UPDATED: China FDA vows to fix vaccine supply 'gaps' in remarks at Boao Forum

China FDA repeated that it will root out any "gaps" in the regulation of vaccines exposed in a case of illegal sales of products in Shandong province, using a public forum to vow a tough response.

China FDA Deputy Director Wu Zhen, at a Boao Forum on Drug Evaluation and Approval reforms, said that though China's vaccine regulations are "very strict" there are "some gaps and imperfections" that remain, according to a statement on the regulator's website.

The comments came at event attended by former U.S. FDA chief Margaret Hamburg and representatives from the Bill & Melinda Gates Foundation Global Health Program which has a global vaccine effort underway, state-run Xinhua news agency said.

On Thursday, Reuters reported that more than 130 suspects were arrested as linked to the Shandong case that saw the improper sale and distribution of $88 million worth of vaccines and other products over 5 years in the province with 69 criminal case filed nationwide.

The sales to clinics and improper handling of supplies, including some past expiration dates, has rocked the China FDA as it attempts to assure the public that a safety and quality push that includes a robust supply chain is working to root out flawed products from the market.

In the web are nearly 30 pharmaceutical companies that were involved in the chain of manufacture, distribution and sales, Reuters said, with at least 16 clinics buying the products. In a notice published earlier in the week, China FDA named three firms, including Shandong Zhaoxin Bio-tech that previously saw its manufacturing certificate revoked.

Among a dozen vaccines identified are ones against meningitis and rabies that were sold by a mother-and-daughter team, according to reports, who were arrested last month and had been charged with similar illegal sales of drug products in the past.

At the weekend, China Daily reported that most of the vaccines in question had been administered, though about 20,000 unused doses have been recovered. Of particular note, China Daily said that all of the vaccines involved are in Category 2. "Unlike Category 1 vaccines, which are compulsory and free, Category 2 vaccines are provided upon request to recipients, who must pay for them," the newspaper said.

China FDA posted a World Health Organization explanation of the categories and the potential implications of receiving a vaccine beyond its expiration date, or from one that was improperly handled in the supply chain. The notice however said the risk of a reaction had likely passed, though it did suggest that in some cases it would be advisable to revaccinate.

A series of fake or adulterated drug scandals in China have soured the public on many locally made pharmaceuticals.

CFDA Commissioner Bi Jingquan

But China FDA Commissioner Bi Jingquan said last month the regulator was aiming for the "most stringent standards" for food, drug and device safety along with the "most severe punishment" for fraud.

After the chemical melamine was found in local infant formula brands in 2007 that caused infant deaths and serious illness for many children, China executed the top food and drug regulator at the time, Zheng Xiaoyu, for his role in the scandal.

- here's the Xinhua story
- here's the article from Reuters
- China FDA deputy director Wu Zhen's remarks on vaccines (Chinese language)
- here's the China Daily story
- and the China FDA release on WHO vaccine guidelines (Chinese language)

Editor's note: This story was updated with details from a China Daily report and a China FDA statement.

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