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On the evening of August 30, the "Merck China" WeChat public account announced that the new indication of its nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) (hereinafter referred to as "nine-valent HPV vaccine") has been approved by the State Drug Administration of China.
Approval, this approval marks the expansion of Merck's nine-valent HPV vaccine in the domestic applicable population to women aged 9-45 years old
.
Subsequently, "HPV nine-valent vaccine age expansion to 9 to 45 years old" quickly became the number one trending search on Weibo
.
Approval, this approval marks the expansion of Merck's nine-valent HPV vaccine in the domestic applicable population to women aged 9-45 years old
.
Subsequently, "HPV nine-valent vaccine age expansion to 9 to 45 years old" quickly became the number one trending search on Weibo
.
The vaccine has not changed, why can it be expanded from 16 to 26 years old to 9 to 45 years old?
According to the official website of the State Food and Drug Administration, on April 28, 2018, the State Food and Drug Administration conditionally approved the marketing of the above-mentioned nine-valent HPV vaccine, which is suitable for women aged 16 to 26 years
.
Why can the same vaccine be expanded from 16 to 26 years old to 9 to 45 years old in a few years?
.
Why can the same vaccine be expanded from 16 to 26 years old to 9 to 45 years old in a few years?
"The approval of the applicable age of vaccines in China needs to be supported by strict research data .
" Bi Hui, chief physician of the Department of Obstetrics and Gynecology of
Peking University First Hospital , said in an interview with a reporter from the China Famous Doctor of China Central Radio Network: "Previously, the HPV nine-valent vaccine has always been The clinical research in China has not been completed
.
However, in 2018, the World Health Organization proposed the goal of eliminating cervical cancer globally.
Based on vaccine availability, it also recommended the clinical application of three HPV vaccines
.
At that time, the industry's voice for the HPV nine-valent vaccine was also Very high
.
As a result, the State Food and Drug Administration conditionally approved its marketing based on the data of the East Asian population
.
”
" Bi Hui, chief physician of the Department of Obstetrics and Gynecology of
Peking University First Hospital , said in an interview with a reporter from the China Famous Doctor of China Central Radio Network: "Previously, the HPV nine-valent vaccine has always been The clinical research in China has not been completed
.
However, in 2018, the World Health Organization proposed the goal of eliminating cervical cancer globally.
Based on vaccine availability, it also recommended the clinical application of three HPV vaccines
.
At that time, the industry's voice for the HPV nine-valent vaccine was also Very high
.
As a result, the State Food and Drug Administration conditionally approved its marketing based on the data of the East Asian population
.
”
In this regard, the official website of the State Food and Drug Administration has clearly pointed out that the listing of the nine-valent HPV vaccine is based on the urgent clinical needs of drugs and the direct use of overseas clinical data for registration in China
.
The reason why the approved group is women aged 16 to 26 is based on three aspects:
.
The reason why the approved group is women aged 16 to 26 is based on three aspects:
1.
The subjects of the pivotal clinical trial supporting the marketing of the HPV nine-valent vaccine are females aged 16 to 26 years old.
The State Food and Drug Administration reviewed and analyzed the global registered clinical research data and the East Asian population, all showing the same protective efficacy, reflecting the The benefits outweigh the risks
.
The subjects of the pivotal clinical trial supporting the marketing of the HPV nine-valent vaccine are females aged 16 to 26 years old.
The State Food and Drug Administration reviewed and analyzed the global registered clinical research data and the East Asian population, all showing the same protective efficacy, reflecting the The benefits outweigh the risks
.
2.
An immunogenic bridging test was used in female pediatric subjects aged 9-15 years, and there are limited clinical data from this trial in East Asian populations
.
An immunogenic bridging test was used in female pediatric subjects aged 9-15 years, and there are limited clinical data from this trial in East Asian populations
.
3.
Women over 26 years of age are more likely to be exposed to HPV infection, and evidence of the vaccine's protective effect in this age group post-exposure population was not available at the time
.
