DOCTOR IS IN: Nation moves quickly toward H1N1 vaccine

BY SRILATHA EDUPUGANTI, MD, MPH

Assistant professor of medicine in the Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine; Medical director of the Hope Clinic of the Emory Vaccine Center; investigator in the adult H1N1 influenza clinical trials.

With the arrival of fall, and schools and colleges well under way, Georgia already has seen a substantial number of cases of novel H1N1 flu. Although it appears that most cases have been mild, there have been more serious cases, just as there are every year with seasonal flu.

Doctors in the region have noted serious illness not only among individuals with underlying medical conditions but also among young, previously healthy individuals.

The U.S. government declared the H1N1 outbreak a public health emergency in April 2009, and two months later the World Health Organization classified the outbreak a pandemic, reflecting its widespread nature. To minimize the impact of H1N1 flu in our community, public health experts have been providing information on prevention and management to the public and health care providers.

Clinical trials testing H1N1 vaccines in adults and children have been under way since August at Emory and a few other academic medical centers around the nation. The H1N1 flu vaccine clinical trials were designed to answer three key questions:

  1. Are the H1N1 vaccines safe?
  2. How large a dose and how many doses are needed to induce an effective immune response?
  3. Can the 2009 H1N1 vaccines be safely administered with the seasonal flu vaccine, and will both vaccines induce a protective immune response?


Participants in one Emory adult and senior study received a total of two H1N1 vaccinations, either concurrent with, before, or after, the seasonal flu shot. Participants in the Emory and Children’s Healthcare of Atlanta pediatric trial also received a total of two H1N1 shots, and one seasonal flu shot.  Another adult and senior study (currently enrolling) is evaluating the safety, tolerance and immune responses with an adjuvanted H1N1 vaccine. The adjuvanted vaccine contains an extra “helper” material (an oil-in-water emulsion) mixed with H1N1 vaccine that may strengthen the immune response to the vaccine.

The trials have been conducted in a compressed timeframe so that the government could quickly make recommendations for the vaccines. Early data already have shown the unadjuvanted vaccines to be safe and well tolerated.  Recently, the Food and Drug Administration approved four companies’ vaccines, which will be distributed as soon as they are available, most likely in mid to late October. The nasal spray H1N1 flu vaccine is expected be available in early October. The adjuvanted H1N1 vaccine trial has just begun so those safety and immunogenicity data are pending.

The clinical trials will continue for the next several weeks and will help experts continue to make decisions about how the vaccines should be used. Initial immune response data show only one dose will be needed for healthy adults and children 10 and older, but the Centers for Disease Control and Prevention (CDC) will make specific recommendations when the vaccines are distributed.

The CDC already has recommended certain high priority groups for H1N1 vaccination when it becomes available. In making its recommendations, the group considered current disease patterns and current trends that showed populations most at risk of serious illness, among other factors.

The CDC reports that it does not expect a shortage of 2009 H1N1 vaccine, but availability and demand can be unpredictable. There is some possibility that initially the vaccine will be available in limited quantities.

It is recommended that the following groups receive the vaccine before others: pregnant women, people who live with or care for children younger than 6 months of age, health care and emergency medical services personnel with direct patient contact, all people from 6 months through 24 years of age, and people aged 25 through 64 years who have health conditions associated with higher risk of medical complications from flu.

Once these priority groups have received vaccinations, everyone from ages 25 through 64 should get the vaccine, followed by those over age 65.

It is important to remember that the seasonal flu vaccine will not protect against the H1N1 flu. Receiving both vaccines this fall will be key in keeping you and your family healthy. The vaccines can be given on the same day in separate shots, but flu experts are asking that individuals, particularly those over age 65, go ahead and get a seasonal vaccine now, if possible.

For more information about the H1N1 flu vaccine trials at Emory, call 877-424-HOPE (4673) or visit http://www.medicine.emory.edu/id/hopeclinic for adult trials; or 404-727-4044 for the pediatric trials.

8 comments Add your comment

HSR0601

September 28th, 2009
2:59 pm

1. Swine flu vaccines are thought to be safe and effective as the initial symptom is mild.

2. Folks need to stay vigilant on refraining form the in-take of pork, just in case of the mutation.

(( Genes included in the new swine flu have been circulating undetected in pigs for at least a decade, according to researchers who have sequenced the genomes of more than 50 samples of the virus. The findings suggest that in the future, pig populations will need to be monitored more closely for emerging influenza viruses, reported a team led by Rebecca Garten of the federal Centers for Disease Control and Prevention in a report released by the journal Science.))

3. Additionally, a simple action like brushing teeth following each and every meal could make a big difference in our immune system, let alone workout, I believe.

Thank You !

