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In response to the widespread floods that ravaged most parts of Iran last month, the EU is providing 100,000 (over 4,75 billion Iranian rial) in humanitarian funding to assist the most affected communities.

The aid will benefit over 22,000 people in some of the hardest hit areas in the provinces of Hormozgan, Kerman, Sistan Baluchestan and Fars.

EU funding supports the Iranian Red Crescent Society (IRCS) in providing the most vulnerable communities with food packages and essential household items.

Iran has one of the worlds highest numbers of COVID-19 cases and all necessary measures will be in place to minimise the transmission of the virus during the operation.

The funding is part of the EUs overall contribution to the Disaster Relief Emergency Fund (DREF) of the International Federation of Red Cross and Red Crescent Societies (IFRC).

More than 80,000 people in 20 provinces have been affected by the floods, triggered by days of heavy rainfall that started on 1 January. The floods have killed 10 people, and damaged homes and agricultural landsthe main livelihood for many.

The floods, which also caused widespread destruction of the drinking supply system, vital facilities, and other infrastructure, have brought transportation to a halt. They have forced relief teams to bring critical supplies to flood-ravaged communities by air.

Affected people have been evacuated to safe areas and medical care has been provided to those injured.

The European Union together with its Member States is the world's leading donor of humanitarian aid. Relief assistance is an expression of European solidarity towards people in need around the world.

It aims to save lives, prevent, and alleviate human suffering, and safeguard the integrity and human dignity of populations affected by natural hazards and human-induced disasters.

Through its European Civil Protection and Humanitarian Aid Operations, the European Union helps millions of victims of conflicts and disasters every year.

The European Commission has signed a 3 million humanitarian contribution agreement with the International Federation of Red Cross and Red Crescent Societies (IFRC) to support the Federation's Disaster Relief Emergency Fund (DREF). Funds from the DREF are mainly allocated to small-scale disasters those that do not give rise to a formal international appeal.

The Disaster Relief Emergency Fund was established in 1985 and is supported by contributions from donors. Each time a National Red Cross or Red Crescent Society needs immediate financial support to respond to a disaster, it can request funds from the DREF.

For small-scale disasters, the IFRC allocates grants from the Fund, which can then be replenished by the donors. The contribution agreement between the IFRC and ECHO enables the latter to replenish the DREF for agreed operations (that fit in with its humanitarian mandate up to a total of 3 million.

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EU brings relief to victims of Iran floods - European Commission

PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market

EMAs safety committee (PRAC) has recommended that marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union (EU). These products were authorised as an addition to other treatments for plasma volume replacements following acute (sudden) blood loss.

The safety of HES solutions for infusion was reviewed in two separate procedures in 2013, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, i.e. a bacterial infection in the blood) were put in place at the time.

As a result of a third review conducted in 2018, the use of HES solutions for infusion was further restricted to accredited hospitals, and healthcare professionals prescribing or administering the medicines had to be trained in their appropriate use. Companies marketing HES solutions for infusion were also requested to conduct a drug utilisation study to check that the restrictions were adhered to in clinical practice, and to submit the results of this study to EMA.

The PRAC has now reviewed the results from this study, which show that HES solutions for infusion are still being used outside the recommendations included in the product information. In view of the serious risks that certain patient populations are still exposed to, the PRAC has therefore recommended the suspension of the marketing authorisations for HES solutions for infusion in the EU.

More information is available inEMAspublic health communication.

The PRAC has started a review of the safety of Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis).

The review was prompted by the final results from a clinical trial (study A3921133) of the JAK inhibitor Xeljanz (tofacitinib). The results showed that patients taking Xeljanz for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem (such as heart attack, stroke or death due to cardiovascular disease) and had a higher risk of developing cancer than those treated with medicines belonging to the class of TNF-alpha inhibitors. The study also showed that compared with TNF-alpha inhibitors, Xeljanz was associated with a higher risk of death due to any cause, serious infections and blood clots in the lungs and in deep veins (venous thromboembolism VTE).

In addition, preliminary findings from an observational study involving another JAK inhibitor, Olumiant (baricitinib), also suggest an increased risk of major cardiovascular problems and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors.

In the treatment of inflammatory disorders, Olumiant and other JAK inhibitors work in a similar way to Xeljanz. PRAC will therefore carry out a review to determine whether these risks are associated with all JAK inhibitors authorised in the EU for the treatment of inflammatory disorders1 and whether the marketing authorisations for these medicines should be amended.

