As U.S. health officials struggle to vaccinate tens of millions of Americans against the pandemic of swine flu, some are looking regretfully at one easy way to instantly double or triple the number of doses available -- by using an immune booster called an adjuvant.
These additives, often as simple as an oil and water mixture, broaden the body's response to a vaccine, reducing the amount of active ingredient called antigen needed.
They are widely used in European flu vaccines as well as in Canada. But not in the United States -- even though the federal government has spent nearly $700 million buying them.
About 22 million Americans have become ill with pandemic H1N1 influenza in the past six months and 3,900 have died, according to new estimates by the Centers for Disease Control and Prevention.
The number of pediatric deaths -- about 540 -- is four times as high as the number that physicians, hospitals and health departments had reported to the public health agency in Atlanta.
The new estimates, drawn from detailed surveillance and record-checking in 10 states, sketch the most detailed picture by far of the national toll from the new flu strain that emerged in California and Mexico in April.
When I tell nonmedical friends that our clinic is vaccinating children against the H1N1 flu virus, here is what they say.
With about half, it is something like: “Oh, my God, our doctor doesn’t have it! Can you get me a dose?” And with the other half, it is something like, “Oh, my God, that brand-new vaccine — do you really think it’s safe?”..Read More
Why does CDC advise pregnant women to receive the 2009 H1N1 influenza (flu) vaccine (shot)?
Getting the flu shot is the single best way to protect against the flu. It is important for a pregnant woman to receive both the 2009 H1N1 flu shot and the seasonal flu shot. A pregnant woman who gets any type of flu has a greater chance for serious health problems. Compared with people in general who get 2009 H1N1 flu (formerly called “swine flu”), pregnant women with 2009 H1N1 flu are more likely to be admitted to hospitals. ...Read More
An expert committee that advises the World Health Organization (WHO) today updated its guidance on pandemic H1N1 vaccines, recommending a single dose for most age-groups and advising that any of the forms are safe for pregnant women. ..Read More
Objective: To investigate the intention of the Hong Kong general population to take up vaccination against influenza A/H1N1.
Conclusions: The uptake of vaccination against influenza A/H1N1 by the general population of Hong Kong is unlikely to be high and would be sensitive to personal cost. Evidence about safety and efficacy is critical in determining the prevalence of uptake of vaccination....Read More
In a reminder that the new strain of H1N1 influenza may not be as benign as originally thought, federal health officials reported Thursday that 100 pregnant women infected with the virus were hospitalized in intensive care units in the first four months of the outbreak, and 28 have died.
"What we are seeing is quite striking," said Anne Schuchat, a physician at the Centers for Disease Control and Prevention in Atlanta who is helping direct the government's response to the pandemic. ...Read More
Large-scale infectious epidemics present the medical community with numerous medical and ethical challenges. Recent attention has focused on the likelihood of an impending influenza pandemic caused by the H5N1 virus. Pregnant women in particular present policymakers with great challenges to planning for such a public health emergency. By recognizing the specific considerations needed for this population, we can preemptively address the issues presented by infectious disease outbreaks. We reviewed the important ethical challenges presented by pregnant women and highlighted the considerations for all vulnerable groups when planning for a pandemic at both the local and the national level. ...Read More
Pregnant women are deluged with advice about things to avoid: caffeine, paint, soft cheese, sushi. Even when evidence of possible harm is weak or purely theoretical, the overriding caveat is, “Don’t take it, don’t use it, don’t do it.” In a few contexts, the admonition is warranted; in most, it is merely inconvenient and anxiety provoking. But in the case of pandemic influenza, it may be deadly. With the second wave of swine flu at hand, and up to 50 percent of the public at risk, the usual mode of thinking about pregnancy and medications threatens to make a worrisome situation worse.
The dangers of this mentality became frighteningly apparent this summer, when a study in The Lancet reported strikingly high rates of death and of complications like pneumonia in pregnant women with H1N1 influenza. Pregnancy meant a fourfold risk of hospitalization, sometimes with a tragic outcome; all the pregnant women who died had been relatively healthy to begin with.
The Centers for Disease Control and Prevention have since put pregnant women at the top of the priority list for the vaccine, and have recommended that pregnant women start antiviral medications as soon as possible after exposure to the virus and after the onset of flu symptoms. ...Read More
Data suggest that Mexico has seen two waves of infection — the first, which peaked in late April, affected the Mexico City area, and the second, broader wave spanned June through August in southern states, including Chiapas, Yucatan and Quintana Roo. To prepare for a potentially larger wave this winter, Mexico is raising public awareness, standardizing timely diagnosis and treatment and reinforcing equipment and management protocols in intensive-care units throughout the country. ...Read More
THE PRESIDENT: Good afternoon, everybody. Before I say a few words about the meeting we just had I'd like to mention some good news that came out today about our economy. For the first time in 18 months, our manufacturing sector has expanded, and the statistics used to measure manufacturing output is the highest it's been in over two years.
This means greater production of transportation equipment like cars, and electronic equipment like computers and appliances, and it means these companies are starting to invest more and produce more, and it is a sign that we're on the path to economic recovery.
There's no doubt that we have a long way to go, and I and the other members of this administration will not let up until those Americans who are looking for jobs can find them. But this is another important sign that we're heading in the right direction, and that the steps we've taken to bring our economy back from the brink are working.
