WHO SAGE Meeting/Malaria Vaccine+

WHO SAGE Meeting/Malaria Vaccine+

WHO – Press Conference on Outcomes of SAGE Immunization Meeting (Geneva, 23 October 2015)
Briefing on outcomes and recommendations of the meeting of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, held this week.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization, which was established to advise WHO on policies and strategies for immunization, met on 20-22 October 20-22 to review the best available scientific evidence on development and use of vaccines including those for use against Ebola virus, poliovirus and malaria. .
Speaker: Professor Jon S. Abramson – Chair of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization

News release
Pilot implementation of first malaria vaccine recommended by WHO advisory groups
Global move to remove type two oral polio vaccine agreed for April
23 October 2015 | GENEVA – The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) jointly recommended pilot projects to understand how to best use a vaccine that protects against malaria in young children.

“This was a historic meeting with two of WHO’s major advisory committees working together to consider current evidence about this vaccine,” said Professor Fred Binka, acting chair of MPAC. “The committees agreed that pilot implementations should be the next step with this vaccine.”

The vaccine, known as RTS,S, is the first vaccine for malaria, but there is one primary question. It requires four doses for a child to be fully protected and therefore requires additional contacts with the health care system. The first three doses are given one month apart followed by an 18-month pause before the fourth dose. Without the fourth dose, children had no overall reduction in severe malaria.

“The question about how the malaria vaccine may best be delivered still need to be answered,” said Professor Jon S. Abramson, chair of SAGE. “After detailed assessment of all the evidence we recommended that this question is best addressed by having 3-5 large pilot implementation projects.”

The malaria vaccine, RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa. It offers no protection against P. vivax malaria, which predominates in many countries outside of Africa. The vaccine is being assessed as a complementary malaria control tool that could potentially be added to—but not replace—the core package of proven malaria preventive, diagnostic and treatment measures.

In other sessions during the SAGE meeting, held from 20-22 October, the group reviewed evidence and offered recommendations on the development and use of vaccines against Ebola virus, poliovirus and measles.

Polio vaccine
Oral polio vaccine (OPV) is the primary tool used to eradicate polio worldwide, thanks to its unique ability to interrupt person-to-person spread of the virus. However, on very rare occasions, the live attenuated vaccine-viruses contained in OPV can be associated with cases of vaccine-associated polio paralysis (VAPP) or circulating vaccine-derived polioviruses (cVDVPs). Withdrawing OPVs is therefore a crucial part of the polio endgame strategy.

The type 2 component of OPV accounts for 40% of VAPP cases, and upwards of 90% of cVDPV cases. By contrast, wild poliovirus type 2 has not been detected anywhere since 1999 and the Global Commission for the Certification of Poliomyelitis Eradication (GCC) declared this strain globally eradicated at its meeting in September 2015. Countries have therefore been preparing to remove the type 2 component from OPV, by switching from trivalent OPV (containing all three serotypes) to bivalent OPV (containing only type 1 and 3 serotypes). All oral polio vaccines will be removed after global eradication of wild poliovirus types 1 and 3 has been certified.

SAGE confirmed that the globally synchronized switch from trivalent oral polio vaccine (tOPV) to bivalent OPV (bOPV) should occur between 17 April and 1 May 2016.

SAGE also concluded that significant progress had been made since its last meeting, in April 2015, with no cases of wild poliovirus in Africa since August and more than a year having passed since the last case was seen in the Middle East, strengthened surveillance and more children being reached with vaccines in key areas of Pakistan and Afghanistan. As a result of these steps, all countries and the partners of the Global Polio Eradication Initiative (GPEI) should intensify their preparations for the global withdrawal of OPV type 2 (OPV2) in April 2016.

SAGE cautioned, however, that more work needs to be done ahead of the switch date. It is critical that countries meet deadlines to protect populations by moving towards destruction of wild poliovirus type 2 stocks or their containment in ‘poliovirus essential’ facilities. Ongoing vaccine-derived type 2 polio outbreaks in Guinea and South Sudan need to be stopped. A global shortage of inactivated polio vaccine needs to be managed ahead of the switch, with available supplies prioritized for the highest-risk areas.

Measles vaccine
Currently 13 percent of measles cases are occurring in children before they reach 9 months – the youngest age at which the first dose is typically given, so SAGE is recommending, in specific circumstances, that a dose may be given earlier to infants as young as 6 months when the risk of contracting measles is high.

SAGE also offered provisional recommendations on vaccination in response to an outbreak of Ebola, based on interim trial results suggesting high safety and efficacy. These recommendations are provisional because candidate vaccines are currently being used only in the context of clinical trials, and recommendations for use outside trial settings will depend on the vaccines receiving regulatory approval. The recommendations do not apply to any specific vaccine. Recommendations will be adjusted when more data become available.