Some measures to minimise these risks are already in place for Xeljanz as a result of a review finalised in 2020, which analysed the interim results of study A3921133. In addition, the product information for Xeljanz was further updated in 2021 to reflect the increased risk of major cardiovascular problems and cancer observed after the release of additional data from this study.

More information is available inEMAspublic health communication.

The PRAC is assessing reported cases of heavy menstrual bleeding (heavy periods) and absence of menstruation (amenorrhea) with the COVID-19 vaccines Comirnaty and Spikevax.

The Committee had previously analysed reports of menstrual (period) disorders in the context of the safety summary reports for COVID-19 vaccines approved in the EU and concluded at the time that the evidence did not support a causal link between these vaccines and menstrual disorders.

In view of spontaneous reports of menstrual disorders with both vaccines and of findings from the literature, the PRAC decided to further assess occurrences of heavy periods or amenorrhea following vaccination.

Menstrual disorders are very common and can occur with a wide range of underlying medical conditions as well as from stress and tiredness. Cases of these disorders have also been reported following COVID-19 infection.

Heavy periods may be defined as bleeding characterised by a volume, which may interfere with the persons physical, social, emotional and material quality of life. Amenorrhea may be defined as the absence of menstrual bleeding for three or more months in a row.

After reviewing the available evidence, thePRACdecided to request an in-depth evaluation of all available data, including reports fromspontaneous reporting systems,clinical trialsand the published literature.

At this stage, it is not yet clear whether there is a causal link between the COVID-19 vaccines and the reports of heavy periods or amenorrhea. There is also no evidence to suggest that COVID-19 vaccines affect fertility.

EMA will communicate further when more information becomes available.

The PRAC has adopted updated guidance on core requirements for risk management plans (RMPs) of COVID-19 vaccines.

As for any medicinal product that is authorised in the EU, companies need to submit their RMP when applying for a marketing authorisation to detail their plan for the post-marketing surveillance and what measures they must put in place to further characterise and manage risks. In the context of the pandemic, EMA adopted specific RMP guidance for COVID-19 vaccines, which complements theexisting guidelines on the RMP format in the EUand guidance ongood pharmacovigilance practices.

Following discussion at the PRAC, this guidance has been updated in light of the experience accrued during the pandemic to include specific considerations on:

The new version of the guidance is available on EMAs website.

As part of its advice on safety-related aspects to other EMA committees, thePRACdiscussed a direct healthcare professional communication (DHPC) containing important safety information for infliximab.

Advice to postpone use of live vaccines in infants exposed to infliximab during pregnancy or via breastfeeding

This DHPC informs healthcare professionals on the need to postpone the use of live vaccines in infants who are exposed to infliximab during pregnancy or via breastfeeding.

Infliximab is an anti-inflammatory medicine authorised for the treatment of adults with rheumatoid arthritis (an immune system disease causing inflammation of the joints), Crohns disease (a disease causing inflammation of the digestive tract), ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut), ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine), psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) or psoriasis (a disease causing red, scaly patches on the skin). Infliximab is also authorised in patients aged between 6 and 17 years with severe, active Crohns disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.

Following treatment during pregnancy, it has been reported that infliximab crosses the placenta and it has been detected in infants up to 12 months after birth. Live vaccines should not be given to infants for 12 months after birth if they have been exposed to infliximab during pregnancy. If infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier time point if there is a clear clinical benefit for the individual infant.

Infliximab has also been detected at low levels in breast milk, therefore, administration of a live vaccine to a breastfed infant while the mother is receiving the medicine is not recommended unless infant infliximab serum levels are undetectable.

It is important that women treated with infliximab who become pregnant or who breastfeed their infant inform the healthcare professional responsible for vaccination of their infant about their treatment with infliximab.

The DHPC for infliximab will be forwarded to EMAs human medicines committee, theCHMP.

Following theCHMP decision, the DHPC will be disseminated to healthcare professionals by themarketing authorisation holders according to an agreed communication plan, and published on theDirect healthcare professional communicationspage and innational registersin the EU Member States.

1 Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib) and Xeljanz (tofacitinib).

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022 | European Medicines Agency - European Medicines...

European Commission chief Ursula von der Leyencannot repeat often enough how close stepping up climate action is to her heart.

She described the European Green Deal as "Europe's man on the moon moment."She has called climate neutrality "our European destiny."And she solemnly proclaimed that no effort will be spared for Europe to become the world's first continent with net-zero emissions.

But as often, the devil is in the detail.

The big question is how exactly the European Union intends to achieve its goals.

