Swine flu vaccine ready, enters Europe

Global pharma major Novartis Friday announced it is ready with a swine flu vaccine and has started first deliveries to governments in Europe, giving hopes to people in many parts of the world.
"Novartis has already started first deliveries of pandemic vaccines under quarantine to governments in Europe, despite the initially low yields with the current production seed strain provided by the World Health Organisation (WHO). A new seed strain could provide higher volumes," the company said in a statement issued in Switzerland.


The company announced that Focetria®, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, Friday received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).


The company has started first deliveries of pandemic vaccines under quarantine to European countries, which means the vaccine is now ready with the governments but only after getting the formal approval the governments can start vaccination.


"The positive opinion clears the way for European Union approval in all 27 member states as well as in Iceland and Norway. Today's announcement marks a significant milestone in bringing a pandemic vaccine to market in Europe," the company added.


"Only three months after the declaration of the pandemic by the WHO, Novartis was able to ship the first batches of our pandemic vaccine under quarantine to governments in Europe pending EU approval," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.


This CHMP positive opinion paves the way for EU approval, which will allow governments to begin their vaccination campaigns with the goal of reaching more patients before the rapidly spreading virus reaches them, Oswald added.


The pharma major, however, did not give details of the number of doses it has despatched or the countries which have received the first deliveries.


More than 150 countries have been affected by the new millennium's first pandemic. It has taken hundreds of lives across the globe.


In India, the virus has killed 286 people and infected more than 9,200 people till Sep 25.

Pvt hospitals still not ready for Swine flu

More than a week after Delhi Government's second deadline expired on September 15, private hospitals are yet to open doors to influenza A H1N1 patients.

Delhi reported 2,079 cases - 80 new cases - and 9 deaths till Wednesday evening. While most of the hospitals claimed to be ready and waiting for the state health department's approval, State Health Minister Kiran Walia said they were not.

"Our experts are going on a round of private hospitals virtually every day, and there are minor things that are hampering the approval process like system of ventilation," said Walia. "These hospitals aren't used to the concept of isolation and mostly work in a centralised system.

We may delay it by a few days but absolute compliance is a must. We can't cut corners and risk lives of people," she said.

"Our set-up is ready and we have conveyed this to the health department. Now, we are waiting for their inspection," said B.K. Rao, chairman of Sir Ganga Ram Hospital.

"Our infrastructure is in place, but we are awaiting formal approval from the government," said the Moolchand Medcity spokesperson. Similar reactions were given by Indraprastha Apollo Hospital, which said the hospital was waiting for the second inspection before starting the facility for swine flu patients.

On August 12, Principal Secretary (health) J.P. Singh issued a circular directing "all 200-bed non-government medical institutions/hospitals to set up a 10-bed isolation treatment facility with 15 days". The direction was issued under section 2 of the Epidemic Disease Act, 1897, which empowers the state government to take special measures and prescribe regulations in case of a dangerous epidemic disease.

"The step was taken as a precautionary measure in case the disease takes epidemic shape," said Singh. The hospitals had asked for more time and the state government extended the deadline by 15 days.

But none of the wards were functional

H1N1 vaccine data shows no side effects

Early data on the H1N1 vaccines show the vaccines to be highly effective with no adverse effects. Two peer-reviewed articles now published in the online first addition of new England Journal of medicine, which has the preliminary data of the monovalent H1N1 vaccine, have shown that the vaccines are working in a large number of healthy adults.

The two rivals, Greenberg et al and Clark et al, describe preliminary data on the immunogenicity of the influenza A (H1N1) 2009 monovalent vaccine. This data has been awaited, as governments, public health officials, and other stakeholders respond to the first influenza pandemic in over 40 years.

The study by Greenberg et al. shows that a single dose of nonadjuvanted vaccine containing the usual 15 �g of hemagglutinin (HA) antigen is immunogenic, or creates immunity, in a high proportion of healthy young and middle-aged adults. The study was conducted in Australia during a time when the virus was circulating, and one participant had laboratory-confirmed infection with the 2009 H1N1 virus.

The report evaluates immunogenicity and safety of the vaccine 21 days after the first of two scheduled doses is given. A total of 240 subjects, equally divided into two age groups, less than and over 50 years of age, underwent randomisation to receive either 15 �g or 30 �g of hemagglutinin antigen by intramuscular injection. No deaths or serious adverse events were reported, but mild discomfort like headaches were reported in a few cases.

The study by Clark et al, involving 175 adults between 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, concluded that the vaccine generates antibody responses within 14 days after a single dose is administered. The antibody tier protection was higher in those who had received two doses of the same vaccine.

