Saturday, November 21, 2009

Mutations in H5N1 Influenza Virus Hemagglutinin that Confer Binding to Human Tracheal Airway Epithelium.

Medline Abstract:

Guadalupe Ayora-Talavera, Holly Shelton, Margaret A Scull, Junyuan Ren, Ian M Jones, Raymond J Pickles, and Wendy S Barclay
PLoS One, January 1, 2009; 4(11): e7836.

Department of Virology, Imperial College London, London, United Kingdom.

The emergence in 2009 of a swine-origin H1N1 influenza virus as the first pandemic of the 21st Century is a timely reminder of the international public health impact of influenza viruses, even those associated with mild disease. The widespread distribution of highly pathogenic H5N1 influenza virus in the avian population has spawned concern that it may give rise to a human influenza pandemic. The mortality rate associated with occasional human infection by H5N1 virus approximates 60%, suggesting that an H5N1 pandemic would be devastating to global health and economy. To date, the H5N1 virus has not acquired the propensity to transmit efficiently between humans. The reasons behind this are unclear, especially given the high mutation rate associated with influenza virus replication. Here we used a panel of recombinant H5 hemagglutinin (HA) variants to demonstrate the potential for H5 HA to bind human airway epithelium, the predominant target tissue for influenza virus infection and spread. While parental H5 HA exhibited limited binding to human tracheal epithelium, introduction of selected mutations converted the binding profile to that of a current human influenza strain HA. Strikingly, these amino-acid changes required multiple simultaneous mutations in the genomes of naturally occurring H5 isolates. Moreover, H5 HAs bearing intermediate sequences failed to bind airway tissues and likely represent mutations that are an evolutionary "dead end." We conclude that, although genetic changes that adapt H5 to human airways can be demonstrated, they may not readily arise during natural virus replication. This genetic barrier limits the likelihood that current H5 viruses will originate a human pandemic.

PMID: 19924306

Tamiflu Resistance Found In Italy

hat-tip Florida1

November 20, 2009, 1 submitted by Fondazione IRCCS Policlinico San Matteo, Italy:

Influenza A virus


* This sequence has the H274Y mutation that confers resistance to Oseltamivir.

Commonground Summary: Tamiflu Resistant Comparisons of Wales & NC

North Carolina

- 4 patients
- Onset: October
- Results of specimens for resistance to antiviral came back approx. 11/7.
- In hospital at time of becoming infected
- All were severely ill at time of infection
- In same ward of hospital housing patients with cancer or severe blood disorders
- 3 of the 4 died.
- 4th is extremely ill, treating with Relenza, appears to be recovering
- Investigation launched w/CDC (3 Epidemic Intelligance Svc.) to determine whether Tamiflu-resistance flu is circulating elsewhere in NC.
--Testing virus samples to see whether they are identical.

- 5 people confirmed with Tamiflu resistance
- In hospital at time of becoming infected
- All were severely ill at time of infection
- In same ward of hospital housing patients with severe illnesses
- 2 have recovered and discharged
- 1 in critical care
- 2 still being treated
- 4 others infected (“with same genetic mutation” Health Protection Agency)
- 1 of these were helped with Tamiflu
- 3 others it is not clear.
- Same ward as the 5 confirmed Tamiflu resistance

As a side-note...I was reminded of the new addition to the vaccines. GlaxoSmithKline. In the Package Insert, it states this:

Immunosuppressive therapies may reduce immune responses to Influenza A (H1N1) 2009 Monovalent Vaccine. (7.2)”....and this:
Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2)”

Post located here:

Drug-Resistant Swine Flu Emerges In Wales

11:42am UK, Saturday November 21, 2009
Hugh Westbrook,

Five people have been diagnosed with a strain of swine flu which appears to be resistant to Tamiflu. It is also believed the strain could be the first one to pass directly from person to person.

Three of the five affected people at the University Hospital of Wales, Cardiff, appeared to pick up the infection on the ward.

The patients were on a ward for those with severe underlying health conditions.

A Department of Health spokeswoman said: "Examples of Tamiflu resistance are very rare, but when this does occur it has often been among these especially vulnerable patients.

"In other words, because their immune systems are compromised, it is more likely for resistant viruses to develop."

The Health Protection Agency said: "There is no evidence that the oseltamivir-resistant virus is any more virulent than any other type of flu. The situation is being kept under review.

"The virus remains sensitive to the other frontline drug, Relenza, which is being used as an alternative anti-viral and patients are responding well.

"Although further epidemiological investigation is under way, it would seem likely that transmission of oseltamivir-resistant H1N1 virus has taken place."

Two of the five have recovered and have been discharged from hospital, one is in critical care and two are being treated on the ward.

Dr Roland Salmon, director of the NPHS Communicable Disease Surveillance Centre, said the emergence of a resistant strain was "not unexpected" in patients with serious underlying conditions.

Other experts said the development was not unexpected, with virologist Nigel Dimmock of the University of Warwick saying: "If you use Tamiflu at the level they are using it you get resistance.

"The fact people have recovered is a good sign, there doesn't seem to be anything sinister about developing a resistance and it is what everybody expected.

"Resistance will become more and more common so we will use Relenza and then it will become resistant to Relenza. These drugs are useful but they are short term."


Reuters: UPDATE 1-UK investigates spread of drug resistant swine flu

Fri Nov 20, 2009 3:42pm EST
(Adds details and reaction)

* Five H1N1 patients resistant to Tamiflu

* Possible person-to-person spread of resistant strain

LONDON, Nov 20 (Reuters) - British health officials are investigating the likely person-to-person spread of a drug-resistant strain of swine flu, the Health Protection Agency said on Friday.

There have been five confirmed cases in Wales of patients infected with H1N1 resistant to oseltamivir -- the generic name of Roche AG (ROG.VX) and Gilead Sciences Inc's (GILD.O) antiviral drug Tamiflu, the agency said.

Four other patients are infected with H1N1 with the same genetic mutation but one was helped by Tamiflu and the status of three others is not clear. Another antiviral, GlaxoSmithKline (GSK.L) and Biota Inc's (BTA.AX) Relenza, was effective in the patients, the HPA said.

The patients had serious conditions that suppressed their immune systems, which can give the virus a better than usual opportunity to develop resistance, the HPA added.

"Although further epidemiological investigation is underway, it would seem likely that transmission of oseltamivir-resitant H1N1 virus has taken place," it said in a statement. "At present we believe the risk to the general healthy population is low."

John McCauley of the Medical Research Council said the patients involved were in an at-risk group.

"It is well established that patients with immunodeficiency do have problems with eliminating virus, giving it a greater chance to acquire resistance," he said in a statement.


Norwegian health authorities reported a mutation of H1N1 in some patients with severe disease but other officials noted quickly that other patients infected with the same mutant have had mild disease. [ID:nLK669768] (Reporting by Kylie MacLellan; editing by David Stamp)

Posted Article Here Has Been Edited and Rewritten

The article below, entitled: "Drug resistant swine flu found in N.C. hospital" has now been edited and rewritten. Original article is located here:

Previous entry:
In addition, the Reuters wire service has reported a cluster of nine Tamiflu resistant cases of swine flu, also called H1N1 flu, in Wales.

