Sanofi flu vaccine batches rejected after inspectors in Taiwan, Hong Kong find impurities: reports

Flu vaccine doses were sent back to Sanofi after inspectors found visible impurities. (Pixabay)

After a manufacturing hiccup led Chinese regulators to temporarily hold off on imports of Sanofi's pediatric vaccine Pentaxim earlier this year, authorities in Taiwan and Hong Kong have returned several batches of flu vaccines made by the global giant.

Taiwan imported the flu vaccine batches—which contained more than half a million doses—in October, according to Focus Taiwan. During an inspection, Taiwan FDA employees found that some doses contained black and white suspended matter, according to the publication, rather than being translucent and colorless. 

None of the vaccines made it into public distribution, authorities told Focus Taiwan. 

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

Sanofi expressed regret in a statement to Focus Taiwan and said it will release a report on the batches after it's able to conduct a review of the situation.

The same week, authorities in Hong Kong returned a batch containing 175,000 doses, according to the South China Morning Post. About 75,000 of the doses had been sent to clinics and administered, the publication reports.

It's not the only manufacturing setback for Sanofi in the region this year. In May, the company reported that Pentaxim troubles in China hurt its financial results after several batches failed tests there. In response, Chinese officials put a hold on new shipments.

So far this year, authorities in Taiwan have purchased more than 6 million flu vaccine doses from Sanofi and domestic manufacturer Adimmune Corp, according to Focus Taiwan. The Taiwanese government makes flu vaccines available for free to anyone 50 and older, plus pregnant women, children and others at an increased risk of getting the flu. 

Sanofi is the world’s largest flu vaccine manufacturer. Last year, the company generated €1.589 billion ($1.8 billion) in flu vaccine sales.

Meanwhile, in China, authorities are cracking down on vaccine quality after recent scandals rocked public trust in vaccines there. The latest controversy came this summer, when Chinese regulators found data integrity problems during a surprise inspection at Changchun Changsheng Life Sciences. The episode triggered a nationwide controversy over rabies vaccines that led to arrests of company executives, plus resignations, demotions and firings for government officials. 

Officials eventually fined the company $1.3 billion and reinspected every other vaccine maker in the country. Now, the Financial Times reports that tougher inspections have led to a flu vaccine shortage in China.

Suggested Articles

FDA officials say Novartis took too long to launch a formal probe into allegations of Zolgensma data manipulation.

Should Johnson & Johnson owe billions to fix Oklahoma's opioid crisis? After weeks of trial testimony, a judge will have his say Monday afternoon.

After Endo and Allergan agreed to settle with two Ohio counties on opioid charges this week, the state’s AG has a message: You’re not off the hook.