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Commission approves €80 million Slovak scheme to support research, development and testing infrastructure for #Coronavirus relevant products

EU Reporter Correspondent

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The European Commission has approved a €80 million Slovak scheme to support industrial research and experimental development projects, as well as testing and upscaling infrastructures related to the production of coronavirus relevant products.The scheme was approved under the state aid Temporary Framework. The public support will be co-financed by the European Structural and Investment Funds. It will take the form of direct grants and will be open to companies of all sizes, except financial institutions. The aim of the scheme is to enhance and accelerate the development and the production of products directly relevant to the coronavirus outbreak, including vaccines, hospital and medical equipment, medicinal products and protective equipment. The Commission found that the Slovak scheme is in line with the conditions set out in the Temporary Framework.

In particular, (i) the aid will cover a significant share of the costs of the eligible research and development (R&D) and investment projects; (ii) any result of the research activities will be made available, upon request, to third parties within the European Economic Area, through non-exclusive licences and under market conditions; and (iii) there will be a “bonus” (in terms of additional share of the costs that can be covered by the state aid) for R&D projects for industrial research and experimental development that are supported by more than one member state, or for projects that are carried out in cross-border collaboration with research organizations or other companies. The Commission concluded that the measure is necessary, appropriate and proportionate to fight the public health crisis, in line with Article 107(3)(c) TFEU and the conditions set out in the Temporary Framework. On this basis, the Commission approved the measures under EU state aid rules.

More information on the Temporary Framework and other actions taken by the Commission to address the economic impact of the coronavirus pandemic can be found here. The non-confidential version of the decision will be made available under the case number SA.57829 in the state aid register on the Commission's competition website once any confidentiality issues have been resolved.

COVID-19

US supports WTO waiver of Intellectual Property on COVID-19 vaccines

Catherine Feore

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In a surprise announcement by the US Trade Representative Katherine Tai has announced that the US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and will “actively participate in WTO negotiations to make this happen”.

The USTR said that extraordinary times and circumstances called for extraordinary measures. 

In March, European Commission trade spokesperson Miriam Garcia Ferrer told journalists that the current view of the European Union was that the problem of access to vaccines would not be resolved by waiving patent rights. 

Garcia Ferrer said that the real problem lay in insufficient manufacturing capacity to produce the required quantities. The European Commission very much welcomed the statement of WTO Director-General Ngozi Okonjo-Iweala who has said there should be a third way to broaden access to vaccines through facilitating technology transfer within the multilateral rules, to encourage research and innovation while at the same time allowing licensing agreements that helped to scale up manufacturing capacities. 

South African/Indian proposal

WTO members recently debated the proposal submitted by South Africa and India calling for a waiver from certain provisions of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in relation to the “prevention, containment or treatment” of COVID-19. Since its submission, the proposal has received further support from Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt and the African Group within the WTO. 

The proponents argue that the waiving of certain obligations under the agreement would facilitate access to affordable medical products and the scaling-up of manufacturing and supply of essential medical products, until widespread vaccination is in place and the majority of the world’s population is immune. 

However, there is a lack of consensus and divergence on what role intellectual property plays in achieving the goal of providing timely and secure access to safe, efficacious and affordable vaccines to all. Proponents argue that existing vaccine manufacturing capacities in the developing world remained unutilized because of IP barriers. Other delegations asked for concrete examples of where IP would pose a barrier that could not be addressed by existing TRIPS flexibilities.

The outgoing chair of the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter of South Africa, said swift action is urgently required to help scale up COVID-19 vaccine production and distribution. She called on members to shift gears and move towards a solution-oriented discussion.

The next regular TRIPS Council meeting is scheduled for 8-9 June, but members agreed to consider additional meetings in April in order to assess potential progress on the IP waiver discussion.

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EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated

EU Reporter Correspondent

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EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. The EU applicant for this medicine is Life'On S.r.l.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies. These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.

EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.

EMA will assess the compliance of COVID-19 Vaccine (Vero Cell) Inactivated with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

EMA will communicate further when the marketing authorization application for the vaccine has been submitted.

How is the vaccine expected to work?

COVID-19 Vaccine (Vero Cell) Inactivated is expected to prepare the body to defend itself against infection with SARS-CoV-2. The vaccine contains SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease. COVID-19 Vaccine (Vero Cell) Inactivated also contains an ‘adjuvant’, a substance that helps strengthen the immune response to the vaccine. 

When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it. If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend the body against it.

What is a rolling review?A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorization. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies. Once the CHMP decides that sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can come to an opinion on the medicine’s authorisation sooner.During the rolling review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force (COVID-ETF). This group brings together experts from across the European medicines regulatory network to advise on the development, authorization and safety monitoring of medicines and vaccines for COVID-19 and facilitate quick and coordinated regulatory action.

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Ukraine's capital Kyiv eases coronavirus restrictions

Reuters

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Ukraine's capital Kyiv on Saturday (1 May) eased tough restrictions imposed last month to prevent the rapid spread of the new coronavirus.

In early April, Kyiv limited its public transport services, closed schools and kindergartens, theatres and shopping centres, and banned spectators from sporting events.

Starting from Saturday, the capital will allow the operation of transport, cafes and restaurants, although passenger and customer numbers will be restricted. Wearing masks is still mandatory in transport and public places.

Shopping malls and sports clubs were able to reopen on Saturday, while schools and kindergartens will open from 5 May, local authorities said.

Last month, Kyiv recorded some of highest numbers of new infections among Ukrainian regions, but new cases dropped significantly last week.

Ukraine has registered more than 2 million infections and 44,436 deaths since the pandemic started last year.

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