This is incorrect. There are not 9 people in Wales. I went back to the article, and sure enough, it has been edited, and in fact was total rewritten, including a new title. I will keep USA Today in mind, in the future, for this kind of journalism. I have colored the "changes" in blue. For instance, the first article said the results of tamiflu resistance came back 2 weeks ago. This article states they came back 1 week ago.

Here is the "new" version:
Updated 14h 32m ago
Drug resistant H1N1 found in U.S. and U.K.

By Steve Sternberg, USA TODAY
Epidemic experts say they are investigating the apparent spread of Tamiflu-resistant swine flu virus among four patients at Duke University Medical Center in Durham, N.C., and five in a hospital in Wales.

These clusters appear to be the first in which a virus resistant to the antiviral Tamiflu, a mainstay of flu treat, has spread from person to person, researchers said Friday.

If Tamiflu-resistant virus spreads widely, swine flu will become tougher to treat and may cost more lives, says Duke's Daniel Sexton, who is leading the hospital's investigation.

Doctors say investigations of the two hospital outbreaks are underway, but the preliminary genetic evidence suggests that the virus spread among patients at the hospitals.

"The four patients involved in this situation had the same resistance pattern," says Sexton, adding that researchers at the Centers for Disease Control and Prevention are now testing virus samples from Duke to see whether they're identical.

"The resistance pattern suggests that might be the case," he says.

All of the Duke patients were located in a ward for people with cancer or severe blood disorders. All were severely ill and were highly susceptible to infections, Sexton says.

The patients became ill with flu in October. When they didn't respond to Tamiflu two weeks ago, the hospital sent specimens of their virus to see whether it might be resistant to antiviral treatment. The results came back this week, prompting Duke to launch an investigation.

CDC spokesman Dave Daigle confirmed that three CDC epidemiologists have arrived at Duke to assist in the investigation, alongside infectious disease experts from the hospital and the state health department. The research team is also trying to determine whether Tamiflu-resistant flu is circulating elsewhere in North Carolina.

Three of the four Duke patients have died, Sexton says. The fourth is extremely ill but is being treated with another antiviral called Relenza and appears to be recovering.

In Wales, doctors have confirmed five Tamiflu-resistant swine flu cases in one ward of an unidentified hospital. Three more patients on the ward are being tested for drug-resistant virus; a ninth patient is infected with virus that is still susceptible to Tamiflu.

"At present we believe the risk to the general healthy population is low," Britian's Health Protection Agency said in a statement, noting that there is no evidence that the resistant virus is any more virulent than any other form of flu. A community-wide investigation is ongoing, the agency said.

So far, like the swine flu virus isolated from the Duke patients, the Wales virus remains sensitive to the antiviral drug Relenza.

As of Friday, the World Health Organization has reported 57 cases of Tamiflu-resistant virus worldwide.

Friday, November 20, 2009

CDC: 2009-2010 Influenza Season Week 45 ending November 14, 2009


During week 45 (November 8-14, 2009), influenza activity decreased slightly in the U.S.

  • 3,106 (28.8%) specimens tested by U.S. World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories and reported to CDC/Influenza Division were positive for influenza.
  • Over 99% of all subtyped influenza A viruses being reported to CDC were 2009 influenza A (H1N1) viruses.
  • The proportion of deaths attributed to pneumonia and influenza (P&I) was above the epidemic threshold for the seventh consecutive week.
  • Twenty-one influenza-associated pediatric deaths were reported. Fifteen of these deaths were associated with 2009 influenza A (H1N1) virus infection, and six were associated with an influenza A virus for which the subtype was undetermined.
  • The proportion of outpatient visits for influenza-like illness (ILI) was 5.5% which is above the national baseline of 2.3%. All 10 regions reported ILI above region-specific baseline levels.
  • Forty-three states reported geographically widespread influenza activity, Puerto Rico and seven states reported regional influenza activity, the District of Columbia reported local influenza activity, and Guam and the U.S. Virgin Islands reported sporadic influenza activity.


Antiviral Resistance:

Since September 1, 2009, four influenza A (H3N2), one influenza B, and 353 2009 influenza A (H1N1) virus isolates have been tested for resistance to the neuraminidase inhibitors (oseltamivir and zanamivir), and 856 2009 influenza A (H1N1) original clinical samples were tested for a single known mutation in the virus that confers oseltamivir resistance. In addition, one influenza A (H3N2) and 182 2009 influenza A (H1N1) virus isolates have been tested for resistance to the adamantanes (amantadine and rimantadine). Additional laboratories perform antiviral testing and report their results to CDC. The results of antiviral resistance testing performed on these viruses are summarized in the table below.

Click on box:

*The adamantanes (amantadine and rimantadine) are not effective against influenza B viruses.
†Two screening tools were used to determine oseltamivir resistance: sequence analysis of viral genes or a neuraminidase inhibition assay.
‡Additional laboratories perform antiviral resistance testing and report their results to CDC. One additional oseltamivir resistant 2009 influenza A (H1N1) virus has been identified by these laboratories since September 1, 2009, bringing the total number to 11.

Over 99% of all of the subtyped influenza A viruses reported during week 45 were 2009 influenza A (H1N1) viruses, and the majority of 2009 H1N1 viruses tested since April 2009 have been resistant to the adamantanes (amantadine and rimantadine).

Antiviral treatment with oseltamivir or zanamivir is recommended for all patients with confirmed or suspected influenza virus infection who are hospitalized or who are at higher risk for influenza complications. Additional information on antiviral recommendations for treatment and chemoprophylaxis of influenza virus infection is available at

2009 influenza A (H1N1) viruses were tested for oseltamivir resistance by a neuraminidase inhibition assay and/or detection of genetic sequence mutation, depending on the type of specimen tested. Original clinical samples were examined for a single known mutation in the virus that confers oseltamivir resistance in currently circulating seasonal influenza A (H1N1) viruses, while influenza virus isolates were tested using a neuraminidase inhibition assay that determines the presence or absence of neuraminidase inhibitor resistance, followed by the neuraminidase gene sequence analysis of resistant viruses.

The majority of 2009 influenza A (H1N1) viruses are susceptible to the neuraminidase inhibitor antiviral medication oseltamivir; however, rare sporadic cases of oseltamivir resistant 2009 influenza A (H1N1) viruses have been detected worldwide. A total of 21 cases of oseltamivir resistant 2009 influenza A (H1N1) viruses have been identified in the United States since April 2009. In specimens collected since September 1, 2009, 11 cases have been identified in the United States, including seven newly identified cases since last week and one case reported during a previous week that was reclassified. All tested viruses retain their sensitivity to the neuraminidase inhibitor zanamivir. Of the 21 cases, 12 patients had documented exposure to oseltamivir through either treatment or chemoprophylaxis, eight patients are under investigation to determine exposure to oseltamivir, and one patient had no documented oseltamivir exposure. Occasional development of oseltamivir resistance during treatment or prophylaxis is not unexpected. Enhanced surveillance and increased availability of testing performed at CDC are expected to detect additional cases of oseltamivir resistant 2009 influenza A (H1N1) viruses, and such cases will be investigated to assess the spread of resistant strains in the community.

