The European Medicines Agency has tarted the rolling review of sotrovimab (VIR-7831), a monoclonal antibody developed for the treatment of COVID-19. The review follows hot on the heels of the EU COVID-19 Therapeutics Strategy and is a first step towards the Strategy's target of starting seven rolling reviews of COVID-19 therapeutics in 2021. The rolling review launched by EMA will assess sotrovimab's effectiveness in preventing hospitalisation and death; safety and quality. A rolling review is quicker than a regular evaluation as data is reviewed as it comes in. Should the European Medicines Agency recommend authorising the treatment at the end of its review, the European Commission will move swiftly to authorise it. The EU Therapeutics Strategy supports the development and availability of much needed COVID-19 therapeutics and covers the lifecycle of medicines: from research, development and manufacturing to procurement and deployment. It is part of the strong European Health Union, in which all EU countries prepare and respond together to health crises and ensure the availability of affordable and innovative medical supplies – including the therapeutics needed to treat COVID-19. More details on the EU Therapeutics Strategy are available in a press release and factsheet.
Mainstream media risks becoming a threat to public health
In recent weeks the controversial claim that the pandemic might have leaked from a Chinese laboratory - once dismissed by many as a fringe conspiracy theory - has been gaining traction. Now, US President Joe Biden has announced an urgent investigation that will look into the theory as a possible origin of the disease, writes Henry St.George.
Suspicion first arose in early 2020 for obvious reasons, the virus having emerged in the same Chinese city as the Wuhan Institute of Virology (WIV), which has been studying coronaviruses in bats for over a decade. The laboratory is located just a few kilometres from the Huanan wet market where the first cluster of infections emerged in Wuhan.
Despite the glaring coincidence, many in the media and politics dismissed the idea outright as a conspiracy theory and refused to consider it seriously throughout the past year. But this week it has emerged that a report prepared in May 2020 by the Lawrence Livermore National Laboratory in California had concluded that the hypothesis claiming the virus leaked from a Chinese lab in Wuhan was plausible and deserved further investigation.
So why was the Lab Leak Theory overwhelmingly dismissed from the get go? There is no question that from the mainstream media’s perspective the idea was tarnished by association with President Donald Trump. Granted, skepticism of the President’s claims surrounding any given aspect of the pandemic would have been warranted at almost any stage. To put it euphemistically, Trump had shown himself to be something of an unreliable narrator.
During the course of the pandemic Trump dismissed the seriousness of COVID-19 repeatedly, pushed unproven, potentially dangerous remedies like hydroxychloroquine, and even suggested at one memorable press briefing that injecting bleach might help.
Journalists also reasonably feared similarities with the narrative of weapons of mass destruction in Iraq, whereby vast threats were cited and assumptions granted to an antagonistic theory with too little evidence to back it up.
However, it’s impossible to ignore the fact that a general animus felt towards Trump by large swathes of the media brought about a large-scale dereliction of duty and failure to uphold objective standards of journalism as well as science. In reality the Lab Leak was never a conspiracy theory but a valid hypothesis all along.
Suggestions to the contrary by anti-establishment figures in China were also summarily quashed. As early as September 2020, the ‘Rule of Law Foundation’, connected with prominent Chinese dissident Miles Kwok, appeared on the title page a study that alleged the coronavirus was an artificial pathogen. Mr. Kwok’s long-standing opposition to the CCP was sufficient to ensure the idea was not taken seriously.
Under the pretense that they were combatting misinformation, the social media monopolies even censored posts about the lab-leak hypothesis. Only now – after almost every major media outlet as well as the British and American security services have confirmed that it is a feasible possibility – have they been forced to backtrack.
“In light of ongoing investigations into the origin of COVID-19 and in consultation with public health experts,” a Facebook spokesman said, “we will no longer remove the claim that COVID-19 is man-made or manufactured from our apps.” In other words, Facebook now believes that its censorship of millions of posts in the preceding months had been in error.
