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Home-grown seasonal flu vaccine enters trial

Indonesia's first seasonal flu vaccine will soon be launched publicly, after it successfully passes a clinical trial phase currently being conducted by state-owned vaccine maker PT Bio Farma

Yuli Tri Suwarni (The Jakarta Post)
Bandung
Wed, January 28, 2009

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Home-grown seasonal flu vaccine enters trial

I

ndonesia's first seasonal flu vaccine will soon be launched publicly, after it successfully passes a clinical trial phase currently being conducted by state-owned vaccine maker PT Bio Farma.

Rustan, Bio Farma corporate secretary, said Friday the vaccine, the first to be made domestically, would enter the production phase this year after receiving certification from the Food and Drug Monitoring Agency (BPOM).

The clinical trial is being conducted to monitor any possible side effects from the vaccine on human body, as well as to check the stability of vaccine's expiry date.

However, Rahman declined to reveal the planned production capacity prepared by Bio Farma.

"Initially, we are eyeing the domestic market for haj and umrah *minor haj* pilgrims and for corporations that may already *need* a large number *of vaccines*,"

Rahman told a discussion organized by the Bandung Journalists' Discussion Forum in cooperation with Millennium Challenge Corporation Indonesia (MCCI) in Bandung on Friday.

He added the technology to manufacture the seasonal flu vaccine was acquired in cooperation with a Japanese vaccine producer that already possessed the technology.

"The technology transfer is very important for Indonesia to be able to develop the manufacture of a bird flu vaccine in the future," he said.

"Although we are not expecting a bird flu pandemic among humans, we really have to prepare for it from now."

Rahman said the seasonal flu vaccine was cultivated using sterile chicken eggs as the medium, under the specific pathogenic free (SPF) standard.

"The seasonal flu vaccine will use a different strain each year, depending on the trend of which strain outbreak is taking place," he added.

Bambang H. Djalinus, head of Bio Farma's product surveillance and evaluation division, said the current demand for a seasonal flu vaccine came from the need to immunize Indonesian haj pilgrims - more than 200,000 people per year - as well as pilgrims embarking on the minor haj.

Vaccines are currently still being imported from France and the United States, making them far more expensive than other vaccines already being produced domestically.

The vaccines range in price from Rp 150,000 (US$13.22) to Rp 350,000 per dose.

"The price will be much more competitive if the vaccine is manufactured here," Bambang added.

Both Rahman and Bambang declined to reveal how much Bio Farma has invested to produce the seasonal flu vaccine.

However, records from Bio Farma's former planning and development director, Iskandar, show the company has invested Rp 400 billion to manufacture the new vaccine. Iskandar also said that after producing the seasonal flu vaccine, Bio Farma planned to produce a bird flu vaccine by 2011, with an initial target of 20 million doses.

Bio Farma also plans to produce three other new vaccines this year: TD, for tetanus and diphtheria; Pentavalent, for diphtheria, whooping cough, hepatitis B, tetanus and haemophilus influenza type B (HIB); and DTaP for diphtheria, tetanus and whooping cough.

Bio Farma spokesman Tedi Herawan said the vaccine maker had an annual production capacity of 1.1 billion doses, with an income of Rp 850 billion and profit of Rp 120 billion.

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