Sanofi Pasteur Global CEO: China Accelerates New Drug Approvals, Plans to Launch Pediatric Hexavalent Vaccine

Beijing, April 8 (Xinhua) — By Wang Kunshuo. The “Healthy China 2030” Planning Outline explicitly sets forth the strategy of “prevention first.” As an effective tool for safeguarding public health security, vaccines will play an increasingly important role. Recently, David Loew, Global Head of Sanofi Pasteur, a renowned French vaccine manufacturer, gave an interview to the media in Beijing, providing in-depth insights on innovative vaccines, vaccine safety, and cooperation with China.

　　New vaccines, including recombinant quadrivalent influenza vaccine and hexavalent pediatric combination vaccine, will be launched

In recent years, the Chinese government has continuously accelerated the review and reform of innovative drugs, prompting many multinational pharmaceutical companies to intensify their efforts, frequency, and pace of launching new drugs in the Chinese market.

In 2018, Sanofi Pasteur’s innovative Flublok recombinant quadrivalent influenza vaccine received approval for clinical trials in China. This was the first vaccine product clinical trial approval in China to follow the 60-working-day review timeline, marking a significant milestone in China’s accelerated approval process for innovative vaccines.

David Loew stated that Flublok is a high-tech, innovative influenza vaccine produced using recombinant DNA technology. It has been successfully launched in the United States and will initiate clinical trials in China this year.

Sanofi Pasteur plans to launch a hexavalent pediatric vaccine in China, a fully liquid, ready-to-use six-in-one vaccine that protects infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive infections caused by Haemophilus influenzae type b (Hib).

“Administration of the hexavalent vaccine for children can improve vaccination coverage and timeliness. It also increases the number of vaccines administered during a single visit, meaning that one injection can prevent six diseases,” said David Loew. He noted that reducing the number of injections enhances infant comfort and adherence to vaccination schedules, minimizes local reactions, alleviates parental anxiety, and reduces the workload of healthcare personnel.

David Loew stated that Sanofi Pasteur also plans to launch a pertussis booster vaccine in China this year.

In addition, Sanofi Pasteur also plans to launch in China a monoclonal antibody for the prevention of respiratory syncytial virus (RSV)-related diseases in newborns and infants.

　Supporting Legislative Efforts for Vaccine Regulation in China

In 2018, vaccine safety issues sparked widespread public concern. At this year’s “Two Sessions,” the safety and regulation of pharmaceuticals and vaccines also became one of the hot topics. The Government Work Report pointed out that pharmaceuticals and vaccines are critical to life and health; therefore, full-process supervision must be strengthened, violators must be severely punished without leniency, and those guilty of negligence or dereliction of duty must be seriously investigated and dealt with, so as to firmly safeguard the people's lives and health.

“It is gratifying to see the Chinese government implement policies that raise regulatory requirements for pharmaceuticals and vaccines, establishing more stringent quality standards and a more rigorous quality control system,” said David Loew. “As a vaccine manufacturer with over a century of history, Sanofi Pasteur supplies one billion doses of vaccines to the global market annually. Because vaccines are injected into the human body, they must meet the highest quality standards—a principle we have always upheld.”

David Loew explained that the vaccine production process is complex, requiring stringent control at every stage; manufacturing a vaccine can take up to 22 months, with approximately 70% of that time dedicated to quality control.

“We conduct 500,000 quality control tests on our products annually and invest substantial resources in maintaining and updating our quality assurance system to ensure that vaccines are manufactured in accordance with the best Good Manufacturing Practice (GMP) standards, complying with the specifications approved by health regulatory authorities in all countries and regions where we hold licenses,” he said.

David Loew stated that the Chinese government had also engaged with Sanofi Pasteur to learn from its experience in quality systems and invited it to provide input on the draft Vaccine Administration Law then under development in China. “We are pleased, as a company, to participate in this process and contribute to the scientific and legal-regulatory framework for vaccine oversight in China.”

Globally, the application of medical big data or new artificial intelligence technologies in pharmaceutical R&D has become a trend. In this regard, David Loew stated that the prerequisite for applying big data and artificial intelligence is the availability of electronic medical records (EMRs), and only a few countries worldwide have relatively comprehensive EMR systems.

He pointed out that many current big data-based studies are often retrospective, whereas Sanofi Pasteur is also conducting prospective studies. “For example, a study we conducted in California, USA, involved randomizing 1.6 million participants to compare the effectiveness of novel influenza vaccines with conventional quadrivalent influenza vaccines. This study can be described as groundbreaking. Few companies in the industry are currently undertaking such prospective studies.”

　Collaboration in the Field of Preventive Immunization Supports “Healthy China 2030”

The “Healthy China 2030” Planning Outline proposes to grasp the development laws in the health field and adhere to the principle of prevention first, combining prevention and treatment.

David Loew stated that he strongly agrees with the viewpoints put forth in the outline plan. “Prevention is the most effective health intervention after clean drinking water. Doing a good job in prevention and avoiding illness is better than treating someone after they become sick, which is also the basic principle of the vaccine industry.”

David Loew stated that more efforts are needed worldwide in disease prevention, including increasing vaccination rates. “Sanofi Pasteur is a trusted partner of China in the field of preventive immunization. We have a long-standing cooperative relationship with China. We are proud to be among the first foreign biological products companies to enter China in the early 1980s.”

Since 1995, Sanofi Pasteur has introduced to China the first Vero cell rabies vaccine, the first influenza vaccine, the first Haemophilus influenzae type b (Hib) conjugate vaccine, the first inactivated poliovirus vaccine, and the first pentavalent combination vaccine. In 2007, Sanofi Pasteur invested US$94 million to establish a modern influenza vaccine manufacturing facility in Shenzhen, enabling local production.

It is reported that Sanofi Pasteur supports the Chinese health authorities in incorporating inactivated poliovirus vaccine (IPV) into the National Immunization Program, in response to the World Health Organization’s goal of eradicating polio.

In addition, Sanofi Pasteur partnered with the Chinese Preventive Medicine Association and launched a three-year collaborative program on vaccine-preventable diseases in 2017, aiming to promote the implementation of vaccination as an effective measure and strategy for increasing life expectancy and improving quality of life, thereby actively demonstrating the important role and value of vaccines in supporting the realization of “Healthy China 2030” and addressing public health challenges.