Where does the 26-year age limit for hpv vaccination come from?

　　The idea that you have to get the nine-valent HPV vaccine before the age of 26 has led many women who are about to turn 26 to pay high prices to get the nine-valent vaccine rather than get the dual-valent and quadrivalent vaccines through regular channels. The latter two vaccines are available for women aged 9 to 45 years and 20 to 45 years respectively.

　　There are even more people who have already received the dual-valent vaccine and still want to catch up with the nine-valent vaccine before the age of 26, with a view to enhancing the preventive effect. "What if I can't get the nine-valent vaccine after the age of 26?" This has become a problem for many people.

　　The reporter found that some of the nine-valent HPV vaccines are available in the United States, Hong Kong and other countries and regions, not from 16 to 26 years old, but from 9 to 45 years old. As a result, many women over the age of 26 have gone overseas to receive the nine-valent HPV vaccine at the cost of more time and money.

　　The manufacturer of the nine-valent HPV vaccine, Merck Sharp & Dohme, states in the HPV Vaccination Recommendations on its website that "The nine-valent HPV vaccine is recommended for all boys and girls aged 11 or 12 years (but can be started at age 9 years), and for those who have not been vaccinated or have not been adequately vaccinated before age 26 years who have been adequately vaccinated.

All adults aged 27 to 45 years should have a shared decision-making discussion with their clinician to determine if they should be vaccinated."

　　This also means that the vaccination recommendations given on the Merck Sharp & Dohme website state that the nine-valent HPV vaccine is available for ages 9 to 45. It is worth mentioning that the reporter checked the manual of the nine-valent HPV vaccine listed by Mercer in the Mainland but found the words "This product is suitable for vaccination of women aged 16 to 26 years old".

　　How exactly was the age limit of 16 to 26 years determined? This reporter found the "Technical Review Report on the Application for Listing of the Nine-Valent Human Papilloma Virus Vaccine (Brewer's Yeast) (JXSS1800008/9)" issued by the Drug Review Centre of the State Food and Drug Administration in October 2018, following the approval of the Mercer 9-valent HPV vaccine in the Mainland, which stated the following.

　　

"This application for import registration of this product is based on data from overseas clinical studies, and no clinical trials have been conducted in China. In accordance with the spirit of Document 42 of the General Office of the CPC Central Committee and the General Office of the State Council, the import registration of this product was considered to be supported by clinical study data from overseas.

The global clinical trial data of this product basically confirms the consistency of safety, immunogenicity and protective efficacy between the East Asian population and the total population, and can be considered for conditional approval of the product for domestic marketing based on overseas data.

　　 "In view of the lack of evidence on the lower age groups of the East Asian population (especially the Chinese population) in the current overseas clinical data, the fact that women in China have a later sexual life than in Western countries, and taking into account a number of factors such as health economics, it is tentatively determined that women aged 16 to 26 years are the suitable vaccination population for this product, and that the effectiveness and safety of this product in the lower age groups will be fully demonstrated in the domestic clinical trial data submitted by the applicant.

The instructions will be updated when the applicant submits data from domestic clinical trials to fully demonstrate the efficacy and safety of the product in the lower age groups."

　　The age of eligibility for the nine-valent HPV vaccine was thus established in the Mainland and continues to be so today.

At the same time, the instruction also implies that the age of applicability, 16 to 26 years, is not unchangeable, and that at least with the accumulation of clinical trial data in China, being able to receive the nine-valent HPV vaccine before the age of 16 is possible.

　　In fact, trials of the nine-valent HPV vaccine for a wider age range of mainland women are in order. Publicly available information shows that Mercer has launched a Phase 3 open clinical study titled "Evaluation of the immunogenicity and safety of the nine-valent human papillomavirus vaccine (V503) in Chinese women aged 9 to 45 years" in March 2019, with a total of 1,990 Mainland women planned to be enrolled in the trial, which aims to test the safety of the company's nine-valent HPV vaccine in Mainland women aged 9 to 45 years.

　　Subject recruitment for this study has been completed and the trial is ongoing.