Gavi and Global Fund Statement on Malaria Vaccine Recommendations
23 October 2015
GENEVA – Today’s recommendations by two advisory bodies to the World Health Organization, the Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC), for use of the RTS,S malaria vaccine are a step toward making the vaccine available in countries with a heavy malaria burden as well as an opportunity to assess its likely real world impact.

They have called for pilot implementations of the vaccine in three to five settings in sub-Saharan Africa. This follows an earlier four-year trial of the vaccine that found it safe and effective, providing 39 percent efficacy at preventing clinical cases of malaria.

Replicating that success rate in a non-clinical setting poses challenges. The RTS,S vaccine requires four doses and the last dose is critical for sustaining the protective effect of the vaccine. The first three doses of the vaccine will be administered to children between 5 and 9 months of age and the fourth dose is given around the second birthday. This is partially outside the existing immunization schedule in which most vaccines are administered to infants 6 to 14 weeks after birth, potentially posing logistical challenges to health systems in low-income countries. Further assessing the feasibility of providing these vaccinations and the resulting impact is therefore a prudent approach.

While additional studies could demonstrate RTS,S’s utility in the malaria control toolkit, global efforts must continue to expand access to proven methods of malaria control. The RTS,S vaccine could complement – not replace – existing proven and cost-effective methods, such as insecticide-treated mosquito nets and spraying. Tools such as insecticide-treated mosquito nets have significantly reduced the burden of malaria, more than halving the number under-five deaths since 2000. Despite such progress, there are still more than 200 million cases of malaria worldwide each year, resulting in 438,000 deaths, the vast majority of them African children.

It is now for the World Health Organization to confirm its recommendations on the first-ever malaria vaccine based on the recommendations received from SAGE/MPAC. The boards of Gavi and the Global Fund will review the WHO’s recommendation to determine next steps.

Gavi and the Global Fund are continuing to work together to plan for the possible use of a malaria vaccine, if recommended by WHO and if the Gavi and Global Fund boards decide to support the vaccine in conjunction with other proven malaria interventions, as part of an integrated approach towards malaria control. Both organisations are working in close coordination with the Global Malaria Programme at the WHO, other technical and donor partners and implementing countries.


PATH [to 24 October 2015]
GSK and PATH joint statement on WHO advisory group recommendation on use of RTS,S malaria vaccine candidate
October 23, 2015—The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) and Malaria Policy Advisory Committee (MPAC) have today jointly recommended implementation of GlaxoSmithKline’s (GSK) malaria vaccine candidate RTS,S (Mosquirix™) through a number of pilot projects. This is an important step in the process toward making RTS,S available alongside existing tools currently recommended for malaria prevention, diagnosis, treatment, and control. GSK and PATH will now review the SAGE/MPAC advice as we wait for the final policy recommendation from the WHO expected by the end of 2015.

GSK and PATH stand ready to work with the WHO on the pilot implementation of the vaccine, in order to provide the additional information needed about how to best deliver the vaccine in a real-world setting, enabling implementation of a wider scale immunisation programme in children in sub-Saharan Africa (SSA). The results of a large scale phase III efficacy and safety trial of RTS,S, have shown that RTS,S could provide a meaningful public health benefit in reducing the burden of malaria when used alongside currently available interventions such as bed nets and insecticides.

The SAGE/MPAC joint recommendation comes after the vaccine candidate received a positive scientific opinion from the European regulators in July 2015 for the prevention of malaria in young children in SSA.

In 2013, there were an estimated 584,000 deaths from malaria with around 90 percent of these occurring in SSA, and 83 percent in children under the age of five.

Press release | October 20, 2015
Visualize No Malaria campaign to prove malaria elimination possible in Africa
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Global Fund [to 24 October 2015]

Global Fund Statement on Cambodia’s Programs against Malaria
20 October 2015
Cambodia has made impressive progress against malaria, with a 70 percent decline in the number of cases from 2009 to 2014, and a sharp reduction in deaths in the same period.
However, the situation remains critical, and preliminary data on an increase in malaria cases in parts of Cambodia since mid-2014, as well as resistance to artemisinin-based combination therapies, carries serious implications for the broader Mekong region.

The Global Fund is working with key partners, including the Government of Cambodia and the United Nations Office of Project Services and others, to take all possible measures to reverse the recent increase.

The Global Fund implements a framework of accountability that requires transparent reporting on investments in health, so that a maximum of available resources go toward serving people affected by malaria and other diseases.

The Global Fund has a zero tolerance policy for fraud and corruption, and requires a high degree of transparency and accountability from all partners, even in challenging operating environments where governance and accountability systems do not meet international standards.

In Cambodia, the Global Fund is working with the Ministry of Health to address implementation challenges and to support efforts that maximize results and impact and that further strengthen systems for health to serve the people of Cambodia.