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. 

What’s the problem with H1N1? “Our results show there was broad awareness of the public health messages on H1N1; approximately 3/4 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. 

—Mitchel Zoler (on Twitter @mitchelzoler)

In the interest of reporting the news without becoming part of the news, I got my H1N1 shot just before traveling for the holidays on Dec. 26.

My personal physician still hadn’t received his shipment of vaccine. So, I went to a walk-in clinic at one of the major pharmacy chains, which had an ample supply.

I was prepared for the possible redness or soreness around the injection site, but experienced neither. In fact, I completely forgot about the vaccination until eight days later, when I returned from my Florida vacation aboard a plane crowded with coughing passengers.

Studies suggest that even after eight days, I should have a high level of protection against H1N1 with that single shot. But that’s not necessarily the case for young children.

This morning, Health and Human Services Secretary Kathleen Sebelius, Education Secretary Arne Duncan and Surgeon General Regina Benjamin vistied a school-based flu vaccination clinic in Arlington, VA, to underscore the importance that children under 10 years of age receive a second dose of H1N1 vaccine to build up full immunity to the virus.

Although H1N1 activity is lower now than in the fall, the Centers for Disease Control and Prevention reported a slight uptick in the week following Christmas.

“We don’t know whether that was just a blip or whether it will continue to increase,” said Anne Schuchat, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. “I wish I could tell people exactly what the risks are, exactly what the chances are that you’ll come down with flu in the next several weeks or months. But what I can say is there is a risk. And the best way to reduce that, to take chance out of the equation, is to get vaccinated.”

Dr. Schuchat is scheduled to update reporters on the last H1N1 statistics later this afternoon.

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On Friday, CDC predicted a shortfall in the supply of the H1N1 vaccine, as the numbers of cases, hospitalizations and deaths grow to levels unprecedented for this time of year. The H1N1 virus is now widespread in 41 states, and flulike illnesses account for 6.1 percent of all doctor visits.  “That’s high for any time, particularly for October,” said Dr. Anne Schuchat, the director of the National Center for Immunization and Respiratory Diseases at the CDC.

As can clearly be seen from this weeks FluView map, the entire country has the flu!

A chilling number was released…43 children have died from H1N1 since Aug. 30 — about the same number that usually die in an entire flu season. “These are very sobering statistics,” Dr. Schuchat said in a news briefing, “and unfortunately they are likely to increase.”

The age breakdown looked like this:

• 19 of the 43 who died were teenagers
• 16 were ages 5 to 11 years old
• The rest were under 5.

This shows the number of influenza deaths over the past five flu seasons going back to 2005 and as you can see 2008-2009 blends into 2009-2010.

Those who are hospitalized are often very, very sick.  Between 15 – 20 percent of the patients who were hospitalized with the flu landed in an intensive care unit, a rate comparable with that for seasonal flu. There is one light of good news, although the disease continues to spread, its severity is not increasing…there is just lots and lots of sick people.

This graph shows 3 years of influenza…you can see wave #1 starting around week 15 and wave 2 starting week 31. Since that time it has had a vertical ascent. Red = 2008-2009 Green = 2007-2008 Blue 2006 -2007

Projections of the supply of H1N1 vaccine have widely varied. During the summer, health officials said 120 million doses would be ready in October. They later dropped the estimate to 40 million doses by the end of the month. Now, Dr. Schuchat said, they expect only 28 million to 30 million doses, adding that the exact numbers were impossible to predict and could change daily. She said vaccine manufacturers were reporting that production was behind schedule. “Vaccine production for influenza is pretty complex,” she said in explaining the delay, “and the complex process this year is taking a bit longer than we had hoped. The yield of antigen is lower than they had hoped for.”  The antigen is the part of a virus included in vaccine to stimulate the body’s protective response. It is crucial; a vaccine will not work without it.

Dr. Schuchat also said that once batches of vaccine were prepared, they had to be tested for potency and purity. “We are not cutting any corners,” she said. “It’s important to us that this process be done carefully and safely.” She acknowledged that some people were having trouble obtaining vaccinations, saying, “I’m sorry it’s a difficult time in terms of looking for vaccine.” As of Wednesday, Dr. Schuchat said, 11.4 million doses of the H1N1 vaccine were available, with more being shipped. She predicted that by early November, there would be widespread vaccine availability and information on where people should go for it.

Dr. Schuchat acknowledged that some people had fears about the H1N1 vaccine, but she emphasized that it was safe and urged pregnant women to be vaccinated because they were especially prone to severe complications and had accounted for a disproportionate number of deaths. Studies of the swine flu vaccine are being conducted in pregnant women. But, Dr. Schuchat said, “if I were pregnant, I would not wait for the results of those trials; the risk in pregnant women has been very striking.”

On the seasonal flu, Dr. Schuchat said 82 million doses of vaccine had been distributed, out of an expected total of 114 million. But the vaccine has been running low in some areas. Dr. Schuchat urged the public to “keep looking” and emphasized that there was time because seasonal flu did not usually take hold until December. Virtually all cases now are the H1N1 swine flu, she said.

http://www.nytimes.com/2009/10/17/health/17flu.html?_r=1&th&emc=th

http://www.cdc.gov/flu/weekly/

Last week, the new vaccine for pandemic influenza H1N1 reached the American public, with some four 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

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, secretary of the Department of Health and Human Services, 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, the Department of 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, these days 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 goverment 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 this past week of salesmanship than bureaucratic responsibility and fear of failure. While I have no prior, personal experience with 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)