Tag Archives: H1N1

Quickening Pandemic Flu Vaccine Production

If a strain of avian H5N1 influenza that readily spread from person to person were to appear in the real world, the great fear is that it would produce a deadly pandemic to dwarf what happened in 1918.

The best defense against flu pandemics are vaccines, and the most recent experience with a global flu pandemic, in 2009, highlighted the gaps that existed in getting vaccine quickly made in large amounts. Three years ago, despite the U.S. government marshaling all its infectious disease-fighting muscle, the effort wound up delivering most of the vaccine too late to matter. The pandemic peaked in October 2009, while the vaccine supply didn’t hit its stride until sometime in December.

Novartis influenza-vaccine plant in Holly Springs, N.C./courtesy Novartis

In a report published today in Science as part of its H5N1 flu package, Dr. Rino Rappuoli, head of vaccines research for Novartis, spelled out seven steps that could hasten vaccine production for a newly appearing pandemic flu. The two most novel moves involve having vaccine manufacturers prepare in advance synthetic “vaccine seed” viruses and also adopting new ways to quantify viral antigens, a process that alone took about 2 months in 2009, he said. Adopting these two technological innovations could transform the vaccine-producing process “from a mid-20th century system … into a 21st century system of instantaneous electronic information exchange followed by immediate production.”

The modernized system would mean sequencing a newly isolated pandemic virus in the field and then — instead of shipping the virus — just sending gene sequences, followed by replicating the hemagglutinin gene at a remote site, putting the new gene into a waiting scaffold vaccine virus, and launching vaccine production.

If these two changes had been in place in 2009, “the vaccine would have been available in large quantities before the peak of viral infection,” Dr. Rappuoli said in his paper.

More importantly, speaking at a June 20 press conference Dr. Anthony Fauci said that the National Institutes of Health, as well as the Centers for Disease Control and Prevention and the Food and Drug Administration, had already begun to move on this, adopting “the fundamental principles of bringing influenza vaccinology into the 21st century.” Steps already taken along the lines of what Dr. Rappuoli suggested carry the potential for “a significant change right now” in the time needed to get out a pandemic vaccine, Dr. Fauci said.

He particularly cited NIH studies underway using an immunoadjuvant to expand the coverage potential of stockpiled H5N1 vaccine, a step that would “markedly accelerate availability.

“We are right now in a much better position [to distribute pandemic vaccine quickly] than we were in 2009 when we had vaccine available only after the peak of the H1N1 pandemic,” Dr. Fauci said.

—Mitchel Zoler (on Twitter @mitchelzoler)

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H1N1 Flu Virus Goes “Post-Pandemic”

The pandemic caused by the 2009 H1N1 influenza virus is now post-pandemic, according to a statement issued today by WHO Director-General Dr. Margaret Chan.

We should consider ourselves lucky that the 2009 H1N1 virus remained relatively mild, despite its hostile takeover of other circulating flu viruses last fall. Now, according to data from the WHO, many countries where seasonal flu is occuring are reporting a mix of viruses. So, it sounds like the 2009 H1N1 is settling down to play happily in the mix with other circulating flu viruses, learning how to take turns with the likes of H1N3 and influenza B, which join 2009 H1N1 in the 2010-2011 seasonal flu vaccine. But hold on to your hand sanitizer—“Pandemics, like the viruses that cause them, are unpredictable,” Dr. Chan said in her statement. And she’s right: Think back to every horror movie you have ever seen, or any book where it seems like the villain must be dead.

courtesy of flickr user sdecoret (creative commons)

“No one could have survived that fall/ explosion /fire/gunshot wound/ decapitation/banishment to a parallel universe.”

Not until it’s time for the sequel.

The 2009 H1N1 pandemic was, in many ways, a trial run for how the government and the medical community can work together to provide information—and health care—to the public in an emergency. There is room for improvement, especially as social media evolves, but the regular media updates and availability of information online was at least a starting point for communicating this type of news effectively. And even though there has been some controversy over whether governments ordered too much of the H1N1 vaccine, one could argue that it is better to have too much than not enough. Imagine the panic if the H1N1 virus had been deadlier, and there was a vaccine shortage.That’s another potential positive side effect of the 2009 H1N1 pandemic—a revisiting of the vaccine-making process. Maybe we can look forward to quicker, more efficient vaccine production. Maybe not right away, but perhaps in time for H1N1 II: The Swine Flu Strikes Back. Coming Soon to a Germy Person Near You.

