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POST 00912E : JE VACCINE INTRODUCTION 17 April 2006

________________________________

Vikram Singh (mailto:vikmanu2000@yahoo.com) from India, contributes some
information of interest on the introduction of Japanese Encephalitis
vaccination in India. The information he requests has been sent to him
privately by WHO. Members are welcomed to share their own comments.

________________________________

Dear members,

Here is some update on introduction of JE in India.

The Government of India had decided to introduce JE Vaccination in high
endemic districts, in a phased manner, starting with 11 districts in 5
States. The vaccination will start from May, 2006 and all children between
1-15 year of age would be vaccinated, as one-time campaign, followed by
integration to Routine Immunization for vaccination of the new cohort.

The global production capacity of mouse brain vaccine is not adequate to
meet the vaccine requirement for implementation of JE during 2006. Also, 3
numbers of doses of this vaccine is required to develop complete immunity.

Looking into the safety, efficacy and availability of JE Vaccine, it was
decided to use Live Attenuated SA 14-14-2 for JE Vaccination Programme.
Indian Council of Medical Research has also recommended use of this vaccine.

This vaccine is manufactured in China only and there are three
manufacturers in China, out of which, only M/s Chengdu Institute of
Biological Products is authorized by China National Biotech Corporation to
register and supply Live- Attenuated JE Vaccine to India.

Accordingly, 13.50 million doses of Live Attenuated SA 14-14-2 JE Vaccine
is being procured from M/s Chengdu Institute of Biological Products on
single source procurement provision. The vaccine has not been
pre-qualified by the WHO.

If I can get some information on the global scenario, with regard to
production of this vaccine.

