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EUROPE
* Novartis, Glaxo vaccines earlier won approval
NEW YORK, Oct 7 (Reuters) - The European Commission has approved Baxter International Inc's (BAX.N) Celvapan vaccine against H1N1 flu, the company said on Wednesday.
The positive ruling was expected after the European Medicines Agency recommended the vaccine last week. European regulators earlier gave a green light to the first H1N1 swine flu vaccines from GlaxoSmithKline (GSK.L) and Novartis (NOVN.VX).
Governments have been scrambling for vaccines to target the new H1N1 flu strain, ahead of a feared second wave of infection.
Baxter said initial quantities of its vaccine have already been delivered to a number of countries, including Britain and Ireland, for use in their national vaccination programs.
Last week the European Medicines Agency (EMEA) gave their recommendation for two vaccines to combat the H1N1 or swine flu that is facing the world. This recommendation leads the way for mass vaccine programs to begin as soon as they are approved which could happen as early as next week. Government and healthcare professionals have been worried about dealing with a second outbreak that could begin as we approach winter so the entire process has been expedited to be better prepared.
The EMEA gave the nod to the two new drugs which are manufactured by GlaxoSmithKline and Novartis. The vaccines are called Pandermix and Focetria.
A third vaccine by Baxter did not pass the committees approval process but it is still being considered.
The World Health Organization (WHO) announced last week that there will only be enough vaccines produced by drug makers to cover about half the planet – roughly 3 million doses a year. It will be determined who is most at risk and who would be top priority to receive the vaccines.
It is also being decided whether one dose or two shots will do the trick. The WHO feels that one vaccine will be effective in treating the pandemic but the EMEA thinks that some people should receive one vaccine and then get another dose after three weeks.
The vaccines are considered safe to use and both the new versions contain adjuvants which are substances that build up the immune system so they require less of the active ingredient, the antigen, in each dose.
The Glaxo vaccine has only 3.75 micrograms of the antigen in each dose while the Novartis shot has almost twice that amount – 7.5 micrograms. Non-adjuvanted vaccines normally carry 15 micrograms.
While richer nations have enough money to ensure that they can obtain enough vaccines for their people, poorer countries have to rely on the generosity of others. In the beginning of September, the Food and Drug Administration (FDA) approved vaccines to fight the H1N1 swine flu from four drug companies: AstraZeneca’s MedImmune division, Sanofi-Aventis, CSL and Novartis.
According to the WHO, an initial distribution of the more than 300 million doses, which were donated by other countries to over 90 countries in need, will begin sometime in November.
Symptoms of the swine flu include headache, sore throat, runny nose, loss of appetite, aching muscles, diarrhea or vomiting and unusual feelings of fatigue. One of the first signs of the flu is a fever so officials suggest you keep a thermometer on hand and know how to determine your temperature.
You should contact your physician if you are someone who would be considered at risk, such as someone who is pregnant, has a compromised immune systems and children under the age of one who are already ill. Contact your physician if your symptoms get worse suddenly or they do not appear to be going away after a week, five days for small children.
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TORONTO - CANADA
The window of opportunity for accelerating the pandemic flu vaccination program in Canada may be starting to close, unless word of a change of plans comes soon, experts suggested Tuesday.
But despite pressure to speed up the start of the program, the country's chief public health officer continued to insist that the projected start date of early November is still the target.
The early November start will allow Health Canada to follow the regulatory process it set out for approving the pandemic vaccine, Dr. David Butler-Jones said Tuesday.
Butler-Jones had recently said that if the risks of waiting to November started to outweigh the benefits of following the established regulatory pathway, the vaccination program could be brought forward a bit.
"(But) we're now into October ... (and) we're not seeing any of those conditions being met," Butler-Jones said in an interview with The Canadian Press.
"So at this point I'm anticipating that the regular regulatory process with a target that we can start immunizing by the first week of November, that that should all roll out fine."
With that point approaching, provinces and territories need to know when they will start taking possession of vaccine so they can finalize plans for what public health officials hope will be the biggest mass vaccination effort in the country's history.
Plans are currently set for clinics to take place in November. Those plans cannot be changed on a dime. Dr. Perry Kendall, British Columbia's chief medical officer of health, said provinces and territories would need at least a week or two of notice to get clinics organized and staffed if the start date is going to change.