European Commission President Ursula von der Leyen paints herself as a friend of the climate

One measure being put into place is a so-called taxonomy, "a classification system, establishing a list of environmentally sustainable economic activities,"according to the EuropeanCommission.

This taxonomy could be described as the EU's green investment rulebook, intended to serve the goal of allowing the continent to become climate neutral by 2050.

Critics say the objective of climate neutrality could be under threat, as the European Commission, the EU's executive arm, decided to give nuclear energy and natural gas a green label under this taxonomy.

In a proposal presented this Wednesday, the EU Commission stated that certain strings remained attached. For example, gas plants could only be considered green if the facility switched to low-carbon or renewable gases, such as biomass or hydrogen produced with renewable energy,by 2035.

Nuclear power plants would be deemed green if the sites can manage to safely dispose of radioactive waste. So far, worldwide, no permanent disposal site, has gone into operation though.

At a news conference in Brussels, Mairead McGuinness, the EU commissioner responsible for financial services, said her institution was not guilty of "greenwashing," as gas and nuclear were labeled as "transitional" energy sources in the taxonomy. "Our credibility is still strong," McGuinness added.

Natural gas can be liquified, allowing it to be shipped relatively easily via tanker

Environmental organizations most certainly see this critically, saying the proposal could jeopardize the EU's aim to reach climate neutrality by 2050. The Climate Action Network Europe wrote that theEU Commission"sacrifices the scientific integrity of the taxonomy on the altar of fossil gas and nuclear lobbies"and failed to "reorient financial flows towards genuinely climate-positive investments."

And it's not justclimate activists: Also a group of experts advising the EU on the matter had announced how they are worried about "the environmental impacts that may result," for example the consequences of a nuclear accident. Building new nuclear plants would also take too long to contribute to the 2050 neutrality goals, they believe.

The proposal was preceded by a heated debate among EU countries. While some consider nuclear to be agood bridging technology, others are strongly opposed, andprefer gas instead.

Germany has opted to use gas as a bridge away from more polluting fossil fuels and toward zero-carbon energy sources

France, which derives about 70 percent of its electricity from nuclear plants, is unsurprisingly heading up the pro-nuclear fraction. It is supported by a group of EU states including Poland, Hungary, the Czech Republic, Bulgaria, Slovakia and Finland.

Especially France wants to invest in new nuclear power plants, particularly innew generation, so-called small modular reactors.

Energy expert Nicolas Mazzucchi,who works for the Foundation of Strategic Research think tank in Paris, supports the French government's plans. "These reactors can be produced on an industrial level at factories, as automated as possible, to make it cheaper and guarantee quality,"Mazzucchi toldDW.

Germany, however, has argued against nuclear power also unsurprisingly, as it decided to shut down all its nuclear power plants by the end of 2022 following the Fukushima disaster in 2011.

Denmark, Austria and Luxembourg share this view, highlighting the controversial point ofwhere to safely store highly radioactive nuclear waste.

In a letter to the EuropeanCommission, Germany's current governing coalition hasclearly said that gas is needed as an interim energy sourceuntil enough renewables are available.

To avoid a clash with its EU neighbor France, German Chancellor Olaf Scholzdownplayed the importance of the taxonomy at an EU leaders' meeting last year, saying the debate was "completely overrated."

Georg Zachmann, a senior fellow at the Brussels-based Bruegel think tank, has been following the EU's energy and climate policy for years. He said that, in the end, he was relatively sure no decision would be taken in Brussels to prevent France, for example, from investing in and building new nuclear reactors.

The Commission is keen to have the taxonomyviewed as the "gold standard" forguidingprivate investmenttowardmeasures that help fight climate change.

But in Zachmann's view, no investor would be interested in nuclear or gasif the EU "invested political capital"in getting member states to substantially expand their renewable energy production.

"We know that onshore wind and solar power are not very costly in most European countries,"he pointed out.

Nuclear versus gas: French President Emmanuel Macron (left) and German Chancellor Olaf Scholz

The European Commission's taxonomy proposal will now be reviewed by the 27 EU member states and by the European Parliament.

As the EU's executive opted for a delegated act, a type of fast-track legislative procedure, only a total of 20 EU countries, or a majority of EU lawmakers at the European Parliament,would be able to reject it.

While EU states are not likely to turn down the taxonomy, a win in the European Parliament is not yet certain. Parliamentarians from across the political spectrum have expressed anger over the inclusion of fossil gas and nuclear power in the EU taxonomy.

Green lawmaker Rasmus Andresen said he was "disappointed" by the proposal, adding that the Green parliamentary fraction would fight hard to gather a majority against the taxonomy.

