Medical Research: Serologic Surveys Reveal H1N1 Infection Much Higher Than Estimated in Young Populations

CIDRAP reports that British researchers published one of the first large serologic studies of pandemic H1N1 infection. Serology typically involves a blood test to detect the presence of antibodies against an infecting microorganism.

According to experts, serologic studies provides a sharper picture of the burden of disease than is available from flu-surveillance, and this helps public health planners better assess vaccination efforts.

KEY research findings were:

In regions with high H1N1 incidence, as many as one in three children under 15 years of age were infected with H1N1 in the first wave of infections.

A substantial proportion of older adults had preexisting immunity to H1N1, which may have resulted from prior exposure to “antigenically similar” flu viruses.

Editor’s Comment: These findings strongly underscore the risks of H1N1 to young populations;  they should remain a priority target group for vaccination, The findings suggest some upper and lower bounds on pre-existing immunity to H1N1 for seniors.  However, it is fair to say a significant proportion of seniors are at risk.

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CIDRAP: Serologic study finds H1N1 infections surged past official estimates
The Lancet: Incidence of 2009 pandemic influenza A H1N1 infection in England: a cross-sectional serological study

H1N1 Vaccine Safety: FDA Letter to Health Care Professionals

Commissioner’s Letter to Health Care Professionals
Letter from the Commissioner to Nation’s Health Care Professionals on H1N1 Vaccine Safety
U.S Food and Drug Administration (FDA) Jan 14, 2010

KEY points and excerpts:

  • FDA and CDC are assessing H1N1 vaccine safety on a continuing basis and have published a detailed report describing the safety profile of H1N1 vaccines in the United States.
  • To date, our experience with the H1N1 influenza vaccination program has met high safety expectations, based on the track record of the licensed seasonal vaccines, including live attenuated and inactivated vaccines.
  • At the heart of our monitoring efforts are two surveillance systems used to help identify safety issues: the Vaccine Adverse Event Reporting System (VAERS) and the CDC’s Vaccine Safety Datalink (VSD).
  • No substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported. No increase in any of the pre-selected adverse events under surveillance, such as Guillain-Barré syndrome, has been seen in VSD data.
  • The National Vaccine Advisory Committee (NVAC) created the H1N1 Vaccine Safety Risk Assessment Working Group to review 2009 H1N1 vaccine safety data. This working group of outside experts conducts regular, rapid reviews of available data from the federal safety monitoring systems.. for policy followup.

VIDEO:  More from Norman Baylor, Director of the Office of Vaccines Research Review in the Center for Biologics Evaluation and Research.


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CDC: Safety of Influenza A (H1N1) 2009 Monovalent Vaccines — United States, October 1 — November 24, 2009 (MMWR)
FDA: 2009 H1N1 (Swine) Flu Page
HHS: National Vaccine Advisory Committee – Report on 2009 H1N1 Vaccine Safety Risk Assessment

HHS: Vaccine Adverse Events Reporting System – H1N1 Updates

H1N1 Vaccine Safety: Guillain-Barré Syndrome – Less Mysterious, More Manageable and Very Rare

Guillain-Barré Syndrome (GBS) is a very rare disorder in which the body’s immune system attacks part of the peripheral nervous system. Specifically, “GBS damages the nerves’ protective covering (myelin sheath) and this interferes with the signaling process, causing weakness, numbness or paralysis.”  There is no cure for GBS but it is treatable.  Most recover and this may involve months of physical therapy.

GBS is termed a “syndrome” as there is no apparent disease-causing agent involved. There are 6000-9100 cases of GBS annually. Most instances of GBS (around two-thirds) have occurred after severe respiratory or intestinal infections.  GBS has also been associated with bacterium Campylobacter jejuni and the Epstein-Barr virus. Surgery or vaccinations, on rare occassions, can trigger GBS. 

In 1976, around 45 million Americans — almost 25% of the population — received swine flu vaccine as part of a national vacination campaign.  However, the program was halted after 10 weeks in operation.  “More than 500 people (were) thought to have developed Guillain-Barré syndrome after receiving the vaccine; 25 died. The federal government paid millions in damages to people or their families.”