Pneumonia and Influenza (P&I) Mortality Surveillance

During week 45, 7.5% of all deaths reported through the 122-Cities Mortality Reporting System were due to P&I. This percentage was above the epidemic threshold of 6.9% for week 45. Including week 45, P&I mortality has been above threshold for seven consecutive weeks

Influenza-Associated Pediatric Mortality

Twenty-one influenza-associated pediatric deaths were reported to CDC during week 45 (Arizona [2], Colorado [3], Georgia [2], Louisiana [2], Minnesota, Mississippi, New York, New York City, Ohio, Oklahoma, Oregon [2], Texas, Virginia, Washington, and Wisconsin). Fifteen of these deaths were associated with 2009 influenza A (H1N1) virus infection, and six were associated with an influenza A virus for which the subtype is undetermined. The deaths reported during week 45 occurred between September 20 and November 14, 2009.

Since August 30, 2009, CDC has received 138 reports of influenza-associated pediatric deaths that occurred during the current influenza season (24 deaths in children less than 2 years old, 16 deaths in children 2-4 years old, 50 deaths in children 5-11 years old, and 48 deaths in children 12-17 years old). One hundred thirteen (82%) of the138 deaths were due to 2009 influenza A (H1N1) virus infections, and the remaining 25 were associated with influenza A virus for which the subtype is undetermined. A total of 171 deaths in children associated with 2009 influenza A (H1N1) virus infection have been reported to CDC.

Among the 138 deaths in children, 74 children had specimens collected for bacterial culture from normally sterile sites and 23 (31.1%) of the 74 were positive; Staphylococcus aureus was identified in eight (34.8%) of the 23 children. One S. aureus isolate was sensitive to methicillin, six were methicillin resistant, and one did not have sensitivity testing performed. Fifteen (65.2%) of the 23 children with bacterial coinfections were five years of age or older, and six (26.1%) of the 23 children were 12 years of age or older.

Swine Flu surge: 18 more die in Ontario, 22 in Alberta, two in B.C.

OTTAWA – 52 more Canadians have died from Swine Flu to take the national fatalities from the novel pandemic virus H1N1 to 250 from the 198 deaths that were being reported just two days ago.

The Public Health Agency of Canada reported the new tally on Thursday, indicating that between Nov. 17 and 11 a.m. EST on Nov. 19, Ontario reported an additional 18 deaths while Alberta reported 22.

B.C.’s death toll climbed to 32 with two additional deaths since the last B.C. government report which indicated on Tuesday that there had been 30 deaths across the province.

The starling jump in a reporting period of less than three days is the highest national death toll reported since the Swine Flu pandemic hit Canada in a second, more lethal wave.

Seven additional deaths were reported in Quebec to take that provinces total fatalities to 65. Quebec’s death toll has jumped significantly in one week.
hat-tip 6180

Drug resistant swine flu found in N.C. hospital

Drug resistant swine flu found in N.C. hospital

Posted 29m ago
By Steve Sternberg, USA TODAY
Epidemic experts have launched an investigation of four Tamiflu-resistant swine flu cases at Duke University Medical Center to see whether the resistant virus has begun spreading person-to-person at the Durham, N.C. hospital and beyond.

If so, the cluster appears to be the first instance in which Tamiflu-resistant virus has been transmitted from person to person.

"The four patients involved in this situation had the same resistance pattern," says Daniel Sexton, the hospital epidemiologist leading the investigation, adding that the Centers for Disease Control and Prevention are now testing virus samples to see whether they're identical.

"The resistance pattern suggests that might be the case," he says.
All of the patients were located in a ward for people with cancer or severe blood disorders. All were severely ill and were highly susceptible to infections, Sexton says.

The patients became ill with flu in October. When they didn't respond to Tamiflu, the hospital sent specimens of their virus to see whether the virus might be resistant to antiviral treatment. The results didn't come back until two weeks ago, prompting Duke to launch an investigation.

Sexton says three epidemiologists from the CDC as well as experts from the state health department are now at Duke assisting in the investigation. The investigation has now been extended outside Duke to determine whether Tamiflu-resistant flu is circulating elsewhere in North Carolina.
CDC spokesman Dave Daige says the agency did confirm the cases and has sent three Epidemic Intelligence Service "disease detectives" to assist in the investigation.

Three of the four Duke patients have died; the fourth is extremely ill but is being treated with another antiviral called Relenza and appears to be recovering. In addition, the Reuters wire service has reported a cluster of nine Tamiflu resistant cases of swine flu, also called H1N1 flu, in Wales.

Ann Schuchat, director of CDC's national center for immunization and respiratory diseases, said Friday that she had not heard of the Wales cluster, but acknowledged that CDC has been tracking other instances of Tamiflu resistance. "We've seen a dozen or so at this point, but the cluster issue will be an important thing to track and understand because that would be a sign of transmission," she says.

If resistant strains start spreading in the midst of a pandemic, Sexton says, they could represent a global threat and potentially increase the number of flu deaths.

Wales: Tamiflu-resistant swine flu spreads 'between patients'

hat-tip Boneset

By Fergus Walsh
Health correspondent, BBC News

Health officials say a Tamiflu-resistant strain of swine flu has spread between hospital patients.

Five patients on a unit treating people with severe underlying health conditions at the University Hospital of Wales, Cardiff were infected.
Three appear to have acquired the infection in hospital.

They are thought to be the first confirmed cases of person-to-person transmission of a Tamiflu-resistant strain in the world.
There have been several dozen reports around the world of people developing resistance to Tamiflu while taking the drug - but they have not passed on the strain to others.

Just one possible cases of person-to-person transmission of a resistant strain has been recorded - between two people at a US summer camp - and this has never been confirmed.

Two of the University Hospital Wales patients have recovered and have been discharged from hospital, one is in critical care and two are being treated on the ward.

The health officials stressed there was no risk to anyone else.

They said tests were being carried out to confirm exactly what happened.
The UK has bought enough doses of Tamiflu, which can shorten the duration of swine flu and reduce the risk of complications, for half the population.

Serious concern
So any spread of a Tamiflu-resistant strain of the illness is a serious public health concern.
The H1N1 virus has been remarkably stable since it emerged in April, but virologists had been half expecting new resistant strains to emerge.

Dr Roland Salmon, director of the National Public Health Service for Wale's Communicable Disease Surveillance Centre, said: "The emergence of influenza A viruses that are resistant to Tamiflu is not unexpected in patients with serious underlying conditions and suppressed immune systems, who still test positive for the virus despite treatment.

"In this case, the resistant strain of swine flu does not appear to be any more severe than the swine flu virus that has been circulating since April."
Dr Tony Jewell, Chief Medical Officer for Wales, said: "We know that people with suppressed immune systems are more susceptible to the swine flu virus, which is why they are a priority group under the first phase of the vaccination programme in Wales which is progressing at pace.

"We have stringent processes in place for monitoring for antiviral resistance in the UK so that we can spot resistance early and the causes can be investigated and the cases managed.

"Identifying these cases shows that our systems are working so patients should be reassured.

"Treatment with Tamiflu is still appropriate for swine flu and people should continue to take Tamiflu when they are prescribed it.
"It's also important that good hygiene practices are followed to further prevent the spread of the virus."

