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COVID-19

EMA approves several vaccine manufacturing facilities, including AstraZeneca's Halix site

Catherine Feore

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The European Medicine’s Agency (EMA) human medicines committee (CHMP) has adopted several recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

New manufacturing site for AstraZeneca’s COVID-19 vaccine

A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring the total number of manufacturing sites licensed for the production of the active substance of the vaccine to four.

AstraZeneca finally submitted its application for EMA approval for the site two days ago, it is unclear why it has taken so long to apply for approval.

When the advanced purchase agreement was agreed in August last year AZ CEO Pascal Soriot said: “With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020. I would like to thank the entire European Commission, and especially the Commissioner for Health and Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may soon be protected with a vaccine against this deadly virus, enabling our global society and economy to rebuild.”

More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine

A new site has also been approved for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The facility, which is in the German city of Marburg, will produce both active substance and the finished product.

In addition to the new manufacturing facility for this vaccine, EMA is also allowing the company to transport and store the vials of the vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks. This is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold  (-90 to -60˚C) storage in special freezers throughout the supply chain. 

Scale-up processes for Moderna’s COVID-19 vaccine

In addition to the approval for a new manufacturing site for the production of active substance and finished product intermediates last week, Moderna will add new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that are intended to scale-up production capacity and increase supply of the vaccine for the EU market.

COVID-19

EU launches new strategy to develop therapeutic treatments for COVID-19

Catherine Feore

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European Commissioner for Health and Food Safety stella kyriakides

The European Commission has today (6 May) launched a strategy on COVID-19 therapeutics, including those for the treatment of ‘long COVID'. The strategy covers the full lifecycle of medicines: from research, development and manufacturing to procurement and deployment.

The Strategy’s target is to authorize three new therapeutics treatments for COVID-19 by October 2021 and possibly two further medicines by end of the year. 

Health and Food Safety Commissioner Stella Kyriakides said: “Vaccinations save lives, but they cannot yet eradicate COVID-19. We need a strong push on treatments to limit the need for hospitalisation, speed up recovery times, and reduce mortality. Patients in Europe and across the world should have access to world-class COVID-19 medicines. This is why we have set a very clear goal: by October, we will develop and authorise three new effective COVID-19 therapeutics that can have the potential to change the course of the disease. We will do so by investing in research and innovation, the identification of new promising medicines, ramping up production capacity and supporting equitable access. Our Therapeutics Strategy is a strong European Health Union in action.”

A ‘therapeutics innovation booster' will be set up by July 2021 to support the most promising therapeutics from preclinical research to market authorization. Funds will be used to help countries set up and expedite clinical trials that meet the European Medicine Agency’s high standards. It is hoped that ten potential COVID-19 therapeutics and identify five of the most promising ones by June 2021.

The EU will also organize matchmaking events for industrial actors involved in therapeutics to ensure enough production capacity and swift manufacturing. 

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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. 

This morning European Commission President Ursula von der Leyen tweeted: "We are open to discuss any other effective and pragmatic solution. In this context we are ready to assess how the US proposal could help achieve that objective."

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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COVID-19

Europe puts forward plan to reopen tourism to countries outside the EU

Catherine Feore

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The European Commission has put forward a proposal on reopening non-essential travel from outside the EU. Tourism is one of the sectors that has been most hit by the pandemic and there is pressure from countries such as Greece, Cyprus and Spain to re-open as quickly as possible with the EU and to valuable markets outside the EU, like the British and Israelis.

In March, the EU outlined its approach to Europe's safe re-opening and agreed to keep the temporary restriction on non-essential travel into the EU under close review, and to propose amendments in line with relevant developments. The approach outlined reflects the latest scientific advice showing that vaccination considerably helps to break the transmission chain of the disease.

In parallel to preparing for the resumption of international travel for vaccinated travellers, the Commission proposed a ‘Digital Green Certificate’, showing proof that a person has been vaccinated against COVID-19, received a negative test result or recovered from COVID-19, to help facilitate safe and free movement inside the EU. This proposal also provides the basis for recognizing non-EU countries' vaccination certificates.

The Commission is proposing to allow entry to the EU for non-essential reasons, not only for all persons coming from countries with a good epidemiological situation, but also all people who have been fully vaccinated with an EU-authorised vaccine. This could be extended to vaccines having completed the WHO emergency use-listing process.

To reassure some EU countries, the European Commission is also proposing an ‘emergency brake' mechanism, to be co-ordinated at EU level that would allow states to act quickly and temporarily limit to a strict minimum all travel from any countries affected by any variant of the virus which raises concern. 

The Council will take into consideration whether the third countries are also offering reciprocal measures for EU travellers.

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