Pfizer Inc. is ceasing its vaccine commercial operations in China after the government failed to renew its license for a key shot for children, the latest sign of the uncertainties facing international drugmakers in the nation.
The Chinese import license for the Prevenar-brand vaccine expired last year, the U.S. pharmaceutical company said in a statement Thursday. It expects a shortage of the product in China before the launch of a newer version, called Prevenar 13, that it already sells in other parts of the world.
Drugmakers in China have faced delays in approvals in recent years because of changing rules. At least thirty-four applications from foreign multinationals have been or are set to be delayed after Chinese regulators began requiring an added procedure, according to R&D-Based Pharmaceutical Association Committee, an industry group.
“This won’t have too big an effect on the children’s immunization process” as the drug isn’t included in China’s vaccination program, said Shi Lichen, a manager at Beijing Dingchen Medical Consultancy, a privately run company that gives advice on the industry.
While Prevenar is the only vaccine for pneumococcal disease approved in China for children under two, no data proves infants have a high infection rate, Shi said. China has a much cheaper vaccine available for older children, he said. The U.S. Centers for Disease Control and Prevention recommends the vaccination for youngsters under 5 years old. Pneumococcal infection can lead to potentially fatal sicknesses such as pneumonia, blood infections and meningitis.
An official at the China Food and Drug Administration’s media office said it was looking into questions from Bloomberg News and couldn’t immediately comment.
The effect of the lost license on Pfizer might be more pronounced as Prevenar is the only vaccine the company sells in China. Most of the 200 employees at its China vaccine business will be “impacted” and it will work to help those affected to find new roles at its other business units, the statement said. The company hires more than 9,000 people in China, according to its website.
Pfizer is now in the process of working with the Chinese government to get Prevenar 13 onto the market and the lost license won’t affect any of its other operations in China, spokeswoman Trupti Deepak Wagh said.
“The registration application for Prevenar 13 is currently underway in China,” Pfizer’s statement said. “We can’t speculate on timelines but are working very closely with the relevant regulatory agencies to expedite the availability of Prevenar 13 in China.” The relevant authorities are “keen” to provide children with the new vaccine, it said.
Other foreign drugmakers have faced challenges in China. Johnson & Johnson’s chief scientific officer in January said that the Chinese market is becoming more challenging for drug companies because of how long regulators there take to approve new medicines. GlaxoSmithKline Plc was fined 3 billion yuan ($484 million) last year for bribery related to drug sales after a probe that lasted for more than a year.
— With assistance by Hui Li