European Medicines Agency  [to 25 November 2017]
New guidelines on good manufacturing practices for advanced therapies
Adaptations ensure a high level of quality for ATMPs and patient protection

European Vaccine Initiative  [to 25 November 2017]
20 November 2017
MVVC2 study published
EDCTP funded MVVC2 study published today in Frontiers in Immunology: showing safety and immunogenicity of malaria vectored…
FDA [to 25 November 2017]
November 21, 2017 –
FDA approves first two-drug regimen for certain patients with HIV
The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca…
IAVI  [to 25 November 2017]
November 21, 2017
New Findings to Help HIV Scientists Establish ‘Template’ for Potent Antibodies
Natural-infection studies in Africa and India continue to inform HIV vaccine design
New data published today in Immunity further illuminate how some human beings generate powerful, HIV-blocking antibodies. Led by scientists at the International AIDS Vaccine Initiative (IAVI) and The Scripps Research Institute (TSRI), the results offer important insight into a potential AIDS vaccine design.
“Uncovering the process by which neutralizing antibodies develop is critical to HIV vaccine design,” said Elise Landais, Senior Research Scientist with IAVI and lead author of the study. “A small fraction of people living with HIV can naturally produce exceptionally powerful and broad antibodies that could prevent HIV from infecting their immune cells, but not until several years post-infection – long after that protection can help them. But it is of enormous interest to vaccine researchers.”…
MSF/Médecins Sans Frontières  [to 25 November 2017]
Press release
MSF: India’s Decision to Give Pfizer Unmerited Patent on Lifesaving Pneumonia Vaccine Limits Access for Children Globally
November 20, 2017
At High Court of Delhi hearing tomorrow, Doctors Without Borders will urge India to remain the “pharmacy of the developing world” and rethink decision that solidifies Pfizer monopoly on critical pneumonia vaccine

Sabin Vaccine Institute  [to 25 November 2017]
Monday, November 20, 2017
Journalists Gather for Information Session on Vaccines
BUENOS AIRES, ARGENTINA – Today, the Sabin Vaccine Institute (Sabin) convened journalists from across Latin America to contribute to their understanding of the science of vaccines…
During the three-day information session hosted by Sabin, in partnership with the Universidad I Salud and the Centro de Estudos para la Prevención y el Control de Enfermedades Transmisibles, journalists will learn from public health experts about clinical trials, vaccine safety, how to communicate the impact of immunization, and basic epidemiology and immunology of vaccines, among other topics. By bringing together public health experts and 25 journalists from 18 countries, the information session will provide Latin American journalists with a baseline understanding of vaccines, vaccine safety and related global health issues….

UNAIDS [to 25 November 2017]
Global ministerial conference ends with adoption of the Moscow Declaration to End TB
23 November 2017
A global ministerial conference held in Moscow, Russian Federation, on 16 and 17 November that united more than 1000 participants, including 75 ministers and 114 country delegations, concluded with the adoption of the Moscow Declaration to End TB.

The Moscow Declaration to End TB is a new commitment to increase multisectoral action and enhance accountability in the global TB response towards ending tuberculosis (TB) by 2030. The declaration will also inform the first United Nations General Assembly High-Level Meeting on TB, in 2018, which will seek to advance commitments to end TB from heads of state and government.

The declaration outlines the importance of international action to address key areas to respond to TB: sustainable financing, pursuing science, research and development and the establishment of a multisectoral accountability framework.

The conference, the First World Health Organization Global Ministerial Conference on Ending Tuberculosis in the Sustainable Development Era: a Multisectoral Response, was opened by the President of the Russian Federation, Vladimir Putin. It was attended by high-level United Nations leaders, including Amina J. Mohammed, the United Nations Deputy Secretary-General, Tedros Adhanom Ghebreyesus, the World Health Organization Director-General, and Michel Sidibé, the UNAIDS Executive Director…
[See last week’s edition for more detail]

UNICEF  [to 25 November 2017]
Geneva Palais Briefing Note: Urgent measures to improve hygiene practices underway inside Rohingya refugee camps
GENEVA, 21 November 2017 – This is a summary of what was said by Christophe Boulierac, UNICEF Spokesperson in Geneva – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.

Despite progress, 180 million children face bleaker prospects than their parents – UNICEF
NEW YORK, 20 November 2017 – Despite global progress, 1 in 12 children worldwide live in countries where their prospects today are worse than those of their parents, according to a UNICEF analysis conducted for World Children’s Day.

Wellcome Trust  [to 25 November 2017]
November 21, 2017  STAT
First Opinion
Focused projects can help Tedros restore confidence in the WHO
By Jeremy Farrar
Like many people around the world, I was dismayed last month by the appointment of Robert Mugabe, the embattled president of Zimbabwe, as a World Health Organization goodwill ambassador. While I believe it is important for the WHO to work with political leaders of every variety, Mugabe’s record in Zimbabwe, which has led to incredible pressure for him to step down, made him profoundly unsuitable for such a role. That wasn’t the only reason this decision seemed so extraordinary to me: It stands as an outlier amid many very sound judgments made by Tedros Adhanom Ghebreyesus, WHO’s newly elected director-general.

In his first 100 days in office, Tedros, as he is known, has assembled an able and extremely diverse senior leadership team. He has also engaged meaningfully and constructively with critics — not least by quickly reversing the Mugabe appointment and without equivocation. He acknowledged a misstep and, I believe, deserves our support because his leadership is a critical opportunity to rebuild the WHO into the force it should be in global health.

Tedros’s election has given him a mandate that no other head of a United Nations agency can claim. His election was the first of its kind in terms of transparency and openness, complete with manifestos, an election platform, and a vote among all WHO member states. His legitimacy, coupled with focused minds at WHO after the failures of Ebola, means he can do what the global health community has been asking the WHO director-general to do for decades: lead its member states with an ambitious program of effective and measurable work, rather than simply reacting passively to their diverse wishes…