China's mass swine flu vaccination

China is to become the first country in the world to start a mass swine flu vaccination programme for its population following a big surge in the number of cases.

No one's died yet from the virus in China but the authorities there describe the situation as 'grim'.

The big rise coincides with the start of the school year and the approaching winter.

Quentin Somerville reports.

Most Germans don't want swine flu vaccinations

The German government has ordered 18 million more vaccinations against swine flu. But two-thirds of Germans say they don't want to be immunized.

In the latest step to fight an anticipated breakout of the H1N1 swine flu virus, Germany's 16 state health ministers have announced they plan to order another 18 million vaccination units. That's enough to immunize nine million more people and ensures there is enough stock should demand surge later in the year.

The health ministers have already ordered 50 million swine flu vaccinations for 25 million people, as each person requires two doses of the vaccine. That means there will be enough vaccine to cover 40 percent of the German population.

The latest order is subject to funding being available. The thorny question of who will bear the cost of this – the federal government, the health insurers, the state health departments or local authorities – is being discussed at a special working group meeting in Berlin on Wednesday.

Two-thirds reject swine flu immunization

A new study conducted by the Forsa Institute for DAK, one of Germany's largest health insurers, revealed that a surprising number of Germans do not plan to get immunized.

In the study of 1,001 people aged between 18 and 60 years, 62 percent said they would "definitely not," or "almost definitely not" let themselves be vaccinated this autumn when the first swine flu vaccines become available.

Eighty-two percent of Germans said that swine flu poses a "fairly low" or "very low" danger.

Bavarians, in Germany's south, in particular rejected vaccination. Only nine percent said they would "definitely" go to their doctor to be immunized compared to 14 percent of Germans on average. It's a different picture in eastern Germany, where almost a quarter of those who took part in the study said they were "definitely" going to get immunized.

"If the situation changes in the next few weeks, than we expect the number of people prepared to vaccinate themselves to increase sharply," said Horst Boelle, the director of the claims department at DAK.

Are vaccinations worth the risk?

The German Medical Association is urging the government to reassess its mass vaccinations plan, the largest such scheme in postwar history.

"Many people have already had swine flu and never even noticed that had it," said Frank Ulrich Montgomery, the association's vice president.

Montgomery also questioned whether the risks of vaccinating outweigh those of actually getting swine flu. Swine flu is highly infectious but it produces fairly mild symptoms and no one in Germany has died of it so far.

"The disease could take a turn for the worse, and claim its first fatalities," said Deputy Health Minister Klaus Theo Schroeder.

"I have the impression that we are now able to do that which we need to do in the next few weeks," he added.

The first vaccinations are expected to be available in October and more units will be delivered on a weekly basis. Schroeder said mass vaccinations should be completed by the end of January or early February next year.

Testing of the vaccine is ongoing. In one pilot study, it was shown that a single vaccination was enough to provide protection in 80 percent of all test persons.

What scientists know about swine flu

Preliminary analysis of the swine flu virus suggests it is a fairly mild strain, scientists say.

It is believed that a further mutation would be needed in order for the H1N1 virus to cause the mass deaths that have been estimated by some.

But at this point, it is impossible to predict with any accuracy how the virus will continue to evolve.

UK experts at the National Institute for Medical Research outlined on Friday the work they are due to start on samples of the virus sent from the US.

The research, being done at the World Influenza Centre in Mill Hill, will be vital for working out the structure of the virus, where it came from, how quickly it is capable of spreading and its potential to cause illness.

Structure

Analysis done so far suggests what they are dealing with is a mild virus and nowhere near as dangerous as the H5N1 avian flu strain that has caused scientists so much concern over the past decade.

Influenza A viruses are classified according to two proteins on the outer surface of the virus - hemagglutinin (H) and neuraminidase (N).


The swine flu strain is a H1N1 virus, the same type as seasonal flu which circulates throughout the world every year, and kills roughly 0.1% of those infected or higher in an epidemic year.

Professor Wendy Barclay, chair in influenza virology at Imperial College London says initial indications suggest there is nothing about the genetic make-up of the new virus which is a cause for particular concern.

The key to its potential lies largely in the H1 protein.

"There are two aspects - one is which receptors the virus tends to bind to and what we see is that it is binding to the upper respiratory tract rather than deep in the lungs."

When a flu virus binds to the upper respiratory tract, it tends to cause mild illness but can be easily spread as people cough and sneeze, Professor Barclay explains.

If a virus binds further down in the lungs, it tends to cause much more severe illness, as in the case of the H5N1 avian flu virus which has caused concern in recent years.

"With the H1 gene we also look at the cleavage site," she adds.

"The virus has to be cut into two pieces to be active and it uses an enzyme in the host to do that.