The consequences of the idea not having been taken seriously are profound. There is evidence that the lab in question may have been conducting what is called “gain of function” research, a dangerous innovation in which diseases are deliberately made more virulent as part of scientific research.
As such, if the lab theory is in fact true, the world has been deliberately kept in the dark about the genetic origins of a virus that has killed over 3.7m people to date. Hundreds of thousands of lives could have been saved if the key properties of the virus and its propensity to mutate had been understood sooner and better.
The cultural ramifications of such a discovery cannot be overstated. If the hypothesis is true - the realization will soon set in that the world’s fundamental mistake was not insufficient reverence for scientists, or inadequate respect for expertise, but not enough scrutiny of mainstream media and too much censorship on Facebook. Our main failure will have been the inability to think critically and acknowledge that there is no such thing as absolute expertise.
Commission approves €800 million Italian scheme to support companies in context of coronavirus outbreak
The European Commission has approved a €800 million Italian scheme to support companies affected by the coronavirus outbreak, active in Italy under “Development Contracts” for the implementation of priority projects. The scheme was approved under several sections of the State Aid Temporary Framework.
Executive Vice President Margrethe Vestager (pictured), in charge of competition policy, said: “This €800 million Italian scheme will ensure liquidity support to companies affected by the coronavirus outbreak. At the same time, it will contribute to much needed research activities and products to respond to the coronavirus outbreak. We continue working in close cooperation with member states to find workable solutions to mitigate the economic impact of the coronavirus outbreak, in line with EU rules.”
The Italian measures
Italy notified to the Commission a €800 scheme addressed to companies performing priority projects under so-called “Development Contracts under the COVID-19 Temporary Framework” (mainly COVID-related projects). The scheme supports companies affected by the coronavirus outbreak and provides incentives to companies for directing their activities to research and/or production of certain products that are crucial to address the coronavirus outbreak.
These “Development Contracts” will be administered by the National Agency for Inward Investment and Economic Development S.p.A. (Invitalia) and will be open to companies of all sizes, active in all sectors, except the financial, primary production of agricultural products, fishery and aquaculture, construction, insurance and real estate ones.
The aid will take the form of:
- Direct grants and loans up to a maximum of €1.8m per company and with an overall maximum nominal value equal to 45% of the eligible costs;
- direct grants for coronavirus-related research and development (R&D) projects, with a maximum allowable aid intensity equal to 80% of the eligible costs;
- direct grants and repayable advances for testing and upscaling infrastructures that contribute to the development of coronavirus relevant products, with a maximum allowable aid intensity equal to 75% of the eligible costs, and;
- direct grants and repayable advances for the production of coronavirus-relevant products, with a maximum allowable aid intensity equal to 80% of the eligible costs.
The Commission found that the Italian scheme is in line with the conditions set out in the Temporary Framework. In particular, (i) the aid granted under the first measure will not exceed €1.8 million per company, (ii) the aid granted under the other measures will cover a significant share of the necessary R&D and investment costs, iii) for the second measure in particular, any result of the research activities will be made available to third parties in the European Economic Area at non-discriminatory market conditions through non-exclusive licences, and (iv) all aid will be granted no later than 31 December 2021.
The Commission therefore concluded that all the measures are necessary, appropriate and proportionate to remedy a serious disturbance in the economy of a member state, in line with Article 107(3)(b) TFEU or to fight the health crisis, in line with Article 107(3)(c). On this basis, the Commission approved the aid measures under EU state aid rules.
The Commission has adopted a Temporary Framework to enable member states to use the full flexibility foreseen under state aid rules to support the economy in the context of the coronavirus outbreak. The Temporary Framework, as amended on 3 April, 8 May, 29 June, 13 October 2020 and 28 January 2021, provides for the following types of aid, which can be granted by member states:
(i) Direct grants, equity injections, selective tax advantages and advance payments of up to €225,000 to a company active in the primary agricultural sector, €270,000 to a company active in the fishery and aquaculture sector and €1.8m to a company active in all other sectors to address its urgent liquidity needs. Member states can also give, up to the nominal value of €1.8m per company zero-interest loans or guarantees on loans covering 100% of the risk, except in the primary agriculture sector and in the fishery and aquaculture sector, where the limits of €225,000 and €270,000 per company respectively, apply.
