SWIFTWATER, Pa. – The federal government originally promised 120 million doses of swine flu vaccine by now. Only 13 million have come through.

As nervous Americans clamor for the vaccine, production is running several weeks behind schedule, and health officials blame the pressure on pharmaceutical companies to crank it out along with the ordinary flu vaccine, and a slow and antiquated process that relies on millions of chicken eggs.

There have been other bottlenecks, too: Factories that put the precious liquid into syringes have become backed up. And the government itself ran into a delay in developing the tests required to assess each batch before it is cleared for use.

What effect the delays will have on the course of the outbreak is unclear, in part because scientists cannot say with any certainty just how dangerous the virus is, how easily it spreads, or whether it will mutate into a more lethal form.

Since April, swine flu has killed more than 800 people in the U.S., including 86 children, 39 of them in the past month and a half, according to the Centers for Disease Control and Prevention. More than half of all hospitalizations since the beginning of September were people 24 and under.

“We’re in this race against the virus, and only Mother Nature knows how many cases are going to occur over the next six to 10 weeks,” said Michael Osterholm, a vaccine expert at the University of Minnesota.

In the meantime, many states have had to postpone mass vaccinations. Clinics around the country that managed to obtain doses of the vaccine have been swamped. And doctors are getting bombarded with calls from worried and angry parents.

“Nobody has it,” said AnnMarie O’Connor, who waited more than four hours for the vaccine in Rockville, Md., standing in line with her two young children and about 1,000 other people. Health officials “said the shots would be here in early October. But where are they?”

Federal officials counsel patience, saying that eventually there should be enough of both vaccines for everyone who wants them.

“We wish we had better ways to produce vaccines perfectly predictably, but this is how influenza vaccine production often goes,” Dr. Anne Schuchat, who heads the CDC’s immunization and respiratory disease section, said last week.

The delays have led to renewed demands for a quicker, more reliable way of producing vaccines than the chicken-egg method, which is 50-year-old technology and involves injecting the virus into eggs and allowing it to feed on the nutrients in the egg white.

Federal officials initially projected that as many as 120 million doses of the vaccine would be ready to dispense by mid-October. They later reduced their estimate to 45 million. As of Tuesday, only 12.8 million were available. (Health officials say a single dose will protect adults, while children under 10 will need two doses.)

In a sign of how rapidly the virus is spreading, education officials said 198 schools in 15 states were closed Wednesday because of swine flu, with more than 65,000 students affected. That was up from 88 school closings the day before.

“Right now, the vaccine is in a race against the virus, and the virus is winning,” Osterholm said.

The government now hopes to have about 50 million doses out by mid-November and 150 million in December, Dr. Nicole Lurie, assistant health and human services secretary for preparedness, told The Associated Press on Wednesday.

“By the end of November, I think we’re going to be pretty well back on track,” she said.

However, a study by Purdue University researchers said the vaccinations will probably come too late to significantly reduce the number of infections. The study, published last week, predicted that infections would peak in late October and that by the end of the year, 63 percent of the U.S. population will have caught the virus.

The blame for the delays has been placed in part on the chicken-egg technology. It is a slow process, and the pressure on manufacturers to produce two vaccines at the same time — for both swine flu and ordinary flu — has made it even slower.

Also, the virus on which the swine flu vaccine is based was found to reproduce very slowly in eggs — much more slowly than the ordinary flu virus. Health and Human Services Secretary Kathleen Sebelius, who on Wednesday was grilled about the delays by the Senate Homeland Security Committee, said the problem has been fixed.

The U.S. government is funding newer technologies that hold the promise of a more reliable and expandable vaccine supply.

“We need a man-to-the-moon effort for flu vaccine if we don’t want to find ourselves in the same position in the future,” Osterholm said.

Flu vaccines are not nearly as profitable as other kinds of drugs, and most of the biggest vaccine makers have little incentive to switch from a method with which they are familiar.

At its two plants in the Pocono Mountains town of Swiftwater, Sanofi Pasteur, the top U.S. supplier of seasonal vaccine, is churning out more than 75 million doses of swine flu vaccine and 50 million doses of the winter flu variety.

Sanofi spokeswoman Donna Cary said egg-based production of flu vaccine is “tried and true” and will probably remain the dominant method for years to come.

