GlaxoSmithKline (GSK) announced yesterday that Cervarix® (human papillomavirus vaccine [types 16 and 18]) has received marketing approval from the China Food and Drug Administration (CFDA), making it the first HPV vaccine approved in China to prevent cervical cancer. HPV vaccination, together with cervical cancer screening, will provide Chinese women with a better means of preventing cervical cancer. Cirex® is registered in China for vaccination of women aged 9 to 25 years using a 3-dose immunization schedule, and is expected to be officially launched early next year. How does the HPV vaccine work? Cervical cancer is the second most prevalent cancer among women aged 15 to 44 years in China, with approximately 130,000 new cases each year. Each year, China accounts for more than 28% of cervical cancer cases worldwide. Globally, on average, one new case is detected every minute, and one woman dies of cervical cancer every two minutes. The famous entertainer Anita Mui died of cervical cancer at the age of 40. Therefore, the introduction of HPV vaccination along with cervical cancer screening programs in China will significantly reduce the incidence of cervical cancer and precancerous lesions, thus reducing the disease burden. The bivalent vaccine (Cirex) is primarily for the prevention of cervical cancer associated with two high-risk HPV infections, and the quadrivalent vaccine Gardasil comes with the prevention of genital warts (which we don’t have here yet). Who is suitable for the injection? Population effectiveness decreases with age. HPV-related cancers occur more frequently in women than in men, so adolescent women are better candidates for HPV vaccination than adult women or adolescent men. There are no studies to compare, but the order of vaccination is adolescent females, adolescent males, adult females, and adult males. The CDC and the American College of Obstetricians and Gynecologists recommend vaccination for women ages 9 to 26 years, and HPV vaccination is also recommended for HIV-infected women ages 9 to 26 years. Girls are encouraged to get HPV vaccination before the age of exposure to HPV comes. The age limit is not absolute, but depends on the presence or absence of sexual life. HPV vaccine works best for women with no sexual history, and whether or not to vaccinate over the age of 26 depends mainly on one’s own sexual life; if one is not yet sexually active, one can be vaccinated; for those who are married or have a regular sexual partner, vaccination is not very meaningful. If you are still not having sex by the age of 35, then it is a good idea to get vaccinated at this time. If someone plans to never have sex for the rest of his or her life, there is very little need for the vaccination. Can’t I get the HPV vaccine after I’ve had sex? No. Basically, you can get the vaccine at any time, but once you start having sex, your chances of getting HPV increase significantly, and the official authorities do not think it is cost effective from a pharmacoeconomic point of view. Do I need to be tested for HPV before vaccination? Serological testing or human papillomavirus (HPV) DNA testing is not required prior to immunization. For women who are sexually active, they should be tested for HPV infection before vaccination to clarify whether they want to be vaccinated or not. The reason this testing is not very meaningful is that even if you are infected with HPV, you will still choose to be vaccinated. The reason is that the vaccine is available to prevent multiple HPV infections and it is extremely unlikely that a woman will be infected with multiple HPV infections at the same time. Do I need to be monitored for HPV after vaccination? Yes. 70% of cervical cancers are associated with HPV16 and HPV18, which are prevented by the vaccine, but having the vaccine still does not guarantee 100% prevention of cervical cancer, and regular checkups are still recommended. Some studies have shown that the HPV vaccine is still protective 4-5 years after vaccination [9,10], but after all, the vaccine has been on the market for a relatively short time compared to other vaccines, and its long-term effectiveness needs to be confirmed by long-term observation and further studies. However, it is important to note that even women who receive the HPV vaccine do not protect against all HPV types that cause cervical cancer. Therefore, married or sexually active women should also undergo regular cervical smear testing to detect cervical cancer and precancerous lesions as early as possible. Can pregnant women get the vaccination? HPV vaccine is an inactivated vaccine and theoretically has no adverse effects on pregnancy. No adverse effects of the vaccine on pregnant women and fetuses have been found in studies, but guidelines from various countries recommend that pregnant women should not receive the vaccine and that follow-up vaccination should be discontinued if pregnancy is detected after vaccination, and that other doses should be continued after delivery. And women planning pregnancy in Hong Kong are advised to start pregnancy one month after the full vaccination. Extended reading: At the end of April this year, 13-year-old Chantele in the UK had her first HPV vaccination. Before the vaccination, she was told that all the symptoms that occurred with the procedure were normal and that any side effects would pass. However, after the vaccination, Chantele began experiencing flu symptoms and became ill, after which Chantele would suddenly faint 3-8 times a day without any signs, sometimes even fainting in the bathroom. The cervical cancer vaccine disrupted Chantele’s immune system, making her weak and more susceptible to other infections. Like all vaccines, the HPV vaccine can cause certain adverse reactions, including pain, swelling, redness, fever, dizziness, and nausea. Some are concerned that the HPV vaccine has been on the market for less than a decade from development to launch, which is too short a time to prove its safety. As of March 2014, 170 million doses of HPV vaccine have been administered worldwide and there have been no particularly serious adverse reactions. Using surveillance data from the Merck Sharp & Dohme vaccine as an example, 91 percent of adverse reactions were less serious side effects, such as dizziness, malaise, painful swelling at the vaccination site, fever, and nausea; 9 percent were serious adverse events, such as death, disability, and serious illness. “A link between the occurrence of these serious adverse events and the vaccine has not been indicated and may be coincidental. In addition to safety, the high price of the HPV vaccine is not affordable for the general public. A single HPV vaccination in Hong Kong currently costs about 1,000 yuan, and a full vaccination costs 3,000 yuan. People who can afford the current price of the vaccine are often not the ones who need it the most. Those who never get a cervical biopsy, or who come from areas with poor sanitation, are the ones who really need the vaccine. Therefore, it is thought that even if the vaccine is marketed, it may not be very effective in controlling the incidence of cervical cancer in China. And, the Chinese vaccine, Hirex, is only a one-generation version of the HPV vaccine: the approved HPV vaccine is only bivalent, i.e., it can only prevent types 16 and 18, which is the Chinese version of the one-generation Huuyin Kang vaccine. There is still a big difference with the current mainstream nine-valent HPV vaccine. Because there are many subtypes of HPV, the wider the coverage, the greater the benefit to the vaccine population. Countries and regions such as the United States, South Korea, and Hong Kong have upgraded from a generation of bivalent and quadrivalent to nine-valent. In conclusion, vaccination should not follow the fashion, but should be done according to your own situation. In addition, please understand the suitability, safety and efficacy of the vaccine before vaccination. Vaccines alone will not prevent all diseases.