(ii) State guarantees for loans taken by companies to ensure banks keep providing loans to the customers who need them. These state guarantees can cover up to 90% of risk on loans to help businesses cover immediate working capital and investment needs.
(iii) Subsidized public loans to companies (senior and subordinated debt) with favourable interest rates to companies. These loans can help businesses cover immediate working capital and investment needs.
(iv) Safeguards for banks that channel State aid to the real economy that such aid is considered as direct aid to the banks' customers, not to the banks themselves, and gives guidance on how to ensure minimal distortion of competition between banks.
(v) Public short-term export credit insurance for all countries, without the need for the member state in question to demonstrate that the respective country is temporarily “non-marketable”.
(vi) Support for coronavirus related research and development (R&D) to address the current health crisis in the form of direct grants, repayable advances or tax advantages. A bonus may be granted for cross-border cooperation projects between member states.
(vii) Support for the construction and upscaling of testing facilities to develop and test products (including vaccines, ventilators and protective clothing) useful to tackle the coronavirus outbreak, up to first industrial deployment. This can take the form of direct grants, tax advantages, repayable advances and no-loss guarantees. Companies may benefit from a bonus when their investment is supported by more than one member state and when the investment is concluded within two months after the granting of the aid.
(viii) Support for the production of products relevant to tackle the coronavirus outbreak in the form of direct grants, tax advantages, repayable advances and no-loss guarantees. Companies may benefit from a bonus when their investment is supported by more than one member state and when the investment is concluded within two months after the granting of the aid.
(ix) Targeted support in the form of deferral of tax payments and/or suspensions of social security contributions for those sectors, regions or for types of companies that are hit the hardest by the outbreak.
(x) Targeted support in the form of wage subsidies for employees for those companies in sectors or regions that have suffered most from the coronavirus outbreak, and would otherwise have had to lay off personnel.
(xi) Targeted recapitalisation aid to non-financial companies, if no other appropriate solution is available. Safeguards are in place to avoid undue distortions of competition in the Single Market: conditions on the necessity, appropriateness and size of intervention; conditions on the state's entry in the capital of companies and remuneration; conditions regarding the exit of the State from the capital of the companies concerned; conditions regarding governance including dividend ban and remuneration caps for senior management; prohibition of cross-subsidisation and acquisition ban and additional measures to limit competition distortions; transparency and reporting requirements.
(xii) Support for uncovered fixed costs for companies facing a decline in turnover during the eligible period of at least 30% compared to the same period of 2019 in the context of the coronavirus outbreak. The support will contribute to a part of the beneficiaries' fixed costs that are not covered by their revenues, up to a maximum amount of €10m per undertaking.
The Commission will also enable member states to convert until 31 December 2022 repayable instruments (e.g. guarantees, loans, repayable advances) granted under the Temporary Framework into other forms of aid, such as direct grants, provided the conditions of the Temporary Framework are met.
The Temporary Framework enables member states to combine all support measures with each other, except for loans and guarantees for the same loan and exceeding the thresholds foreseen by the Temporary Framework. It also enables member states to combine all support measures granted under the Temporary Framework with existing possibilities to grant de minimis to a company of up to €25,000 over three fiscal years for companies active in the primary agricultural sector, €30,000 over three fiscal years for companies active in the fishery and aquaculture sector and €200,000 over three fiscal years for companies active in all other sectors. At the same time, member states have to commit to avoid undue cumulation of support measures for the same companies to limit support to meet their actual needs.
