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Encouraging signs in US malaria vaccine research

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081208_malariaUS government health researchers have report some successful indicators in initial human testing of a malaria vaccine. In a trial involving fewer than 60 patients, the vaccine cleared three important hurdles: it is safe for humans, it produces an immune response and it offered malaria protection in adults.

Sanaria Inc., a biotechnology firm in Maryland, has developed the vaccine. The National Institute of Allergy and Infectious Diseases (NIAID), with collaborators from the Walter Reed Army Institute of Research and the Naval Medical Research Center, evaluated the Sanaria product at the National Institutes of Health (NIH) near Washington.

Fifty-seven healthy adults consented to be in what is called a Phase 1 trial. Among the volunteers, 40 participants received the vaccine and 17 did not. Making sure a vaccine is safe is one of the key objectives in a trial at this stage, so after the volunteers were vaccinated intravenously, the researchers let a week pass to see if adverse reactions emerged, or if any signs of malaria were induced by the vaccine.

The trial vaccine is known as PfSPZ, after Plasmodium falciparum, the most deadly of the malaria-causing parasites. PfSPZ is made from live but weakened sporozoites, the offspring of the infective malaria spores. The NIAID volunteer patients showed no signs of the disease itself over that first week, and developed varying levels of antibodies against malaria, depending on the level of the PfSPZ dose they received.

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Three weeks after volunteers received their final vaccination, the researchers let the malaria-carrying mosquitoes loose, and participants were bitten by the insects. Deliberate human malaria infection under controlled conditions is a standard process in malaria vaccine trials, according to the August 8 NIAID press release about the test.

Twelve of the participants who received the higher doses of the vaccine did not get malaria. Three of the high-dose volunteers did come down with the disease, but that compares to infection among 16 of 17 participants in the low-dosage group.

Another 12 participants received no vaccine at all, and 11 of those volunteers came down with malaria.

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“In this trial, we showed in principle that sporozoites can be developed into a malaria vaccine that confers high levels of protection and is made using the good manufacturing practices that are required for vaccine licensure,” said Dr. Robert A. Seder, the principal investigator of the trial at the NIAID Vaccine Research Center.

The volunteers were all in the NIH Clinical Center as researchers waited for symptoms to appear. The participants remained there through diagnosis and treatment with anti-malarial drugs. They were all shown to be free of infection at the end of the trial.

Seder said the trial is a “promising first step in generating high-level protection against malaria.” Future studies, he added, will attempt to find the best dosage, schedule and delivery method for PfSPZ. In the Phase 1 trial, patients got the vaccine intravenously, not a common route for vaccine. A vaccine that requires injection in a vein is more complex to administer, especially considering some of the rural and underdeveloped regions where malaria inflicts the greatest suffering.

“The global burden of malaria is extraordinary and unacceptable,” said NIAID Director Dr. Anthony S. Fauci. “Scientists and health care providers have made significant gains in characterizing, treating and preventing malaria; however, a vaccine has remained an elusive goal. We are encouraged by this important step forward.”

In 2010, some 219 million cases of malaria and an estimated 660,000 malaria-related deaths occurred globally, according to World Health Organization (WHO) statistics issued earlier this year. The majority of malaria deaths occur among African children, age 5 years and younger.

The NIAID vaccine trial is just one of many activities backed by the U.S. government to lessen the burden of this disease. The President’s Malaria Initiative (PMI) works in 19 focus countries in sub-Saharan Africa and Asia’s Greater Mekong subregion. For the last seven years, PMI has worked in concert with national governments; The Global Fund to Fight AIDS, Tuberculosis and Malaria; the World Bank and other donors to reduce the occurrence of the disease, which research has shown contributes to a generational cycle of poverty. WHO’s 2012 World Malaria Report offered evidence of success in the anti-malarial campaign, with the estimated annual number of global deaths falling by more than one-third since 2000.

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Economy

Issuance of green bonds will strengthen the international role of the euro

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Eurogroup ministers discussed the international role of the euro (15 February), following the publication of the European Commission's communication of (19 January), ‘The European economic and financial system: fostering strength and resilience’.

