Dk Sophie Biernaux
Kutoka ;London UK
GSK leo Julai 24-2014, imetangaza imewasilisha maombi ya udhibiti wa chanjo ya malaria RTS,S katika shirika ya Ulaya ya Madawa Agency (EMA).
Uwasilishaji unafuata Ibara ya 58 ya utaratibu, ambayo inaruhusu EMA kutathmini ubora, usalama na ufanisi wa chanjo au dawa, zinazotengenezwa viwandani vya nchi za Umoja wa Ulaya (EU) kwa kutibu magonjwa yanayo tambuliwa na Shirika la Afya Duniani (WHO) kama magonjwa ya athari ya afya ya umma, lakini lengo kwa ajili tu ya matumizi nje ya EU. Utathmini huu hufanywa na EMA kwa kushirikiana na WHO, na huhitaji madawa na chajo kufikia viwango vinavyokubalika kwa ajili ya matumizi katika nchi za EU. Uhakiki kwa ajili ya maombi ulipewa na CHMP baada ya mkataba kutoka kwa WHO kuwa RTS, S kukamilisha vigezo kwa tathmini hiyo.
Matumizi ya RTS,S yamelengwa dhidi ya vimelea vya malaria vya Plasmodium falciparum, ambao vimenea zaidi katika bara la kusini mwa sahara Afrika. Makadirio yananoneyesha karibu asilimia 90 ya vifo kutokana na malaria hutokea katika bara la kusini mwa sahara Afrika , na asilimia 77 ya haya ni katika watoto chini ya miaka 5.
Uwasilishaji wa EMA ni hatua ya kwanza katika mchakato wa udhibiti kwa kufanya chanjo ya RTS,S inapatikana kama mojawapo ya suluhisho za kuzuia malaria. Matumizi ya chanjo pamoja na suluhisho nyingine kama vile vyandarua na madawa ya kupambana na malaria huonyesha ukuaji wa mbinu za kudhibiti malaria. Hadi sasa hakuna chanjo yeyote ambayo imepata leseni ya matumizi kwa kuzuia malaria.
Kama maono mazuri yatatoka kwa Ema, WHO imesema itapendekeza sera kabla ya mwisho wa mwaka 2015. Mapendekezo ya sera ni mchakato rasmi ya WHO yalioyoundwa kusaidia katika maendeleo ya ratiba ya chanjo ya magonjwa yanayoathari afya ya umma, kama vile malaria.
Maoni chanya kutoka EMA pia yatakuwa msingi ramsi ya idhini ya maombi ya masoko kwa mamlaka ya udhibiti ya Taifa (NRAs) katika nchi za kusini mwa bara la afrika. Utathmini kutoka Shirika la madawa Ulaya unahitajika na mamlaka za udhibiti ya nchi mbalimbali za Afrka kabla ya usajili wa dawa za zinazotengenezwa Ulaya. Kama maamuzi haya ha uthibity yatakuwa chanya, itasaidia kupata njia ya kuwezesha utekelezaji kwa kiasi kikubwa Maoni chanya , maamuzi haya ya udhibiti ingesaidia kusafisha njia kuelekea utekelezaji wa chanjo kupitia programu za taifa za chanjo Afrika.
Dk Sophie Biernaux, Mkuu wa Malaria Vaccine Franchise, GSK alisema: "Huu ni wakati muhimu katika safari GSK ya miaka 30 kuendeleza RTS, S na inatuleta hatua moja mbele kwa upatikanaji wa chanjo ya kwanza ya malaria duniani na itasiaidia kulinda watoto wa Afrika kutokupata malaria. "
Takwimu kutoka awamu ya III ya majaribio ya chanjo uliofanyika katika vituo 13 vya utafiti ziliomo katika nchi nane za Afrika (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Msumbiji, Nigeria, na Tanzania) ikiwa ni pamoja na zaidi ya 16,000 watoto wachanga na watoto wadogo waliounganishwa kuunga mkono jalada
-----
KWA ENGLISH;
Issued: [Thursday, July 2014, London UK
GSK announces EU regulatory submission for malaria vaccine candidate RTS,SDescription: dottedline_orange-small
GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.
The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognised by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU. This assessment is done by the EMA in collaboration with the WHO, and requires products to meet the same standards as vaccines or medicines intended for use in the EU. Eligibility for the application was granted by the CHMP after agreement from WHO that RTS,S met criteria for such an evaluation.
RTS,S is intended exclusively for use against thePlasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90 per cent of estimated deaths from malaria occur in SSA, and 77 per cent of these are in children under the age of 5.
The EMA submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention. An effective vaccine for use alongside other measures such as bednets and anti-malarial medicines would represent a advance in malaria control. To-date there is no licensed vaccine available for the prevention of malaria.
If a positive opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015. A policy recommendation is a formal review process by WHO designed to assist in the development of optimal immunisation schedules for diseases that have a global public health impact, such as malaria.[i]
A positive opinion from the EMA would also be the basis for marketing authorisation applications to National Regulatory Authorities (NRAs) in SSA countries. A review by a European medicines agency is required by the majority of African countries prior to registration of a medicinal product manufactured in Europe. If positive, these regulatory decisions would help pave the way toward the large-scale implementation of the vaccine through African national immunisation programmes.
Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise, GSK said: "This is a key moment in GSK's 30-year journey to develop RTS,S and brings us a step closer to making available the world's first vaccine that can help protect children in Africa from malaria."
Data from the phase III vaccine trial programme conducted at 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) including over 16,000 infants and young children have also been included to support the filing.
0 comments:
Post a Comment