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COVID-19

‘We are not seeking an outright ban’ Šefčovič

Catherine Feore

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The European Commission has today (24 March) adopted a revision of its export, transparency and authorization mechanism for vaccines. The new mechanism will add an assessment of reciprocity and proportionality to its existing mechanism.

On reciprocity, the Commission will assess whether destination countries are failing to export vaccines and other raw materials essential to vaccine production, either through an actula export ban or measures that are equivalent to a ban. 

The inclusion of materials in the supply chain means that the US would meet this requirement, as the US has exported drug substance to the EU. The assessment is likely to encompass the UK which does not have an export ban, but has not exported to the EU, despite having received almost 11 million vaccine doses from EU-based facilities.

The proportionality test will look at the scale of the epidemic in the destination country, the level of vaccination and access to vaccines. A senior official said that the Commission would take an overall view and would not be setting thresholds, such as the percentage of the population that had already been vaccinated. 

Again the UK, which has a much higher rate of vaccination than the EU, would probably be considered to have failed this test of proportionality.

A UK spokesperson said: “We are all fighting the same pandemic – vaccines are an international operation; they are produced in collaboration by great scientists around the world. And we will continue to work with our European partners to deliver the vaccine rollout.

“We remain confident in our supplies and are on track to offer first doses to all over 50s by April 15th and all adults by the end of July. Our plan to cautiously reopen society via our road map also remains unchanged.”

A Commission official confirmed that the EU was in constant contact with the UK. The UK side described the talks as being very intense and that there may be a breakthrough this evening.

UPDATE 18:48 :

Asked if the Commission would block the export of Pfizer vaccines to the UK if the UK doesn’t send vaccines to the EU, the Commission said that decisions would be taken on a case-by-case basis - without confirming or denying that this would be their approach.

The mechanism has also been extended to 17 additional neighbouring countries*, because of what a senior Commission official described as the risk of circumvention.

Yesterday (23 March), following the General Affairs Council, Commission Vice President Maroš Šefčovič told journalists: “I'm sure that by now all of you know that AstraZeneca (AZ) continues to under-deliver,” but added: “We are not seeking an outright ban on vaccines export, but we expect manufacturers to live up to their contractual obligations.”

Šefčovič underlined: “Europe is one of the most open regions exporting COVID-19 vaccines, but we see that there are many restrictions for the vaccines coming to Europe. We therefore, want reciprocity and proportionality. The export authorization mechanism is enabling us for the very first time to have full transparency about what is supposed to be exported, in what amounts and to what country.” 

In an exchange between the Director General of DG Sante Sandra Gallina and the European Parliament's Budgetary Control committee, Gallina said that while Pfizer and Moderna had been delivering, with small glitches, AZ had been the problem. She said that the Commission had been discussing solutions with member states and would be taking further action, saying: “We will use all the tools at our disposal to get the doses.” She underlined that there was no problem with the other companies exporting as they had fulfilled their commitments under the Advanced Purchase Agreements they had reached with the EU. 

In an answer to a question from Tomáš Zdechovsky MEP (EPP, CZ), who said that he was sick of AZ’s “dirty tricks”, Gallina said that she shared his frustrations with the company. AZ had established a plan of production with the EU and were under an obligation to produce before authorization was granted and therefore to have had the doses ready for rapid rollout: “It's now producing with one plant of the five plants that were included in the contract, as the plant with which they have to supply the European market...It's not in a very good position to defend itself.”

*List of countries included: Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Israel, Jordan, Iceland, Lebanon, Libya, Liechtenstein, Montenegro, Norway, North Macedonia, Serbia and Switzerland.

Background

The Commission has so far signed Advance Purchase Agreements (APAs) with six companies (AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac, and Moderna), securing access to up to 2.6 billion doses. Negotiations are advanced with two additional companies. 

The APAs finance the upfront costs faced by vaccines producers and is considered as a down-payment on the vaccines that are actually purchased by member states. It reduces the risk for a company allowing investment for the company to pre-produce, even before a vaccine is granted marketing authorization by the European Medicines Agency. The aim is to achieve a steady delivery as soon as the authorization has been granted.

COVID-19

EMA finds AstraZeneca vaccine has no specific risks linked to age or gender

Catherine Feore

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Emer cooke, executive director, European medicines agency

EMA’s safety committee has concluded today (7 April) that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria - AstraZeneca vaccine.

The European Medicines Executive Director, Emer Cooke, said: "The safey committee, after an in-depth analysis, has concluded that the reported cases of unusual blood clots following vaccination with AstraZeneca vaccine should be listed as possible side effects of the vaccine.” In reaching its conclusion, the committee took into consideration all currently available evidence. However, Cooke was at pains to underline that the benefits of the AstraZeneca vaccine in preventing Covid far outweigh the risks of side effects.

The safety Committee (PRAC) have concluded, based on current evidence, that there are no specific risk factors, such as age, gender, or previous medical history of clotting disorders linked to the AstraZeneca vaccine. However, the agency encouraged people to continue to come forward and to report any symptoms that they believe may be linked to their vaccination. 

At the same time as EMA reported its findings, the UK’s regulator reported that it would be recommending a different vaccine for under 30s - a group that is not yet broadly eligible for vaccination. Based on the 20.2 million doses of the AstraZeneca vaccine the UK has administered, it estimates that the overall risk of blood clots is approximately 4 people in a million who receive the vaccine.