Since that experience, most studies have found no association between GBS and the seasonal influenza vaccine.  However, two studies suggested that around one additional person out of one million vaccinated people may be at risk for GBS.  The H1N1 vaccine is expected to have the same safety record as seasonal flu vaccine.

HHS tracks adverse reactions to the H1N1 vaccine using a passive reporting system termed “VAERS” (Vaccine Adverse Events Reporting System), along with other surveillance mechanisms. VAERS data can be accessed online through CDC’s WONDER (Wide Ranging Online Data for Epidemiological Research)

More than 60 million Americans have been vaccinated against H1N1 in 2009 (20% of the population). Suspected GBS cases associated with the H1N1 vaccine are rareEditor’s Note: A query of VAERS data on WONDER for GBS reports in 2009, involving the injection and nasal spray H1N1 vaccines, returned 38 records.

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CBS: GBS a Side Effect of H1N1 Vaccine?
CDC: Fact Sheet: Guillain-Barré Syndrome (GBS)
CDC: General Questions and Answers on Guillain-Barré syndrome (GBS)
LA Times: Swine flu ‘debacle’ of 1976 is recalled
Mayo Clinic: Guillain-Barré Syndrome
MSNBC: Va. teen suffers rare illness after swine flu shot
NIH/NINDS: Guillain-Barré Syndrome Information Page
NYTimes: Fear of a Swine Flu Epidemic in 1976 Offers Some Lessons, and Concerns, Today
UPI: CDC H1N1 Guillain-Barre syndrome remote

2010 January 12 21:53:09 UTC – Misery in Haiti

Background on Haiti Earthquake

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Don't get the flu.  Don't spread the flu.  Get Vaccinated. www.cdc.gov/flu

Video Digest: H1N1 Vaccination Push – Sketches from Maine and California; Memories of Flu Resurgence in Winter 1958

 

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World Notes: Dispatches from Asia. Pyongyang on H1N1 “Alert”; Ludhiana (India) on H1N1 “War Footing”

PYONGYANG: The H1N1 flu situation remains unclear in North Korea. Indications, though somewhat tenuous, suggest the situation is serious. The Wall Street Journal reported the country issued a nationwide alert on H1N1 in late December. Earlier that month North Korea’s official news agency (KCNA) reported that nine people had contracted the H1N1 virus in the capital Pyongyang and in the city of Sinuiju, which is near the Chinese border. Aid groups based in Seoul relayed that dozens had actually died from H1N1. North Korean strategies to deal with H1N1 include early closure of schools for the winter break and the strengthening of customs inspections on the border with China. In mid December, the South Korean government shipped 500,000 doses of antiviral medicines to North Korea, whose hospitals have scarce supplies and equipment.

 

 

LUDHIANA: The Times News Network reported that the Indian Medical Association (IMA) has asked the government for 50 ventilators to help get city hospitals “on a war footing.” According to IMA, only 160 ventilators are currently available. A stream of reporting in Indian media indicate that city hospitals are unable to cope with increasing swine flu patient case loads. Isolation wards are at capacity and patients have been refused admission. To relieve case burdens, the government set up a temporary 24-hour OPD (Out Patient Department). However, news accounts suggest the facility has been underutilized and under-publicized.

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ABC: Fighting Off Swine Flu With Mugwort Tea & Garlic Juice?
TNS: Isolation wards full, hospitals say no to H1N1 patients
TNN: H1N1: Request for 50 ventilators
TNN: H1N1 OPD fails in objective
WSJ: North Korea Seen Battling Wave of Flu

World Notes: “Grim” Winter Flu Outlook for China

 

BEIJING: Agence France Presse reported that all but six of China’s 659 deaths from H1N1 were recorded in the last two months of 2009, suggesting the flu is on the upswing. While H1N1 is declining in major cities, China’s Health Ministry reports H1N1 is spreading into the countryside. Ministry officials described the winter flu outlook as “grim” and fear a rise in cases in connection with upcoming Lunar New Year celebrations. China has vaccinated around 50 million people. The country’s population is 1.3 billion. News accounts suggest China’s H1N1 death counts are understated. In November 2009, Dr Zhong Nanshan (who had exposed government coverups in the 1993 SARS epidemic) accused officials of not testing deaths from severe pneumonia cases, resulting in lower H1N1 mortality figures.