On Thursday it was announced that more than three million healthy children under five across the UK will be offered the swine flu jab.
Figures released on Thursday showed an estimated 53,000 new cases of swine flu in England in the last week, down from 64,000 in the week before.
In Scotland, the figure was 21,200, down from about 21,500 in the previous seven days.
The rate of flu-like illnesses diagnosed by GPs in Wales dropped to 36 cases for every 100,000 people from 65.8 the previous week.

Flu vaccine batch pulled in Manitoba Higher rates of allergic reaction,

More than 900 unused doses of H1N1 vaccine have been pulled out of circulation in Manitoba after health authorities received word other vaccines from the same batch have been causing higher rates of allergic reactions than expected.

Dr. Joel Kettner, Manitoba's chief public health officer, said the Public Health Agency of Canada's monitoring of the H1N1 immunization program identified about 1 in 20,000 people in Manitoba were suffering severe allergic reactions to one particular lot of the vaccine, which is about five times the usual rate in other flu vaccines and what had been expected for the H1N1 shot.

"We've been asked by the manufacturer, GlaxoSmithKline, to not use this vaccine at this time," Kettner said. "Nobody knows if anything's wrong with it at all. All we've observed so far is a somewhat higher rate of anaphylactic reaction."

Kettner said the batch of vaccine in question was distributed across the country and other provinces are also being asked to hold whatever they have left of that lot.

In Manitoba, 63,000 doses from the lot arrived during the week of Oct. 19. It was distributed to clinics in Winnipeg, Brandon, and the Parkland and Northeastman health regions, as well as to a third-party organization. It was made available as of the first week of immunization, and the vast majority has been used up. Only 930 doses remain unused: 630 in Northeastman and 300 with the organization.

Kettner stressed anyone who would have suffered a reaction to the shot would have done so within 15 to 20 minutes of getting it, and there is no lasting danger to anyone who received a shot from the lot.

Three people in Manitoba suffered a severe anaphylactic reaction to the shot from that batch, all of whom were properly diagnosed and treated at their injection clinics, with none suffering any lasting effect, he said.

Meanwhile, Manitoba Health provided its weekly statistical update on the H1N1 flu yesterday, revealing 251 more cases have been confirmed in the past week, while another person with a confirmed case has died. It is the second death from H1N1 in Manitoba this fall and the ninth since the virus appeared in the spring.

The WRHA is advising its H1N1 immunization clinics will only be open to pregnant women and healthy people age 10 to 65 until it receives more adjuvanted vaccine. Its supply of adjuvanted vaccine will likely all be used up by early this morning, leaving it only with the unadjuvanted variety to use in its clinics today and tomorrow.

The unadjuvanted version is not recommended for children younger than 10, adults older than 65, or anyone with a weakened immune system.

The WRHA's 12 mass clinics will be open 9:30 a.m. to 4 p.m. today, while two special Saturday clinics will operate during those same hours tomorrow at the University of Manitoba and at the Holy Eucharist Parish Centre on Munroe Avenue.

More adjuvanted vaccine is expected to arrive in Manitoba early next week.
hat-tip Tonka

Thursday, November 19, 2009

Gripes about swine flu vaccine abound

ATLANTA — When the nation's swine flu vaccination program began in early October, health officials predicted it was going to be "messy." They were right. The program has been plagued with problems and information gaps:

_Health officials have been terrible at predicting when and how much vaccine would be available. Only about 44 million doses have been shipped so far. Initially, officials said more than three times that would be out by now.

_At times vaccine shipments have been inexplicably lopsided. For example, smaller counties in Illinois and California have received the same amount delivered to counties with seven times as many people.

_Health officials have stressed that people most at risk for swine flu complications should go to the head of the line, but they haven't tried to make sure that actually happened.

_And despite pledges that they would be transparent about the vaccine program, some health officials have refused to disclose where all the doses are going, and they have held back on public service announcements telling people who should be coming in for shots. Also, many states were slow to establish Web sites that give vaccination locations.

To be fair, health officials say, the government deserves credit for a herculean effort to develop and distribute a safe and effective vaccine against a deadly virus that was first identified only seven months ago.

"You have a brand-new disease that gets identified in April. By October, you have a vaccine for it. By any standards, it's a miracle," said Dr. Diane Helentjaris, director of the Virginia Department of Health office handling swine flu response.

But complaints have been mounting, with lawmakers this week holding hearings in Washington and elsewhere, pressing for explanations.

"Calls are still coming in to me about, 'Why can't I get the vaccine?'" said Andrea Stillman, a Connecticut state senator speaking at a Wednesday hearing in Hartford.

She noted reports of uneven distribution within her state, and of places where vulnerable patients can't get the vaccine. "Obviously we're very frustrated in southeastern Connecticut," she said.

People are frustrated everywhere, said Sen. Susan Collins, R-Maine. At a hearing in Washington on Tuesday, she complained of "layers of misinformation and miscommunication."

Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, said health officials should have done more to make sure limited doses get to the people most at danger from the virus. And he said they should have been tougher on nurses and other health-care workers who are putting their patients at risk because they declined to get a shot.

"It is not working right at all," Caplan said.

In their defense, officials at the U.S. Centers for Disease Control and Prevention have said that the main issue is insufficient vaccine from manufacturers — something CDC can't control — and that health authorities are doing the best they can.

"A lot of this is a function of not having as much vaccine as we would like to have," said Dr. Anne Schuchat, who heads the agency's immunization section.

The new swine flu, also called 2009 H1N1, has not turned out to be the deadly global disaster that experts have long feared. But it has sickened an estimated 22 million Americans, hospitalized about 98,000 and killed 4,000. It has proved to be similar to seasonal flu but a much bigger threat to children and young adults.

There was no vaccine to protect against the new virus, so manufacturers had to create a new one. In July, a government health official estimated 120 million vaccine doses would be available by late October. Later, the government backed away from that estimate when manufacturers couldn't crank out vaccine so rapidly.

The CDC has been coordinating the vaccine campaign, but it is not fully in charge. As a matter of tradition and law, states have had more public health authority than the federal government. Each state health department has made decisions about which clinics, doctor's offices and other sites get vaccine from a federally contracted distributor.

"It's a little bit of a messy process and we expect it to be somewhat bumpy in the first few weeks," CDC Director Dr. Tom Frieden said in early October.

The bumps lasted more than a few weeks.

Health officials seem to have a poor idea of how many doses to expect. Two weeks ago, they predicted 8 million doses in the following seven days; it turned out to be 5 million — largely because a tropical storm nearly derailed some deliveries.

Blown delivery promises have had ripple effects at the state and local level. In Alaska, deliveries have lagged significantly, and other states report similar experiences. "We've learned to not put too much faith" in any extended vaccine supply estimates, said South Dakota Health Secretary Doneen Hollingsworth.

Demand has far exceeded supply in many places, and hundreds and even thousands people have waited hours in line. Many have been turned away when the vaccine ran out or the clinic hours ended.

One Delaware pediatrician, Dr. David Epstein, said patients were "banging on the door" for swine flu vaccine, and at some moments he felt like a United Nations relief worker in a refugee camp. "Everybody is desperate for it," said Epstein, who ordered 2,300 doses but had received only 300 as of last week.

