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)

Flu activity seems to have quieted down recently, for which we can all be thankful. But the flu season is not over yet. Influenza is still out there.

Many states are reporting flu activity, which still remains a threat. Seasonal influenza usually peaks in February and March and can continue as late as May. So increased activity from the seasonal influenza, the H1N1 flu or both is still possible.

We need to remember the 1957-58 pandemic, when flu activity decreased in December and January. Thinking the worst was over, officials relaxed their push to get people vaccinated. When flu activity significantly returned in February and March, many were hospitalized, and deaths increased, as well. This could be a good lesson for us today.

So far during this flu season, most activity has been attributed to the H1N1 virus, which first appeared in April.

By the middle of November, the United States had reported roughly 47 million H1N1 flu cases. This resulted in well over 200,000 hospitalizations and caused nearly 10,000 deaths. About a thousand of those deaths were in children younger than 18, a number of whom were healthy before they caught the flu. That is why it is important not to take this disease lightly.

Although I think everyone would benefit from the flu vaccine, it is especially important for certain groups. You should be vaccinated if you:

• Have a chronic illness such as asthma, heart disease, or diabetes.

• Are pregnant.

• Are 65 years or older, and therefore are at increased risk of complications.

• Care for or live with a baby less than 6 months of age, as these infants are too young to be vaccinated for influenza.

Children who are 9 years old or younger need two doses of vaccine about a month apart; however, waiting more than a month between doses does not seem to decrease the effectiveness of the vaccine. Adults need only one dose.

Regarding popular worries about side effects of the H1N1 vaccine, data from the established surveillance systems would indicate that H1N1 has a safety profile similar to that of the seasonal flu vaccine. No significant pattern of adverse health events have been seen with either of the vaccines.

The bottom line is that although flu activity has died down this past month, the season is not over. It is still important to get vaccinated and be prepared for a possible increase in flu activity, which could occur between now and May. At this time, there appears to be enough vaccine for anyone who wants it.

I would like to thank the Palo Alto Medical Foundation’s Santa Cruz Incident Command Committee for supplying some of the information for this article.

Flu activity seems to have quieted down recently, for which we can all be thankful. But the flu season is not over yet. Influenza is still out there.

Many states are reporting flu activity, which still remains a threat. Seasonal influenza usually peaks in February and March and can continue as late as May. So increased activity from the seasonal influenza, the H1N1 flu or both is still possible.

We need to remember the 1957-58 pandemic, when flu activity decreased in December and January. Thinking the worst was over, officials relaxed their push to get people vaccinated. When flu activity significantly returned in February and March, many were hospitalized, and deaths increased, as well. This could be a good lesson for us today.

So far during this flu season, most activity has been attributed to the H1N1 virus, which first appeared in April.

By the middle of November, the United States had reported roughly 47 million H1N1 flu cases. This resulted in well over 200,000 hospitalizations and caused nearly 10,000 deaths. About a thousand of those deaths were in children younger than 18, a number of whom were healthy before they caught the flu. That is why it is important not to take this disease lightly.

Although I think everyone would benefit from the flu vaccine, it is especially important for certain groups. You should be vaccinated if you:

• Have a chronic illness such as asthma, heart disease, or diabetes.

• Are pregnant.

• Are 65 years or older, and therefore are at increased risk of complications.

• Care for or live with a baby less than 6 months of age, as these infants are too young to be vaccinated for influenza.

Children who are 9 years old or younger need two doses of vaccine about a month apart; however, waiting more than a month between doses does not seem to decrease the effectiveness of the vaccine. Adults need only one dose.

Regarding popular worries about side effects of the H1N1 vaccine, data from the established surveillance systems would indicate that H1N1 has a safety profile similar to that of the seasonal flu vaccine. No significant pattern of adverse health events have been seen with either of the vaccines.

The bottom line is that although flu activity has died down this past month, the season is not over. It is still important to get vaccinated and be prepared for a possible increase in flu activity, which could occur between now and May. At this time, there appears to be enough vaccine for anyone who wants it.

I would like to thank the Palo Alto Medical Foundation’s Santa Cruz Incident Command Committee for supplying some of the information for this article.

