccine Supply to Trickle In

Texas Department of State Health Services officials report that the amount of H1N1 flu vaccine available for the state over the next few weeks will be low and are urging the public and health care providers waiting for it to be patient.

“We’ve been told that we’ll have about 15 million doses for Texas after all is said and done, but it won’t be available all at once,” said Dr. David Lakey, DSHS commissioner. “The vaccine will trickle in week to week, especially at first. It’s a fluid situation driven primarily by how much vaccine the manufacturers produce each week.”

He said some 3.4 million doses of the vaccine had been projected for Texas by mid-October, but the latest estimates are that no more than 1.7 million doses will be available by then. Weekly allotments are expected to be larger after mid-October.

Some 12,000 doctors and other health care providers in Texas have signed up to provide the vaccine.

Starting this week, the U.S. Centers for Disease Control and Prevention will tell DSHS and other states’ health departments how much vaccine is available for them to order for the week. DSHS then tells the CDC where to send it based on provider registration information, priority groups, vaccine formulation, geography and other factors. It may be one to two weeks later before that vaccine is in the hands of providers.

All of us will have to be patient and flexible as we meet this challenge,” Lakey said. “For example, pregnant women are one of the highest priority groups for vaccination, but the first vaccine available to us is FluMist. Pregnant women should not receive FluMist.”

He said the first week’s allocation of about 237,000 doses of FluMist will go to registered providers to give to children 2 and 3 years of age. Children are another high priority group.

Lakey said the total of 15 million doses should be enough vaccine to meet anticipated demand in Texas but that it could be late January before all doses are received. He reminded Texans to get the seasonal flu shot, cover coughs and sneezes, wash hands often and stay home if sick.

I will be at a medical meeting for a few days.  I’m going to take my patient list and try to prioritize the patients that are at high risk.  I still don’t know how many doses of the vaccine that I will receive and when (if?) I will receive them.

Stay tuned.

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