Cecolin HPV Vaccine

One-Dose HPV Vaccinations Save More Women from Cervical Cancer

Karen McClorey Hackett — Sun, 17 Nov 2024 18:48:21 +0000

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Four years ago to the day, 194 countries resolved to eliminate cervical cancer, with the World Health Organization (WHO) leading a global strategy. Since then, significant progress has been made.

According to the WHO, on November 17, 2024, at least 144 countries had introduced a human papillomavirus (HPV) vaccine, and over 60 countries now include HPV testing in their cervical screening programs, the fourth most common cancer in women.

As world leaders arrive in Brazil for the G20 Summit this weekend, health prevention advocates are joining the WHO to mobilize efforts on a worldwide "Day of Action for Cervical Cancer Elimination."

"I thank all the health workers who are playing a critical role in this global effort," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a media release.

"Only with strong leadership and sustained investment can we achieve our shared goal of equitable access for communities most in need."

In 2022, the WHO aimed to fully vaccinate 90% of women with the HPV vaccine by age 15.

While the 90% vaccination goal has not been achieved, the WHO has led an expansion in access to HPV vaccines and a reduction in the suggested number of doses.

Data released in July 2024 indicates that the one-dose HPV vaccine coverage among young women increased from 20% in 2022 to 27% in 2023.

In 2023, 37 countries were implementing the single-dose schedule.

WHO estimates that the single-dose schedule adoption has resulted in at least 6 million additional young women being reached with HPV vaccines in 2023.

And as of late 2024, 57 countries are implementing the single-dose schedule.

Furthermore, the WHO took action to increase HPV vaccine supply.

WHO announced in October that a fourth WHO-prequalified HPV vaccine product, Cecolin®, has been confirmed for use in a single-dose schedule. This important milestone will contribute to improving the sustainable supply of HPV vaccines—allowing more women to be reached with the vaccines that prevent cervical cancer, says the WHO.

Dr Kate O'Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO, commented in a previous press release, "Given the continuing supply challenges, this addition of single-dose vaccine product means countries will have greater choice of vaccines to reach more girls."

In the United States, HPV causes about 37,800 cancer cases. In addition to cervical cancer, HPV causes cancers of the vagina, vulva, penis, anus, rectum, and oropharynx.

HPV vaccinations are recommended for two and three doses and are available at health clinics and pharmacies.

Sub Title:

37 countries offer one dose HPV vaccines for young women

References:

2020 - Global strategy to accelerate the elimination of cervical cancer

WHO and partners rally cervical cancer elimination efforts

WHO adds an HPV vaccine for single-dose use

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by Keith Johnston

China’s HPV Vaccine Coming Soon

Don Hackett — Thu, 30 Apr 2020 22:13:32 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

In a major step forward in fighting cervical cancer in China, a human papillomavirus (HPV) vaccine developed by Chinese researchers will be widely available for women under the age of 45.

Starting in May 2020, the first batch of the Cecolin HPV vaccine will be available in community hospitals in provincial-level regions, including Hubei, Jilin, and Xinjiang Uygur Autonomous Region reported Xinhuanet on April 26, 2020.

The Cecolin vaccine was jointly developed by Xiamen University and a subsidiary of YangShengTang Group in east China's Fujian Province, after an 18-year study. It was approved by the National Medical Products Administration in December 2019.

The newly available vaccine can protect people against HPV 16 and 18, two major HPV types causing 70 percent of all cervical cancers, the third most common cancer among women.

The World Health Organization (WHO) and many other countries recommend people to get vaccinated between the ages of 9 through 14.

British pharmaceutical giant GlaxoSmithKline's Cervarix is the first HPV vaccine introduced in China and the current market-available HPV vaccine with the same type of coverage.

Both vaccines require three shots over six months, but the Chinese vaccine is cheaper, with one shot priced at 329 yuan (about 46.5 U.S. dollars). One shot of Cervarix meanwhile is priced at 580 yuan in the Chinese market.

"Many cervical cancer patients are on low incomes," said Sui Long, a chief gynecologist at the Obstetrics and Gynecology Hospital affiliated to Fudan University in Shanghai, adding that the domestically produced vaccine will make the vaccination affordable for many poor patients.

Due to safety concerns, many vaccines were not available on the Chinese mainland until Cervarix was approved in July 2016. Mainland residents had to travel to Hong Kong or abroad to get the three-shot vaccination, making the cost higher.