The commonly used influenza vaccine is effective when it comes to protecting patients suffering from asthma and on inhaled steroids against type A flu though the protection may not be the same for type B flu in patients who take high doses of inhaled steroids, as per a researcher from Baylor College of Medicine in a publication.

It was remarked by Dr. Nicola Hanania, BCM assistant professor of medicine and director of the Asthma Clinical Research Center, that the findings of this study reassure physicians and patients that the influenza vaccine is effective for providing protection against influenza in most asthma patients on inhaled steroids.

From News-Medical.Net:

There are occasional outbreaks of influenza type B, and in the event this happens, people who use inhaled steroids to control their asthma may need to receive other medications in addition to the vaccine, he said. Hanania was the lead researcher among the six centers belonging to the American Lung Association-Asthma Clinical Research Centers Network that participated in this study. The study looked at 294 asthma patients who were randomly assigned to receive either the flu vaccine or a placebo (an inactive medication). Seventy-five percent of patients who received the vaccine were on steroids while 70 percent of those received placebo were on steroids. The immune response of patients on steroids at all doses who received the vaccine was higher than that seen in patients on steroids who received placebo, said Hanania. However, patients on high doses of inhaled steroids had a lower immune response to type B influenza. A previously published study performed by this network confirmed the safety of influenza vaccine in children and adults with asthma.

The report appeared in an issue of the Journal of Allergy and Clinical Immunology.

In 2009, the world responded to its first influenza pandemic since 1968. A new strain of the virus was discovered in March when three children (California and Texas) were hospitalized for respiratory infections. The following month, the H1N1 virus took its first victim: a young boy in Mexico. As the severity of the outbreak became clearer, a massive coordinated response effort was undertaken by government agencies, scientists, private industry, and the general public.

Over the next few months, a vaccine was tested and developed. In July, all communications about H1N1 and seasonal flu became centralized on a new website: www.flu.gov, providing users with a one-stop comprehensive site for flu-related information from across HHS and other federal agencies.  In October, distribution began. Early on, the vaccine was allocated to priority groups who were most vulnerable. Today everyone is encouraged to get vaccinated. Supplies have increased and there are over 118 million doses available – setting a record for production in eight months time.

The threat of the H1N1 flu is still very serious and very real. The virus is unpredictable and it’s unclear whether we’ll see a third wave of outbreak. The increase in vaccine supplies means that now is a good window of opportunity to get yourself, and your family, vaccinated. This is the best way to keep ourselves and our communities safe and healthy.

This interactive timeline will take you step-by-step, month-by-month through the events of the 2009 H1N1 flu pandemic. This site may be useful for presentations and evaluation of lessons your organization has learned.

The multimedia timeline captures the following information across 10 months, beginning in March 2009:

• Waves of illness
• Vaccine development and doses allocated
• Government actions
• A sampling of news headlines, maps, and videos
• Brief synopses for each month

http://www.flu.gov/about/h1n1yearreview.html

Guest Contributor, John Bogen, MD, provides another update on the H1N1 pandemic along with his observations with what to expect in the coming year.

Photo: UCSD.edu

Since August 30, 2009, 99+% of subtyped influenza A have been novel 2009 pandemic strains (944 different strains have been identified). And so far, seasonal H1N1 and H3N2 strains have not been resurgent, and have killed very few compared to past years. If the oft-quoted 36,000 deaths annually from seasonal influenza is correct (of which 90% are elderly), then we can be thankful this season that influenza has “only” killed about 10,000 due to it’s low virulence compared to seasonal H1N1 and H3N2, and the fact that elderly have some immunity to the pandemic strain due to their birth before the 1957 pandemic when H2N2 replaced H1N1 as the dominant strain.

H1N1 Influenza Virus. Photo: CDC

The CDC website has posted weekly updates (usually on Fridays). The presentation has been quite clear.

What could have been done better? One could blame the foreign manufacturers for the delay in vaccine, which admittedly has made the vaccine have little impact on the pandemic this season, but I cut them some slack – the virus was identified in California in April, and the pandemic was not declared until June.

