New HPV vaccine proves popular despite shortages
Expert says US drug developer is struggling to keep up with China, world demand
Chang Yan has always been afraid of needles. Yet the 22-year-old college student has now joined the masses of young Chinese women getting injected with a new vaccine to prevent cervical cancer, one of the most common types among females in China.
“I decided to get vaccinated after my mother repeatedly urged me too,” Chang said.
“She said I needed it, but I think cancer is still a distant threat for me.”
The vaccine that Chang received, Gardasil 9, was developed by US pharmaceutical company MSD to work against up to nine types of HPV. It was approved by China’s top drug regulator in April. Previously, women on the Chinese mainland had to go overseas to receive the so-called nine-way vaccine.
A complete three-dose treatment with Gardasil 9 will cost Chang 5,660 yuan ($823) at American-Sino OB/GYN/Pediatrics Services, a private hospital in Beijing. She received her first two doses in July and September.
“My parents think the price is acceptable,” she said. “After all, we can get the vaccine nearer to home now, rather than having to go abroad or to Hong Kong to get the vaccination.”
Chang is one of the lucky ones, however. A shortage of the vaccine in China has meant that many women have been left waiting.
Han Zhengzheng, director of Beijing Desheng Community Health Center in Beijing’s Xicheng district, said that they had yet to receive a supply of the vaccine, months after it was approved for use on the Chinese mainland.
“Hopefully we will be able to purchase it within half a month,” she said. “Many people have been inquiring about it but we have not started taking appointments yet, due to its unavailability.”
Han predicted the vaccine will prove very popular once the health center does have it in stock. Other types, such as a four-way vaccine that protects against up to four types of HPV, might also be purchased in future, she said.
“The nine-way vaccine will be most popular, as it is more effective,” she said, before adding that some people may opt for fouror two-way vaccines because they are cheaper.
In Anzhen Community Health Center, Beijing’s Chaoyang district, a staff member said that their stocks of all HPV vaccines, including the nine-way vaccine, were depleted and that they did not know when new stocks would arrive.
HPV, or human papillomavirus, infections often go away by themselves within two years, according to medical experts, but sometimes infections last longer and can cause certain cancers and other diseases.
Nearly all cervical cancer, the secondmost common cancer among Chinese women ages 15 to 44, is caused by HPV, yet vaccines for it were not available on the Chinese mainland until last year.
Cervarix, a two-way vaccine developed by British pharmaceutical company GlaxoSmithKline, entered the mainland market in July 2017 after being approved by China’s top drug regulator in 2016, becoming the first HPV vaccine to be available on the Chinese mainland.
It was followed in November by four-way Gardasil, developed by US company MSD. The two vaccines have been used in the United States since 2006.
Many experts had called for the introduction of HPV vaccines earlier, including Qiao Youlin, a leading cancer epidemiologist at the Chinese Academy of Medical Sciences.
“They have been used in the United States since 2006, and are already available in more than 130 countries,” he said. “We have waited more than 10 years before allowing their use in China.”
Cervical cancer is the only form of the disease that is preventable through vaccination, Qiao said, adding that every year about 100,000 women in China are diagnosed with it and it is responsible for 30,000 deaths annually.
In the past, many medicines that were popular elsewhere were not available on the Chinese mainland, meaning patients had to go overseas or risk buying them online.
This was due to previous regulations that stated drugs developed outside of the mainland had to be subjected to lengthy clinical trials and approval procedures before they could be made available in the domestic market, despite being certified and widely available outside the country.
In October last year, the State Council, China’s Cabinet, released a guideline that said China will accept data from clinical trials conducted outside the mainland when assessing applications to register drugs and medical equipment. This cuts back on unnecessary trails and reduces the amount of time needed for drugs to be approved, speeding up domestic patients’ access to imported drugs.
The reform has resulted in a number of new drugs being made available on the Chinese mainland, including Gardasil 9, which entered the US market in 2014.
The vaccine was approved by the China Drug Administration — part of the State Market Regulatory Administration — in April, eight days after the application for its use among women in China ages 16 to 26 was received from developer MSD.
The administration prioritized the application, accepted data from clinical trials conducted overseas and approved the drug’s importation within the shortest time period possible, it said.
Qiao, from the Chinese Academy of Medical Sciences, said with rising health awareness and affluence among Chinese women, HPV vaccines will become increasingly popular.
Cao Yue, a 25-year-old Beijing resident, said she decided to get vaccinated right after the four-way vaccine became available in November, but was not able to find a hospital that had the drug in stock until the end of February.
“I had heard a lot about HPV vaccines, and some of my relatives and friends abroad had been vaccinated,” she said. “I think nowadays young women are very concerned about their health, and try their best to reduce health risks.”
But a shortage of the vaccine meant Cao and her peers struggled to receive a full three-dose treatment.
“Some of my friends had to go to another hospital to get the second shot due to a lack of vaccines in the hospital where they had received the first shot,” she said.
Cao only received her third and final dose of the four-way HPV vaccine in September, after shortages began to ease in the capital.
Qiao, from the Chinese Academy of Medical Sciences, said MSD currently has a monopoly over the production of four-way and nine-way HPV vaccines, which has caused the wide gap between supply and demand.
“It is very difficult for the company to produce enough vaccines to meet the need of hundreds of millions of people around the world,” he said.
In an earlier statement, MSD said it was working with its partners to increase its capacity for supplying the nine-way vaccine, while ensuring drug safety and quality.
Qiao said some Chinese companies are also researching and developing HPV vaccines, which are expected to ease supply shortages once they enter the market.
Innovax, a pharmaceutical company based in Xiamen, Fujian province, has completed six years of clinical trials on its two-way HPV vaccine, which may become the first domestically developed HPV vaccine to enter the mainland market, he said.
A nine-way HPV vaccine, developed by Walvax Biotech, based in Kunming, Yunnan province, won approval from China’s top drug regulator for clinical trials in January, according to the company.
Yet unvaccinated women and those who do contract HPV need not worry too much, according to Qiao.
“Infection with HPV is quite different from getting cervical cancer,” he said. “Only a sustained infection over a long period of time could result in cervical cancer, and it may take more than 10 years.”
However, Tan Xianjie, a gynecologist at Peking Union Medical College Hospital, cautioned that although nine-way HPV vaccines can prevent cervical cancer in most cases, women who are vaccinated should still be screened regularly, as no available vaccine can currently protect against all types of HPV.