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AFP: China records 659 swine flu deaths in 2009
Reuters: China’s official H1N1 death count suspect: report
Reuters; China says H1N1 flu spreading into the countryside

A Shot in the Arm: New Public Information Campaign Push for H1N1 Vaccination

As the nation enters 2010 with ample H1N1 vaccine supplies and a public weary from H1N1, HHS has ramped up public information efforts encouraging Americans to get vaccinated.

Several events are planned for National Influenza Vaccination Week, which has been rescheduled to the week of Jan 10. New public-service announcements (PSA’s) are appearing on radio, TV and the Internet featuring young people, governors and congressmen urging people to fight and prevent the flu. The H1N1 vaccination information campaign will continue over the next eight weeks.

 

Editor’s Comment: All PSA’s have a positive and upbeat quality and will not scare the public. Some are quite clever. An unpredictable virus with unknown potential for more virulent waves, is a future that can be hedged against through widespread vaccination. This is an undercurrent in HHS and CDC communications.

Going forward, PSA planning perhaps can assume a difficult information environment as audiences may be harder to convince due to: “H1N1 fatigue“; perceptions that H1N1 dangers have passed; and entrenched suspicions about the H1N1 vaccine. Internet rumors and misinformation are always on the horizon. The H1N1 public information effort could require the dexterity of a political campaign.

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Ad Council: H1N1 Flu Prevention
CDC: National Influenza Vaccination Week
FLU.gov: Flu Public Service Announcements
HHS: HHS Secretary Sebelius Unveils New H1N1 Advertisement That Will Air During New Year’s College Football Bowl Games
WSJ: U.S. Urges H1N1 Shots as Supplies Surge

Op-Ed: 2009 in Review – Public Information and Awareness, Transparency are Indispensable to H1N1 Fight

As 2009 comes to a close, an estimated 60 million Americans have been vaccinated for H1N1. This represents a remarkable achievement.

Despite waning H1N1 infection rates in the U.S., recent surveys show that half of all Americans desire the vaccine. While HHS handling of the H1N1 pandemic has drawn criticism, overall public awareness has been an underreported success.

In April, when little was known about the H1N1 virus, American public reaction was swift, if irrational. As one news account described it…

Travel to Mexico fell dramatically, pork-belly futures collapsed, and protective masks flew off the shelves. Mexico City virtually shut down

Whether motivated by fear or caution, market signals are indicative of public interest in H1N1. Business journalists reported triple (and double) digit gains in sales of hand sanitizers, cough/cold/allergy medications, analgesics, and spray disinfectants, reversing downward trending in these products due to the recession.

American public perceptions of H1N1 vaccine safety were apparently influenced by memories of the flawed experiences with swine flu vaccine in 1976, and Guillain-Barré syndrome. Medical research notwithstanding, widespread distrust of H1N1 vaccine safety unfortunately persists. When news media were granted inside access to sensitive vaccine plants, subsequent reporting probably has served to reduce public concerns.

CDC and HHS blended traditional and Internet media to provide a regularized flow of information to the public. However, HHS came under sharp criticism when initial vaccine deliveries fell far short of projections. Long queues of American families waiting for scarce vaccines were striking visuals broadcasted around the world. School vaccinations also had controversial optics, but worked well in retrospect.

H1N1 continues to make news. The World Health Organization reports that the virus is circulating at elevated levels in parts of central and southern Asia. Recent H1N1 vaccine product recalls suggest the shelf-life of vaccines bears watching.

We can not forget the 10,000 American lives lost to H1N1. With safe vaccines, transparent mechanisms, and effective public information and awareness campaigns, we will not lose more lives. Best Wishes for the New Year !

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Crain’s NY Business: Public reaction to H1N1 boosts some retail sales
LA Times: More H1N1 vaccine is recalled
LA Times: Twitter trackers follow public reaction to swine flu
MSNBC: 5 reasons the H1N1 flu is actually good for us
MSNBC: 60 million in U.S. vaccinated against swine flu
Reuters: Flu pandemic may change US flu approach forever
WHO: Pandemic (H1N1) 2009 – update 81

Video Digest: H1N1 in Asia – Vignettes from New Delhi and Bishkek (Kyrgyzstan)

 

 

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