“Continued vigilance is extremely important,” Dr. Chan said in her statement. To that end, the WHO offers recommendations for the post-pandemic period on its website, and the CDC continues to provide the latest flu information.
—Heidi Splete (On Twitter @HSplete)
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H1N1 Vaccination in U.S. Children Shows Remarkable Variation

The Centers for Disease Control and Prevention today released nationwide data on H1N1 vaccine uptake rates from October through the end of January, and the state-by-state variation in rates, especially in children aged 6 months-17 years, is nothing short of astonishing. And as of now, the CDC really has no good explanation for what’s been going on.

MMWR April 2, 2010;59:363-7

State H1N1 vaccination rates in this age group varied from a remarkably high 85% in Rhode Island to a low rate of 21% in Georgia. In contrast, the state-by-state variation among adults aged 18 or older was far tighter, ranging from a high of 39%, als0 in Rhode Island, to a low of 13% in Mississippi. In other words, the gap between the highest and lowest state rates among children–64%–was about 2.5-fold higher than the range in adults–26%.

The state by state rates for children (see map, upper panel) also seems to defy any logical pattern, aside from the cluster of high-rate states in New England. There is a high-rate state, Arkansas (50% vaccination rate) sitting next to several low-rate states including Louisiana (24%) and Texas (25%). Georgia’s low-ball rate of 21% juxtaposes with the relatively high rate of 45% in nearby North Carolina. Even in New England, there is a relative outlier in New Hampshire, where its 46% rate pales next to neighboring Vermont (72%), Massachusetts (60%), and Maine (60%).

The CDC offered some possible explanations for the states with high rates: a focus on childhood vaccination, use of an existing childhood vaccination infrastructure, running school-based vaccine clinics, and better recognition of the value of vaccination by parents and providers. Among these, the school-based clinics got the biggest play today, but even that doesn’t seem to tell the whole story. As the CDC’s Dr. Anne Schuchat noted, most states had at least some school-based clinics.

As the CDC noted in its report, the good news for vaccine advocates is that having locations with such high rates bodes well for eventually finding out what happened and building on it in the future. And trying to extend it to adults. But the CDC has a lot of data mining in its future to figure out what was behind this incredible regional variation.

Find my news article on today’s data from the CDC here.

—Mitchel Zoler (on Twitter @mitchelzoler)

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H1N1: The Vaccine Few People Want

The H1N1 vaccination numbers are in for January, and the federal effort to promote this vaccine has come up way short. 

The upshot, last Friday, was a plea from the Dr. Anne Schuchat during a CDC press conference: “Many people believe the outbreak is over, and I think it’s too soon for us to have that type of complacency…We are not at all out of the woods because the [H1N1] virus continues to circulate.” 

courtesy Public Health Image Library, CDC

Dr. Schuchat, a leader of the CDC’s H1N1 vaccination campaign, faces a tough sell to the American public, and the numbers she reported Friday tell the story: According to a U.S. survey by the CDC, about 70 million Americans (23% of the U.S. population) received at least one H1N1 vaccine dose through January 30, an increase of only 9 million since the last survey that covered the period through January 2. In contrast, 61 million received the vaccine from its U.S. introduction at the start of last October through Jan 2. In other words, an average of 20 million people a month got the vaccine during the first 3 months, when distribution was mostly limited to high-risk people, compared with 9 million during January, when the vaccine was available to anyone who asked for it. 

These statistics were largely confirmed by results from a second, independent survey conducted by Harvard researchers, who also reported on Friday that 21% of Americans had received the vaccine as of late January. The Harvard poll also found that 44% of Americans said that the H1N1 outbreak was over. 

The H1N1 vaccine uptake numbers look especially bleak given the heavy publicity the campaign received when the vaccine came out last fall, and again early in January during the National Influenza Vaccination Week. And in a striking contrast, last fall 32% of Americans received the seasonal flu vaccine for 2009-2010, according to a RAND corporation report, an incredible irony because the flu strains covered by that vaccine have largely been out of circulation this flu season. Near the end of the 2008-2009 flu season, 38% of Americans had received that season’s vaccine, RAND also reported.

What’s the problem with H1N1? “Our results show there was broad awareness of the public health messages on H1N1; approximately 3/4ths of the public reported seeing ads regarding the importance of getting the H1N1 vaccine since December, but many people did not respond to the message,” said a researcher from the Harvard survey. 

The CDC and its parent federal department need to do a lot of self-examination to figure out how they failed so dramatically. 

