Beijing - A Chinese biological company has issued a recall of a batch of its human rabies vaccine over concerns for consumer safety, the State Food and Drug Administration (SFDA) announced.

The vaccine, which was made and released by the Wuhan Institute of Biological Products in Central China's Hubei province under batch number 200905007-3, involved 10,902 doses, of which 8,376 had been used by Monday, the administration said in an online statement on Tuesday.

To date, drug authorities have received no reports of adverse sideeffects associated with the substandard vaccine, the statement said.

The vaccine was found to contain an excessive amount of bacteria endotoxin, which can cause fever.

Other factors, such as whether and how this would impact its effectivenes, as well as when and where it was released and used, were not mentioned.

Health professionals recommend that people who have been bitten by dogs or other animals receive the human rabies vaccine as soon as possible, because the disease is nearly 100 percent fatal for those infected.

Each year, more than 40 million people are attacked by animals on the mainland, mostly dogs, with more than 2,400 deaths from human rabies, official statistics showed.

"Without a timely, quality vaccination, one would develop the fatal human rabies after a bite by infected dogs," said He Xiong, deputy director of the Beijing Center for Disease Control and Prevention.

Of the 75 million dogs on the mainland, less than 20 percent have been vaccinated against rabies.

To help ensure the safety and quality of biological products like the human rabies vaccine, the SFDA began to send inspectors to manufacturing companies.

Most of them were fresh out of university and inexperienced in detecting problems, according to an industry insider who wished to remain anonymous.

He also indicated that corruption might have been involved.

In recent years, stories of substandard vaccines have periodically made headlines in China.

Two Chinese drug firms were previously punished for producing more than 200,000 doses of substandard human rabies vaccine.

Some experts have blamed limited production capacity as the cause of inferior vaccines.

"That's particularly true in the case of human rabies vaccine," said He.

If the output exceeds the real capacity, the vaccine will not work as well, he noted.

"The manufacturers should be held accountable for such incidences and the drug authority should work toward improving supervision," he recommended.

In the latest case, the official website of the Wuhan company made no comment on the recall, despite the SFDA calling it a voluntary one initiated by company.

China Daily

(China Daily 05/27/2010 page4)