German Social Democrat Joachim Schuster told DW he thought it possible that the EuropeanParliament could vote against the act.

And even if lawmakers were to supportit, there is another threat looming:Austria and Luxembourg have already threatened to sue the European Commission over the taxonomy rules.

Edited by: Sonya Diehn

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European Commission declares nuclear and gas to be green - DW (English)

DAMASCUS, 1 February 2022 3,996,000 doses of the Johnson & Johnsons Janssen COVID-19 vaccine arrived on 26 of January to Syria donated by Italy through the COVAX facility.

In May last year, as chair of the G20, Italy hosted The Global Health Summit alongside the European Commission, which saw many European countries pledge to share millions of vaccine doses to priority countries like Syria, boosting short-term supplies.

EU and its Member States are so far the biggest donor of COVID-19 vaccines in the world, having shared over 350 million doses for donation to countries around the world, via COVAX (around 300 million) and bilaterally (over 45 million).

Italy is donating doses to COVAX on top of the USD 470 million it has pledged to the Gavi COVAX Advance Market Commitment (Gavi COVAX AMC) and this donation in particular will allow a large number of people in Syria to access vaccines now, said the Italian Charge dAffaires a.i., Massimiliano DAntuono. Italy stands by the Syrian population and, in cooperation with the EU humanitarian aid, UNICEF and WHO, supports the efforts in tackling the COVID-19 pandemic and in general the consequences of the dire humanitarian situation across the country, he continued.

The roll out of the vaccines donated by Italy and the awareness campaign will be funded by EU humanitarian aid and implemented by WHO. The EU, in particular, is providing humanitarian support to WHO in Syria to help the health system deal with the ongoing pandemic and reach the target of 70% people vaccinated by mid-2022. EU humanitarian funding allows for vaccine roll-out and the deployment of vaccination teams. Humanitarian aid is essential at a time when vulnerable Syrians and caregivers are not only threatened by COVID-19, but also by the consequences of continued conflict, economic decline and harsh winter conditions.

The Charg daffaires a.i. of the European Union to Syria, Dan Stoenescu, stated: "As part of our #TeamEurope humanitarian pledge to the Syrian people, the EU supports the vaccination efforts in Syria, where immunization against COVID-19 is lower than in other countries. The European Union is working hard with COVAX and vaccine manufacturers, with donors and other partners, to accelerate the delivery of doses worldwide, including in Syria. Our aim is to ensure that most of Syria's population is vaccinated by the end of this year. The generous donation of Italy is timely and will further help us reach this goal."

The vaccine coverage in Syria is among the lowest globally.

Vaccine supply to Syria has been slow. While we aimed to vaccinate 20 per cent of the population by end of December 2021, the available vaccines by then were only enough to cover 13 per cent of the population. This consignment generously donated by the Government of Italy will reach additional 20 per cent of the population with life-saving COVID-19 vaccines, said Akjemal Magtymova, Head of Mission and WHO Representative in Syria. Availability of vaccines is an important step in ensuring equitable vaccination, but so are vaccine administration and demand generation. We need to step up our concerted efforts to continue building public trust in COVID-19 vaccines to reach the national vaccination target of 40 per cent by April this year and at least 70 per cent by end of the year 2022, Dr Magtymova added.

The donated vaccines can be stored and transported using standard equipment for routine vaccines. This enables distribution to remote areas and provides an opportunity to the hardest to reach populations in the country to be protected with a single dose. Frontline workers, elderly, people with pre-existing conditions and eligible people continue to be prioritized with the vaccination.

This donation from the Government of Italy is incredibly timely and important in our fight against the pandemic. Unless we protect health workers and other frontline workers, health systems will continue to be overstretched and the most vulnerable women and children will lose access to life-saving services, jeopardizing years of progress and culminating in the poorest children falling behind, said UNICEF Syria Representative, Bo Viktor Nylund.

UNICEF and WHO will continue to support efforts to deliver the vaccines safely through cold chain management; supporting vaccinators in fixed facilities and mobile teams; increasing testing and lab capacity to detect COVID-19 cases and prevent the further spread of the pandemic; and boosting public knowledge and confidence in vaccines.

Notes to editors

Just over 2,2 million doses of vaccines against COVID-19 have been administered in Syria to date. As of 24 January 2022, only 5.1 per cent of the total population have been fully vaccinated, most with two doses, and 10 per cent have received at least one dose of the vaccine.

The numbers above do not include the figures from northwest of Syria. In the northwest, more than 287,000 people have received their first dose and nearly 146,500 people their second one.