To read more about this topic, see my article from February 11.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Selling of the H1N1 Vaccine: Phase 2

The U.S. is currently observing National Influenza Vaccination Week, in case you didn’t know, designated by the Centers for Disease Control and Prevention and the Department of Health and Human Services. 

CDC H1N1 vaccine promotional ad/photo by Mitchel Zoler

As you might guess, the current edition of National Influenza Vaccination Week (NIVW) is all about trying to get the H1N1 vaccine into the U.S. public, a goal that will need a few weeks of hindsight to gauge the Week’s success. This goal also faces a significant challenge now that the most recent wave of the H1N1 pandemic in the U.S. has dropped to a vanishingly small level, a juxtaposition I wrote about in a post here last week

But, as the CDC and HHS note in their NIVW promotions, the calendar says we’re nearing the hot zone of the traditional U.S. flu season, and how that will play out this year is anyone’s guess. A new wave of H1N1 infection is certainly possible, and might be prevented if lots more people get vaccinated. 

The federal government’s current promotion of NIVW is pretty remarkable, if only because of the full-page ads it’s run in several national and regional newspapers with an endorsement of the H1N1 vaccine signed by more than 30 U.S. health organizations. The CDC’s website includes a NIVW page with a long list of other promotional events and items, including a presidential proclamation, and an interesting mix of “ready-to-use”  articles that enterprising site-visitors are encouraged to try to place in local media outlets. 

As I noted in a post here last October, the U.S. Department of HHS, the CDC, and the federal government in general has committed a lot of effort, prestige, and reputation as well as several billions of dollars to make the 2009-2010 pandemic response work, and clearly that commitment remains in place.

What metric should we use to judge the results? The number of vaccine doses delivered? The number of influenza infections or deaths by the end of this spring? The latter is, of course, the only end point that matters, but that will depend largely on the virus itself. The number of vaccines administered is the outcome that the CDC and the public health community direct affects, and that will depend on how many people are persuaded to roll up their sleeves. 

—Mitchel Zoler (on Twitter @mitchelzoler) 

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H1N1 Pandemic Slip Sliding Away?

U.S. public health officials haven’t given up on the influenza H1N1 pandemic, but it seems like the American public has. 

Has the specter of H1N1 faded like last October's goblins?/image courtesy of Flickr user chrisstreeter

The irony is that just as the H1N1 vaccine became widely available in December, rates of pandemic flu infection dropped to vanishingly low levels and concurrently concern about H1N1 largely dropped off the national radar.

The recent downturn in H1N1 infections helped further blunt any fear. Slow-to-build vaccine supplies undercut the vaccination push. The bottleneck made widespread vaccination impossible during the hyped-up early days of the pandemic’s current wave. The result: the momentum to get much of the American public vaccinated fizzled out. The only thing that could reinvigorate the vaccination campaign now would be a third wave of infection later this winter or in the spring – certainly a possibility, but hardly a given. 

The U.S. H1N1 vaccine supply stream remained at a disappointingly moderate level in December.  During the 5 weeks from late November through the last day of 2009, an additional 48 million doses shipped, bringing the total since the vaccine began appearing in early October to a hair under 100 million doses through the end of last year, half the total ordered and paid for by the Department of Health and Human Services. 

 What this meant was that until mid-December, access to the vaccine was officially limited to high risk groups. According to a report last Friday in the New York Times by Douglas G. McNeil Jr., 60 million Americans had received the H1N1 vaccine through the end of 2009. Just when vaccine availability began to open up, the pandemic wave ebbed away. During the week ending Dec 26, the Centers for Disease Control and Prevention reported that its surveillance labs identified 83 isolates as H1N1 (with another 76 isolates influenza type A, with subtyping not done). That compared with more than 9,500 H1N1 isolates identified (with another 2,100 type A isolates not subtyped) during the current wave’s peak, the week of Oct. 18-24. Four states were reporting widespread flu at the end of December, down from a peak of about 40 states in late October. 

Here’s a personal story that typifies the missed opportunities and misinformation that have hampered the H1N1 public health campaign. I’m not a member of a high-risk group, and so waited till mid-December to call my physician’s office about getting the vaccine, only to hear that they would not carry the vaccine at all, not now or at any time in the future. I was amazed, as this practice routinely administers flu vaccine each fall. I asked why, and the practice’s nurse told me: Their patients are almost entirely middle-aged or elderly, and hence faced little or no risk from H1N1. That was their conclusion, despite the fact that so far this flu season essentially the only virus in U.S. circulation has been H1N1, and despite the fact that infection by H1N1 is still a nasty experience even for older adults. During the current U.S. flu season starting last September, U.S. surveillance labs identified about 60,000 H1N1 isolates compared with fewer than 300 isolates of other flu A types or B type.