President of the Eurogroup, Paschal Donohoe said: “The aim is to reduce our dependence on other currencies, and to strengthen our autonomy in various situations. At the same time, increased international use of our currency also implies potential trade-offs, which we will continue to monitor. During the discussion, ministers emphasized the potential of green bond issuance to enhance the use of the euro by the markets while also contributing to achieving our climate transition objective.”

The Eurogroup has discussed the issue several times in recent years since the December 2018 Euro Summit. Klaus Regling, the managing director of the European Stability Mechanism said that overreliance on the dollar contained risks, giving Latin America and the Asian crisis of the 90s as examples. He also referred obliquely to “more recent episodes” where the dollar’s dominance meant that EU companies could not continue to work with Iran in the face of US sanctions. Regling believes that the international monetary system is slowly moving towards a multi-polar system where three or four currencies will be important, including the dollar, euro and renminbi. 

European Commissioner for the Economy, Paolo Gentiloni, agreed that the euro’s role could be strengthened through the issuance of green bonds enhancing the use of the euro by the markets while also contributing to achieving our climate objectives of the Next Generation EU funds.

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Ministers agreed that broad action to support the international role of the euro, encompassing progress on amongst other things, Economic and Monetary Union, Banking Union and Capital Markets Union were needed to secure the euros international role.

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EU

European human rights court backs Germany over Kunduz airstrike case

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An investigation by Germany into a deadly 2009 airstrike near the Afghan city of Kunduz that was ordered by a German commander complied with its right-to-life obligations, the European Court of Human Rights ruled on Tuesday (16 February), writes .

The ruling by the Strasbourg-based court rejects a complaint by Afghan citizen Abdul Hanan, who lost two sons in the attack, that Germany did not fulfil its obligation to effectively investigate the incident.

In September 2009, the German commander of NATO troops in Kunduz called in a U.S. fighter jet to strike two fuel trucks near the city which NATO believed had been hijacked by Taliban insurgents.

The Afghan government said at the time 99 people, including 30 civilians, were killed. Independent rights groups estimated between 60 and 70 civilians were killed.

The death toll shocked Germans and ultimately forced its defence minister to resign over accusations of covering up the number of civilian casualties in the run-up to Germany’s 2009 election.

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Germany’s federal prosecutor general had found that the commander did not incur criminal liability, mainly because he was convinced when he ordered the airstrike that no civilians were present.

For him to be liable under international law, he would have had to be found to have acted with intent to cause excessive civilian casualties.

The European Court of Human Rights considered the effectiveness of Germany’s investigation, including whether it established a justification for lethal use of force. It did not consider the legality of the airstrike.

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Of 9,600 NATO troops in Afghanistan, Germany has the second-largest contingent behind the United States.

A 2020 peace agreement between the Taliban and Washington calls for foreign troops to withdraw by May 1, but U.S. President Joe Biden’s administration is reviewing the deal after a deterioration in the security situation in Afghanistan.

Germany is preparing to extend the mandate for its military mission in Afghanistan from March 31 until the end of this year, with troop levels remaining at up to 1,300, according to a draft document seen by Reuters.

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EU

Digitalization of EU justice systems: Commission launches public consultation on cross-border judicial co-operation

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On 16 February, the European Commission launched a public consultation on the modernization of EU justice systems. The EU aims to support member states in their efforts to adapt their justice systems to the digital age and improve EU cross-border judicial co-operation. Justice Commissioner Didier Reynders (pictured) said: “The COVID-19 pandemic has further highlighted the importance of digitalization, including in the field of justice. Judges and lawyers need digital tools to be able to work together faster and more efficiently.

At the same time, citizens and businesses need online tools for an easier and more transparent access to justice at a lower cost. The Commission strives to push this process forward and support member states in their efforts, including as regards facilitating their cooperation in cross-border judicial procedures by using digital channels.” In December 2020, the Commission adopted a communication outlining the actions and initiatives intended to advance the digitalization of justice systems across the EU.

The public consultation will gather views on the digitalization of EU cross-border civil, commercial and criminal procedures. The results of the public consultation, in which a broad range of groups and individuals can participate and which is available here until 8 May 2021, will feed into an initiative on digitalisation of cross-border judicial cooperation expected at the end of this year as announced in the 2021 Commission's Work Programme.

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