Connect with us

coronavirus

Commission approves extension of Hungarian scheme to support research and development and production of coronavirus-relevant products

EU Reporter Correspondent

Published

on

The European Commission has approved an extension of a Hungarian aid scheme to support research and development (R&D) and investments into the production of products that are relevant to the coronavirus outbreak, approved on 10 August 2020 under case number SA.58202. This extension makes available an additional budget of around €100 million (HUF 35 billion) that will be co-financed by the European Structural and Investment Funds, for a total budget of around €243 million (HUF 85 billion) including the initial scheme.

The extended measure will be open to all companies, while under the initial scheme only enterprises with more than 9 and fewer than 5000 workers are eligible.

The aim of the extended scheme is to further enhance and accelerate the development and the production of products directly relevant to the coronavirus outbreak, including vaccines, hospital and medical equipment and medicinal products, as well as the development of innovative processes for an efficient production of such products. The public support will take the form of direct grants that may cover a significant share of the necessary R&D and investment costs.

The Commission concluded that the extended scheme remains necessary, appropriate and proportionate to fight the health crisis, in line with Article 107(3)(c) TFEU and with the conditions set out in the Temporary Framework. On this basis, the Commission approved the measure 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.58718 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

Published

on

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.

Continue Reading

coronavirus

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

EU Reporter Correspondent

Published

on

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.

Continue Reading

coronavirus

Ukraine's capital Kyiv eases coronavirus restrictions

Reuters

Published

on

By

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.

Continue Reading

Twitter

Facebook

Trending