Unless the H1N1 pandemic resurges, the U.S. legacy will be a vaccine that wasn’t available for most people until the infection threat died down, and  a triaging of initially-limited vaccine supplies to high-risk groups that got mistaken by even well-informed people to mean that high-risk people were the only ones at risk. 

–Mitchel Zoler (on Twitter @mitchelzoler) 

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H1N1 Vaccine: The Slow Supply Slogs On

It had been a month since I wrote about the H1N1 influenza vaccine supply, and I was curious what had happened during November. The numbers aren’t pretty.

According to a Dec. 4 Webpost by the Centers for Disease Control and Prevention, as of Dec. 3, a total of 63.3 million H1N1 doses had shipped to U.S. providers. Shipments began Oct. 5, so this total represented the output of the first 8.5 weeks of H1N1 vaccine availability. That works out to an average of about 7.5 million doses shipped per week.

To put the numbers in perspective, the U.S. government paid for  production of roughly 200 million doses for administration to Americans this season. As recently as Sept. 18, CDC officials predicted that by October, 20 million new doses would reach providers weekly, a timetable that suggested all 200 million doses would be available by the end of this year. Sure looks now like that’s not going to happen.

Officials running the H1N1 vaccine program began warning in late October that the supply stream wasn’t moving nearly as fast as initially predicted because the vaccine seed strains turned out to have unexpectedly low yields. A little analysis of how the supply has dribbled out so far provides  probably the best guidance on what the near future may hold for when all 200 million doses will reach the U.S. public. 

Here is the vaccine picture in a little more detail. The numbers come from the almost daily tally that the CDC updates (at least give the agency credit for transparency). I focused on the number of doses shipped, rather than the number allocated, as this seems like the most relevant statistic. Here is a week by week tally of how many doses shipped, and the running cumulative total:

Week     Ending Date     Doses Shipped                          Cumulative Total

1                  Oct 12                3.9 million                                  3.9 million

2                  Oct 19                4.9 million                                  8.8 million

3                  Oct 26                4.9 million                                 13.7 million

4                  Nov 2                 8.1 million                                 21.8 million

5                   Nov 9                9.7 million                                31.5 million

6                  Nov 16               9.2 million                                40.7 million

7                  Nov 23              8.9 million                                 49.6 million

8                   Nov 30            7.4 million                                 57.0 million

**8.5           Dec 3                6.3 million**                             63.3 million

Unless a sudden breakthrough in the supply stream occurs, these numbers show some revealing trends. The 3 days since Nov. 30 (what I highlighted with stars to stress that it wasn’t a full week) were the best showing yet, so maybe the process is speeding up. The pace for those 3 days works out to about 15 million doses/week. Even at that rate the last of the 200 million doses won’t reach providers till late January.

But another valid interpretation is that the spurt during the first days of December was catch up from the slow week ending Nov. 30, which included Thanksgiving. If you discount that as an outlier, past performance suggests that the best supply rate we can expect in the coming weeks is about 10 million doses/week. In that case the 200 million dose goal gets met sometime in March.

I think it would be safe to call that timetable disappointing, especially compared with earlier expectations from the CDC and the U.S. Department of Health and Human Services. 

—Mitchel Zoler (on Twitter @mitchelzoler)

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All’s Fair in Love and Influenza?

lu_lu

Image courtesy of Flickr user Lu_Lu (cc)

I’m a healthy 39-year-old with no chronic health conditions that put me into one of the H1N1 vaccine priority groups.  Still, when I found out yesterday at a routine visit that my ob.gyn was offering the vaccine to all patients, I couldn’t roll up my sleeve fast enough.  I felt a little guilty given shortage problems with the H1N1 vaccine in recent weeks…but not guilty enough to forego the shot.  I rationalized getting the vaccine by thinking that the public health is better off with everyone who wants the H1N1 vaccine getting it.  Why turn away those who want it?

What do you think?  Let us know by casting your vote in our poll.

—Kerri Wachter, @knwachter on Twitter

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Pulling Back The Curtain on the FDA

From the FDA’s Public Meeting on Transparency at the National Transportation Safety Board Conference Center, Washington, DC

Outside of the C.I.A., the Food and Drug Administration (FDA) has been one of the most enigmatic federal agencies, inscrutable to the industries it regulates, a mystery to the public, and feared by executives at small publicly traded companies whose stock can take wild swings in response to the slightest whisper from the Emerald City, that is, White Oak, Md.