Women over 26 years of age are more likely to be exposed to HPV infection, and evidence of the vaccine's protective effect in this age group post-exposure population was not available at the time
.
Bi Hui introduced: "Now, the HPV nine-valent vaccine has clinical research data in China, and it is found that the immunogenicity of women aged 9-15 and 27-45 is the same as that of people aged 16-26
.
That is to say, they have the same protection.
Effective
.
Therefore, the applicable age can be extended to 9 to 45 years old
.
”
.
That is to say, they have the same protection.
Effective
.
Therefore, the applicable age can be extended to 9 to 45 years old
.
”
She pointed out that a vaccine is a special kind of medicine, and safety and effectiveness are its two foundations
.
It is precisely because of these two points that the above-mentioned change in age adjustment occurs
.
.
It is precisely because of these two points that the above-mentioned change in age adjustment occurs
.
Regardless of the price of the vaccine, timely vaccination is the key
Currently, there are three types of HPV vaccines on the market: bivalent, quadrivalent, and ninevalent
.
Since the nine-valent HPV vaccine is the highest-priced vaccine available on the market to protect against HPV virus, it is more sought after by the vaccinated population, and there is often a situation where "one vaccine is hard to find"
.
.
Since the nine-valent HPV vaccine is the highest-priced vaccine available on the market to protect against HPV virus, it is more sought after by the vaccinated population, and there is often a situation where "one vaccine is hard to find"
.
"Although vaccination with the nine-valent HPV vaccine can achieve higher protection effects, it is not necessary to simply stick to the 'high price'.
Early vaccination and early protection are the key
.
" Bi Hui introduced that there are 3 types of 5 HPV vaccines in China
.
According to a document issued by the State Food and Drug Administration, international research data shows that more than 70% of cervical cancers are caused by HPV16 and HPV18 virus infections; domestic research shows that more than 84.
5% of cervical cancers are caused by these two virus infections
.
At present, the bivalent and quadrivalent vaccines marketed in China can prevent and control 84.
5% of cervical cancer risks; the nine-valent vaccine can prevent 92.
1% of cervical cancers
.
Recently, the latest research by 17 research teams including Professor Zhao Fanghui of National Cancer Center/ Tumor Hospital of Chinese Academy of Medical Sciences and Professor Wu Ting of Xiamen University published in the top international academic journal "The Lancet-Infectious Diseases" shows that China's first domestically produced The HPV vaccine has a protection rate of 100% in preventing HPV16 and HPV18-related precancerous lesions in females aged 18 to 45, with good immune persistence and high safety
.
It can be said that the protective effect of bivalent and quadrivalent vaccines has been "enough"
.
Early vaccination and early protection are the key
.
" Bi Hui introduced that there are 3 types of 5 HPV vaccines in China
.
According to a document issued by the State Food and Drug Administration, international research data shows that more than 70% of cervical cancers are caused by HPV16 and HPV18 virus infections; domestic research shows that more than 84.
5% of cervical cancers are caused by these two virus infections
.
At present, the bivalent and quadrivalent vaccines marketed in China can prevent and control 84.
5% of cervical cancer risks; the nine-valent vaccine can prevent 92.
1% of cervical cancers
.
Recently, the latest research by 17 research teams including Professor Zhao Fanghui of National Cancer Center/ Tumor Hospital of Chinese Academy of Medical Sciences and Professor Wu Ting of Xiamen University published in the top international academic journal "The Lancet-Infectious Diseases" shows that China's first domestically produced The HPV vaccine has a protection rate of 100% in preventing HPV16 and HPV18-related precancerous lesions in females aged 18 to 45, with good immune persistence and high safety
.
It can be said that the protective effect of bivalent and quadrivalent vaccines has been "enough"
.
After vaccination, regular screening is still required
"HPV vaccination cannot be done once and for all
.