Another HPV vaccine developed by Xiamen University covering 9 HPV types will undergo a phase three clinical trial, the last test before reaching the market, the university source noted.

During 2019, the university announced that it had made a breakthrough in developing a new-generation vaccine that has the potential to protect against almost all of the most lethal HPV forms.

In September 2019, the university, with the YangShengTang Group, signed an agreement with GlaxoSmithKline to work on developing the next-generation HPV vaccine together.

In the USA, the Centers for Disease Control and Prevention (CDC) currently recommends a 2-dose regimen for all children starting the series before age 15 or a 3-dose regimen if the series is started between ages 16 to 26.

The latest generation of HPV vaccine (Gardasil 9) can protect against nearly 90 percent of cancer-causing HPV infections.

HPV vaccine news published by Vax Before Cancer.

Sub Title:

Cecolin HPV vaccine was approved by the China National Medical Products Administration

Reference:

China Focus: Chinese HPV vaccine to be available in May

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Initial Made-In-China HPV Vaccine Approved

Don Hackett — Thu, 02 Jan 2020 14:37:53 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

According to a notice from the National Medical Products Administration (NMPA), China has approved its first domestically made cancer prevention vaccine against the human papillomavirus (HPV) for use by females between the ages of 9 to 45.

This newly approved cancer prevention vaccine is designed to protect against HPV Type 16 and Type 18 the most common virus strains that lead to cervical cancer, reported China Daily on January 2, 2020.

China’s NMPA notice is reported to say ‘the (approval) green light granted to the domestically developed vaccine was intended to meet public demand.’

The new HPV vaccine, known as Cecolin, was jointly developed by Innovax, a biotechnology company based in Xiamen, Fujian province, China, in cooperation with Xiamen University.

Innovax reported more than 7,300 females across 5 provincial-level regions took part in the vaccine's 3rd-stage clinical trial in China's four-tier drug approval system.

During this clinical trial, Cecolin was able to provide protection against precancerous lesions related to HPV for all recipients and protection against persistent HPV infection for 97.8 percent of them, while demonstrating its safety.

These study results put the 2-valent vaccine on a par with the imported types in terms of its efficacy and safety, making it a world-leading vaccine product, the company said.

While most HPV vaccines are administered as a 3-dose injection, the Cecolin vaccine will require only 2-doses for a full vaccination procedure.

Zhang Jun, vice-dean of Xiamen University's School of Public Health, told the news website Jiemian.com that the domestic HPV vaccine was made using E. coli bacteria, which will cut production costs compared with its foreign counterparts and boost manufacturers' production capacity.

The company added that it will accelerate efforts to submit Cecolin’s applications for World Health Organization (WHO) vaccine prequalification, which examines the capacity and quality of a manufacturer, in order to expand the reach of the Chinese-made HPV vaccine and step up the global fight against cervical cancer.

According to a May 2018 study, China’s cervical cancer burden has a substantial effect on global estimates. An estimate suggested that the number of new cervical cancer cases in China was 100,000 every year, accounting for 29 percent of the world’s total.

The increasing trend in the incidence and mortality due to cervical cancer may be related to inadequate screening, increasing prevalence of HPV infection, and the lack of an HPV vaccine.

This study found only 21 percent of women in China reported ever undergoing a Pap Test.

In 2009, China’s government launched the National Cervical Cancer Screening Program in rural areas. It was the first time that the Chinese government had proposed to gradually widen access to cervical cancer screening services in rural areas, and it represented a step toward the nationwide provision of cervical cancer screening.

As of January 2019, the WHO says HPV is a group of 100 viruses that are extremely common worldwide, with at least 14 types cancer-causing. The HPV types (16 and 18) cause about 70 percent of cervical cancers and pre-cancerous cervical lesions.

HPV is mainly transmitted through sexual contact and most people are infected with HPV shortly after the onset of sexual activity, says the WHO.

To enhance vaccine quality control in China, the government announced to innovate solutions, which are:

The NMPA and the National Health Commission announced on December 16, 2019, that China has a goal of launching a national vaccine tracking system before March 31, 2020.
China’s Vaccine Administration Law was enacted on June 29th, 2019. This new law took effect on December 1, 2019, could be the foundation for better regulation and sound development of China’s vaccine industry.

Worldwide, HPV vaccines are produced by Glaxo-SmithKline and Merck & Co. As of April 2018, they had gained approval for commercial release in China, but some consumers had complained about a shortage of vaccines due to a sudden surge in demand following their approval in the country.