Supply problems have forced states to make hard decisions about where to send the doses and which patients should get it.

Tennessee kicked off its campaign by targeting health-care workers, and many rejected the offer. Georgia emphasized getting initial doses to pediatricians and clinics that serve children. Minnesota randomly sent vaccine to clinics across the state as it became available, and then let the providers decide which patients should get it first.

"We haven't tried to micromanage the administration of the vaccine," said Buddy Ferguson, a spokesman for the Minnesota Department of Health.

Authorities made few attempts to police the crowds to make sure priority groups — like pregnant women, young people and those with certain health problems — got vaccine first.

There were inequities, too.

According to Illinois newspaper reports, tiny Kendall County got enough doses to cover nearly 20 percent of its residents, while Will County — with nearly seven times as many people — got just enough for 2 percent.

In California, Santa Cruz County at one point got nearly 30,000 doses, while Santa Clara County — again, with nearly seven times as many people — got less than half as much, local media reported.

In New York, Buffalo schools wanted to start vaccine clinics but hadn't received a single dose. School officials there were irate to learn New York City schools had begun vaccinating hundreds of thousands of students.

"How could the city of Buffalo, which contains the second-largest school district in New York State, not have been designated by your office to receive a proportional share of vaccine supply?" Buffalo schools Associate Superintendent Will Keresztes wrote Nov. 5 to the state health department.

Some inequities were corrected as more vaccine became available. But suspicions that money or politics played a role in some places were fed by news two weeks ago that Wall Street giants Goldman Sachs and Citigroup received swine flu vaccine for some employees.

Also contributing to public mistrust are health officials themselves. CDC officials have stressed repeatedly that they are striving to be transparent. They have held frequent news conferences and given updates on vaccine availability and the disease's toll.

But the CDC has refused to release information about where all the publicly financed vaccine has been going. The agency punted the question to states, but some states have been tightlipped, too.

If swine flu had turned out to be deadlier, the delays and communication problems might have been catastrophic. Now, cases are declining across much of the country.

Indeed, health officials are now beginning to worry that demand for the vaccine may wane, just as vaccine is becoming more plentiful, just as states are perfecting Web sites that help people locate providers, just as new efforts are under way to encourage more health workers to get vaccinated.

Federal health officials say they expect to start running a public service campaign about the shots shortly.

Associated Press writers Carla K. Johnson in Chicago; Zinie Chen Sampson in Richmond, Va.; Kristin Hill in Nashville, Tenn.; Susan Haigh in Hartford, Conn.; Carolyn Thompson in Buffalo, N.Y.; Randall Chase in Dover, Del.; Wayne Ortman in Sioux Falls, S.D.; Rachel D'Oro in Anchorage, Alaska; and Steve Karnowski in Minneapolis contributed to this report.

H5N1 reminds us it's still here, despite swine flu pandemic

Scott McPhearson's blog:

Recent reports confirm the return of H5N1 bird flu in poultry in Thailand and Vietnam. And in today's proMED report, a 21-year old Egyptian college student has a case of confirmed H5N1 bird flu.

The reports of the return of bird flu should not be surprising. Just because we're in the (so far, mild) grip of the first pandemic of the information age (I coined that term, as everyone knows) does not mean other flu strains cannot also continue infecting animals.

What is interesting is the case of the Egyptian college student. He reportedly had slaughtered poultry just days before his onset of symptoms, and it is to the Egyptian doctors' credit that they had the presence of mind to test the lad for H5N1 as well as H1N1.

There is no word if a co-infection was present, but this does confirm the concern that Egyptian authorities have expressed ever since they ordered the slaughter of every pig in the nation (overkill, to be sure). Namely, they were worried about Egypt becoming the mixing vessel for an H1/H5 mutant virus.

This makes the third time and third locale that H5 and H1 have rubbed elbows. In Vietnam and in Indonesia, the two viruses were in extremely close physical proximity to one another. Now, in the midst of the current (first?) wave of swine flu in Egypt, a young adult acquired bird flu.

I don't have the stats on seasonal flu in Egypt currently, but here in the US, of some 5,400 suspected flu samples submitted to the CDC for testing, only four -- FOUR! -- were seasonal flu. The remaining positive samples were confirmed H1N1v, influenza B, or the nefarious "untyped" influenza A.

Is it possible, then, that there are more diagnosed and undiagnosed H5N1 human cases in Egypt currently than there are cases of human seasonal flu? Interesting speculation. I leave it to you.

As winter approaches, we know we will get more H5N1 cases in birds and in people. And we know this H1N1v pandemic has a long way to go. So settle in for the long haul.


A ProMED-mail post

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

Date: Mon 16 Nov 2009
Source: Pan American Health Organization (PAHO), Epidemiological
Alerts [edited]

Regional update: pandemic (H1N1) 2009
The information contained within this update is obtained from data
provided by Ministries of Health of Member States and National
Influenza Centers through reports sent to the Pan American Health
Organization (PAHO) or updates on their web pages.

Evolution of the pandemic
North America
In Canada, the national influenza-like illness (ILI) consultation
rate slightly decreased compared to last week but remained above
average for the 6th consecutive week. The number of influenza
outbreaks remained high and these outbreaks were mostly reported in
the school setting. The proportion of tests positive for influenza
again increased this week to 38.1 percent from 36.3 percent (EW 43).
The total number of hospitalizations of persons with pandemic
influenza increased again this week; and hospitalization rates were
highest among those less than 20 years of age.

In Mexico, trends of acute respiratory disease remained unchanged,
with high intensity of acute respiratory disease, and moderate impact
of acute respiratory disease on health care services. Of note is that
the number of ILI [influenza-like illnesses] and severe acute
respiratory illness (SARI) cases, in EW 39 [27 Oct-3 Nov 2009],
surpassed what was observed in the 1st wave of the pandemic.

In the United States, the proportion of outpatient consultations for
ILI decreased for the 2nd consecutive week. Laboratory-confirmed
influenza hospitalization rates remained high, especially in children
0 to 17 years of age. The proportion of deaths attributed to
pneumonia and influenza remained above the epidemic threshold for the
6th consecutive week. 9 of 10 sub-national surveillance regions
reported decreases in proportion of outpatient visits for ILI as
compared to the previous week, but all 10 reported a the ILI
proportion to be above their region-specific baseline. A total of 35
influenza-associated pediatric deaths were reported this week, of
which 26 were associated with the pandemic virus. In total, since 30
Aug 2009, 98 pediatric deaths associated with the pandemic virus have occurred.

These countries are reporting mostly unchanged trends in acute
respiratory disease and high intensity of acute respiratory disease.
Impact of acute respiratory disease on health care services was
reported as moderate. In countries providing these data, severe acute
respiratory infection (SARI) hospitalization rates decreased this
week, after 4 consecutive weeks of increases.

Central America
This week, among the countries that provided information, trends of
acute respiratory disease decreased. Intensity of acute respiratory
disease remained low/moderate and impact of acute respiratory disease
on health care services was low.