"If vaccine were available today, we'd still need time to train the delivery system for this specific vaccine, arrange clinics, advertise, review consent forms, pre-position vaccine supplies, ensure labeling and mixing (is) understood by all, etc.," Kendall said in an email.
Given that the first week of November is just three-and-a-half weeks away, unless word of a change comes soon there may be little gain from moving up the program start.
Meanwhile, Canadian TV sets tuned to U.S. TV channels are seeing images of Americans already being immunized against the virus. The U.S. effort began Monday, with 2.4 million doses of a nasal spray vaccine expected to be shipped to states by the end of this week. That vaccine, FluMist, is not currently licensed in Canada. Injectable vaccine supplies will start to flow in the U.S. next week.
But where the U.S. is buying its pandemic vaccine from five suppliers, Canada has purchased its 50.4 million doses from a single producer, GlaxoSmithKline. The U.K.-based pharmaceutical giant has a flu vaccine production facility in Ste-Foy, Que.
GSK's European plant, based in Dresden, Germany, is already shipping vaccine. But it started making the pandemic product sooner than the Quebec facility, a senior GSK executive said in a media briefing on Monday.
Dr. Thomas Breuer explained the European production facility has two buildings and was able to start making pandemic vaccine in one while finishing its seasonal flu product in the other. The Quebec plant has only one building, so it had to finish the seasonal shots before starting on the pandemic product.
"It is currently envisioned that product will come out of the Canadian facility end of October, beginning November," said Breuer, a senior vice-president and chief medical officer for GSK.
But Dresden's quicker start will help speed vaccine approval here, Butler-Jones said.
Data generated by GSK in clinical trials in Europe will be used to approve the Canadian vaccine, he said. Health Canada will use those data to assess the safety and immunogenicity of the vaccine - in other words, its ability to induce a protective response.
"It's the same vaccine. It's not made in the same plant but all the processes and everything are the same," Butler-Jones said.
"So there's no need to wait for the Canadian confirmatory data which will come later. Because it's exactly the same process, the same vaccine from the same company."
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CHINA
H1N1 Vaccine is Launched in CHINA, and the country braces for impact
Parents waiting to pick up their children from Beijing's Sanlitun Primary School are greeted by a new sign, "If your child has any kind of a temperature don't bring them to school tomorrow. Keep them at home."
Parent Xuan Yen said that her daughter's treatment at school seems more like the treatment she would get at a hospital. "Every day the school takes my daughter's temperature twice a day and administers Chinese herbal medicine to keep the H1N1 virus away."
But the precautions are not just in the schools. China's population of 1.3 billion people makes up one-fifth of the world's population, and tens of millions of Chinese could get H1N1. So China is acting quickly to prevent such a disaster by releasing the world's first vaccine.
After a relatively unremarkable summer, China saw a spike of 1,600 cases in just three days last week. Sixty percent of China's cases were confirmed only in the last three weeks.
The country's health minister Chen Zhu, unusually silent about the threat, suddenly stated the obvious after 14,000 cases of H1N1 cases were confirmed nationally.
No independent organization has declared the Chinese vaccine safe, but the vaccine maker has marketed it to the world as of a "quality and standard not just to suit the Chinese but also the international level." Across the board, the Chinese government is urging its people to be vigilant. Chinese airports are on high alert — arriving travelers have their temperatures scanned as airport workers wear masks at all airports, and a bizarre in-flight video advises passengers to be vigilant, both during and after their trip. The message states, "H1N1 is dangerous. Eat soup. And open your windows at home, not on the plane, and keep circulating fresh air to reduce germs."
Over the summer, thousands of Americans were quarantined after arriving to China simply because someone on board their plane had a slightly elevated temperature. In the last month the American Embassy says that has tapered off, because the Chinese realize the threat is no longer from the outside — it's inside the country. Cases of H1N1 have been diagnosed in every province.
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ISTANBUL
Rich countries should make more vaccine available to poorer nations where the H1N1 virus is starting to hit, U.N. health officials said on Sunday.
They said increased readiness for swine flu was needed in developing countries with weaker medical systems and with large, young populations, who are most vulnerable to the disease.
