Pfizer halts China vaccine sales after import licence not renewed

US drugmaker Pfizer has halted vaccine sales in China after an import licence for one of its top-selling treatments expired, dealing a blow to the company's business and potentially creating a vaccine shortage for Chinese toddlers.

Pfizer did not state why the China Food and Drug Administration did not renew its import licence for Pevenar, a treatment that protects against pneumonia and other diseases caused by pneumococcal bacteria. The drug is marketed as Prevnar in the US.

“Based on a careful assessment of this situation, we have decided to cease our vaccines’ commercial operations in China at this time, effective immediately,” said Trupti Deepak, company spokesman, in an emailed statement.

"Pfizer anticipates a supply shortage of Prevenar in China before the launch of Prevenar 13," she said, adding that the World Health Organisation recommends replacing the version of Prevenar now sold in China with Prevenar 13, which offers broader protection.

The company said that “most” of the 200 employees of its vaccines division would be affected by the unit’s closure but that the company would work with them to find other positions with the company.

Pfizer employs 9,000 workers in 300 Chinese cities and has made investments worth $1bn since entering the country in the 1980s, according to the company’s website. Prevenar 13 generated $4.5billion in revenue globally in 2014, second only to epilepsy drug Lyrica among all Pfizer’s products, according to the company’s latest annual report.

The company doesn’t break out China revenue from its global total but lists the country among its largest markets alongside the US and Canada.

Foreign pharmaceuticals companies in China have struggled with regulatory problems in recent years, including more stringent approval requirements.

GlaxoSmithKline was forced to pay a £297 million fine last year after a Chinese court found it guilty of bribery — the biggest such penalty ever in China — while its former top executive was given a suspended prison sentence.

The China Food and Drug Administration did not answer calls seeking comment.

Financial Times