" Bi Hui said that the currently marketed HPV vaccines do not cover all high-risk genotypes, and their protective effect on infected people is weakened
.
Moreover, there are some elderly people who are outside the applicable age range of the vaccine
.
Therefore, to prevent cervical cancer, HPV vaccination is only an important part of the primary prevention of cervical cancer, and cannot replace routine cervical cancer screening
.
.
" Bi Hui said that the currently marketed HPV vaccines do not cover all high-risk genotypes, and their protective effect on infected people is weakened
.
Moreover, there are some elderly people who are outside the applicable age range of the vaccine
.
Therefore, to prevent cervical cancer, HPV vaccination is only an important part of the primary prevention of cervical cancer, and cannot replace routine cervical cancer screening
.
"Even if you have been vaccinated against HPV, you should have regular screening
.
" It takes 8 to 10 years from HPV infection to cervical cancer
.
Bi Hui suggested that during this period, if the lesions caused by HPV infection can be detected early, or early diagnosis and appropriate treatment and long-term follow-up, the development of lesions to cancer can be prevented to the greatest extent
.
According to the risk of HPV infection and tumor risk, she recommends that women aged 25 to 29 should undergo cytological screening every 3 years, and after the age of 30, HPV-based screening can be performed every 5 years, or every 3 years.
A cytology screening
.
.
" It takes 8 to 10 years from HPV infection to cervical cancer
.
Bi Hui suggested that during this period, if the lesions caused by HPV infection can be detected early, or early diagnosis and appropriate treatment and long-term follow-up, the development of lesions to cancer can be prevented to the greatest extent
.
According to the risk of HPV infection and tumor risk, she recommends that women aged 25 to 29 should undergo cytological screening every 3 years, and after the age of 30, HPV-based screening can be performed every 5 years, or every 3 years.
A cytology screening
.
On the evening of August 30, the "Merck China" WeChat public account announced that the new indication of its nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) (hereinafter referred to as "nine-valent HPV vaccine") has been approved by the State Drug Administration of China.
Approval, this approval marks the expansion of Merck's nine-valent HPV vaccine in the domestic applicable population to women aged 9-45 years old
.
Subsequently, "HPV nine-valent vaccine age expansion to 9 to 45 years old" quickly became the number one trending search on Weibo
.
Approval, this approval marks the expansion of Merck's nine-valent HPV vaccine in the domestic applicable population to women aged 9-45 years old
.
Subsequently, "HPV nine-valent vaccine age expansion to 9 to 45 years old" quickly became the number one trending search on Weibo
.
The vaccine has not changed, why can it be expanded from 16 to 26 years old to 9 to 45 years old?
The vaccine has not changed, why can it be expanded from 16 to 26 years old to 9 to 45 years old? According to the official website of the State Food and Drug Administration, on April 28, 2018, the State Food and Drug Administration conditionally approved the marketing of the above-mentioned nine-valent HPV vaccine, which is suitable for women aged 16 to 26 years
.
Why can the same vaccine be expanded from 16 to 26 years old to 9 to 45 years old in a few years?
medicines _.
Why can the same vaccine be expanded from 16 to 26 years old to 9 to 45 years old in a few years?
"The approval of the applicable age of vaccines in China needs to be supported by strict research data .
" Bi Hui, chief physician of the Department of Obstetrics and Gynecology of
Peking University First Hospital , said in an interview with a reporter from the China Famous Doctor of China Central Radio Network: "Previously, the HPV nine-valent vaccine has always been The clinical research in China has not been completed
.
However, in 2018, the World Health Organization proposed the goal of eliminating cervical cancer globally.
Based on vaccine availability, it also recommended the clinical application of three HPV vaccines
.
At that time, the industry's voice for the HPV nine-valent vaccine was also Very high
.
As a result, the State Food and Drug Administration conditionally approved its marketing based on the data of the East Asian population
.