“If it weren’t for the egg-based process, we wouldn’t be able to respond to this pandemic,” she said.

More than 30 farms in the eastern United States are under long-term contract to provide eggs for vaccines, tending 9 million to 12 million chickens.

Once the fertilized eggs arrive at the vaccine plant, the flu virus is injected into them and allowed to multiply for several days. Then the eggshells are cracked; the virus-laden fluid is extracted, the flu virus is killed and the substance is purified. The inactivated strain is tested to determine purity, potency and yield.

From start to finish, the process takes about six months. In normal years, that is usually enough time to get the vaccine to anyone who wants it. But in an all-out epidemic, egg-based production is incapable of producing huge batches quickly.

The government has awarded a $487 million contract to Novartis for a plant in North Carolina that will make flu vaccine by growing the virus inside animal cells, preferably from mammals. The plant is expected to be up and running by 2011 or 2012.

Also, Protein Sciences Corp. of Meriden, Conn., landed a five-year, $147 million contract to develop a vaccine using its recombinant technology — flu proteins grown in insect cells. The hope is that the first doses would be available within 12 weeks of the beginning of a pandemic. That is about twice as fast as flu vaccine produced from eggs.

“I think you’re going to see these new technologies come on board rapidly, especially given what’s happened this year,” said Paul Radspinner, president and chief executive of FluGen Inc., a Madison, Wis., company working on several new vaccine technologies of its own.

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AP Medical Writer Lauran Neergaard in Washington contributed to this report.

WHEN I read recently that a pregnant woman and her unborn baby had died of complications due to H1N1 infection, I was terribly saddened that not one, but two lives, were robbed from this earth.

It’s easy to see why women, particularly pregnant mothers, are worried about H1N1 – both for themselves and their unborn babies.

This is not any ordinary flu virus, but a novel (meaning new) strain that has never infected humans before. It is highly contagious and most people have not developed natural immunity against it yet.

Is it harmful during pregnancy?

Many of my patients have already asked me about the potential dangers of H1N1. Many are worried that if they become infected, there will be serious consequences.

There is cause for concern, because pregnancy is considered one of the risk factors that make a person more vulnerable to infection and developing complications.

If you’re pregnant, your immunity to infection is slightly lowered – this is Nature’s way of stopping you from rejecting your unborn baby. This increases your risk to infections, even to normal flu.

A pregnant woman’s immune system also shifts away from the kinds of immune responses most effective in battling viral infections. This makes her more susceptible to some viral diseases such as flu.

Pregnancy also increases the risk of developing complications of the flu, such as pneumonia and respiratory distress. This is because pregnancy puts extra stress on the heart and lungs, pushing a woman’s diaphragm upward and decreasing her lung capacity. This makes any type of respiratory disease more dangerous.

In turn, flu complications may lead to miscarriage, premature labour or other pregnancy problems.

But don’t panic – remember that I have only mentioned “risk”. That does not mean certainty, and it definitely means that you can protect yourself.

If you are healthy and fit, your immune system will still function well and you will probably only have mild symptoms of H1N1.

What to do if you are infected

The truth is, H1N1 is so contagious that most people who come down with flu today probably have this strain of virus. So everyone, including pregnant women, must be prepared to manage this and learn to recognise the signs of danger.

Be wary if you have flu-like symptoms, such as cough, sore throat, runny nose, and muscle pain together with a fever above 38ºC.

You should also monitor for more severe signs like acute abdominal pain, continuous diarrhoea, vomiting, coughing up blood or fever above 38ºC for more than two days.

Antivirals and pregnant women

If the serious symptoms above occur, you should go to the nearest clinic or hospital immediately and tell them that you are pregnant.

You will most likely be prescribed antiviral drugs. These drugs do not cure H1N1 but will relieve the symptoms and reduce the likelihood of complications developing.

Many pregnant women are worried about the possible side-effects of antiviral drugs on their unborn baby. There is no evidence that antivirals will cause adverse effects in pregnancy – and remember that untreated H1N1 infection will be more dangerous to you and your baby than the effects of the medication.

