Posts or Comments 28 September 2021

Monthly Archive for "August 2021"



Elimination &Vaccine Bill Brieger | 23 Aug 2021

Malaria Vaccine Approval Nearing

Over the coming three days the Malaria Vaccine Implementation Programme (MVIP) Advisory Group in its capacity as SAGE/MPAG Working Group will conduct a full evidence review of the RTS,S/AS01 malaria vaccine and develop proposed recommendations for Strategic Advisory Group of Experts (SAGE) on Immunization and MPAG. This comes on the heels of the recent 74th World Health Assembly Resolution that, “Urges Member States to step up the pace of progress through plans and approaches that are consistent with WHO’s updated global malaria strategy and the WHO Guidelines for malaria. It calls on countries to extend investment in and support for health services, ensuring no one is left behind; sustain and scale up sufficient funding for the global malaria response; and boost investment in the research and development of new tools.”

The large scale pilot intervention of the RTS,S/AS01 malaria vaccine started two years ago in selected districts in three countries countries: Ghana, Kenya and Malawi.  For example, “Two years on from the launch of a pilot programme, more than 1.7 million doses of the world’s first malaria vaccine have been administered in Ghana, benefitting more than 650,000 children with additional malaria protection.” WHO says that, “Insights generated by the pilot implementation will inform a WHO recommendation on broader use of the vaccine across sub-Saharan Africa,” which will then be considered by global advisory bodies for immunization and malaria, i.e. the SAGE and MPAG.

WHO is asking the Working Group to address the following question, “Does the additional evidence on the feasibility, safety and impact of the RTS,S/AS01 vaccine support a WHO recommendation for use of the vaccine in children in sub-Saharan Africa beyond the current pilot implementation?” WHO has set the following meeting objectives:

  1. To examine and provide input to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence profiles of the quality of the evidence used to inform the recommendations;
  2. To review and interpret the evidence, with explicit consideration of the overall balance of benefits and harms;
  3. To formulate recommendations – in alignment with the endorsed 2019 RTS,S Framework for Decision – taking into account benefits, harms, values and preferences, feasibility, equity, acceptability, resource requirements and other factors, as appropriate.

Hopefully decisions will be forthcoming soon so that planning can get underway to address immunization as part of the overall malaria elimination effort.

Schistosomiasis &water Bill Brieger | 20 Aug 2021

Schistosomiasis in Mozambique, the Importance of WASH

As part of the class blog in the Course, Social and Behavioral Foundations in Primary Health Care at the Johns Hopkins Bloomberg School of Public Health, students occasionally write about tropical diseases. Below we are re-posting one such blog by an author going by the username of “kamilinea.”

Photo by mrjn Photography on Unsplash

Schistosomiasis is a parasitic disease, estimated to affect more than 240 million people globally, in which transmission and propagation is dependent upon human exposure to contaminated freshwater. This disease, which has a prevalence of approximately 50% in Mozambique, can cause significant morbidity including blood in the urine or stool, scarring and calcification of the bladder, kidney damage, liver and spleen enlargement, scarring of the liver, genital lesions, vaginal bleeding, infertility, and eventual possible cancer of the bladder along with rare spinal cord damage. Children, who are particularly susceptible to this disease through playing in freshwater, can develop anemia, stunted growth, and intellectual delays.

Exposure typically occurs while bathing, washing clothes, swimming, fishing, or working in contaminated fresh water including lakes, streams, and rivers. Although mass drug administration (MDA) with praziquantel is a main focus of disease control, treatment does not prevent reinfection. Multiple studies have concluded that elimination is currently impossible without infrastructure changes resulting in improvements in water, sanitation, and hygiene (WASH) throughout Mozambique. Providing these changes would allow citizens to avoid exposure to schistosomiasis as well as many other infectious diseases.

Figure 2.

Distribution of Schistosomiasis haematobium in Mozambique, The American Journal of Tropical Medicine and Hygiene Am J Trop Med Hyg

A policy that implements infrastructure changes throughout Mozambique to increase WASH is necessary to improve control and progress toward elimination. More specifically, a policy that would support development of safe-water wells throughout rural regions of Mozambique would allow for sustainable access to safe water. For this policy to be effective, buy-in and support from many stakeholders is imperative including the communities themselves, the government, and the Ministry of Health and organizations such as the WHO, the Schistosomiasis Control Initiative, and the Water and Sanitation Program. The government would need to provide financial support, however funding could be obtained through the World Bank which already supports some WASH programs throughout the country.

Schistosomiasis is a disease that could be eliminated in Mozambique through various control efforts, however elimination is currently not possible without improvements in WASH. All efforts should be made to encourage the government of Mozambique to prioritize this effort and involve supporting organizations in order to eliminate schistosomiasis.

Economics &poverty Bill Brieger | 16 Aug 2021

With all its recent troubles, Haiti is still challenged by malaria

In the past month Haiti has experienced a political assignation, a magnitude 7.2 earthquake and a flood-threatening tropical storm. Add to these are endemic health problems like malaria. The Pan American Health Organization reported that in 2019 Haiti suffered more than 4,600 cases of the disease.

The difficulties responding to the above mentioned challenges is deep seated in efforts to suppress the country since it won its independence in 1804. The rest of the world, particularly Europe and the United States have been responsible for destabilization over the past two centuries.