Now, we just had a good meeting about our ongoing efforts to prepare this country for the H1N1 flu virus this fall. And I want to thank John Brennan, our CDC Director Tom Frieden, and Secretaries Sebelius, Napolitano, Duncan, and Locke, for all the good work that they've been doing to get us ready today. ...Read More
...A total of 600 children will be enrolled by Maryland and five other sites around the country to test the pediatric vaccine. For years, little medical research was done on children due to worries about what might happen to them. But this put them at a disadvantage, as doctors were left without guidance as to how much of a certain medication, for example, a sick child should receive.
Dr. Holly Taylor, who is on the faculty at the Johns Hopkins Berman Institute of Bioethics, said many factors have to be considered when determining whether something should be tested on children, but the risk to the child should be as small as possible, and there should be a benefit to the child and to children at-large.
"We're always more careful when we conduct research with children," she said. "We learned a long time ago that kids are not mini-adults and might have different kinds of responses" to medications or vaccines than adults....Read More
August 17, 2009
A Moral Obligation? Should the U.S. produce enough H1N1 flu vaccine to help developing countries? by Ruth Faden and Ruth Karron (The Baltimore Sun)
As the nation prepares for the return of the H1N1influenza pandemic, public health officials are faced with difficult choices. While some doses of the vaccine for what is known as "swine flu" will be ready by October, the entire supply will not be available for several more months.
Recently, two landmark meetings have been convened to discuss plans for the evaluation and use of vaccines against H1N1. On July 23rd, the Vaccine and Related Biological Products Advisory Committee (VRBPAC) of the FDA met to discuss ongoing vaccine trials and pathways for licensure or emergency use authorization of a variety of vaccines. On July 29th, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control met to determine who should receive vaccine first.
A single number has dominated these discussions: 600 million. That's the number of doses that would allow every American to be immunized twice (since this is a new virus, it is possible that everyone will need two doses of vaccine to achieve protection). Debate and discussion have centered over the fastest and safest way to get to this number: whether, for example, some inactivated (killed) vaccines used in the U.S.could contain dose-sparing additives called adjuvants that might be used to stretch the supply of inactivated vaccine to get to 600 million more quickly, or how to best package a live attenuated vaccine, normally dispensed by nasal spray if, as appears likely, there will be more doses of this vaccine available than spray devices to administer them.
But is 600 million the right number? That the United States should aim to produce enough vaccine to protect all Americans is not at issue. What is not being addressed, however, is whether we ought to aim to do more. Nowhere in these discussions has the prospect of upping the ante been raised. Should we use available technologies to provide not only enough vaccine for the U.S. but also to allow for excess capacity to assist other countries who have no capacity to procure or produce the vaccine on their own?
In Guadalajara, the three North American leaders will also work on a plan to coordinate a response to the H1N1 virus, better known as swine flu. Public health officials across North America are preparing for a major outbreak of the disease this fall and winter. On Friday, the U.S. government began trials of a vaccine for the virus, but none of the volunteers testing this vaccine will be pregnant women, even though they have priority access to receive it. Testing vaccines and drugs on pregnant women poses an ethical dilemma. And that's where Berman Institute Director,Ruth Faden comes in. She's a bioethicist and public health expert at Johns Hopkins University. Ruth Faden joins NPR host Guy Raz on All Things Considered.
A Custom DrugBy Ruth Faden, Anne Drapkin Lyerly and Maggie Little (New York Times)
When diseases like swine flu hit, pregnant women are especially at risk. And yet we know surprisingly little about how to treat them. In its guidelines for the antiviral drugs Tamiflu and Relenza, the Centers for Disease Control and Prevention says that pregnant women infected or at high risk for infection should take the recommended adult dosage: "Pregnancy should not be considered a contraindication" to taking the drugs, because the benefits of treatment "likely outweigh the theoretical risks of antiviral use."
But we don’t know whether this is true. Concerns about the ethics of performing drug studies on pregnant women mean we know far less about how to treat them. It is perfectly possible that the standard adult dose of antivirals will not work in the pregnant body....Read More
The World Health Organization raised its global alert level for the swine flu on Monday, as Mexican officials reported that the death toll from the outbreak had reached 149. In the United States, the number of people sickened by the virus reached 50 (with 28 cases in one New York City school), though officials said that none of the cases were serious. Amid travel advisories and health warnings, how worried should Americans be that the disease might turn into a far more serious epidemic?
As the numbers of reported swine flu cases increase, anxiety over the possibility of a pandemic is a natural response.
But now is not the time to panic. Panicking never helps; moreover, it distracts from things we all should be doing to reduce the impact of swine flu on ourselves and on others....Read More
At this point, it is impossible to predict whether we are on the brink of an influenza pandemic. The threat is real, however, and governments across the globe are working hard to mitigate the potential impact of swine flu.
This is right and proper. Our government has an obligation to protect the public's health, which it exercised responsibly by declaring a national public health emergency on Sunday. ...Read More
An international group of experts in public health, animal health, virology, medicine, public policy, economics, bioethics, law and human rights met in Bellagio, Italy from 24 to 28 July 2006 to consider questions of social justice and the threat of avian and human pandemic influenza, with a particular remit to focus on the needs and interests of the world's disadvantaged....Read More