H1N1 and breastfeeding

If you are currently breastfeeding your baby, you should continue to do so even if you are infected or suspected to be infected with H1N1. This is because breastmilk contains antibodies that help your baby fight off infections, including influenza viruses.

So do not stop breastfeeding if you are ill with influenza-like symptoms. You can also breastfeed if you are being treated for the flu with normal flu medication or antivirals. Breastfeed early and often, and limit formula milk.

Be careful not to sneeze or cough into your baby’s face, and wear a mask when you are nursing or near your baby. Wash your hands regularly with soap and water, especially before and after nursing.

If you are too sick to breastfeed, try to express your milk and have someone give the milk to your baby so that you will continue producing milk after you have recovered.

Preventing H1N1 infection

The best strategy, of course, is to minimise the chances of infection. Personal hygiene is the best answer here.

Wash your hands frequently with soap and water, or with a hand sanitiser, especially after touching surfaces in public places like doorknobs, telephones, and banisters.

Avoid contact with people who have flu-like symptoms, or try to stay at least one metre apart from them. Wearing a mask can also help reduce your chances of infection, but be sure not to wear a mask that will cause breathing difficulties.

Don’t touch your eyes, nose, or mouth with your hands because that’s how the germs will enter your body.

Avoid going to crowded places or unnecessary travel if you are pregnant, because it is better to be safe.

Do your part to minimise infection to others as well by covering your nose and mouth with a tissue when you cough and sneeze. Wash your hands with water and soap after coughing or sneezing.

Finally, if you have flu-like symptoms, drink plenty of fluids, stay at home, and get bed rest in a ventilated room, and eat a healthy diet with plenty of fruits, vegetables, and wholegrain foods.

H1N1 is among us all today, and we should all play our part in ensuring that we protect each other from becoming infected, especially those who are more vulnerable, such as children, pregnant women, the elderly, and people with chronic medical conditions.

Seaton is among the 240 healthy adult volunteers in Australia who CSL Ltd. began injecting today with its experimental vaccine against H1N1, the new virus strain that sparked the first influenza pandemic in 41 years.

“It was fine, I didn’t even feel it,” Seaton, a 28-year- old post-office assistant, said from the Royal Adelaide Hospital, where she received the shot.

CSL is testing the vaccine over the next seven weeks as it prepares to fill orders from Australia, the U.S. and Singapore. The World Health Organization and Melbourne-based CSL’s larger rivals such as Sanofi-Aventis SA will be watching the test to help determine whether one or two shots are needed to protect people and how many doses can be produced.

“The fundamental data that we and others around the world are interested in are the immune response to the first and second dose,” Andrew Cuthbertson, CSL’s chief scientific officer, told reporters in Adelaide. The test results will also show the effects of different doses, he said.

Volunteers are required to keep a diary for six months and record any signs and symptoms, including nausea, increased temperature and swelling around the injection area, Seaton said.

Swine flu has killed more than 700 people globally and sickened so many the WHO has stopped issuing a daily tally.

Other Makers

Novartis AG expects to start trials of its shot this month, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today, without giving a date. Sanofi plans to start tests of its shot in August, Albert Garcia, a spokesman for the Paris-based company’s vaccines unit, said in a phone interview.

“It is reasonable to say that, if all goes well, we will start delivering the vaccine by November or December,” Garcia said late yesterday. “This is the most reasonable time frame.”

David Outhwaite, a spokesman for GlaxoSmithKline Plc, declined to answer questions about the London-based drugmaker’s plans to test its shot. Deerfield, Illinois-based Baxter International Inc. will produce a vaccine by early August, after which it will perform clinical tests, spokesman Chris Bona said.

CDC Forecast

The Atlanta-based U.S. Centers for Disease Control and Prevention has said it expects a vaccine ready for widespread distribution in October.

Vaxine Pty, a South Australian biotechnology company, said it started tests on 300 volunteers in Adelaide on July 22 using a vaccine that’s boosted with a novel sugar-based compound. The company, based in Adelaide’s Flinders Medical Centre, has no orders yet for its experimental shot, Research Director Nikolai Petrovsky said in a telephone interview today.

There isn’t any commercial advantage to being the first maker to start human trials, as most manufacturers already have orders to supply vaccines to governments, said David Low, a health-care analyst at Deutsche Bank AG in Sydney.

