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Coronavirus: Commission signs first contract with AstraZeneca

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The first contract the European Commission has negotiated on behalf of the EU Member States with a pharmaceutical company entered into force following the formal signature between AstraZeneca and the Commission. The contract will allow the purchase of a vaccine against COVID-19 for all the Member States of the EU as well as the donation to lower and middle income countries or the re-direction to other European countries.

Through the contract, all Member States will be able to purchase 300 million doses of the AstraZeneca vaccine, with an option for further 100 million doses, to be distributed on a population-based pro-rata basis.

The Commission continues discussing similar agreements with other vaccine manufacturers and has concluded successful exploratory talks with Sanofi-GSK on 31 July, Johnson & Johnson on 13 August, CureVac on 18 August and Moderna on 24 August.

Ursula von der Leyen, President of the European Commission, said: “The Commission is working non-stop to provide EU citizens with a safe and effective vaccine against COVID-19 as quickly as possible. The entry into force of the contract with AstraZeneca is an important step forward in this respect. I am looking forward to enriching our portfolio of potential vaccines thanks to contracts with other pharmaceutical companies and engaging with international partners for universal and equitable access to vaccination.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “Our negotiations have now delivered clear results: a first contract signed delivering on our commitment to ensure a diversified vaccine portfolio to protect the public health of our citizens. Today’s signature – made possible by the important groundwork  undertaken by France, Germany, Italy, and the Netherlands – will ensure that doses of a vaccine which, if proven effective and safe, will be delivered across Member States. We expect to announce additional agreements with other vaccine manufacturers very swiftly. “

AstraZeneca and the University of Oxford joined forces to develop and distribute the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

AstraZeneca’s vaccine candidate is already in large-scale Phase II/III Clinical Trials after promising results in Phase I/II concerning safety and immunogenicity.

Today’s contract is based on the Advanced Purchase Agreement approved on 14 August with AstraZeneca, which will be financed with the Emergency Support Instrument. The “Inclusive Vaccine Alliance” countries (Germany, France, Italy, the Netherlands) who started negotiations with AstraZeneca asked the Commission to take over through an agreement signed on behalf of all Member States.

The decision to support the vaccine proposed by AstraZeneca is based on a sound scientific approach and the technology used (a non-replicative recombinant chimpanzee adenovirus-based vaccine ChAdOx1), speed at delivery at scale, cost, risk sharing, liability and the production capacity able to supply the whole of the EU, among others.

The regulatory processes will be flexible but remain robust. Together with the Member States and the European Medicines Agency, the Commission will use existing flexibilities in the EU’s regulatory framework to accelerate the authorisation and availability of successful vaccines against COVID-19, while maintaining the standards for vaccine quality, safety and efficacy.

The necessary safety requirements and specific assessment by the European Medicines Agency as part of the EU market authorisation procedure guarantee that citizens’ rights will remain fully protected.

In order to compensate for such high risks taken by manufacturers, the Advanced Purchase Agreements provide for Member States to indemnify the manufacturer for liabilities incurred under certain conditions. Liability still remains with the companies.

Background

Today’s contract with AstraZeneca is an important step in the implementation of the European Vaccines Strategy, adopted by the Commission on 17 June 2020.  This strategy aims to secure for all European citizens high-quality, safe, effective and affordable vaccines within 12 to 18 months.

To do so, and together with the Member States, the Commission is agreeing Advance Purchase Agreements with vaccine producers reserving or giving the Member States the right to buy a given number of vaccine doses for a certain price, as and when a vaccine becomes available.

Advanced Purchase Agreements are financed with the Emergency Support Instrument, which has funds dedicated to the creation of a portfolio of potential vaccines with different profiles and produced by different companies.

The European Commission is also committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it has raised almost €16 billion since 4 May 2020 under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery.

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Substantial progress made in Vienna; sides focusing on Safeguards

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image source: Tehran Times

The third day of talks between experts from Iran and the EU centered around technical and legal matters regarding the Safeguards agreement between Iran and the International Atomic Energy Agency (IAEA).

Delegates from Iran, the EU and the U.S. resumed talks in Vienna on Thursday after nearly a five-month hiatus. This round of talks started on Thursday without the presence of nuclear negotiators from the European trio – Germany, France and Britain. Only experts from these three countries have attended the negotiations.  

Iran believes that any agreement on restoring the nuclear deal, officially called the Joint Comprehensive Plan of Action (JCPOA), is dependent on putting an end to unsubstantiated allegations about Iran’s past nuclear program. Iran insists that these questions had already been resolved within the PMD, when the nuclear deal was signed in July 2015.

According to reports, substantial progress has been made in bringing the views of Iran and the U.S. closer together during the last three days. However, in Tehran’s view nothing is resolved until everything is settled.

Behrouz Kamalvandi, the spokesman for the Atomic Energy Organization of Iran (AEOI), also confirmed on Saturday that talks are mainly focused on Safeguards issues.

“We are now negotiating,” Kamalvandi said of the talks between Iran’s nuclear experts with Mora.

On the atmosphere of the talks, he said, “It is not bad.”

