Recently, the World Health Organization (who) announced on its official website that the organization held an immunization strategy expert group (SAGE) meeting from April 4 to 7 to review the evidence of single dose human papillomavirus (HPV) vaccination. It was concluded that the single dose HPV vaccination scheme can effectively prevent cervical cancer caused by continuous HPV infection, and the effect is equivalent to that of two or three doses.
This may lead to important changes in the prevention and control rules of cervical cancer. How much impact will it have on the HPV vaccine industry?
Persistent infection of high-risk HPV is the main inducement of a variety of cancers. Among the multiple cancers associated with persistent infection of high-risk HPV, cervical cancer is the most common. In cervical cancer, more than 70%of cervical cancer is caused by HPV-16 and HPV-18. Cervical cancer is also a cancer with clear etiology, which can be prevented early and is expected to be eliminated. The prevention is divided into three levels, of which the primary prevention is mainly preventive HPV vaccination. HPV vaccination can effectively prevent about 70%- 90%of cervical cancer, and is also regarded as one of the main and effective means to prevent cervical cancer.
Sage’s current new recommendations are based on concerns about the slow introduction of HPV vaccines into immunization programmes and the low overall population coverage, especially in poorer countries.
The who said that globally, the use of life-saving vaccines has been slow, and the coverage rate in some countries is far below the target of 90%. By 2020, the global coverage rate of three doses of vaccines will be only 13%. Behind the slow speed and low coverage of HPV vaccination, it is also restricted by some factors such as insufficient supply and high vaccination cost.
As early as November 2020, who has released the global strategy for accelerating the elimination of cervical cancer. One of the goals is that by 2030, 90%of girls will complete HPV vaccination before the age of 15. Who assistant director general nothemba simelela currently believes that the single dose HPV vaccination proposal is likely to promote the achievement of this goal faster. At the same time, the single dose vaccination has lower cost, takes less resources and is easier to manage. It also makes the replanting campaign for different age groups easier to carry out and reduces the challenge of tracking and managing multiple vaccinations, The savings in health spending and human resources can be used for other health priorities.
At present, sage recommends the following immunization procedures:women aged 9-14 (the highest priority population) are vaccinated once or twice; Women aged 15-20 years were vaccinated once or twice; Women over 20 years old were vaccinated twice (with an interval of 6 months).
In 2021, global HPV vaccine sales totaled about $6.3 billion. Up to now, there are five HPV vaccines approved for listing in the world, including GlaxoSmithKline’s bivalent HPV vaccine, Merck’s tetravalent HPV and jiuvalent HPV vaccine, Wantai biological (603392. SH) bivalent HPV vaccine and Watson biological (300142. SZ) bivalent HPV vaccine. The latter two enterprises are Chinese enterprises.
In China, these five vaccines have been approved for marketing. According to the approved HPV vaccine immunization procedures, two or three doses are basically used for vaccination, and there is no single dose vaccination yet. In terms of pricing, in China, the price of each dose of listed products is more than 300 yuan, or even more than 1000 yuan.
According to the above suggestions, some people believe that the future market demand of HPV vaccine may face a certain decline.
Prior to this, frost Sullivan said that in terms of the total population, the overall vaccination rate of HPV vaccine in China is low, less than 1%. Even considering the expected growth of HPV vaccination rate, 234 million women aged 9 to 45 in China will not be vaccinated with HPV vaccine by 2025. Assuming three doses per person, an additional 701.7 million doses may be required. Based on the number of people vaccinated by frost Sullivan, now, assuming two doses per person, the additional demand is reduced to 467.8 million doses; Assuming a single dose per person, the additional requirement becomes 233.9 million doses.
The who said its recommendations would be updated after further consultation with stakeholders.
However, whether the WHO recommendations can be truly implemented still faces a game with relevant HPV vaccine manufacturers.
Some HPV vaccine manufacturers told the first financial reporter that the who’s proposal is to solve the huge gap between the supply and demand of HPV vaccine, but this proposal does not have legal effect, and is inconsistent with the listed vaccination instructions, which have legal effect.”For listed vaccine enterprises, if they rashly reduce the times of vaccination at this time, it may cause some disputes.”
After the news was released, on April 14, Zhifei biological quickly dived down by more than 10%, and the total market value fell back below 200 billion. The growth enterprise market turned green after rising by more than 1%.