Polly

September 28th, 2009
5:49 pm

Given that the percentage of persons (blood samples) showing immune response was negligibly different between, say, persons 63 years old and persons 67 years old, and little different between persons 50 years old and persons 75 years old, with the percentage going over 40 percent only in the very elderly, those alive in the few years immediately after 1918, and given that up to 22 percent of younger persons’s blood showed immune response, why the cut-off age of 65 for vaccine? Especially as elderly persons have a high risk of complications. Sounds like agism is dangerously at work here.

Polly

September 29th, 2009
3:59 am

Dr. Edupuganti, if you know of any serological or epidemiologic studies that definitely contradict my points in the previous post, I’d vastly appreciate the information. (I base my arguments on the May study cited in CDC’s July 30 MMWR (n8) and the late-summer study reported in NEJM Sept 10. Also, one U. Melbourne study this summer concluded the new flu’s epidemiology was like that of any type-A flus, and Dr. Marc Lipsitch (Harvard PH) reported to the IOM recently that what statistical evidence there so far was showed the same epidemiology as other (type-A?) flus. Note too that seniors tend to high rates of seasonal flu shots–and so if the Canada results turn out valid many, many seniors will be at considerably higher risk of infection than those 10 or 20 or 30 years younger. Yet seniors “over 65″ and even if at high risk of complications for other reasons too (and most are) must wait until the 24-64-years group are inoculated? Why?

C.A. Bouthillier

September 29th, 2009
9:42 am

They Try to Change the Set Times: Swine & Seasonal Flu Vaccine Alert
They try to change the set times. The Swine Flu (H1N1) vaccine and apparently regular flu vaccine (Evidence of Thimerosal, H1N1 Virus in Seasonal Vaccine) are being used in an attempt to abruptly kill significant numbers of population, to bring the population numbers (blood types A, B, O – those who do not belong to them) well below 200 million. This is the purpose of forced vaccinations, to kill many all at once and cause debilitating chronic symptoms in the blood types A, B and O, which have damaged DNA/proteins and weakened immune system. The number of these blood types is quickly approaching 200 million. By abruptly bringing the population numbers below 200 million, they believe they can change the set times and have victory over their Creator. But, their end will still come at the appointed time – at that very hour and day predetermined long ago.
Vaccines were developed under the cover (lie) they will protect from harmful viruses and bacteria, and were never needed and are another fraud perpetrated on the people. Harmful viruses and bacteria thrive and replicate in the blood types A, B & O, which have blood pH that has deviated away from a neutral pH of 7.00. A neutral blood pH of 7.00 destroys/removes harmful bacteria and viruses. The blood type AB is the normal healthy blood type with a neutral pH of 7.00 and has normal DNA and immune system.
Vaccination is in fact the most effective and efficient method to transport poisons more directly into the liver, to displace and deplete copper from that location. The liver is where much of the blood proteins (and other proteins) are synthesized and is where the greatest percentage of copper is stored. Copper is vital in protein synthesis. Vaccine poisons settle and accumulate in the liver depleting and displacing copper, thereby causing a mineral imbalance and deviation from a 7.00 pH, resulting in near-immediate massive DNA damage, by disrupting normal protein synthesis. This aberration in protein synthesis is indicated in malformed and missing proteins, reflected in acidic blood (type B) or alkaline blood (types A & O), depending on individual propensity of the mineral imbalance, i.e., toward acidic or alkaline. As of 2005, the blood pH of blood types A/O was set up to average pH of 7.54 and the blood type B was set up to a higher acidity level (lower pH). The blood pH (blood types A,B & O) has been carefully managed through methodical, intentional poisoning, to reach the current life-critical levels specifically targeting this point in time. The vaccines, planned long ago for this period in time, are formulated to push the blood pH past the critical points, in order to kill and disable many.
For explanation see: http://www.unveilingthem.com/PoisoningOfMankindCopperDeficiency.htm

C.A. Bouthillier

Steve

October 1st, 2009
9:28 am

C.A., how do you explain the sucess of the smallpox and polio vaccines? And, where do you get the 200 million number?

Freeone

October 14th, 2009
4:47 pm

None of the trials of the H1N1 shots included sqaline or therimisol. This according the the CDC.gov website. Thus they cannot be considered to be safe.

sexyeldenty

October 29th, 2009
7:19 am

h1 n1?
I have bought Tamiflu here and I am pleased. Delivery all over the world!
pharmtablet.com

Pam Perry

November 5th, 2009
12:21 pm

On Nov. 1, Taiwan’s health authorities launched a vaccination campaign against influenza A (H1N1) at 14 shelters housing victims of Typhoon Morakot, with 884 disaster survivors receiving shots on the first day of the campaign. Taiwan’s Department of Health estimates that 12 million doses of vaccines will be administered before the Lunar New Year Holiday of February 14, with vaccinations for students beginning on November 16.
Taiwan’s DOH will dispense vaccines from domestic company Addimune Corp. And Swiss drug maker Novartis AG.