Vikram Singh,

Director (Immunization) ,
Government of India ,
Ministry of Health & Family Welfare ,
Nirman Bhawan, New Delhi
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POST 00940E : 00934E : JE VACCINE INTRODUCTION Follow-up on Posts 00912E, 00920E, 00926E and 00934E 15 June 2006 ____________________________________________________________ Julie Jacobson (mailto:jjacobson@path.org) from the United States, responds to Vijay Kiran’s request. __________________________________________________________________ In a recent exchange on TechNet concerning Japanese encephalitis (JE) vaccine introduction, there was interest in knowing more about the decision to use the SA 14-14-2 vaccine in India, and specifically in Andhra Pradesh. As Dr. Vijay Kiran points out, the Indian state of Andhra Pradesh (AP) previously used the inactivated, mouse brain-derived vaccine to prevent JE. Through a partnership project between the Government of Andhra Pradesh (GoAP) and PATH, more than 4 million doses of this JE vaccine were procured from both domestic and international markets between 2000 and 2005 all purchased directly by the AP government. This program was a landmark for India showing the systematic use of vaccine for JE control could work in India. Last year the Indian Ministry of Health and Family Welfare made the decision to license and import the live, attenuated JE vaccine known as SA 14-14-2 from its manufacturer in China, the Chengdu Institute of Biological Products. The SA 14-14-2 vaccine has been shown to be a highly effective and safe vaccine, with almost 20 years' experience of use in China. It is the only internationally licensed JE vaccine currently available in sufficient supply to meet the needs of the Indian immunization program. The Indian MOH visited the facility in China and inspected the production and clinical data. The vaccine is made in compliance with the WHO Guidelines for Live JE Vaccine Productions and was deemed to be appropriate for importation. To date, the AP government has procured approximately 4 million doses of inactivated mouse brain-derived vaccine from the Central Research Institute in Kasauli, India, and imported from the Republics of Korea and Vietnam. For the remainder of 2006, the GoAP is procuring 1 million doses of inactivated, mouse brain-derived vaccine from Vietnam. It then plans to transition to use of the SA 14-14-2 vaccine, beginning in 2007. A number of challenges are associated with use of the mouse brain-derived vaccine: * It has a three-dose schedule, with one booster required every three years; * Vaccine production has been insufficient, and therefore the supply is limited; and * Limited vaccine availability coupled with affordability issues meant that the AP government could only target its village-wide mass campaigns at a limited number of children (2 to 12 years of age) in 16 high-risk districts out of 23 districts. In order to better protect all of its high-risk population against JE, and after considering its vaccine options, the GoAP determined that the SA 14-14-2 JE vaccine has several advantages: * It is a single-dose vaccine; * It is available at an affordable price and in adequate supply; * Its supply is supported by the national government of India; and even with patients who received previous doses of the mouse brain-derived vaccine, initial evidence supports that the SA 14-14-2 JE vaccine can be used for follow-up vaccination. These factors, together with a greater supply of the SA 14-14-2 vaccine beginning in 2007, will allow AP to adopt a district-wide approach, thereby protecting more of the population at risk. The Indian national government's decision to approve licensure of the JE vaccine manufactured in China is already helping other states, such as Uttar Pradesh (UP), to protect children against JE. Since May 2006, 6.3 million children in UP were vaccinated with the SA 14-14-2 vaccine. Control of JE in AP, UP, and elsewhere in India is improving. Sustained JE vaccination will protect generations to come. Regular JE surveillance and detection, better case management, and routine JE immunization in JE-affected districts are essential measures for improved JE control. Julie Jacobson, MD Director, PATH's Japanese Encephalitis Project ______________________________________________________________________________ Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:LISTSERV@listes.ulaval.ca Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de coopération internationale en santé et développement, Québec, Canada (http://www.ccisd.org) ______________________________________________________________________________
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POST 00934E : JE VACCINE INTRODUCTION Follow-up on Posts 00912E, 00920E and 00926E 2 June 2006 _____________________________________ Two further contributions were received on this topic. The first is from Vijay Kiran (mailto:vijay@immbasics.org) from India and the second from Julie Milstien (mailto:juliemilstien@yahoo.com) from the United States / France. _____________________________________ This is in response to the update presented by Julie Jacobson on the Introduction of JE vaccine in India. The introduction of SA-14-14-2 is a boon for the Southeast Asian region specially India in view of the disease burden and the ineffective vector control measures. May be it is useful to mention the historic perspective of the mouse brain vaccine usage in Andhra Pradesh, the challenges of vaccine procurement, vaccine administration, the vaccine efficacy, and the Political commitment. I request Julie Jacobson to give a little background on the decision to changeover from Mouse-brain vaccine to introduction of SA-14-14-2. Dr. Vijay Kiran, Country Representative IMMUNIZATIONbasics (USAID) India -------------------------------- Dear Claude, Julie Jacobson has given persuasive arguments for the use of SA-14-14-2 live attenuated JE vaccine. If I were in her