“Being first is probably more of a PR coup,” Low said in a telephone interview on July 16.

CSL may record sales of A$300 million ($244 million) this year for its swine-flu vaccine, said Alexander Smith, a health- care analyst at JPMorgan Chase & Co. in Sydney.

“That sounds reasonable,” said Rachel David, a CSL spokeswoman.

Two Shots

Two shots of vaccine will probably be needed to protect people against the pandemic virus, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy, at the University of Minnesota in Minneapolis.

CSL has a contract to supply 21 million doses to the Australian government and an order from the U.S. for $180 million of antigen, enough for 20 million to 40 million doses, David said. The company also has an order from Singapore, she said, declining to give details.

The company is producing the CSL425 vaccine at capacity with the current customer base, David said.

The vaccine maker will give volunteers aged 18 to 64 years two shots, three weeks apart, to determine how many doses are needed to get the right level of protection, David said.

CSL is also testing the pandemic vaccine, known as Panvax (H1N1 A/California) in Australia, in a regular and double dose to see which is more effective, she said.

Volunteer Seaton said she had no fears about the injection and any possible side effects. The A$400 she received for participating in the trial was a bonus.

“I thought, worst-case scenario, if everyone gets swine flu then I’ll be vaccinated against it,” she said.

To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

Last Updated: July 22, 2009 06:38 EDT

Late April 2009, there has been a growing concern by people all around the world about the swine flu virus. With the shocking death toll in Mexico and increasing number of confirmed cases in the United States, Canada, New Zealand, the United Kingdom, Israel and Spain the probability of a pandemic happening becomes increasingly real. The public needs to be more aware about the disease and understand its risks as well as its consequences.

What we understand at this juncture is that this disease has reached a stage where it is transmittable from human to human, and more and more people have been infected. A simple gesture such as a hand shake or coming into contact with contaminated surfaces such as doorknobs, tables, handrails, lift buttons or towels becomes is another chance to contract the virus. We need to be more aware that we will have to wash our hands with soap more often and thoroughly.

There is no tangible method to distinguish if you have contracted the swine flu virus as it could appear to be nothing more than the average cough and flu. The disease and its symptoms may vary from adult to child, and from individual to individual. However there are some warning signs that we should all be wary of. Consult your doctor immediately should you have flu-like symptoms such as fever, cough and any of  these – muscle ache, headache, sore throat and difficulty in breathing.

UPDATE The World Health Organization, an agency of the United Nations, raised its pandemic flu alert on 6 June 2009 to the top phase 6 on a six-point scale for the influenza A H1N1 virus. The move will trigger heightened health measures in the WHO’s 193 member states. The move to phase 6 reflects the fact that the disease is spreading geographically, but does not necessarily indicate how severe it is. Learn more about WHO’s alert levels.

UPDATE Drugmakers have managed to obtain the seed virus for the A (H1N1) in the past 2 weeks. This will enable them to begin production process of growing the virus in eggs. They are on track to have a vaccine ready for the northern hemisphere in autumn. Remember to sign up to receive the latest updates.

Currently, the new strain can be treated by antiviral drugs called Oseltamivir (the generic name of Roche Holding’s Tamiflu tablets) and Relenza (a spray made by GlaxoSmithKline).

UPDATE 17 July 2009 The WHO stops giving tally on persons affected by A(H1N1) flu as the pandemic is moving around the globe at an “unprecented” speed. Instead, the WHO said that it would focus on regular updates from newly affected countries, in order to keep track of the global progress of the new influenza A(H1N1) pandemic. “In past pandemics, influenza viruses have needed more than six months to spread as widely as the new H1N1 virus has spread in less than six weeks”, the WHO said. The policy shift was partly motivated by the “mildness of symptoms in the overwhelming majority of patients, who usually recover, even without medical treatment, within a week of the onset of symptoms”.