As part of the online roundtable on Brandon R. Byrd’s book, The Black Republic, Leslie M. Alexander noted that, “We Have Not Yet Forgiven Haiti For Being Black”. He explains that, ” few are willing to ask the hard questions about how and why Haiti perpetually appears to teeter on the brink of economic and political disaster,” and might we add health disasters to the list.

Alexander points out that, “The painful truth is that Haiti’s decision to declare its independence from France and to establish itself as a sovereign Black nation caused most Western nations to declare Haiti as public enemy number one. From the birth of Haitian independence in 1804 until the present day, the United States and other western European nations have used their economic and diplomatic strength in an effort to isolate and impoverish Haiti. ”

Malaria persists where there is poverty and conflict. The solution to malaria in Haiti must account for political and economic interventions that address the injustices of the past.

Funding &Vaccine Bill Brieger | 04 Aug 2021

GAVI Press Release: Financing for Malaria Vaccine

Geneva/London, 4 August 2021Gavi, the Vaccine Alliance, GlaxoSmithKline (GSK) and MedAccess today announced an innovative financing agreement to guarantee continued production of the antigen for the RTS,S/AS01e malaria vaccine in advance of key decisions regarding its roll-out.

The RTS,S/AS01e vaccine – the first malaria vaccine to be proven safe and effective in a large Phase 3 clinical trial – is currently being piloted in routine immunisation programmes in Ghana, Kenya and Malawi, through the Malaria Vaccine Implementation Programme (MVIP). The World Health Organization (WHO) is expected to decide later this year whether to recommend the vaccine for broader use based on data emerging from the MVIP. The Gavi Board will then decide whether to finance a new malaria vaccination programme for countries in sub-Saharan Africa. Following its investment of around US$ 700 million in the development of RTS,S,GSK has donated up to 10 million doses for the ongoing pilot programme.

In advance of the key decisions from WHO and Gavi and to address the associated uncertainty around future demand, Gavi, GSK and MedAccess have developed an innovative financing solution to ensure continued manufacturing of the vaccine antigen so that it will be immediately available should there be a positive decision to move forward.

Gavi will fund GSK’s continued manufacturing of the RTS,S antigen for a period of up to three years. If the Gavi Board decides to approve a malaria vaccination programme (following a positive WHO recommendation), GSK will credit the value of the Gavi-funded costs towards procurement of finished doses for the Gavi-supported programme. If the Gavi Board decides not to open a funding window for a malaria vaccination programme, MedAccess will replenish Gavi for the majority of costs incurred to that point.

This arrangement will ensure that vaccine doses made from the production of Gavi-funded bulk antigen can be supplied rapidly after a potential WHO vaccine recommendation and Gavi financing decisions. This will help accelerate vaccine access, if a programme is approved, by avoiding the long production ramp-up phase that would occur if GSK had to restart the dedicated antigen production facility.

A MedAccess analysis estimates that this continuous manufacture agreement could catalyse the vaccine reaching up to 7.5 million more children than would otherwise have been possible if there was a production delay.

“Malaria kills over a quarter of a million children every year; this vaccine has the potential to have a real impact on this toll,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “That’s why it is vital that we keep production lines running while waiting for important decisions around its use in African populations. This is innovative financing at its best: tackling risk and uncertainty to ensure access to what could be an important additional tool in the battle against malaria.”

“In 2020 we saw that risk-taking finance can accelerate the journey of new vaccines to market,” said Michael Anderson, CEO of MedAccess. “The same idea is at work in this agreement, where smart finance can unlock and secure access to an important product at faster pace. This unique partnership is a prime example of how science, public health expertise and innovative finance can combine to save lives.”

Thomas Breuer, Chief Global Health Officer, GSK, said: “Reaching an agreement to support continuous production of RTS,S bulk antigen is a significant achievement built on a unique funding solution and I congratulate all of the partners involved. Continuity of RTS,S manufacturing now will be crucial in how quickly we can offer malaria protection once WHO, Gavi and implementing countries agree to scale up demand.”

Separate to this agreement, GSK and Bharat Biotech of India will continue activities related to the antigen tech transfer to Bharat Biotech, which will become the sole supplier of the vaccine in 2029, an agreement announced by GSK, Bharat, and PATH earlier this year. GSK will ensure the continuous production of the adjuvant (AS01e).

A Phase 3 trial conducted over 5 years from 2009 to 2014 found that among children aged 5–17 months who received four doses of RTS,S/AS01e, the vaccine prevented approximately 4 in 10 (39%) cases of malaria over 4 years of follow-up and about 3 in 10 (29%) cases of severe malaria, with significant reductions also seen in overall hospital admissions as well as in admissions due to malaria or severe anaemia. The vaccine also reduced the need for blood transfusions, which are required to treat life-threatening malaria anaemia, by 29%.

RTS,S/AS01e is currently being piloted in three African countries (Ghana, Kenya, Malawi) and, despite COVID-19, has achieved and maintained high coverage levels. As of July 2021, two years after the start of vaccinations, more than 2 million RTS,S/AS01e doses have been administered across the three countries and more than 740,000 children have been reached with at least one dose of vaccine.

Ministries of Health are leading the implementation of the vaccine, which is being delivered through routine immunisation programmes, with WHO playing a coordinating role, working in collaboration with GSK, PATH, Unicef and a range of other partners. The programme is funded by Gavi, the Global Fund and Unitaid, with doses donated by GSK, and was designed to address several outstanding questions related to the public health use of the vaccine following the Phase 3 trial.