place, I would probably do exactly the same thing. So why has WHO not given its unqualified support to the product? The opinion of the GACVS speaks only to the reported adverse events related to use of the product and the design of the clinical trials to assess safety, but does not consider production consistency nor quality of the product. These depend on the existence at the level of the manufacturer of a well thought out and efficient quality system, to ensure consistency of production. The quality system should be overseen by a fully functional national regulatory authority (NRA). This is the kind of information that the WHO prequalification process can evaluate, and at present there is no other process available to provide this information objectively at the global level. Countries should ensure that the vaccines they use are under the oversight of independent and competent NRAs, and that these NRAs are satisfied with the consistency and quality of any vaccines they intend to use, as well as with clinical information on their safety and efficacy. If this assurance cannot be provided, they should avoid using products that do not meet these criteria. The WHO prequalification process provides this kind of assurance for countries lacking such NRA input. It will be to everyone's advantage if the SA-14-14-2 product as manufactured by Chengdu can successfully undergo the prequalification process as soon as possible. Julie Dr Julie Milstien, Montpellier, France ______________________________________________________________________________ Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:LISTSERV@listes.ulaval.ca Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de internationale en sant, Canada (http://www.ccisd.org) ______________________________________________________________________________
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POST 00926E : JE VACCINE INTRODUCTION Follow-up on Post 00912E and 00920E 18 May 2006 ___________________________________________________________________ Julie Jacobson (mailto:jjacobsom@path.org) from PATH is sending a substantial update on JE Vaccine introduction. For more information, please contact: [email=jeproject@path.org]jeproject@path.org[/email] or visit the Japanese Encephalitis Project Website at : http://childrensvaccine.org/html/jep.htm _________________________________ In response to the recent exchange on TechNet concerning Japanese encephalitis (JE) vaccine introduction, and India's decision to introduce JE vaccine specifically, I would like to provide an update and hopefully clarify a few points. JE vaccination remains the best known way to prevent the disease and, increasingly, countries seeking to prevent JE have vaccine options available to protect their populations. Last year, a JE outbreak with 6,584 cases claimed over 1,800 lives in India. Subsequently, and after careful review of its options, the Indian ministry of health and family welfare decided to import the live, attenuated vaccine known as the SA 14-14-2 vaccine from a Chinese manufacturer. This vaccine has been shown to be a highly effective and safe vaccine, with almost 20 years' experience of its use in China. It is the only internationally licensed JE vaccine currently available in sufficient supply to meet the needs of the Indian immunization program. India intends to begin immunizing in high-risk districts this year. Similarly, Nepal has decided to import the SA 14-14-2 vaccine for widespread use this year after suffering a terrible outbreak with 2,341 cases in 2005. The SA 14-14-2 vaccine has become more widely available in recent years. It has been imported and licensed for use in South Korea (since 2001) and in Nepal. Use of the vaccine in these sites has provided excellent efficacy and safety data. In June 2005, WHO's Global Advisory Committee on Vaccine Safety reviewed data on the vaccine and acknowledged its excellent safety and efficacy profile (World Health Organization. Global Advisory Committee on Vaccine Safety, 9-10 June 2005. Weekly Epidemiological Record. 2005;80(28):242-243). Its efficacy has been estimated to be between 80 to 99 percent following a single dose. Last year The Lancet reported results of a trial in Nepal that showed a single dose of SA 14-14-2 JE vaccine was 99 percent effective after 1 year in protecting children from JE. Several studies have shown that side effects after immunization with SA 14-14-2 JE vaccine are rare. Where side effects have been noted, the most common ones are fever and local reactions such as tenderness, redness, and swelling. The only other currently available JE vaccine is the inactivated mouse brain-derived vaccine used by Japan, Taiwan, and Vietnam, among other countries. In India, the inactivated mouse-brain derived vaccine produced by CRI, Kasauli, is used, but supply of this vaccine is limited. Only about 500,000 doses are produced annually-about enough to vaccinate a maximum of 250,000 children. The dosing schedule for this vaccine is complex, with several doses required to achieve protection, and there are issues with compliance and affordability with this vaccine. Nonetheless, it will be important to continue JE immunization in those Indian states that have already been protecting infants and children previously with JE vaccine, even as India expands its JE coverage to include other states at risk of JE. Regarding the question of prequalification of the SA 14-14-2 vaccine, the process of WHO's prequalification of a vaccine involves evaluation to determine the acceptability of a vaccine to enable procurement by United Nations (UN) agencies such as the United Nations Children's Fund (UNICEF). WHO prequalifies vaccines because international procurement agencies do not have a national regulatory body to advise them on the appropriateness of a vaccine. At the national level, this responsibility lies with the National Control Authority. WHO does not approve vaccines; it only