On 17 February, the European Commission launched its “HERA Incubator” to address the threat of new coronavirus variants. HERA will work with researchers, biotech companies, manufacturers and public authorities to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.
Asked about the status of Sputnik V, European Commission President Ursula von der Leyen raised three issues: authorisation, production site verification, and a question over how Russia could “theoretically” offer millions and millions of doses, “while not sufficiently progressing in vaccinating the own people. This is also a question I think that should be answered.”
Von der Leyen confirmed that the Sputnik V vaccine developers had not applied for conditional market authorization with the European Medicines Agency (EMA), despite reports to the contrary, but added that that might change.
Sputnik like all vaccine candidates will have to follow the EU’s full scrutiny process. The EMA has already published a clarification (10 February) because of misleading press reports claiming that Sputnik V had made an application for a rolling review, or market authorisation for their vaccine, it hasn’t.
Today, the EMA sent a tweet making it clear, again, that the Sputnik vaccine was not under “rolling review” or the later “market authorisation” process.
Instead, the EMA has confirmed that the developers have received scientific advice on the latest regulatory and scientific guidance for the development of their vaccine, those companies that have received advice are listed on the EMA website.
Nevertheless, yesterday, Sputnik V claimed yet again in a Twitter response to von der Leyen: “Sputnik V submitted an application for rolling review, request for market authorization is the next step.”
According to Statista, a company specializing in market data, over 200 million doses have been agreed for export to 20 countries, and there are major plans for production outside Russia in Korea, India, Brazil, Saudi Arabia, Turkey and China, according to the Sputnik website. As of February 2021, vaccination with Sputnik V has started or is starting in the following countries: Bolivia, Algeria, Kazakhstan, Turkmenistan, Palestine, the UAE, Paraguay, Hungary, Armenia, Bosnian Serb Republic, Venezuela and Iran.
The widely respected Lancet peer-reviewed medical journal recently published an article claiming that Sputnik V is safe and effective, based on interim results from a phase 3 trial. The developers Gamaleya National Research Centre for Epidemiology and Microbiology have a successful track record and their two vector approach - using two types of carrier viruses has been used successfully in the past to vaccinate against Ebola.
The vaccine is outside the EU’s advanced purchasing agreements and can be purchased by any EU member state. Hungary has already had a delivery of 40,000 doses, of an order of over 2 million to be delivered over the next three months. Other EU countries are also considering approval for emergency use, something that they are entitled to do under the current rules, as already shown in the UK last year. The EU, however, has not been willing to take the added risks and liability for this approach and will only deploy the vaccine when it has received conditional market authorisation from the EMA.
Von der Leyen said that lessons had been learned about the need to inspect the process and production on site since the start of the pandemic, alluding to the difficulties experienced by both BioNTech/Pfizer and AstraZeneca. Since there is currently no production of Sputnik V in the EU, this would mean that the EU would need to have an agreement to access and verify production of sites in Russia. This could prove difficult given that diplomatic relations have been weakened following the recent visit by EU High Representative Josep Borrell to Moscow.
US supports WTO waiver of Intellectual Property on COVID-19 vaccines
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.
Europe puts forward plan to reopen tourism to countries outside the EU
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.
MEPs set out their conditions for an ‘EU COVID-19 Certificate’
Today (29 April), Parliament adopted its negotiating position on the proposal for what the Commission describes as a ‘Digital Green Certificate’ and what the Parliament prefers to call a ‘EU COVID-19 certificate’ to reaffirm the right to free movement in Europe during the pandemic.
MEPs insist that the documents should be available in digital or paper format and should be in place for twelve months but not longer.
Having agreed their position, and fast-tracked the process by voting this week, both Parliament and Council are ready to begin negotiations. The aim is to reach an agreement ahead of the summer holidays.
Freedom of movement
Following the vote in plenary, Juan Fernando López Aguilar MEP (S&D, ES), chairman of the Civil Liberties Committee and rapporteur, said: “We need to put in place the EU COVID-19 Certificate to re-establish people’s confidence in Schengen while we continue to fight against the pandemic. Member states must co-ordinate their response in a safe manner and ensure the free movement of citizens within the EU.”
MEPs stress that, in order to avoid discrimination against those not vaccinated and for economic reasons, EU countries should “ensure universal, accessible, timely and free of charge testing”.
López Aguilar said: “The certificate and the tests need to be free of charge. They cannot have a prohibitive price. It's a mandatory test. It can't be so expensive!”
No additional travel restrictions
MEPs say once a citizen gains an EU COVID-19 certificate they should not be subject to additional travel restrictions, such as quarantine, self-isolation or testing. The Parliament wants to ensure that the EU certificate is part of a common framework.
Sophie In’t Veld MEP believed that this will be one of the most difficult questions in the negotiations with the Council: “What is the point of having a common European scheme if the member states can ignore the certificate and impose additional restrictions when they want to? Do you really think the citizens are waiting for a debate about subsidiarity now and national competencies? Citizens want their rights, they want their freedom.”
Which vaccines are acceptable?
In the proposal member states must accept vaccination certificates issued in other member states for persons inoculated with a vaccine authorised for use in the EU by the European Medicines Agency (EMA) (currently Pfizer-BioNTech, Moderna, AstraZeneca and Janssen), MEPs say. It will be up to the member states to decide whether they also accept vaccination certificates issued in other member states for vaccines listed by the World Health Organization for emergency use.
Data protection safeguards
The certificates will be verified to prevent fraud and forgery, as will the authenticity of the electronic seals included in the document. Personal data obtained from the certificates cannot be stored in destination member states and there will be no central database established at EU level. The list of entities that will process and receive data will be public so that citizens can exercise their data protection rights under the General Data Protection Regulation.
In’t Veld said: “Trust in the certificate is key for the take up, therefore the temporary nature protected by a sunset clause, data protection clauses, clauses that prevent function creep, are essential.”
Affordable vaccines allocated globally
Finally, MEPs underline that COVID-19 vaccines need to be produced at scale, priced affordably and allocated globally. They also voice concern about the serious problems caused by companies not complying with production and delivery schedules.
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