South America
These countries continued to report widespread influenza activity.
Acute respiratory disease trends were reported as decreasing or
unchanged in most countries of the region, except Colombia and Peru,
which reported an increasing trend in acute respiratory disease. In
Peru, in the last week, the greatest increase in the number of
confirmed cases was observed in parts of the northeast jungle region.
In Ecuador, nationally, trends of acute respiratory disease were
reported as unchanged, but 3 of 24 provinces reported increases in
the number of SARI cases as compared to the prior week.

Venezuela's Ministry of Health reported that the outbreak of acute
respiratory infection in indigenous Yanomami communities has ended.
[For details, see ProMED-mail Influenza pandemic (H1N1) 2009 (90):
Venezuela, Yanomami 20091105.3820].

Southern cone:
Most of these countries reported decreasing or unchanged trends of
acute respiratory disease. This week, Paraguay reported 2 of 17
departments with an increasing trend of acute respiratory disease, as
compared to 8 departments last week; its overall national trend was
decreasing. All of these countries are reporting a low or moderate
impact of acute respiratory disease on health care services.

Weekly summary
- influenza-like illness activity remained above what is expected for
this time of year in Canada and the United States; in Mexico, it
surpassed the level that was observed during the 1st wave of the pandemic
- Caribbean countries reported mostly unchanged trends but high
intensity of acute respiratory disease this week
- Central America continues to report overall decreasing trends in
acute respiratory disease
- Most of South America had stable or decreasing trends of acute
respiratory disease, with the exception of Colombia and Peru, which
reported an increasing trend
- Venezuela reported that the outbreak of acute respiratory illness
in the Yanomami communities has ended
- a median of 99.9 percent of subtyped influenza A viruses were
pandemic (H1N1) 2009
- 294 new confirmed deaths in 8 countries were reported; in total
there have been 4806 cumulative confirmed deaths.

Descriptions of hospitalizations and deaths among confirmed cases of
pandemic (H1N1) 2009
A table containing case counts reported to PAHO can be accessed via
the source URL above.

Approximately half of hospitalized cases were among women. Children
continued to be the age group with highest hospitalization rates.
Underlying co-morbidities were present in approximately half of
hospitalized cases.

Overall, approximately half of deceased cases were among women. In
the Dominican Republic, however, 82 percent of their 22 deaths were
among women and approximately 67 percent of deaths among women were
in pregnant women. The percentage of cases with underlying
co-morbidities varied from 58.3 percent to 76.1 percent.

Viral circulation
For the purpose of this analysis, only countries, which reported data
on influenza A subtypes were considered. We excluded from the
calculations of the percentages, results from samples of influenza A
that were not subtyped or were unsubtypeable. Pandemic (H1N1) 2009
continues to predominate among circulating subtyped influenza A viruses.

Antiviral resistance
The Centers for Disease Control and Prevention (CDC) complete
antiviral susceptibility testing on isolates submitted by various
countries in the Region. To date, 277 samples submitted from 18
countries were found to be sensitive to neuraminidase inhibitors
(oseltamivir and zanamivir). In the United States, a total of 15
cases of oseltamivir-resistance have been identified. Of the 15
oseltamivir-resistant cases, 13 had documented exposure to
oseltamivir, one case had no documented oseltamivir-exposure, and one
case is under investigation.

As of 13 Nov 2009, a total of 4806 deaths have been reported among
the confirmed cases in 27 countries of the Region.

In addition to the figures displayed in the table available at the
URL above, the following overseas territories have confirmed deaths
of pandemic (H1N1) 2009: United Kingdom Overseas Territories; Cayman
Islands (1 death); French Overseas Communities: Martinique (1 death);
Guadeloupe (1 death).

The distribution of cases and deaths at the 1st sub-national level
can be found in the interactive map available through the following
link: .

Communicated by:
ProMED-mail Rapporteur Marianne Hopp

Commonground Comments

In Vietnam, China, Taiwan and South Korea, we get disclosure on the age, location, when they were put on antiviral medication, we get the onset of their illness, and date of death.

The U.S. does not report on names, locations, or ages of it’s victims of A/H1N1. We do not usually get a date of death. We do not get a duration of their illness. Because of the laws that the health officials are beholden to, they also do not report any specifics on their medical protocol for any given victim.

Therefore, we can not track any human-to-human transmission, nor can we track geographic spread. We also can not track any Tamiflu or Relenza resistance.

Some of this is not important for this particular pandemic. It is mild. Some of it is still resistance to antivirals.

We have to wait for the authorities to hand us an update on the situation.

That goes against the grain of my driving force to investigate this pandemic. I have been tracking H5N1 for almost 4 years....because I needed to know myself. Not wait for an update from the “authorities”, with whatever it is they choose to tell me.

I can’t begin to tell you how frustrated and cynical I have become.

Tuesday, November 17, 2009

Fox News Provides: H1N1 Vaccine Map

Click on title for the site.

DO YOU OR A LOVED ONE HAVE DIABETES? You might be at higher risk for complication from H1N1 & seasonal flu

Join experts from the Centers for Disease Control and Prevention for a special webcast to get more information on how flu can affect people with diabetes

Ask our experts your questions and share your concerns
so you can be prepared

DETAILS: Join us WEDNESDAY November 18, 2009 @ 1 PM (EST) to get more information on how flu can affect people with diabetes. Experts will answer your questions specific to H1N1 and diabetes. This show will be webcast live on

WHAT: Know What to Do about the Flu Webcast

WHO: Dr. Beth Bell, M.D., M.P.H., Associate Director for Science, National Center for Immunization and Respiratory Diseases, Centers for Disease Control & Prevention
Ann Albright, PhD, RD, Director, Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control & Prevention

WHEN: WEDNESDAY, November 18, 2009 @ 1 PM (EST)

WHERE: Live on
Participate in the webcast by sending questions to

WHERE CAN I FIND MORE INFORMATION ON H1N1 AND THE H1N1 VACCINE MY COMMUNITY? is your one-stop website for all the latest information about the flu and the new H1N1 flu virus from the CDC and other top scientists and doctors across the federal government. Use our marketing tools to spread the word about to your friends and families and help them get the facts, too.

For more information on H1N1 situation, please visit

Follow on Twitter

via: e-mail (no link)

FTC Warns Internet Peddlers that Marketing Unproven H1N1 Flu Products May Be Illegal

For Release: 11/16/2009

The Federal Trade Commission last week sent 10 warning letters to Web site operators who made questionable claims that their products can prevent, treat, or cure the H1N1 flu, commonly known as swine flu. In an ongoing effort that began during the spring, the FTC told the companies – whose products include dietary supplements, air filtration devices, homeopathic remedies, items containing silver, and cleaning agents – that unless they have scientific proof for their claims, they are violating federal law and must drop the claims or face further action.

The FTC conducted its swine flu surf as part of the International Consumer Protection Enforcement Network’s 11th Internet sweep, which took place from September 21 to 25, 2009. As part of this sweep, consumer protection agencies around the world targeted rapidly growing fraudulent and deceptive conduct on the Internet, with special emphasis on conduct exploiting financial crises or natural disasters such as the H1N1 pandemic. Besides sending warning letters to 10 operators, the FTC referred 14 other Web site operators – which it suspects are located outside the United States – to foreign law enforcement authorities.