"We may well see a different pattern of impact once this virus starts to take off and those explosive outbreaks occur in some of the poorer communities in the world," said Julie Hall, an infections disease expert at the World Health Organization, a U.N. agency.
The WHO, which declared H1N1 a global pandemic in June, says a third of the world's population of nearly 7 billion people could catch it.
Some countries, such as the United States, Brazil and France, have agreed to make 10 percent of their national vaccine stockpile available to developing countries. Manufacturers have also donated about 150 million doses of vaccine.
More is needed, said David Nabarro, the U.N. coordinator for fighting new emerging flu varieties.
"The challenge during the next few weeks is to build up the solidarity between wealthy nations and poor nations to ensure that adequate vaccine is made available," he said.
September and October are usually just the start of flu season in the northern hemisphere, but there are signs of a second H1N1 wave after it first flared this year, Hall said.
"Already we are seeing the U.S., many European countries, Japan and Mexico reporting over the past few weeks a sudden increase in cases," she said.
As of September 20, swine flu had killed 3,917 people in 191 countries since being identified in April, the WHO has said.
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TOKYO - JAPAN
The Japanese government said on Tuesday it would buy enough H1N1 flu vaccine from British drug maker GlaxoSmithKline (GSK.L) and Switzerland's Novartis (NOVN.VX) to treat nearly 50 million people.
The government said last week it would secure enough to treat a total of 77 million people by the end of March next year, with Japanese makers producing enough vaccine to treat 27 million people. It added that it would start importing vaccine from around the end of December or January.
Experts predict that a third of the global population - 2 billion people - will eventually be infected with H1N1, which was first seen in March in California and Mexico.
The World Health Organization said in late August that the new H1N1 swine flu had reached epidemic levels in Japan, signalling the early start to what may be a long influenza season this year. [ID:nN28366771]
The health ministry said in a statement on Tuesday that the government had reached a deal with the two foreign makers, with a contract totalling 112.6 billion yen ($1.26 billion). It did not specify how much it would buy from each of the two companies.
A Japanese newspaper, the Asahi Shimbum, reported last month that the government would spend about a total of 100 billion yen to buy enough vaccine for 35 million people from GlaxoSmithKline and for another 12 million people from Novartis. [ID:nLB571112]
Talks on the purchases have been delayed due to liability concerns, with the foreign makers asking to get immunity from responsibility in case of any side effects from vaccination.
The government now plans to submit a bill to parliament so that it could pay compensation to patients who suffer from any side effects of imported vaccine or pay lawsuit-related costs on behalf of foreign makers.
Tokyo, which has set aside 138 billion yen in budgetary spending to buy H1N1 flu vaccines, plans to start administering vaccines from the week of Oct. 19, with priority given to medical staff, high risk groups such as children, pregnant women and those with underlying medical problems, including diabetes and respiratory illnesses.
At home, four Japanese makers will produce H1N1 flu vaccine: Denka Seiken Co., Ltd, the Research Foundation for Microbial Diseases of Osaka University, the Kitasato Institute, and Kaketsuken (The Chemo-Sero-Therapeutic Research Institute).
Three of them will start shipping the H1N1 flu vaccine from Friday, the health ministry said, to be ready for vaccination staring later this month. In Japan, one will need to pay a fixed cost of 6,150 yen ($69.06) to get two vaccination shots. ($1=89.04 Yen)
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Egyptian Travel Case Below
With the global concern over the H1N1 swine flu virus rising, some tourists are finding themselves inside a quarantine cell as their first sightseeing experience. Egypt is attempting to curb the virus with strict measures, but its policies and quarantine system have some questioning their efficiency. With about 900 confirmed cases of swine flu, the Egyptian government has taken a number of controversial steps to fight the spread of the virus, including the closure of all schools until October 3.
Last month, the government banned elderly Egyptians and those younger than 25 from traveling to Mecca, Saudi Arabia for their Umrah or lesser pilgrimage. Director of the Michigan Center for Public Health Preparedness Dr. JoLynn Montgomery understands the Egyptian government's concern; Cairo is a densely populated city of about 20 million and millions of pilgrims from around the world travel to Mecca. "Certainly time in very crowded areas will result in cases of influenza right now," Dr. Montgomery. "I do know that Mecca is a big calling and a big issue and not being allowed to go is obviously a big issue for them [Muslims], but those locations have proved to be a big opportunity for spreading disease."