”
hospital famous doctor _" Bi Hui, chief physician of the Department of Obstetrics and Gynecology of
Peking University First Hospital , said in an interview with a reporter from the China Famous Doctor of China Central Radio Network: "Previously, the HPV nine-valent vaccine has always been The clinical research in China has not been completed
.
However, in 2018, the World Health Organization proposed the goal of eliminating cervical cancer globally.
Based on vaccine availability, it also recommended the clinical application of three HPV vaccines
.
At that time, the industry's voice for the HPV nine-valent vaccine was also Very high
.
As a result, the State Food and Drug Administration conditionally approved its marketing based on the data of the East Asian population
.
”
In this regard, the official website of the State Food and Drug Administration has clearly pointed out that the listing of the nine-valent HPV vaccine is based on the urgent clinical needs of drugs and the direct use of overseas clinical data for registration in China
.
The reason why the approved group is women aged 16 to 26 is based on three aspects:
female female.
The reason why the approved group is women aged 16 to 26 is based on three aspects:
1.
The subjects of the pivotal clinical trial supporting the marketing of the HPV nine-valent vaccine are females aged 16 to 26 years old.
The State Food and Drug Administration reviewed and analyzed the global registered clinical research data and the East Asian population, all showing the same protective efficacy, reflecting the The benefits outweigh the risks
.
The subjects of the pivotal clinical trial supporting the marketing of the HPV nine-valent vaccine are females aged 16 to 26 years old.
The State Food and Drug Administration reviewed and analyzed the global registered clinical research data and the East Asian population, all showing the same protective efficacy, reflecting the The benefits outweigh the risks
.
2.
An immunogenic bridging test was used in female pediatric subjects aged 9-15 years, and there are limited clinical data from this trial in East Asian populations
.
An immunogenic bridging test was used in female pediatric subjects aged 9-15 years, and there are limited clinical data from this trial in East Asian populations
.
3.
Women over 26 years of age are more likely to be exposed to HPV infection, and evidence of the vaccine's protective effect in this age group post-exposure population was not available at the time
.
Women over 26 years of age are more likely to be exposed to HPV infection, and evidence of the vaccine's protective effect in this age group post-exposure population was not available at the time
.
Bi Hui introduced: "Now, the HPV nine-valent vaccine has clinical research data in China, and it is found that the immunogenicity of women aged 9-15 and 27-45 is the same as that of people aged 16-26
.
That is to say, they have the same protection.
Effective
.
Therefore, the applicable age can be extended to 9 to 45 years old
.
”
.
That is to say, they have the same protection.
Effective
.
Therefore, the applicable age can be extended to 9 to 45 years old
.
”
She pointed out that a vaccine is a special kind of medicine, and safety and effectiveness are its two foundations
.
It is precisely because of these two points that the above-mentioned change in age adjustment occurs
.
.
It is precisely because of these two points that the above-mentioned change in age adjustment occurs
.
Regardless of the price of the vaccine, timely vaccination is the key
Regardless of the price of the vaccine, timely vaccination is the key Currently, there are three types of HPV vaccines on the market: bivalent, quadrivalent, and ninevalent
.
Since the nine-valent HPV vaccine is the highest-priced vaccine available on the market to protect against HPV virus, it is more sought after by the vaccinated population, and there is often a situation where "one vaccine is hard to find"
.
.
Since the nine-valent HPV vaccine is the highest-priced vaccine available on the market to protect against HPV virus, it is more sought after by the vaccinated population, and there is often a situation where "one vaccine is hard to find"
.
"Although vaccination with the nine-valent HPV vaccine can achieve higher protection effects, it is not necessary to simply stick to the 'high price'.
Early vaccination and early protection are the key
.
" Bi Hui introduced that there are 3 types of 5 HPV vaccines in China
.
According to a document issued by the State Food and Drug Administration, international research data shows that more than 70% of cervical cancers are caused by HPV16 and HPV18 virus infections; domestic research shows that more than 84.