Furthermore, the Temporary Framework complements the many other possibilities already available to Member States to mitigate the socio-economic impact of the coronavirus outbreak, in line with EU State aid rules. On 13 March 2020, the Commission adopted a Communication on a co-ordinated economic response to the COVID-19 outbreak setting out these possibilities. For example, member states can make generally applicable changes in favour of businesses (e.g. deferring taxes, or subsidising short-time work across all sectors), which fall outside State Aid rules. They can also grant compensation to companies for damage suffered due to and directly caused by the coronavirus outbreak.
The Temporary Framework will be in place until the end of December 2021. With a view to ensuring legal certainty, the Commission will assess before this date if it needs to be extended.
The non-confidential version of the decision will be made available under the case number SA.62576 in the state aid register on the Commission's competition website once any confidentiality issues have been resolved. New publications of State aid decisions on the internet and in the Official Journal are listed in the Competition Weekly e-News.
More information on the Temporary Framework and other action the Commission has taken to address the economic impact of the coronavirus pandemic can be found here.
EU Digital COVID Certificate: It’s now up to EU countries
MEPs see the EU Digital COVID Certificate as a tool to restore freedom and urge EU countries to implement it by 1 July, Society.
The certificate aims to enable easier and safer travel by proving someone has been vaccinated, had a negative COVID test or recovered from the disease. The infrastructure for it is in place and 23 countries are technically ready, with nine already issuing and verifying at least one type of certificate.
Restoring freedom of movement
In a plenary debate on 8 June, Juan Fernando López Aguilar (S&D, Spain), the lead MEP regarding the certificate, said that freedom of movement is highly prized by EU citizens and that the negotiations on the COVID Certificate "have been completed in record time”. “We want to send out the message to European citizens that we are doing everything we can to restore freedom of movement.”
Justice Commissioner Didier Reynders said: "The certificate, which will be free of charge, will be issued by all member states and will have to be accepted across Europe. It will contribute to a gradual lifting of restrictions."
Member states have to apply the rules
The COVID certificate is “the first step towards getting rid of restrictions and that is good news for many people in Europe - people who travel for work, families that live in border areas, and for tourism,” said MEP Birgit Sippel (S&D, Germany). She said it is now up to EU countries to harmonise the rules on travel.
“All citizens in the European Union rightfully expect to be able to use this system by the start of summer and member states must deliver,” said Jeroen Lenaers (EPP, the Netherlands). He said that this means not only the technical implementation of the certificate, but much more: “European citizens want to finally have some coordination and predictability on our internal borders.”
Sophie in ‘t Veld (Renew, Netherlands) called on member states to ensure that the EU reopens. “Europeans desperately want to regain their freedom. I think it is worthwhile remembering that it isn’t the virus that has taken away their right to free movement in Europe. It is actually the patchwork of national rules that makes it impossible for them to move around."
Respecting people's’ rights
Cornelia Ernst (The Left, Germany) said that it was chiefly Parliament and the Commission that defended people's rights during negotiations with member states: “We need to defend everyone’s freedoms - not just holidaymakers',” she said.
Tineke Strik (Greens/EFA, Netherlands) underlined the importance of non-discrimination and data protection and said this certificate fully respects these requirements. The member states should apply and implement this new harmonised system and MEPs will monitor that non-discrimination is respected, she said.
Joachim Stanisław Brudziński (ECR, Poland) said that the certificate “is supposed to facilitate free movement and not be a condition of it”. The people who have not been vaccinated would still have the right to move within Europe, with restrictions such as tests, self-isolation, or quarantine. He stressed that “this regulation cannot be seen as something that makes vaccines obligatory”.
Christine Anderson (ID, Germany) expressed doubts about whether the certificate could restore freedom of movement and respect people’s rights. She raised concerns that it would force people to be vaccinated. This could lead to having to have “a certificate to prove you’ve got rights”. This shouldn’t be a back door to requiring vaccination, she said.
Find out how to travel safely with the EU Digital COVID Certificate.
EU Digital COVID Certificate
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