Monday, June 15, 2009

Swine Flu vaccine developed as pandemic declared



   

Swiss pharmaceutical company Novartis AG said yesterday it has successfully produced a first batch of swine flu vaccine weeks ahead of expectations.

The vaccine was made in cells, rather than grown in eggs as is usually the case with vaccines, the company said.

The announcement comes a day after the World Health Organization declared swine flu a pandemic. WHO says drugmakers will likely have vaccines approved and ready for sale after September.

Swine flu, also known as Influenza A(H1N1), is now formally a pandemic – a declaration by UN health officials that is expected to speed vaccine production and spur government spending to combat the first global flu epidemic in 41 years.

Last Thursday’s announcement by the WHO doesn’t mean the virus is any more lethal – only that its spread is considered unstoppable. The move indicates that a global outbreak is under way.

Novartis said it would use the first batch of vaccine for pre-clinical evaluation and testing. It is also being considered for clinical trials, the company said.

The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week.

A second plant is being built in Holly Springs, North Carolina, the company said.

Novartis said more than 30 governments have requested vaccine supplies, including the US Department of Health and Human Services, which placed a $289-million order in May.

Since it was first detected in late April in Mexico and the US, swine flu has reached 74 countries, infecting nearly 29,000 people. Most who catch the bug have only mild symptoms and don’t need medical treatment.

WHO chief Dr. Margaret Chan made the long-awaited declaration after the UN agency held an emergency meeting with flu experts and said she was moving to phase 6 – the agency’s highest alert level – which means a pandemic is under way.

“The world is moving into the early days of its first influenza pandemic in the 21st century,” Chan said in Geneva.

Dr. Thomas Frieden, the new head of the US Centers for Disease Control and Prevention (CDC), said in Atlanta that he does not expect widespread public anxiety in the United States as a result of the declaration, noting it came nearly two months after the virus was identified.

For many weeks, US health officials have been treating it as a pandemic, increasing the availability of anti-viral flu medicine and pouring money into a possible vaccination program. And scientists have grown to understand that the virus is generally not much more severe than the seasonal flu.

“That helps to tamp down any fears that may be excessive,” Frieden said at a news conference – his first as CDC director.

But the virus can still be deadly and may change into a more frightening form in the near future, and so people should not be complacent, he added.

So far, swine flu has caused 144 deaths, compared with ordinary flu that kills up to 500,000 people a year.

The pandemic decision might have been made much earlier if WHO had more accurate information about swine flu’s rising sweep through Europe. Chan said she called the emergency meeting with flu experts after concerns were raised that some countries, such as Britain, were not accurately reporting their cases.

Chan said the experts unanimously agreed there was a wider spread of swine flu than was being reported.

She would not say which country tipped the world into the pandemic, but WHO flu chief Keiji Fukuda said the situation from Australia seemed to indicate the virus was spreading rapidly there – more than 1,300 cases were reported by Thursday.

In Chile, authorities have identified almost 1,700 cases to WHO.

Many health experts said the world has been in a pandemic for weeks but WHO became too bogged down by politics to declare one.

WHO will now recommend that pharmaceutical companies make swine flu vaccine. The agency typically recommends which flu strains drug companies should use in the vaccines. In a global outbreak, WHO also advises whether companies should make pandemic vaccine.

The pandemic vaccine gamble

The decision to make pandemic vaccine is a gamble. Most flu vaccine makers cannot make both regular seasonal flu vaccine and pandemic vaccine at the same time. That means they must decide which one the world will need more.

Drug giant GlaxoSmithKline PLC said it could start commercial production of pandemic vaccine in July but that it would take months before large quantities are available.

Glaxo spokesman Stephen Rea said the company’s first doses of vaccine would be reserved for countries that had ordered it in advance, including Belgium, Britain and France. He said Glaxo would also donate 50 million doses to WHO for poor countries.

Pascal Barollier, a spokesman for Sanofi-Aventis, said they were also working on a pandemic vaccine but WHO had not yet asked them to start making mass quantities of it.

WHO described the pandemic as “moderate.” Fukuda said people should not get overly anxious about the virus. “Understand it, put it in context, and then you get on with things,” he said.

Still, about half of the people who have died from swine flu were previously young and healthy – people who are not usually susceptible to flu. Swine flu is also crowding out regular flu viruses. Both features are typical of pandemic flu viruses.

Swine flu is also continuing to spread during the start of summer in the northern hemisphere. Normally, flu viruses disappear with warm weather, but swine flu is proving to be resilient.

“What this declaration does do is remind the world that flu viruses like H1N1 need to be taken seriously,” said US Secretary of Health and Human Services Kathleen Sebelius, warning that more cases could crop up in the fall.

Now that a pandemic has been declared, some countries might be prompted to devote more money to containing the virus. Many developed countries have pandemic preparedness plans that link spending to a WHO declaration.

The UN is keen to avoid panic. “We must guard against rash and discriminatory action, such as travel bans or trade restrictions,” said UN Secretary-General Ban Ki-moon.

Fear has already gripped Argentina, where thousands have flooded hospitals this week, bringing emergency health services in Buenos Aires to the brink of collapse during winter weather. Last month, a bus arriving in Argentina from Chile was stoned by people who thought a passenger had swine flu.

China has quarantined travelers, including New Orleans Mayor Ray Nagin, on the slightest suspicion of contact with an infected person.

The US government has already increased the availability of flu-fighting medicine and authorized $1 billion for developing a new swine flu vaccine. In addition, new cases seem to be declining in many parts of the country, US health officials say, as North America moves out of its traditional winter flu season.

Still, New York City reported three more swine flu deaths Thursday, including a child under 2, a teenager and a person in their 30s.

“Countries where outbreaks appear to have peaked should prepare for a second wave of infection,” Chan warned.

source: philstar.com





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