If you want to improve the system, you could make the case to reduce legal liability and red tape in the U.S. to encourage more vaccine manufacture in the U.S. (only the nasal version was made here this season), and encourage pharmaceutical companies to move past the slow chicken egg processes.

Eggs Being Prepared for Vaccine Production. Photo: Medirsource.com

The one thing I disagree with the official govt policy now is the strong push for healthy individuals to get vaccinated, and consume the vaccine that has already been manufactured and paid for. Herd immunity [Note: herd immunity occurs when a sufficient percentage of the population either has had the influenza, or has been vaccinated against it that there is no longer anyone left to contract the virus-DW]  is now very high due to the fact so many people contracted pandemic H1N1 already, with a smaller herd immunity effect due to the delayed vaccine. Healthy people have an extremely low mortality rate from pandemic H1N1 (most deaths were those with chronic illnesses as per usual, with a shift in absolute numbers towards younger people simply due to the fact that younger folk got so many more cases due to no innate immunity).  In my humble opinion, it is now a waste of time to vaccinate healthy individuals, and time should be spent by us PCPs on our non-vaccine duties.

I offer a prediction that the pandemic is over (i.e. no more peaks this season) in the U.S., and we will not see a resurgence until the usual influenza season next winter. I also would not be surprised if pandemic H1N1 becomes the new dominant seasonal strain in subsequent flu seasons (as happened historically after the 1957 and 1968 pandemics).

I predict the vaccine next season will be quadrivalent, containing pandemic H1N1 strains in circulation now (i.e. an update from current vaccine that contains hemagglutinin from strains present last spring / early summer), the former seasonal H1N1 and H3N2 (just in case they don’t disappear from circulation), and influenza B. I do not have info on the seasonal vaccine being prepared for the southern hemisphere’s upcoming flu season (during our summer).

I'm too cute to cause flu.What? I did? Oops, sorry! Photo Courtesy: MADMAXX174 Photo Bucket

This whole exercise was a “rehearsal” for the event that we ever get a really devastating influenza A pandemic, as would occur if H5N1 (with it’s 60% mortality) ever co-infected an animal or human with a highly contagious influenza A virus (e.g. any H1N1 or H3N2), genetic material was exchanged, and a new virus was born. The WHO and CDC will be even better prepared for future pandemics.

One more thing, we did not know the case-fatality rate or epidemiology of pandemic H1N1 when vaccine planning was performed in spring / early summer 2009. It is better to be over-prepared than under-prepared.

It is true HIV, TB, and malaria are devastating in other parts of the world, but that is a separate debate. The issue here is did public policy officials have the appropriate response in the U.S. to the influenza pandemic (I think yes), and what have we learned to plan better for next winter’s flu season.

And to end on a light note:

Despite how silly this photo looks, it is an actual N-95 mask fitting procedure. You put on the mask securely, the hood is placed over your head and an aerosol odor is puffed into the hood. If you cannot smell the aerosol, then the mask is properly fitted. I know because I've gone though this fitting procedure–DW. Photo Courtesy: PunditKitchen.com

The Vaccine Adverse Events Reporting System (VAERS) of the US Department of Health and Human Services has released a summary of adverse events reported following immunization with the Swine flu/H1N1 vaccine. An adverse event is basically any medical symptom that is reported after receiving a medical treatment – in this case, the Swine flu/H1N1 vaccine.

94% of the adverse events reported to VAERS by Jan 8 2010 were not considered serious – symptoms like soreness or redness at injection site.

Out of 110 million doses that were shipped to providers, 33 deaths were reported. There is currently no evidence to suggest that these deaths were caused by the vaccine, but the CDC, the FDA and applicable State governments are currently investigating each of these cases.

There were also 46 reports of Guillan-Barre syndrome, which is less than the average weekly number of diagnoses of Guillan-Barre syndrome among all Americans – whether or not they had received any influenza vaccine.

The CDC and FDA provide weekly updates on vaccine safety monitoring activities in an effort to put the data that is publicly available through the Vaccine Adverse Event Reporting System (VAERS; http://vaers.hhs.gov) and CDC’s website, WONDER (http://wonder.cdc.gov/vaers.html) in context. The following information summarizes adverse event reports to VAERS after the administration of 2009 H1N1 monovalent influenza vaccine (either nasal spray or shot).

