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
AU YA KIINGEREZA:
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.
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