UPDATE 22 July 2009 - 240 healthy adult volunteers in Australia were injected by CSL Ltd today with its experimental vaccine against H1N1, the new virus strain that sparked the first influenza pandemic in 41 years. CSL is testing the vaccine over the next seven weeks as it prepares to fill orders from Australia, the U.S. and Singapore. The World Health Organization and Melbourne-based CSL’s larger rivals such as Sanofi-Aventis SA will be watching the test to help determine whether one or two shots are needed to protect people and how many doses can be produced. “The fundamental data that we and others around the world are interested in are the immune response to the first and second dose,” Andrew Cuthbertson, CSL’s chief scientific officer, told reporters in Adelaide. The test results will also show the effects of different doses, he said. Volunteers are required to keep a diary for six months and record any signs and symptoms, including nausea, increased temperature and swelling around the injection area, Seaton said.

CSL Limited develops, manufactures and markets human pharmaceutical and diagnostic products derived from human plasma. The Company’s products include pediatric and adult vaccines, infection and pain medicine, skin disorder remedies, antivenoms, anticoagulants and immunoglobulins.

Certain parties would have contrasting opnions about what one should do doing the swine flu outbreak:

The whole swine flu thing is a complete overblown load of nonsense generally beloved by poticians to distract people from an economic recession. It gives an excuse to be discussing something else instead of badly run economies and the economic crisis

Michael O’Leary, head of Ryanair

The swine flu outbreak or influenza A(H1N1) is often compared to the 1918 Spanish flu virus. Here are some quick facts about it:

• The Spanish flu outbreak in 1918 left 40 million people dead
• High number of casualties were mainly caused by the lack of medical care, understanding of infection control and the fact that it happened towards the end of World War I where people were starving

Every day, stories of newly identified cases of swine flu or influenza A(H1N1) appear in the newspapers. To what extend has the disease spread? You will find below a summary of confirmed cases and deaths for each country around the world. The cases were confirmed based on laboratory tests while the statistics were obtained from the World Health Organization.

Global statistics on number of confirmed cases and deaths as at 5 June 2009

The World Health Organisation has six (6) phases of preparedness for swine flu ((or Influenza A(H1N1)):

Phase 1 – No new reports of animal viruses infecting humans

Phase 2 – Animal virus known to have infected humans

Phase 3 – Sporadic outbreaks in people. But no sustained community level human-to-human infection

Phase 4 – Community-level human-to-human outbreaks. “Significant increase of risk of pandemic”.

Phase 5 – Human-to-human outbreaks in two countries. Strong signal that a pandemic is imminent.

Phase 6 – Human-to-human outbreaks in at least three countries. Pandemic underway.

Pandemic Flu Planning – How to protect yourself from the influenza A(H1N1) virus (or swine flu).

Below are several ways to protect yourselves from swine flu or the influenza A(H1N1) virus:

1. Practise general preventive measures for influenza:

• Avoid close contact with people who appear unwell and who have cough and fever
• Wash your hands with soap and water frequently and thoroughly
• Practise good health habits including adequate sleep, eating nutritious food and keeping physically active

2. If there is a sick person at home:

• Try to provide the sick person a separate section in the house. If this is not possible, keep the patient at least one metre (about 3 feet) in distance from the others
• Cover mouth and nose when caring for the sick person. Masks can be bought commercially or made using readily available materials as long as they are disposed of or cleaned properly
• Wash your hands with soap and water thoroughly after each contact with the sick person
• Try to improve the air flow in the area where the sick person stays. Use doors and windows to take advantage of breezes
• Keep the environment clean with readily available household cleaning agents

3. If you feel unwell, have high fever, cough and/or sore throat:

• Stay at home and keep away from work, school or crowds as much as possible
• Rest and take plenty of fluids
• Cover your mouth and nose with disposable tissues when coughing and sneezing and dispose of the used tissues properly
• Wash your hands with soap and water frequently and thoroughly, especially after coughing or sneezing
• Inform family and friends about your sickness and seek help for household chores that require contact with other people such as shopping

Quick facts about the swine flu virus:

• On 30 April 2009, the World Health Orgainsation raised the alert for swine flu to Phase Five, which means that a pandemic is imminent.
• A pandemic is a situation where an infectious disease spreads throughout a population in a large region. Region may mean continents, or even globally.
• The swine flu could be a big a killer as the 1918 Spanish flu if not properly contained
• WHO has changed the name of swine flu to “influenza A (H1N1)”
• There is currently no vaccine to protect against swine flu. Follow developments of the new swine flu vaccine.