On January 9th, MSD announced that its nine valent human papillomavirus vaccine (brewing yeast) (trade name: Jiada Xiu 9) has been approved by the National Medical Products Administration of China for the second dose vaccination program (0, June December) for women aged 9-14 years old.
Merck said that this approval means that on the basis of the previous three dose vaccination program for 9-45 years old, the Jia Da Xiu 9 will add a two dose vaccination program for 9-14 years old, providing more economical and convenient health protection for more eligible women, helping them stay away from HPV infection related cervical cancer and cervical lesions.
In the industry's view, the age range of 9-14 years old is the "golden age" for receiving HPV vaccines. Currently, the penetration rate of HPV vaccines in this age group is relatively low. After the approval of the 9-14 year old two dose vaccination program for the nine valent HPV vaccine, it will help to further expand the market size of the nine valent HPV vaccine, as well as improve market penetration and accessibility. As the exclusive distributor of Merck's HPV vaccine, Zhifei Biotechnology is expected to benefit from the increase in the total demand for the nine valent HPV vaccine.
Teenagers are the primary recipients of HPV vaccines
It is reported that cervical cancer is one of the common gynecological malignancies. Its incidence rate and mortality are on the rise, which has become a serious public health problem threatening women's health. Almost all cervical cancer is associated with HPV infection, and vaccination can effectively prevent cervical cancer by preventing HPV infection. Meanwhile, cervical cancer is currently the only cancer in the world that can be prevented. Because the etiology of cervical cancer is clear, 99.7% of cervical cancer is caused by persistent infection of high-risk HPV.
Currently, getting vaccinated against HPV is the most economical and effective measure to prevent cervical cancer. Multiple authoritative guidelines indicate that adolescents are the primary recipients of HPV vaccines across all age groups.
As explicitly stated by the World Health Organization (WHO) in its Global Strategy to Accelerate the Elimination of Cervical Cancer, 90% of girls are required to complete HPV vaccination before the age of 15. The 2017 "HPV Vaccine: WHO Position Paper" pointed out that in order to prevent cervical cancer, WHO recommends that the primary target of HPV vaccination is girls aged 9-14 who have not engaged in sexual activity. According to the 2019 US "Adult HPV Vaccination: ACIP Update Recommendations," ACIP routinely recommends HPV vaccination for adolescents aged 11-12, starting from the age of 9. According to the 2017 Comprehensive Prevention and Control Guidelines for Cervical Cancer in China, the recommended age range for HPV vaccination in China is 9-45 years old women, with a focus on 13-15 year old girls.
In fact, 9-14 years old is considered the optimal age for receiving the HPV vaccine and is currently recognized as the "golden age" for receiving the HPV vaccine. In terms of the protective effect of vaccines, age is crucial, and the earlier vaccination, the better the immune effect obtained. At the same time, vaccinated individuals aged 9-14 are more likely to have no risk of HPV infection, resulting in a higher protective effect.
According to the clinical trial results previously released by Merck, the antibody positivity rate of the tetravalent HPV vaccine and the nine valent HPV vaccine for Chinese girls aged 9-19 reached 100%. At the same time, both vaccines can provide long-term protection for adolescents. After receiving the quadrivalent HPV vaccine for women aged 16 to 23, the protective effect is 100% after 14 years of follow-up; After receiving the nine valent HPV vaccine, women aged 9-15 years old were followed up for 11 years with a 100% protective effect.
The actual vaccination rate among the 9-14 year old population is very low
Although the age range of 9-14 is the golden age for receiving HPV vaccines, the penetration rate of HPV vaccines is not high in this age group.
Taking the data of Wuhan as an example, according to the news released on the official account of "Wuhan Disease Control and Health Promotion", from January to June 2023, Wuhan will receive 370000 doses of various HPV vaccines, including bivalent, tetravalent, and ninvalent vaccines.
Out of 370000 data points, 60000 data points were stratified and analyzed. Among the 60000 data points, women aged 9-15 received only 381 doses, accounting for 0.64%, which can be almost negligible; 1586 doses were administered to women aged 16-20, accounting for 2.64%; Women aged 21-25 received 5115 doses, accounting for 8.53%. The peak doses were administered to women aged 26-30, 31-35, and 36-40, with 14378 doses (23.96%), 20476 doses (34.12%), and 12933 doses (21.56%) respectively. Women aged 41-45 received 5131 doses, accounting for 8.55%.
According to data from Wuhan, the population aged 9-15 who require priority vaccination is actually the lowest among all age groups. In the industry's view, due to the low penetration rate, the approval of the 9-14 year old two dose vaccination program for the Merck Dong nine valent HPV vaccine is expected to release more vaccine resources. After the burden is reduced, the total demand for the nine valent HPV vaccine may actually increase.