“As consumers grow increasingly anxious about obtaining the H1N1vaccine for their children and other vulnerable family members, scam artists take advantage by selling them bogus remedies online,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection.

In collaboration with other enforcement agencies, including the U.S. Food and Drug Administration, the FTC will continue to work aggressively to identify, investigate, and take additional regulatory and law enforcement action against individuals or businesses that deceptively promote purported H1N1 products.

The FTC reminds consumers that the only products recommended for treatment of H1N1 flu are prescription antiviral drugs, including oseltamivir (brand name Tamiflu) and zanamivir (brand name Relenza).

The FTC’s Consumer Alert, Rx for Products That Claim to Prevent H1N1? A Healthy Dose of Skepticism, warns the public to be skeptical of claims that products like pills, air filtration devices, and cleaning agents can kill or eliminate the virus. The alert advises consumers to:

  • Know the facts: The H1N1 virus is thought to spread from person to person in the same way that seasonal flu spreads – mainly coughing or sneezing by people with the flu. Sometimes people may become infected by touching something with flu viruses on it and then touching their mouth, nose, or eyes.
  • Keep your hands clean: Public health authorities advise that basic personal hygiene is the best protection against infection. Wash your hands thoroughly. When soap and water are not available, health authorities suggest using alcohol-based disposable hand wipes or gel sanitizers. These products are available in most supermarkets and drugstores.
  • Check travel advisories for affected areas: To lower your risk of infection, the Centers for Disease Control and Prevention (CDC) suggests avoiding travel to affected regions.
  • Seek medical attention: If you think either you may have influenza symptoms, or you may have been in direct contact with someone who has the flu, consult a health care professional immediately.
  • Stay informed: For more information from the federal government about the H1N1 flu, check out or visit the CDC at
    To learn more, go to

Consumers who wish to file a complaint against a company that they believe may be deceptively advertising H1N1 flu products are urged to call 1–877–FTC–HELP (1–877–382– 4357) or visit

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 1,500 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s Web site provides free information on a variety of consumer topics.

Betsy Lordan
Office of Public Affairs
Rich Cleland,
Bureau of Consumer Protection

Karen Jagielski
Bureau of Consumer Protection

Additional Information on the latest new vaccine (posted below)

Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomedical Corporation of Quebec)

Package Insert:

These highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine.
Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by ID Biomedical Corporation of Quebec (IDB)
Distributed by GlaxoSmithKline (GSK)
Suspension for Intramuscular Injection
Initial U.S. Approval: 2006
---------------------------RECENT MAJOR CHANGES--------------------
Indications and Usage (1)
----------------------------INDICATIONS AND USAGE---------------------

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine, indicated for active immunization of adults 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. (1)

This indication is based on immune response elicited by the seasonal trivalent Influenza Virus Vaccine manufactured by IDB (FLULAVAL). Influenza A (H1N1) 2009 Monovalent Vaccine and FLULAVAL are manufactured by IDB using the same process. There have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FLULAVAL. (14)

-----------------------DOSAGE AND ADMINISTRATION----------------
Based on currently available information, the vaccination regimen is as follows:
Adults 18 years of age and older: A single 0.5-mL intramuscular injection. (2.2)

---------------------DOSAGE FORMS AND STRENGTHS--------------

Influenza A (H1N1) 2009 Monovalent Vaccine is a suspension for intramuscular injection available in 10-mL multi-dose vials containing 10 doses (each dose is 0.5 mL). (3)

Thimerosal, a mercury derivative, is added as a preservative. Each 0.5-mL dose contains 25 mcg mercury. (3, 11)

Known systemic hypersensitivity reactions to egg proteins, or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reaction to previous influenza vaccination. (4.1, 11)

-----------------------WARNINGS AND PRECAUTIONS----------------

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks. (5.1)

Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2)

------------------------------ADVERSE REACTIONS-----------------------
Adverse reactions information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by IDB (FLULAVAL).

Most common (≥10%) local adverse events for FLULAVAL were pain, redness, and/or swelling at the injection site. (6.1)

Most common (≥10%) systemic adverse events for FLULAVAL were headache, fatigue, myalgia, low grade fever, and malaise. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 and

-------------------------------DRUG INTERACTIONS------------------------

Do not mix with any other vaccine in the same syringe or vial. (7.1)

Immunosuppressive therapies may reduce immune responses to Influenza A (H1N1) 2009 Monovalent Vaccine. (7.2)

-----------------------USE IN SPECIFIC POPULATIONS----------------
Information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by IDB (FLULAVAL).

Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers, and children. (8.1, 8.3, 8.4)

Geriatric Use: Antibody responses to FLULAVAL were lower in geriatric subjects than in younger subjects. (8.5)
Revised: November 2009

FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus

For Immediate Release: Nov. 16, 2009

Media Inquires: Pat El-Hinnawy, 301-796-4763;
Consumer Inquiries: 888- INFO-FDA

FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.15, 2009, ID Biomedical Corporation will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program.

ID Biomedical’s H1N1 monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

For more information
FDA Page on Influenza A (H1N1) 2009 Monovalent Vaccine

2009 H1N1 Flu Information for People with Disabilities and Their Caregivers or Personal Assistants

November 16, 2009 3:00 PM ET

*Health-care personnel (HCP) include all paid and unpaid persons working in health-care settings who have the potential for exposure to patients with influenza, infectious materials, including body substances, contaminated medical supplies and equipment, or contaminated environmental surfaces. HCP might include (but are not limited to) physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, autopsy personnel, students and trainees, contractual staff not employed by the health-care facility, and persons (e.g., clerical, dietary, housekeeping, maintenance, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from HCP. The recommendations in this report apply to HCP in acute-care hospitals, nursing homes, skilled nursing facilities, physicians' offices, urgent care centers, and outpatient clinics, and to persons who provide home health care and emergency medical services. Emergency medical services personnel might include persons in an occupation (e.g., emergency medical technicians and fire fighters) who provide emergency medical care as part of their normal job duties.

Immune System of Healthy Adults May Be Better Prepared Than Expected to Fight 2009 H1N1 Influenza Virus

Monday, Nov. 16, 2009

A new study shows that molecular similarities exist between the 2009 H1N1
influenza virus and other strains of seasonal H1N1 virus that have been circulating
in the population since 1988. These results suggest that healthy adults may have a
level of protective immune memory that can blunt the severity of infection caused by
the 2009 H1N1 influenza virus.

The study team was led by Bjoern Peters, Ph.D., and Alessandro Sette, Ph.D., of
La Jolla Institute for Allergy and Immunology, Calif., grantees of the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of

The investigators looked at molecular structures known to be recognized by the
immune system—called epitopes—on 2009 H1N1 influenza and seasonal H1N1
viruses. Viral epitopes are recognized by immune cells called B and T cells: B cells
make antibodies that can bind to viruses, blocking infection, and T cells help to
eliminate virus-infected cells.

Using data gathered and reviewed from the scientific literature and deposited into
the NIAID-supported Immune Epitope Database and Analysis Resource
(, the investigators found that some viral epitopes are identical in both
the 2009 and seasonal H1N1 viral strains. Those epitopes that could be recognized
by two subsets of T cells, called CD4 and CD8 T cells, are 41 percent and 69
percent identical, respectively. Subsequent experiments using blood samples taken
from healthy adults demonstrated that this level of T-cell epitope conservation may
provide some protection and lessen flu severity in healthy adults infected with the
2009 H1N1 influenza virus.