But some health experts and organizations like the World Health Organization have not always viewed Egyptian government measures as reasonable. Earlier this year, the government ordered the killing of all pigs in Egypt despite WHO officials calling it a misguided attempt to combat the H1N1 virus.
Then in June, the Egyptian government quarantined about 150 people residing in an American University of Cairo dormitory for a week after two students tested positive for the virus. In Egypt, the policy is to quarantine those suspected of having swine flu. And as this reporter experienced firsthand, anyone is a suspect.
Out of the approximately 250 passengers aboard a recent flight from New York, I was the one person ushered to the side while an airport employee handed me a disposable thermometer. They told me I had a fever and would have to wear a white hospital mask. Feeling completely healthy, this was definitely not the warm welcome to Egypt I had in mind.
A young woman wearing a headscarf and over sized sunglasses introduced herself as Dr. Germine. She said I would have to go to a hospital where they would "investigate" if I had swine flu. With my navy blue American passport between her fingers, there seemed to be not much of a choice. The American Embassy, like many others, cannot directly intervene if a private citizen is held upon arrival in a foreign country.
But chief of American Citizens Services in Cairo Yolanda Parra says citizens do have rights.
"If you find yourself in a situation that you're not comfortable with or you have questions about definitely reach out to your embassy right away," said Yolanda Parra. "You can ask anyone at that medical facility that you please want to speak to your embassy and they will comply."
At the hospital, Dr. Germine announced that I would have to pay $300 for a throat swab test and 24-hour observation. I refused to pay. The charge then dropped to $100 and I refused again. After a call to the American embassy, the charge was dropped.
Parra says that it is not standard procedure for governments to charge those quarantined but it can depend on the procedure.
"Each case is different," she said. "We on your behalf make sure that the payments that they're asking for are valid but in that particular case we investigated and the person didn't have to pay anything."
The quarantine area where the throat swab test was processed was, surprisingly, filled with energy. Muffled voices of children carried across the courtyard as they played soccer with surgical masks on. But with a closer look, it was clear many patients were coughing and moving sluggishly nearby. People apparently infected with H1N1 interacted with those under observation.
The WHO does not recommend the mixing of those infected and those under observation. It says it's critical for national authorities to distance patients and avoid crowding. Dr. Montgomery says it's the government's responsibility to uphold these quarantine standards.
"Whether it's mandatory or not, they're playing a role in protecting the rest of us by doing that and so there should be respect and care given to people who are in those situations," said Dr. Montgomery.
The Egyptian Ministry of Health has recently announced that when schools re-open in October, they will be equipped with quarantine rooms.
Keeping up with current closings and regulations is highly recommended in all third world countries, and when traveling, proof of vaccinations and immunization records are very helpful.
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FROM GSK - LEADING GLOBAL PRODUCER OF VACCINE
GSK has agreed another 22 government orders for its adjuvanted swine-flu vaccine - an extra 149 million doses on top of its previous agreements.
The new deals bring the total orders GSK has received to 440 million doses, making it one of the major global suppliers of H1N1 vaccine.
GSK says it is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.
In early August, it confirmed that it had contracts in place to supply 291 million doses of the vaccine and had a variety of agreements in place with the US government to supply pandemic products worth $250 million.
Since then, another 22 orders have been agreed to supply a further 149 million doses of the vaccine, and discussions continue with governments for further supplies.
GSK is using adjuvant technology, which boosts the potency of antigen, meaning the same volume of vaccine can be split into more doses.
Novartis is also using this mechanism on its own vaccine, though other suppliers such as Baxter and Sanofi Pasteur are not.
GSK, along with Novartis, has seen its jabs approved by the European regulator and the company says first supplies of its vaccine are being shipped to governments this week. Further shipments of the vaccine will be delivered in both the fourth quarter of 2009 and the first half of 2010.
Deliveries are contingent on a number of factors including government import and export regulations, regulatory and packaging approvals, and the testing required by reference laboratories.
GSK said it would continue to provide regular updates to governments relating to delivery schedules to support them in planning their vaccination programes.
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