Previously, Xiamen Innovax Biotech said in a press release published on September 6, 2019, they had partnered with GSK Biologicals for the development and commercialization of a next-generation adjuvanted HPV vaccine.

In related HPV vaccine news, a new study from the University of Texas Health Science Center in Houston, Texas (UTHealth) supports making cervical cancer prevention easier for women.

This new UTHealth study published on December 27, 2019, revealed that just 1-dose of the HPV vaccine prevented cancer-causing virus infections.

The Centers for Disease Control and Prevention (CDC) currently recommends a 2-dose regimen for all children starting the series before age 15 or a 3-dose regimen if the series is started between ages 16 to 26.

The latest generation of HPV vaccine (Gardasil 9) can protect against nearly 90 percent of cancer-causing HPV infections.

HPV vaccine news published by Vax Before Cancer.

Sub Title:

Innovax vaccine Cecolin is a generic version of Cervarix that prevents HPV 16 & 18 cancers

References:

Chinese vaccine for HPV approved

WHO: Human papillomavirus (HPV) and cervical cancer

Cervical cancer screening using the Cervista high-risk human papillomavirus test: opportunistic screening of a hospital-based

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China’s National Vaccine Tracking System Coming in 2020

Don Hackett — Mon, 16 Dec 2019 17:38:11 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

China has announced the goal of launching an innovative national vaccine tracking system before March 31, 2020.

According to media reporting by China Daily on December 16, 2019, a recent circular jointly issued by the National Medical Products Administration (NMPA) and the National Health Commission says ‘this system will enable the traceability of all vaccines on the Chinese market.’

This circular specified the responsibilities of the NMPA in building such a system includes the participation of provincial drug regulators, health authorities and authorized manufacturers.

Additionally, the circular said the NMPA is working to launch a collaborative service platform, which will be connected with online systems for immunization programs and those for vaccine data, to integrate information of vaccine production, circulation, and inoculation.

Furthermore, the NMPA and provincial drug regulators will build the national and provincial supervision systems for vaccine traceability, it added.

The system pilot programs include Beijing, Tianjin, Inner Mongolia Autonomous Region, Shanghai, Jiangsu, Hainan, and Chongqing.

These provincial-level areas were demanded to connect regional vaccine tracking systems with the national collaborative service platform before December 31, 2019, and begin to feed the national information by January 31, 2020.

This announcement follows a previous vaccine-management enhancement in China.

On June 29, 2019, the ‘Law of the People's Republic of China on Vaccine Management’ was Adopted at the 11th meeting of the Standing Committee of the 13th National People's Congress.

This Law was enacted in order to strengthen vaccine management, ensure vaccine quality and supply, regulate vaccination, promote the development of the vaccine industry, safeguard public health, and maintain public health safety.

Moreover, this Law applies to those engaged in vaccine research, development, production, distribution, vaccination and their supervision and management activities within the territory of the People's Republic of China.

These announcements are very positive news since China has been the world's biggest producer and consumer of human vaccines over 4 decades of planned vaccination, said a Report Thinker press release on October 21, 2019.

‘China's vaccine market will have a rosy prospect.’

‘The growing demand for vaccines comes with a large population base, the aging of the population, and more than 15 million newborns each year,’ said this press release.

To meet this increased consumer demand, Chinese vaccine companies are now competing with foreign firms on new vaccines, such as the 13-valent pneumococcal vaccine and HPV vaccine.

Walvax Biotechnology's 13-valent pneumococcal vaccine has been applied for certification and is expected to be the first approved homemade vaccine of such kind in China.

Also, Beijing Wantai Biological Pharmacy Enterprise's 2-valent HPV vaccine is expected to be the first approved homemade vaccine of its class in China.

In the USA, the Immunization information system (IIS) is enabling healthcare providers and families by consolidating all vaccine information in one digital file.

By 2 years of age, over 20 percent of US children have seen more than one healthcare provider, resulting in scattered paper vaccination records.

The IIS synchronizes with medical records and pharmacy systems, so families and international travelers have 24/7 access to their current vaccine history, wherever they are in the world.

International vaccine news is published by Precision Vaccinations

Sub Title:

China system will enable the traceability of all vaccines on the Chinese market

References:

China sets timetable for national vaccine tracking system

China’s Human Vaccine Market Looks Very Bright

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