Vaccine row won't delay war on polio

Yuli Tri Suwarni, The Jakarta Post/Bandung/Jakarta

The government has said it will go ahead with its plan to launch the first round of a mass polio vaccination campaign on May 31, despite a report that Indonesia's vaccine producer Bio Farma has been scrapped from the list of United Nations' vaccine suppliers.

"We have used the Bio Farma vaccine for a long period and it has proven to have freed Indonesia from polio since 1995 until the recent outbreak," Minister of Health Siti Fadilah Supari said on the sidelines of a meeting on Thursday with the House of Representatives.

The ministry plans to vaccinate some 6.4 million children under five years old on May 31 and June 28 in Banten, Jakarta and West Java provinces to prevent the first outbreak of polio in Indonesia since 1995.

"A certificate from BPOM (the Food and Drug Control Agency) on the safety and efficacy of Bio Farma's vaccine should be enough," said the ministry's director general for contagious disease control, Umar Fahmi Ahmadi.

"We would not bear the risk of the spread of the virus by delaying the vaccination," Umar said, adding that his office was currently assessing the need for a national immunization program.

The plan has already been carried out with the vaccines being distributed to all regencies in the three provinces.

West Java environment health agency head Fatimah Resmiati said the vaccines had been in the 25 regencies since May 17.

The World Health Organization delisted Bio Farma, the country's sole state-owned vaccine producer, after an assessment last December revealed that the company failed to meet its requirements.

A copy of a letter from the WHO director for immunization, vaccines and biologicals responding to the finding of an inquiry into Bio Farma by the United Nations Children's Fund (UNICEF), was made available to the media by the Health Legal Aid Institute.

The institute claimed that this suggested that vaccines produced by the company were considered ineffective.

However, WHO Indonesia's acting representative for polio cases, Bardan Jung Rana, denied this claim, saying that being delisted would only mean that Bio Farma could not supply vaccines to UN agencies due to its failure to meet standards set by the world's organization.

"It has nothing to do with the quality of the vaccine," he told The Jakarta Post. "Each country has its own standards."

The Bandung-based company had earned some 30 percent of its annual Rp 550 billion sales from supplying polio vaccines to UN agencies, according to Bio Farma president director Marzuki Abdullah.

With an annual oral polio vaccine (OPV) production of 800 million doses, the company has been meeting 35 percent of the world's demands for it. Last June, the company shipped over 1.9 million vials of OPV ordered by UNICEF to help conduct a vaccination program in Nigeria.

Bio Farma earned recognition from the WHO as a certified supplier for polio and measles vaccines in 1997, and DPT, BCG and TT vaccine in 2000.

Its products have been exported to many countries such as Bhutan, the Philippines, North Korea, Malawi, Mali, Myanmar, Namibia, Nepal, Papua New Guinea, Pakistan, Thailand, Uganda, and Yemen, in cooperation with UNICEF.

"From January, there has been a number of foreign companies offering to supply vaccines to Indonesia, but we will stick with Bio Farma," health minister Siti said.

Marzuki said that Bio Farma was one of four polio vaccine producers in the world. The three others were Belgium-based GlaxoSmithKline, Aventis and Italy's Chiron.

"We have used the ASEAN, Indonesian and ISO good manufacturing practice (GMP) standards, but the WHO has raised its standards to meet that of the American Food and Drug Administration and European standards," Marzuki said.

BPOM head Sampurno admitted on Friday that Bio Farma did not have any of the required documents validating the quality assurance of its products.

He and Marzuki said they were unaware of the new requirements until the day of the assessment. "In its previous assessment, WHO never required these documents," Sampurno said.

WHO's Bardan Jung Rana said there may have been a communication breakdown between BPOM and WHO officers regarding the matter.

Currently, Bio Farma was hiring international consultants approved by WHO and planning to invest in more equipment to meet the required standards. "The assessment team will visit us in August to evaluate the progress. Hopefully, we will be reincluded on the list," he added.(003)