"Most influenza viruses are restricted to the respiratory tract because they use enzymes in the lungs.

"But some, like H5 viruses can evolve to cut into two pieces outside the lungs, so they can replicate outside the respiratory tract."


Analysis

These initial indications are largely guesswork from looking at the genetic sequence of the virus and comparing that to what is known from work on other influenza viruses.

It will take weeks and months of biological analysis to properly get a handle on the potential of the H1N1 virus.

The team at Mill Hill, one of four World Health Organisation's centres for influenza research will be working in close collaboration with the Health Protection Agency who are carrying out testing in the UK, and their findings will also feed into the development of a potential vaccine.


Soon, the Wellcome Trust Sanger Institute in Cambridge will begin the genetic sequencing of the virus and will also be monitoring any mutations or changes in how virulent it is.

However, there is one other reassuring aspect about what is known so far.

That is there seems to be nothing unusual as yet in another protein in the centre of the virus, called NS1, which is linked to the strength of the immune response the virus produces.

In some more pathogenic viruses, it is this NS1 protein which initiates a "cytokine storm", a particularly severe immune reaction that can be fatal in even healthy young people.

Predictions

Scientists have also played down concerns that the milder H1N1 virus, could combine with the more dangerous H5N1 avian flu virus, causing a super virus that has the ability to both spread easily between humans and cause severe illness.

This is unlikely - or at least just as unlikely as it ever was and the H5N1 virus has been around for a decade without combining with normal seasonal flu.

Professor Jonathan Ball, an expert in molecular virology at the University of Nottingham said: "The chance of swine H1N1 combining with H5N1 is as likely as any other strain recombining.

"What this outbreak does highlight is how difficult it is to predict new pandemic strains.

"Many people suspected that H5N1 was the most likely candidate for the next pandemic strain, but now it appears that this was a mistake - but that's not to say H5N1 or another reassortment containing parts of H5N1 may not happen in the future.

"That's the trouble - you can't predict."

India's swine flu deaths 101, preventive homeopathy advised

India Tuesday reported one more swine flu death, taking the total toll due to the influenza A (H1N1) virus to 101, health authorities said here.

The latest death was reported from Goa. While two deaths in Karnataka were suspected to be due to the virus, lab reports were still awaited.

Of the 101 deaths, Maharashtra has recorded the highest number of deaths, 55, followed by 27 in Andhra Pradesh.

The union health ministry recommended preventive homeopathy medicine, Arsenicum album 30. The decision to advise people to take the preventive medicine was taken after the Central Council for Research in Homeopathy (CCRH), a state-run research wing, gave the suggestion for curbing the spread of the diseases.

'It has recommended one doze of the medicine daily on empty stomach for three days. The dose should be repeated after one month by following the same schedule in case flu like conditions prevail in the area,' the ministry said in a statement.

Meanwhile, 114 people were tested positive for the influenza A (H1N1) virus Tuesday in the country, taking the total number of cases to 4,101.

Maharashtra continued to top the charts both in terms of deaths and positive cases. On Tuesday, 48 fresh cases were from the state alone. So far, about 1,687 people have been affected due to the virus in the state.

It was followed by Delhi in the number of cases. At least 665 people have been infected with the disease in the capital. On Tuesday, 10 fresh cases were reported in the Indian capital.

Karnataka reported 22 fresh cases, taking the total number of people infected with the virus to 463 - the third highest in the country.

Other fresh cases were reported from West Bengal (18) and Orissa (3). One case each was reported from Haryana, Jammu and Kashmir and Chhattisgarh while Puducherry and Chandigarh reported two swine flu cases each.

Meanwhile, a government study has found that swine flu is killing more young and middle-aged people and those suffering from associated diseases like diabetes and chronic heart ailment.

'We have conducted a study and found that more than 50 percent of those affected by the virus were in the age group of 15-45 years,' R.K. Srivastava, director general of the Directorate General of Health Services, told reporters.

'Deaths were also due to late reporting to identified health facilities and delay in initiation of Tamiflu,' he said.

The report, which was presented to Health Minister Ghulam Nabi Azad during Monday's stock-taking meeting of the ministry, studied the first 82 deaths that occurred till Aug 31.

Among the dead were 43 men and 39 women including three pregnant women.

Srivastava said that of the 82 deaths, 61 were in urban areas and 19 in rural areas.

He said there were five deaths in the age group of 0-5 years and three from 6-15 age group. Thirteen victims were from the age group of 16 to 25 years, while 18 people died in the age group of 26-35 years.

Srivastava said 24 people died in the age group of 36-45, as compared to 18 in the age group of 46-65. Only one person died in the above 65-year category.