No More Needles? Oral Flu Vaccine Tablet Shows Promise in Phase 2 Trial

Flu Vaccine Oral Tablet
Participants were successfully challenged intranasally with homologous A strain influenza virus 90-120 days after vaccination to see if they had developed any immunity,

An investigational H1 influenza oral tablet vaccine was found to provide similar protection against influenza as an injectable quadrivalent influenza vaccine (QIV) in a Phase 2 clinical trial. 

The trial participants were randomized to receive either a single dose of Vaxart oral tablet vaccine and a placebo intramuscular injection, a QIV injection plus a placebo tablet, or a double placebo. They were challenged intranasally with homologous A strain influenza virus 90–120 days after vaccination. Laboratory-confirmed homologous influenza A infections were compared among the groups.

Results showed that the tablet vaccine provided a 39% reduction in clinical disease relative to placebo, compared to a 27% reduction with injectable QIV. The tablet also demonstrated a safety profile similar to placebo.

“These results provide clinical proof-of-concept for Vaxart’s groundbreaking oral tablet vaccine technology,” said Wouter Latour, MD, MBA, CEO of Vaxart, in a press release. “A convenient and effective tablet vaccine could significantly increase current vaccination rates and generate important public health benefits for at-risk groups and the population as a whole.”

For more information visit


Click here to read the original article.






Should my child get the swine flu (H1N1) shot?



by Adrienne Randolph, MD, MSc, Division of Critical Care Medicine

Tilmo, my taxi driver, was there as promised to take me to the Atlanta airport when I left the Centers for Disease Control and Prevention (CDC). He had dropped me off that morning so I could meet with six different influenza researchers and give a talk on life-threatening influenza in children.

“A letter has been sent home from my child’s school,” he said as we drove away. “I must decide whether or not he will get the swine flu shot. Doctor, what would you advise?”

I am an attending physician in the Medical-Surgical Intensive Care Unit (ICU) at Children’s Hospital Boston. In June and July of this year, we had an upsurge of admissions of children with influenza pneumonia who had profound hypoxia (oxygen deprivation) that wasn’t responding to treatment. I immediately said, “Get him vaccinated as soon as it is available. My three children will get the vaccine.”

He asked, “Are there any risks?”

The answer is not completely clear. Testing hasn’t yet been performed in an enormous number of children, and longer-term risks can’t be assessed. “There is a very small risk of developing neurologic side effects from the vaccine, but this virus causes a very severe pneumonia that can kill otherwise healthy children,” I told him. “The risks of not getting vaccinated are higher than the risks of getting vaccinated.”

I had weighed these risks carefully. In 1976-77, with the last swine flu vaccine, as many as 1 in 85,000 people vaccinated came down with Guillain-Barré syndrome — a neurologic condition that paralyzes the muscles, causing respiratory failure. In contrast, there were very few confirmed deaths from swine flu that year.

But it is clear that the 2009 swine flu is more severe. According to the CDC Web site, from August 30 to September 12 alone there were 4,569 hospitalizations and 364 deaths among U.S. adults and children from any type of influenza – and the only flu strain going around at the moment is the novel H1N1 influenza A swine-origin strain. Of the 114 children who died from influenza in the last year, from September 28, 2008 to September 12, 2009, 46 had influenza A H1N1 — the strain that started to infect people in April.

Because I was funded by the CDC in January to investigate why some children get sicker with influenza infection, I knew of severe flu cases in my study network, consisting of 30 pediatric ICUs. We’ve seen cases of encephalitis, an infection in the brain, and cases of influenza myocarditis, an infection of the cardiac muscle causing the heart to have severely depressed function.

We were almost back at the airport. Tilmo had one more question. “Is the vaccine made from swine? I have a problem because swine are considered unclean in my country.” Tilmo is from Ethiopia and is a Muslim. It took me a moment to reply: “The novel H1N1 strain of flu is called swine flu because part of the virus is of the same type that infects swine. It is not actually made of swine.”

I then realized that it is important for Muslim leaders to be educated about this. Despite the attempts of public health experts in many nations, the nickname “swine flu” just won’t go away, and it would be very worrisome if Muslims did not get vaccinated.

Four days after leaving the CDC, I learned that my research network was funded by the NIH to perform surveillance for life-threatening and fatal cases of swine flu in U.S. children. We are also in the final contest for CDC funding to study the effectiveness of the H1N1 vaccine in preventing life-threatening illness. Our government has quickly released millions of dollars to combat H1N1, and I hope that those who are able to get their children vaccinated will take advantage of the opportunity.

