Pfizer ($PFE) has halted vaccine operations in China following failure to get a license renewal for its existing Prevenar shot. A new wider coverage of the same vaccine for pneumococcal diseases also awaits approval, highlighting issues with the approval process in the Middle Kingdom as well as fierce competition in the vaccines space regionally.
Pfizer imports the vaccine from the U.S. and Ireland, but that permit has expired, leading to an expected shortage of the product there and the decision to halt all operations which will affect about 200 employees in that business in China, a Singapore-based spokeswoman for the company said in an emailed statement.
"The import license for Prevenar in China has expired. Pfizer anticipates a supply shortage of Prevenar in China before the launch of Prevenar 13. Based on a careful assessment of this situation, we have decided to cease our Vaccines commercial operations in China at this time, effective immediately, the spokeswoman said.
"We have approximately 200 colleagues in our Vaccines commercial team and most colleagues will be impacted. We are actively working with impacted colleagues in the Vaccines business unit and encouraging them to identify available opportunities within other business units and functions at Pfizer."
Prevenar was the only pneumococcal conjugate vaccine approved for children under the age of two to prevent pneumococcal disease in China.
The company had "7% operational growth in emerging markets, driven by Lipitor mainly in China, as well as Prevenar and Enbrel, which were offset mainly by the unfavorable impact of foreign exchange of approximately $449 million or 3%, "Frank D'Amelio, Pfizer CFO, said on the January earnings call for the fourth quarter.
Countries across Asia including Indonesia, Malaysia, India and Thailand are looking to ramp up vaccine production locally to stem imports or on other concerns such as halal compliance and emergency capabilities in the event of a pandemic
But in the case of Prevenar, the wider issue of China's regulator efficiency has come into play. China had a backlog of more than 18,500 drugs awaiting approval by the end of 2014, an increase of 33% from the previous year, according to the China FDA's Center for Drug Evaluation.
At the same time, the country has ramped up domestic efforts to produce more vaccines for domestic use as well as to get prequalified by the World Health Organization for sales abroad for mass vaccination campaigns for diseases like polio.
In fact, earlier this week Wu Zhen, vice minister of the China Food and Drug Administration met with a delegation led by Kees de Joncheere, the director of the Essential Medicines and Health Products Department of WHO, and Bernhard Schwartlander, WHO Representative in China to discuss drug prequalification, drug regulatory systems and the reform of drug evaluation and approval system, and poliomyelitis vaccines.
Prevenar is typically used for infants and toddlers to protect against pneumococcal disease and is the only vaccine the company sells in China.
However, Pfizer said it is working with CDCs and POVs to minimize and impact on the ability of children to complete their immunization schedule.
Prevenar 13, which includes 13 pneumococcal serotypes, will replace the previous version of Prevenar, which includes 7 pneumococcal serotypes. Current WHO guidelines recommend that Prevenar 13 be used as it provides broader pneumococcus serotype coverage than Prevenar. We will work with the relevant regulatory agencies to expedite the availability of Prevenar 13 in China.
"Pfizer China will continue to provide education and support to healthcare professionals to prevent pneumococcal disease."
The import license for Prevenar in China expired last year for a product of conjugate vaccines currently available in nearly 120 countries and is included in the National Immunization Plans of more than 90 countries.
- for the Pfizer Website
Editor's Corner: Malaysia at unexpected center of vaccine meetings that highlight regional focus