Mohammad Marandi, a senior expert on nuclear issues, also told Al-Mayadeen TV that “progresses” have been made in Vienna, but one should be “cautious”. He argued the success of talks is 50 percent. Marandi said the differences remain only between Iran and the United States.

He added, “We have heard from certain European sources that the Americans have revived their views on certain issues.”

The Russian chief negotiator in the Vienna talks, Mikhail Ulyanov, also tweeted that there is “no unresolvable issue” on the table in the Vienna talks.

Source: Tehran Times

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Escalation of violence in Gaza

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Destruction in Gaza following an Israeli strike (file photo) UNOCHA/Mohammad Libed

The ongoing and serious escalation of violence in and around Gaza between Palestinian militants and Israel has claimed the lives of 13 Palestinians by Israeli airstrikes, including a 5-year-old child and one woman, informed Lynn Hastings, UN Humanitarian Coordinator in the territory.

In a statement published on Saturday, Ms. Hastings expressed her grave concern for the situation that has left more than 100 Palestinians injured, as well as 7 Israelis.

Residential areas in both Gaza and Israel have also been hit and 31 families in Gaza are now homeless.

“The humanitarian situation in Gaza is already dire and can only worsen with this most recent escalation.   The hostilities must stop to avoid more deaths and injuries of civilians in Gaza and Israel. The principles of international humanitarian law including those of distinction, precaution and proportionality must be respected by all parties”, she urged.

Basic services in danger

Ms. Hastings warned that fuel for the Gaza Power Plant is due to run out this Saturday and electricity has already been cut.

“The continued operation of basic service facilities such as hospitals, schools, warehouses, and designated shelters for internally displaced persons is essential and now at risk”, she cautioned.

The Humanitarian Coordinator added that movement and access of humanitarian personnel, for critical medical cases, and for essential goods, including food and fuel into Gaza, must not be impeded so that humanitarian needs can be met. 

She also underscored that Israeli authorities and Palestinian armed groups must immediately allow the United Nations and its humanitarian partners to bring in fuel, food, and medical supplies and to deploy humanitarian personnel in accordance with international principles.

“I reiterate the United Nations Special Coordinator’s appeal on all sides for an immediate de-escalation and halt to the violence, to avoid destructive ramifications, particularly for civilians”, Ms. Hastings concluded.

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Nuclear-free world is possible, test-ban treaty chief says

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Nuclear weapons will continue to pose a risk to humanity unless countries fully adhere to the treaty that prohibits their testing, a senior UN official said at a press conference in New York on Friday. 

Journalists were briefed by Robert Floyd, Executive Secretary of the body that oversees the Comprehensive Nuclear Test-Ban Treaty (CTBT), which opened for signature 25 years ago but has yet to enter into force because it requires ratification by a handful of key countries, which have nuclear capabilities. 

“Once in force, the CTBT will serve as an essential element of a nuclear weapons-free world. In order to achieve this world, we all aspire to, a universal and effectively verifiable prohibition on nuclear testing is a fundamental necessity,” he said. 

World at risk 

Mr. Floyd was speaking against the backdrop of the latest nuclear non-proliferation conference, which began this week at UN Headquarters after two years of pandemic-related delays. 

Countries are reviewing progress towards implementing the 50-year-old Treaty on the Non-Proliferation of Nuclear Weapons

At the opening on Monday, UN Secretary-General António Guterres warned that the world was “just one misunderstanding, one miscalculation, away from nuclear annihilation”

“Until we have full adherence to the CTBT, nuclear testing and the proliferation of nuclear weapons will continue to pose unacceptable risk to humanity,” said Mr. Floyd. 

Drop in testing 

The CTBT complements the non-proliferation treaty, said Mr. Floyd, and it has already made a difference in the world. 

“We’ve gone from over 2,000 nuclear tests conducted between 1945 and 1996, to fewer than 12 tests since the treaty opened for signature,” he said. “Only one country has tested this millennium.” 

The treaty has also received near-universal support. So far, 186 countries have signed the CTBT, and 174 have ratified it, four in the last six months alone.  

However, entry into force requires that the treaty must be signed and ratified by 44 specific nuclear technology holder countries, eight of which have yet to ratify it: China, Egypt, India, Iran, Israel, the Democratic People’s Republic of Korea, Pakistan and the United States. 

Asked about these countries, Mr. Floyd replied “they have their own calculus and strategic objectives and geopolitical considerations as to whether they feel free to move forward”, adding that they all support the CTBT and its objectives. 

Helping nations 

Mr. Floyd also reported on the activities of the organization that promotes the treaty, which he heads. 

The CTBTO, as it has known, has built a state-of-the-art verification system to detect nuclear explosions, capable of 24/7 monitoring.  

Staff also train inspectors from Member States so that they are ready to conduct on-site verifications once the treaty enters into force. Furthermore, countries use CTBTO data for civilian and scientific applications, such as tsunami warning systems and other university research. 

“Even without having entered into force, the CTBT is already helping to save lives in countries around the world,” said Mr. Floyd.  “Even those that have not yet ratified the treaty are benefiting from this global collaboration and technological expertise.” 

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