An adverse event is a health problem that is reported after someone gets a vaccine or medicine. Note that persons may experience adverse events shortly after vaccination which may or may not be caused by the vaccine. While VAERS is an important system for helping to find potential signs, VAERS is primarily used to detect signals that may require further investigation, but is not able to determine if an adverse event was caused by vaccination.

VAERS Summary:

• As of January 8, 2010, over 110 million doses of 2009 H1N1 vaccine had been shipped to vaccination providers in the United States, although the precise number of vaccines administered is unknown.
• As of January 8, 2010, VAERS had received 7814 adverse event reports following 2009 monovalent H1N1 vaccination.
• The vast majority (94%) of adverse events reported to VAERS after receiving the 2009 monovalent H1N1 vaccine are classified as “non-serious” (e.g., soreness at the vaccine injection site).
• Of the 7814 reports, 477 (6%) were reports that were classified as “serious” health events (defined as life threatening or resulting in death, major disability, abnormal conditions at birth, hospitalization, or extension of an existing hospitalization)*.
• The percentage of reports involving what would be considered serious health events is not different between 2009 H1N1 and seasonal influenza vaccines. Additionally, no new or unusual events or pattern of adverse events have emerged.
• VAERS reports continue to be monitored as more vaccine is administered.
• Among the 477 reports of serious health events, there were 33 reports of death.
  • As with all reports of serious adverse events and deaths, the 33 VAERS reports that involve deaths are under review by CDC, FDA and the states where the reported deaths occurred. Preliminary findings do not indicate a common cause or pattern (such as similarities in age, gender, geographic location, illness surrounding death, or underlying medical conditions) to suggest that these deaths were associated with the vaccine. These cases are under further review pending additional medical records (e.g., autopsy reports, medical files).
• VAERS has received 46 reports of Guillian-Barré syndrome (GBS), for which follow-up assessments are underway. In the United States, about 80-160 cases of GBS are expected to occur each week, regardless of vaccination.

VAERS Limitations

When reviewing data from VAERS, keep in mind what the system is designed to do and what it is unable to do:

• VAERS is a national reporting system, in which reports are submitted voluntarily by people who think an adverse event occurred after vaccination. VAERS does not solicit reports in any systematic way from all people who have been vaccinated. Reports can be submitted by anyone, including healthcare providers, patients, or family members. Because of this feature, VAERS reports may and often do include incorrect and incomplete information. VAERS reports often lead to more complete follow-up and review of medical records.
• VAERS staff follow-up on all serious and other selected adverse event reports and obtain additional medical, laboratory, and/or autopsy records when available. As a result of the follow-up/review process, coding terms (e.g., serious or non-serious) for individual VAERS reports may change based on the information received. These changes are reflected in the weekly updates of VAERS data in the WONDER database. VAERS data in WONDER should be used with caution because numbers and conditions are often updated. Events reported in VAERS should not be viewed as evidence that the vaccine directly caused the event. Data does not infer causality. Further investigation is warranted.
• Underreporting, or failure to report events, is also one of the main limitations of VAERS. Serious medical events are more likely to be reported than minor events.
• Most importantly, VAERS cannot determine cause-and-effect. VAERS accepts all reports without regard to whether or not the event was caused by the vaccine. The report of an adverse event to VAERS does not mean that a vaccine caused the event. It only indicates that the event occurred sometime after administration of the vaccine. Proof that the event was caused by the vaccine is NOT required in order for VAERS to accept the report.
• No reports are deleted from VAERS. Therefore, it is possible to have more than one VAERS report on an individual case (e.g., a physician and a patient may have filed separate reports for the same case).
• For all reports of serious adverse events, VAERS staff seeks follow-up medical records on each case and medical officers review them closely to determine if any additional action or studies may be needed.
• The most reliable information about vaccine side effects can be found in the manufacturers’ vaccine package insert. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093830.htm

http://vaers.hhs.gov/resources/2010H1N1Summary_Jan14.pdf