For more information, please contact:

Press and Information team of the EU Delegation to Syria, DELEGATION-SYRIA-PRESS-INFO@eeas.europa.eu

Eva Hinds, UNICEF Syria, ehinds@unicef.org, +963 950 044 304

Gulalek Soltanova, WHO Syria, soltanovag@who.int, +963 953 888 477

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Italy joins other European Union member states to increase pledge of COVID-19 vaccines to Syria [EN/AR] - Syrian Arab Republic - ReliefWeb

The EU foreign policy chief, Josep Borrell, visited Ukraine in January 2022 amidst continuously soaring tensions along the Russia-Ukraine border, conveying a strong message of support to Kyiv. This came at a time when a series of security talks between Russia and the US, NATO, and the OSCE were scheduled to take place from January 10, 2022. The EU put forth its genuine concerns about its exclusion in the talks on the European security architecture and its portrayal as a neutral spectator. Borrell urged that any discussion about European security must happen in coordination with and participation of EU. After all, whatever happens in its neighbourhood affects the EU and its member-states security.

Since the crisis emerged at the Russia-Ukraine frontier in 2014, the EU has majorly assisted Ukraine in sharply reducing the latters economic dependence on its hostile neighbour Russia by supporting with over EUR 17 billion. The EU-Ukraine Association Agreement of 2014 has resulted in the EU becoming Ukraines largest trading partner surpassing Russia. But, what has cast a shadow on the budding EU-Ukraine bonhomie is the EU-Russia economic equation.

The EU is Russias biggest trading partner with 37.3% of the countrys total trade in goods in 2020. Thus, to its advantage, the bloc has attempted to use instrument of economic sanctions to deter Russia from any further misadventures in Ukraine and its neighbourhood. This policy of hitting the bear where it hurts the most has not dissuaded Russia from lessening tensions on its border with Ukraine. Thus, the EU has vowed to impose further stricter sanctions in response by warning Russia: aggression comes with a price tag. Critics, including Ukraine, have not shied away from lambasting the EUs Russia appeasement policies for its failure to define this price tag.

The question remains what hinders a stronger economic response from the bloc to avert Moscows belligerence in its neighbourhood? The crisis in the EUs eastern neighbourhood is exacerbated by a deepening energy crisis at home. Both point towards a common cause: Russia, the main supplier of crude oil, natural gas, and solid fossil fuels to the bloc. The EUs energy dependence on Russia has soared in recent times and Kremlin attempts to exploit Brussels energy insecurity to its advantage. This geoeconomics of energy trade, largely in favour of Russia, makes Brussels position frail in dealing with Kremlin.

Moreover, Nord Stream 2, an offshore natural gas Baltic Sea pipeline running between Russia and Germany, has further added to the question of the EUs dependence on Russia for energy security. If German regulators approve the project, the pipeline would transport 55 billion cubic metres of natural gas from Russia to Europe each year. With this development, possibilities of abandoning the existing Russian energy supply routes to the EU energy market, namely the Ukrainian transit line and the Belarusian-Polish gas pipeline, cannot be denied. This carries a huge economic cost for transit countries like Ukraine and Poland that fear losing out on revenues along with jeopardising their national security.

Nord Stream 2, to see the light of the day, remains in Russias economic interests. Whether Germany, to the EUs advantage, should play the Nord Stream 2 card and list it down overtly as the price for further Russian aggression have divided the member-states.

The EU has fallen short of projecting its influence in the conflict zone in its neighbourhood. In December 2014, the bloc had initiated a civilian support mission, the EUAM Ukraine, aimed to reform law-enforcement and rule of law institutions. On the security front, Brussels plans to support Ukraines armed forces with EUR 31 billion in times to come through the instrument of the European Peace Facility.

But what remains missing is an EU-led military support mission to Ukraine even after almost eight years of the Russian annexation of Crimea and escalating tensions on the Russia-Ukraine border in the blocs neighbourhood. As the crisis is predominantly military, Ukraine has been calling for NATO assistance in case of attempts of invasion from its eastern border, seldom relying on EU military help.

The centrality of the bloc in European security has been questioned by its absence from any meaningful dialogue on the European security architecture surrounding the Russia-Ukraine crisis. The EUs response is still taking shape when Russia is further amassing troops on its western border. Thus, for Brussels, the question should not be what if Russia invades Ukraine?, but how to deter Russia from further misadventures in Ukraine?. Unless it has a strong deterrence package against Moscow, Brussels would continue to be seen as an uninvolved spectator.

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Opinion The European Union's Status in the Russia-Ukraine Crisis - E-International Relations