Dorothythewiz

Courtesy Flickr Creative Commons User dbking

But like Dorothy and her raggedy band of cohorts, FDA Commissioner Margaret Hamburg and her deputy Joshua Sharfstein are determined to pull back the curtain and expose the inner workings of Oz.

As a start, they’ve organized a “transparency” initiative (details are here). On Tuesday, Dr. Sharfstein led discussions with a panel of agency colleagues, industry, physicians, and consumers on hypothetical situations where the agency would be called on to say, communicate to the public about a foodborne disease outbreak, or let manufacturers know how and why it had made a decision about a new drug approval.

The agency plans to eventually make all its decision-making processes more accessible to everyone – and soon, said Dr. Sharfstein.  First, it will create an “FDA 101” area on its website, envisioned as an interactive area for consumers to learn all about the agency’s mission and inner workings.

The second phase will be finding a way to explain to the public how the agency makes its decisions; last, it will become more accountable to industry.

With almost-daily and ever-larger outbreaks of foodborne illnesses, growing pharmaceutical and device recalls, and sporadic epidemics like H1N1 influenza, the discussions are not just academic. Being able to communicate – and quickly communicate — fact-based public health information is crucial, especially when misinformation proliferates so quickly these days.

The Centers for Disease Control and Prevention has long cultivated its reputation as a credible source of information in times of crisis and has also developed strong relationships with the partners it needs to rely on – physicians and scientists – during those crises.

The FDA, which has just as big a stake, has operated in some kind of alternate universe.  But, a whirlwind election blew in the force of change.

Will Dorothy, that is, Dr. Hamburg, be able to bring the agency back to reality?

–Alicia Ault (on Twitter @aliciaault)

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The Selling of the Vaccine

Last week, the new vaccine for pandemic influenza H1N1 reached the American public, with some 4 million doses available nationwide and promises that an additional 20 million doses will reach U.S. vaccine dispensers weekly through the rest of this year.

courtesy Sanofi Pasteur

courtesy Sanofi Pasteur

Along with the vaccine came a high-intensity publicity campaign by government officals urging the American public to get vaccinated. On Tuesday and Wednesday, Kathleen Sebelius, Health and Human Services secretary, appeared on a series of morning news shows promoting the vaccine. Also last Tuesday, Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, spoke in a press conference where his main message was that the new vaccine was safe and effective. On Friday, the CDC’s Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases, made similar pitches in a second news conference.

A cynic might say the CDC, HHS, and possibly the entire Obama administration has a major stake in making sure the H1N1 vaccine gets widely used and succeeds. After all, HHS has spent more than $6 billion in this effort and has placed a whole lot of reputation, credibility, and careers on the line. If the vaccine becomes mired by an adverse effect,  poor performance, or an unconvinced public that refuses to get vaccinated, it’s easy to expect that heads would roll, embarrasment would run rampant, and the vaccine cause would be set back a few decades.

The 2009 H1N1 vaccine program is a public health juggernaut that’s a lot more than business as usual for the CDC and HHS. As Dr. Schuchat noted on Friday, the CDC usually handles about 10% of the annual, seasonal flu vaccine program, with 90% in other hands. In contrast, the H1N1 vaccine is 100% Uncle Sam, with the government fully responsible for footing the bill and hence also in line to take the credit or the blame depending on how it sorts out.

But there’s more to the last week of salesmanship than bureaucratic responsibility and fear of failure. While I have no prior, personal experience covering Secretary Sebelius or Dr. Frieden, I have seen Dr. Schuchat talk on various infectious disease and public health issues over the years, and, based on that history I’m convinced she now sincerely believes this vaccine is what’s best for the health of the nation. It’s moments like these, when a possibly calamitous infection is knocking on the door, that the public-health lifers at places like the CDC train for and live for.

Last week also brought the good news that the uptake bar might not be set very high for the H1N1 vaccine to succeed. A modeling analysis released by Annals of Internal Medicine showed that vaccinating 40% of the population in a hypothetical city of 8 million people in October or November stood to prevent morbidity in tens of thousands and save hundreds of millions of dollars. Even vaccinating just 15% of the population in October could avert more than 700,000 infections and more than 700 deaths and save more than $160 million in one large city.

—Mitchel Zoler, 12:30 AM Oct.12 in Wynnewood, PA (on Twitter @mitchelzoler)

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