Swine flu takes turn for the worse

Swine flu takes turn for the worse

By Meredith Griffiths for AM

A man wears a surgical mask

Six young people with swine flu are on life support in a Sydney hospital as health experts try to work out why the disease is striking some young, healthy people so severely.

The six otherwise healthy people, all under 40, are in intensive care on last-resort life support systems because their lungs cannot handle regular ventilation.

Around 900 people have been taken to hospital with swine flu in what doctors say is no ordinary winter flu season.

Authorities say people with underlying medical conditions are still the most vulnerable to swine flu, but Commonwealth chief medical officer Jim Bishop is warning the disease can strike young and otherwise healthy people quite severely.

He says the warning signs include having a higher respiratory rate and difficulty breathing, but if the disease is identified early it can be easily fixed with medication.

But the Medical Journal of Australia has outlined the cases of five people in Melbourne whose conditions highlight the small but significant risk of swine flu causing life-threatening respiratory failure.

Two of those people had been previously well but then deteriorated rapidly.

In Sydney, Dr Kerry Chant says there has been an increased demand for intensive care this year.

“The ECMO is a particular machine. It is basically where the lungs are given a rest and it is using sort of cardiac bypass,” she said.

She says the machines are being sent to different hospitals around the state as needed.

“The human swine flu is moving across metropolitan Sydney,” she said.

“Last week we have seen the impact most in Sydney’s south-west and then progressively it has been moving through.

“That is actually a positive feature because it means that there are bits of the health system that are being impacted upon at different times.

“There has been extensive planning over many years for a pandemic, so the hospitals in New South Wales all have pandemic plans in place.”

Dr Chant says in some cases the Health Department has reduced the load on intensive care units by deferring elective surgery.

Yesterday the New South Wales Government announced that a 61-year-old woman with underlying medical problems died from swine flu in Lismore.

The Commonwealth’s chief medical officer says there have been 19 confirmed deaths around the country and he has heard of two more overnight.

“Almost all of those swine flu deaths have been in people with prior medical conditions which have been exacerbated but as I said, there will be now some experience with unfortunately people who have been previously well,” Dr Bishop said.

Federal Health Minister Nicola Roxon has set up a clinical taskforce looking at why swine flu is striking young healthy people so severely.

Tags: healthdiseases-and-disordersswine-influenzaaustralianswsydney-2000

Swine Flu and You


H1N1 Flu (Swine Flu) and You

May 3, 2009 3:29 PM ET

H1N1 Influenza virus imageWhat is H1N1 (swine flu)?
H1N1 (referred to as “swine flu” early on) is a new influenza virus causing illness in people. This new virus was first detected in people in April 2009 in the United States. Other countries, including Mexico and Canada, have reported people sick with this new virus. This virus is spreading from person-to-person, probably in much the same way that regular seasonal influenza viruses spread.

Why is this new H1N1 virus sometimes called “swine flu”?
This virus was originally referred to as “swine flu” because laboratory testing showed that many of the genes in this new virus were very similar to influenza viruses that normally occur in pigs in North America. But further study has shown that this new virus is very different from what normally circulates in North American pigs. It has two genes from flu viruses that normally circulate in pigs in Europe and Asia and avian genes and human genes. Scientists call this a “quadruple reassortant” virus.

Click here for the rest of this article  >>>

Swine Influenza (Flu) Current U.S. Case Data

Swine Influenza (Flu)

Swine Flu website last updated April 29, 2009, 9:45 PM ET

U.S. Human Cases of Swine Flu Infection
(As of April 29, 2009, 11:00 AM ET)
# of laboratory confirmed cases
Arizona 1  
California 14  
Indiana 1  
Kansas 2  
Massachusetts 2  
Michigan 2  
Nevada 1  
New York 51  
Ohio 1  
TOTAL COUNTS 91 cases 1 death
International Human Cases of Swine Flu Infection
See: World Health OrganizationExternal Web Site Policy.

The outbreak of disease in people caused by a new influenza virus of swine origin continues to grow in the United States and internationally. Today, CDC reports additional confirmed human infections, hospitalizations and the nation’s first fatality from this outbreak. The more recent illnesses and the reported death suggest that a pattern of more severe illness associated with this virus may be emerging in the U.S. Most people will not have immunity to this new virus and, as it continues to spread, more cases, more hospitalizations and more deaths are expected in the coming days and weeks.


Click here for currently updated data on Swine Flu and the number of people who are currently affected >