5% of cervical cancers are caused by these two virus infections
.
At present, the bivalent and quadrivalent vaccines marketed in China can prevent and control 84.
5% of cervical cancer risks; the nine-valent vaccine can prevent 92.
1% of cervical cancers
.
Recently, the latest research by 17 research teams including Professor Zhao Fanghui of National Cancer Center/ Tumor Hospital of Chinese Academy of Medical Sciences and Professor Wu Ting of Xiamen University published in the top international academic journal "The Lancet-Infectious Diseases" shows that China's first domestically produced The HPV vaccine has a protection rate of 100% in preventing HPV16 and HPV18-related precancerous lesions in females aged 18 to 45, with good immune persistence and high safety
.
It can be said that the protective effect of bivalent and quadrivalent vaccines has been "enough"
.
tumor tumorEarly vaccination and early protection are the key
.
" Bi Hui introduced that there are 3 types of 5 HPV vaccines in China
.
According to a document issued by the State Food and Drug Administration, international research data shows that more than 70% of cervical cancers are caused by HPV16 and HPV18 virus infections; domestic research shows that more than 84.
5% of cervical cancers are caused by these two virus infections
.
At present, the bivalent and quadrivalent vaccines marketed in China can prevent and control 84.
5% of cervical cancer risks; the nine-valent vaccine can prevent 92.
1% of cervical cancers
.
Recently, the latest research by 17 research teams including Professor Zhao Fanghui of National Cancer Center/ Tumor Hospital of Chinese Academy of Medical Sciences and Professor Wu Ting of Xiamen University published in the top international academic journal "The Lancet-Infectious Diseases" shows that China's first domestically produced The HPV vaccine has a protection rate of 100% in preventing HPV16 and HPV18-related precancerous lesions in females aged 18 to 45, with good immune persistence and high safety
.
It can be said that the protective effect of bivalent and quadrivalent vaccines has been "enough"
.
After vaccination, regular screening is still required
After vaccination, regular screening is still required "HPV vaccination cannot be done once and for all
.
" Bi Hui said that the currently marketed HPV vaccines do not cover all high-risk genotypes, and their protective effect on infected people is weakened
.
Moreover, there are some elderly people who are outside the applicable age range of the vaccine
.
Therefore, to prevent cervical cancer, HPV vaccination is only an important part of the primary prevention of cervical cancer, and cannot replace routine cervical cancer screening
.
.
" Bi Hui said that the currently marketed HPV vaccines do not cover all high-risk genotypes, and their protective effect on infected people is weakened
.
Moreover, there are some elderly people who are outside the applicable age range of the vaccine
.
Therefore, to prevent cervical cancer, HPV vaccination is only an important part of the primary prevention of cervical cancer, and cannot replace routine cervical cancer screening
.
"Even if you have been vaccinated against HPV, you should have regular screening
.
" It takes 8 to 10 years from HPV infection to cervical cancer
.
Bi Hui suggested that during this period, if the lesions caused by HPV infection can be detected early, or early diagnosis and appropriate treatment and long-term follow-up, the development of lesions to cancer can be prevented to the greatest extent
.
According to the risk of HPV infection and tumor risk, she recommends that women aged 25 to 29 should undergo cytological screening every 3 years, and after the age of 30, HPV-based screening can be performed every 5 years, or every 3 years.
A cytology screening
.
.
" It takes 8 to 10 years from HPV infection to cervical cancer
.
Bi Hui suggested that during this period, if the lesions caused by HPV infection can be detected early, or early diagnosis and appropriate treatment and long-term follow-up, the development of lesions to cancer can be prevented to the greatest extent
.
According to the risk of HPV infection and tumor risk, she recommends that women aged 25 to 29 should undergo cytological screening every 3 years, and after the age of 30, HPV-based screening can be performed every 5 years, or every 3 years.
A cytology screening
.