Analysis of the database also found that among six viral surface epitopes that can
bind antibody, thereby preventing infection, only one is conserved between 2009
and seasonal H1N1 viral strains.

These results suggest that healthy individuals may have immune memory that recognizes the 2009 H1N1 strain and therefore can mount some measure of an immune attack. The findings also may help explain why the 2009 H1N1 influenza pandemic affects young children more severely than it does healthy older adults and also why two H1N1 vaccinations are needed to protect children ages nine years and under.

ARTICLE: J Greenbaum et al. Pre-existing immunity against swine-origin H1N1 influenza
viruses in the general human populace. Proceedings of National Academy of
Sciences. DOI: 10.1073/PNAS.0911580106.
WHO: Alison Deckhut-Augustine, Ph.D., Chief, Immunoregulation Section, Basic
Immunology Branch, NIAID Division of Allergy, Immunology and Transplantation, is
available for comment.
CONTACT: To schedule interviews, please contact Julie Wu at 301-402-1663,

Indonesia: RI to produce H1N1, H5N1 vaccines

Tue, 11/17/2009 1:18 PM

The government, together with state-owned pharmaceutical company PT Bio Farma, plans to start producing vaccines for the H1N1 and H5N1 strains of influenza by November 2010.

The plan was revealed Monday during the inauguration ceremony of Airlangga University's avian influenza research center (AIRC) bio safety level-3 (BSL-3) in Surabaya by Vice President Boediono.

"I hope the vaccines to be produced will be beneficial to the people of Indonesia," Boediono said.

The center's team of researchers handed over the seed vaccines for both H1N1 and H5N1 to Boediono, who in turn gave them to Health Minister Endang Rahayu Setyaningsih as a symbolic gesture. The minister then passed them on to PT Bio Farma.

Also attending the ceremony were National Education Minister Muhammad Nuh, East Java Governor Soekarwo, Deputy Governor Syaifullah Yusuf and Airlangga University's rector Fasichul Lisan.

Speaking at the ceremony, Boediono expressed his pride that the team of researchers could successfully develop the seed vaccines.

He also encouraged academics and industry to develop other vaccines as well as master the technology to do so for the benefit of the people.

As Indonesia is plagued by tropical diseases, the challenge was to find and develop successful vaccines, he said.

PT Bio Farma director Iskandar said the government had allocated Rp 1.3 trillion (US$139 million) to fund the research, development and production of the vaccines.

He said his company had planned to begin clinical trials in March 2010 and would start producing the H1N1 vaccine by November 2010. "We will produce about 20 million doses in our first production run," he said.

Health Minister Endang said researchers and paramedics would receive vaccines from the first production run, arguing that they were the ones who were critically exposed to the viruses in their work.

Center researcher C.A. Nidom said his team had begun research on the vaccines in 2006 after the Health Ministry handed over five strains of the avian flu virus. In August 2009, it again gave them six strains of the influenza A virus.

Following research, the 13-member team comprising researchers from Airlangga University and PT Bio Farma finally succeeded in creating and developing seed vaccines for both infectious diseases.

Nidom also expressed optimism that the vaccines would be effective in preventing the spread of the diseases among human beings, especially after his team found the vaccines effective in trials on marmots, mice and monkeys.

He claimed that Bio Farma would be successful in mass producing the vaccines as it was the only vaccine producer in Southeast Asia.

Speaking previously in Bandung, Iskandar said the vaccine factory would be established simultaneously with the development of a chicken farm in Lembang, North Bandung.

Around 48,000 poultry seeds will be developed at the facility to support the production of the vaccines by providing clean embryonated eggs as the media for developing the flu viruses using Japanese technology.

Congress Demands Answers Over H1N1 Vaccine Shortage

WASHINGTON, Nov. 17, 2009

The Obama administration has ratchetted up demand for H1N1 flu vaccine, without sufficient supply to meet that demand, two senators charged in a letter to the Department of Health and Human Services.

The "glaring discrepancy" between the demand for the vaccine and the supply available has resulted in pregnant women and others considered high-risk for the flu lining up for hours at clinics across the country to receive the vaccine, only to be turned away because of shortages, the letter said.

Sen. Joe Lieberman, I-Conn., chairman of the Homeland Security and Governmental Affairs Committee, and ranking member Sen. Susan Collins, R-Maine, issued the letter to HHS Secretary Kathleen Sebelius, demanding answers as to why the department "insisted on promoting a plan for which the federal government did not have anywhere near sufficient resources to implement."

The letter, dated Nov. 16, argues that the primary problem is not the pace of vaccine development or the amount of vaccine developed thus far, but the mismanagement of public expectations about who could expect to receive the vaccine, and when.

"This problem was created in part by HHS's decision to promote vaccination of an initial target group that represents almost half the U.S. population; 160 million people," the senators wrote.

"The glaring discrepancy between the demand for and supply of H1N1 vaccine in our country has resulted in pregnant women standing in line for hours, only to find no vaccine at the end," the letter said. "This shortage of vaccine has left many parents of children in high risk groups scrambling, often in frustration, to find the vaccine the government has told them that they need.

"The fact is the response failed to meet the public demand for vaccine -- demand that the federal government accelerated by advising a larger group of the public to be vaccinated than it had the resources to meet," the senators wrote.

This afternoon, the committee has scheduled a hearing, and plans to call on HHS Assistant Secretary for Preparedness and Response Nicole Lurie to testify on behalf of the department.

Health Officials to Testify Today in Congress

Also expected to testify are the Centers for Disease Control's director for immunization and respiratory disease, Anne Schuchat, and Assistant Secretary and Department of Homeland Security chief medical officer Alexander G. Garza.

"We look forward to holding a frank conversation about these issues when representativesw of your Department appear before our Committee at the hearing," Lieberman and Collins said in their letter.

A recent Harvard School of Public Health poll found that a majority of adults who tried to get the H1N1 vaccine for themselves or their children were unable to do so. The poll, conducted Oct. 31 to Nov. 1, found that since the H1N1 flu vaccine became available in October, 17 percent of American adults, 41 percent of parents, and 21 percent of high-priority adults have tried to get it.

Among the adults who tried to get it for themselves, 70 percent were unable to get the vaccine; among the parents who tried to get the vaccine for their children, 66 percent were unable to do so; and of the high priority adults, 66 percent were unable to get it, according to the poll.

The poll also found that nearly a third of those who have tried and could not get the vaccine, either for themselves or for their children, are very frustrated. However, the poll also said 91 percent of those who have tried and not been able to get it yet will try again this year to get the vaccine for themselves, their children or both.

The CDC has identified as high-priority candidates for vaccination pregnant women and recently pregnant women, those who live with or care for children younger than 6 months of age, healthcare and emergency medical services personnel, people aged 6 months through 24 years, and persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza, such as asthma or heart disease.

There have been more 900 deaths related to the H1N1 flu nationwide since the end of August.

hat-tip Missouriwatcher