prequalifies them for purchase after careful evaluation related to safety, efficacy, and production. There are currently no prequalified JE vaccines, as no manufacturers have applied for prequalification. The inactivated vaccine, which has been used widely, was never prequalified by WHO. Currently, a file is in preparation for submission to WHO for prequalification of the SA 14-14-2 JE vaccine. Concerning JE vaccines under development, two are in advanced stages of clinical development: * ChimeriVax-JE The ChimeriVax-JE (Acambis) vaccine is not yet available and not licensed anywhere, but trial results so far look promising. Acambis has a collaboration with Bharat Biotech in India. The vaccine is a live, recombinant JE vaccine (which uses Yellow Fever 17D as its backbone combined with the SA 14-14-2 vaccine virus. Phase III clinical trials are underway in adults in Australia, but no pediatric trials have begun. Plans are underway to initiate trials in children and infants in India. * Intercell's JE vaccine An inactivated, vero-cell derived JE vaccine is under development by Intercell but is currently not licensed or available. It is undergoing adult Phase III clinical trials in Europe, the United States, and elsewhere, but no pediatric trials have begun. This vaccine also looks very promising. Intercell has a collaboration with Biological E in India to develop this vaccine. Plans are underway to initiate trials in children and infants in India. No other JE vaccines are currently available and, as yet, none of the new JE vaccines being developed has been licensed for infants and children, the primary group to be targeted for this vaccine in endemic settings. Information from clinical trials in this age range will be important before the vaccines under development can be considered for use in JE immunization programs. With regards to the availability of the live SA 14-14-2 vaccine from China, the vaccine is produced by several producers in the country but currently only the Chengdu Institute of Biological Products (CDIBP) has authority to export outside of China. Supply from this manufacturer is being increased and pricing for public sector lower income countries (GNP > 1000USD) is available to facilitate access. It is hoped that the range of JE vaccine options and supply will expand in the future. PATH is closely following the progress in development of these vaccines. An encouraging sign is that countries like India, South Korea, Nepal, and others are taking steps to protect their populations by licensing JE vaccines at country level. As JE immunization plans move into action, even more infants and children will be spared from the impact of this devastating disease. I hope this update about JE vaccine options is useful. Julie Jacobson, MD Director, PATH's Japanese Encephalitis Project PATH ______________________________________________________________________________ Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:LISTSERV@listes.ulaval.ca Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de internationale en sant, Canada (http://www.ccisd.org) ______________________________________________________________________________
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POST 00920E : JE VACCINE INTRODUCTION Follow-up on Post 00912E 3 May 2006 ____________________________________________________________ Only one contribution was received on this topic, by Anil Varshney (mailto:anilvarshney@yahoo.com) from India. ______________________________________________________________ Dear Vikram Good to see you active on this forum. As we discussed earlier more than a month back I made querries and search to find out other manufacturers of this Chinese JE vaccine , I could not find any. I had sent a request to Julie Jacob of PATH who is the Director JE program and also to IVI in Seoul - but no response either. The JE vaccine in public sector was first introduced in Andhra Pradesh in 2001, at that time I was serving as Project manager for PATH and provided the technical expertise to the GOAP. During that period also the possibilty of importing JE from China was explored, but since at that time that particular vaccine was NOT WHO-approved, the idea was shelved. Later standard mouse brain JE vaccine was imported from Green Cross via UNICEF through open bidding. The same JE vaccine was introduced in the state in 2001-02. PATH helped the GOAP in this process as well as in surveillance and training in the highly endemic districts for management of the JE cases. The Chinese vaccine is better than the mouse brain. I also understand that facilities at Kasauli were upgraded to manufacture the mouse brain vaccine to meet the demand. Please also note that a number of importers from India actually import the mouse brain vaccine for open market which also creates shortages. In 2001 there was a talk about South Korea being licensed to produce the Chinese vaccine. I am not sure of the position now, there may be some restriction by parent company if any licence has been granted ? One has few choice : Import from China as per their terms & conditions. Production in the country by licencing of Chinese version. Develop own version of JE ( needed as JE is endemic in many states and routine immunization would need millions of doses every year). As regards efficacy and protection the available data is supportive of the same as being efficacious and having long immunity. Regards , Dr Anil Varshney former Project manager PATH Former consultant to : GOI, WHO- SEARO, UNICEF ----------------------------------------------------------------------------------------------------------- Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:LISTSERV@listes.ulaval.ca Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de internationale en sant, Canada (http://www.ccisd.org) ______________________________________________________________________________
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