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Global COVID-19 death toll surpasses 3 million amid new infections resurgence

Reuters

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Coronavirus-related deaths worldwide crossed 3 million on Tuesday (6 April), according to a Reuters tally, as the latest global resurgence of COVID-19 infections is challenging vaccination efforts across the globe, write Roshan Abraham and Anurag Maan.

Worldwide COVID-19 deaths are rising once again, especially in Brazil and India. Health officials blame more infectious variants that were first detected in the United Kingdom and South Africa, along with public fatigue with lockdowns and other restrictions.

Global COVID graphic

According to a Reuters tally, it took more than a year for the global coronavirus death toll to reach 2 million. The next 1 million deaths were added in about three months.

Brazil is leading the world in the daily average number of new deaths reported and accounts for one in every four deaths worldwide each day, according to a Reuters analysis.

The World Health Organization acknowledged the nation’s dire condition due to coronavirus, saying the country is in a very critical condition with an overwhelmed healthcare system.

“Indeed there is a very serious situation going on in Brazil right now, where we have a number of states in critical condition,” WHO epidemiologist Maria Van Kerkhove told a briefing last Thursday, adding that many hospital intensive care units are more than 90% full.

India reported a record rise in COVID-19 infections on Monday, becoming the second nation after the United States to post more than 100,000 new cases in a day.

India’s worst-affected state, Maharashtra on Monday began shutting shopping malls, cinemas, bars, restaurants, and places of worship, as hospitals are being overrun by patients.

The European region, which includes 51 countries, has the highest total number of deaths at nearly 1.1 million.

Five European countries including the United Kingdom, Russia, France, Italy and Germany constitute about 60% of Europe’s total coronavirus-related deaths.

The United States has the highest number of deaths of any country at the world at 555,000 and accounts for about 19% of all deaths due to COVID-19 in the world. Cases have risen for the last three weeks but health officials believe the nation’s rapid vaccination campaign may prevent a rise in deaths. A third of the population has received at least one dose of a vaccine.

At least 370.3 million people or nearly 4.75% of the global population have received a single dose of COVID-19 vaccine by Sunday, according to latest figures from research and data provider firm Our World in Data.

However, the World Health Organization is urging countries to donate more doses of approved COVID-19 vaccines to help meet vaccination targets for the most vulnerable in poorer countries.

Global COVID vaccination graphic

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MEPs clear another hurdle for the COVID-19 recovery plan

EU Reporter Correspondent

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  • Parliament speeds up the reform of the EU’s revenue, allowing the 'Next Generation EU' recovery fund, worth €750 billion, to be used 
  • New sources of revenue will provide new financing for the EU budget, such as a levy on plastic, and help repay the debt created by the recovery fund 
  • EU countries must ratify the key Own Resources Decision as soon as possible 

MEPs approved three laws on implementing the EU’s Own Resources system, paving the way for its reform and the introduction of new sources of EU revenue. On Thursday (25 March), MEPs adopted one implementing and two operational regulations on which methods to use to collect or make available specific Own Resources, which constitute the revenue for the EU budget. The three laws work in conjunction with the key Own Resources Decision (ORD), approved by Parliament in September and by Council in December 2020. The member states are currently in the process of ratifying this decision, with 13 out of 27 having done so already as of 18 March (more information on the ratification here).

The approved regulations include provisions on calculating and simplifying the EU’s revenue, on managing cash flow, and on monitoring and inspection rights. These are needed to ensure the EU budget’s reformed revenue side continues to function smoothly.

Once member states have ratified the Own Resources Decision, the package adopted today will apply retroactively from 1 January 2021. It will introduce the new plastics levy as the first of various new streams of revenue that will be set up between now and 2026. The ORD will enable the EU to borrow €750bn for the Next Generation EU recovery plan.

José Manuel Fernandes (EPP, PT): “Once more, the European Parliament sets the tone. By approving this package, we are ensuring that the EU’s system of own resources will contribute to establishing the ‘Next Generation EU’ recovery plan as soon as the ORD has been ratified by the member states. Today’s vote is a reminder that we need to act quickly and decisively to set up the recovery.”

Valérie Hayer (RENEW, FR): “Parliament is again acting swiftly to make the recovery plan a reality. We now urge all member states to ratify the recovery plan as soon as possible. We cannot afford any delay. In addition, December’s repayment agreement binds the Commission to propose an EU digital levy in June of this year, regardless of what happens at OECD level.”

Vote results

Regulation on own resource based on plastic packaging waste

540 votes in favour, 109 against, 38 abstentions

Implementing measures for the system of own resources

560 votes in favour, 48 against, 82 abstentions

Collection of own resources accruing from value added tax

552 votes in favour, 69 against, 67 abstentions

Background

During the negotiations on the EU’s 2021-2027 long-term budget (“Multiannual Financial Framework”), MEPs obtained a binding road map for new sources of EU revenue. The three steps of the Own Resources road map are as follows:

  • First step (2021): a contribution on plastic introduced in January 2021, new legislative proposals on a carbon border adjustment mechanism, a digital levy and the Emissions Trading Scheme will be submitted by June;
  • Second step (2022 and 2023): Council will deliberate on these new sources of revenue by 1 July 2022 at the latest in order to be able to introduce them by 1 January 2023;
  • Third step (2024-2026): by June 2024, the Commission will put forward a proposal for additional new own resources, which could include a Financial Transaction Tax and a financial contribution from the corporate sector or a new common corporate tax base. Council will deliberate on these new sources of EU revenue by 1 July 2025 at the latest in order to be able to introduce them by 1 January 2026.

    Further information 

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