The European Medicines Agency (EMA) safety committee has concluded that the AstraZeneca vaccine’s proven efficacy in preventing hospitalization and death from COVID-19 outweighs the extremely small likelihood of developing blood clots.
In response to a question on whether the suspension in the use of the AstraZeneca vaccine had cost lives, Executive Director Emer Cooke said: “I think we just have to continually remind ourselves of what a difficult situation we are in in this pandemic. We have vaccines that are safe and effective that can help prevent death and hospitalization. We need to use those vaccines.”
25 cases in 20,000,000 people who received the vaccine
These are rare cases, with only seven cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of clots in the vessels draining blood from the brain (CVST). Around 20 million people in the UK and EEA had already received the vaccine as of 16 March. The EMA review has found no causal link.
The Committee confirmed that:
The benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites, and;
however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).
Italy, France and Luxembourg have already said that they will resume use of the vaccination, while Sweden and Spain are still awaiting the go-ahead from their national regulator.
EMA finds AstraZeneca vaccine has no specific risks linked to age or gender
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.
Global COVID-19 death toll surpasses 3 million amid new infections resurgence
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.
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.
MEPs clear another hurdle for the COVID-19 recovery plan
- 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.”
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
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.
- Committee on Budgets
- In-depth analysis: Reform of the EU own resources
- Adopted text (25.03.2021)
- Video recording of the debate (24.03.2021)
- Recent (17.03.2021) BUDG hearing on Own Resources, including statements by the co-rapporteurs
- Own Resources Decision ratification details (Council website)
- Procedure file (Regulation on own resource based on plastic packaging waste
- Steps of the procedure (2018/0132(APP))
- Steps of the procedure (2018/0133(NLE))
- European Parliament research: Implementing the Own Resources Decision
Mongolia5 days ago
The Mongolian connection to Lukashenko’s money
Brexit4 days ago
MEPs delay Brexit trade vote until UK respects withdrawal agreement
Kazakhstan4 days ago
Kazakhstan’s government determined to enhance engagement with civil society
Uzbekistan5 days ago
Expansion of Uzbekistan’s beneficiary status to GSP+ marks start of new EU-Uzbekistan partnership
coronavirus4 days ago
Coronavirus response: Commission proposes to exempt vital goods and services distributed by the EU from VAT in times of crisis
Business4 days ago
Free ports and the blockchain come together to speed up seamless trade
European Parliament4 days ago
European Parliament gives partial go-ahead to UK trade deal vote
coronavirus4 days ago
Merkel defends stricter lockdown powers as key to beating pandemic