Europe is suffering a brutal second wave of the coronavirus pandemic, with a number of major economies back in lockdown after a brief reprieve over the summer. Last week, Italy joined a growing list of countries with more than a million recorded cases of the virus, Poland’s National Stadium has been transformed into a field hospital, and Spain has declared a national state of emergency that may extend well into 2021. The total number of cases on the continent now exceeds 14 million, and hospital systems are stretched near to their breaking point.
Slivers of good news, however, have begun to emerge. Several hard-hit countries may be experiencing the turning of the tide: though infection rates remain elevated, Germany has noted the “first signs” that the curve is flattening, while the virus’ reproduction rate (R0) recently dropped below 1 in France. Even in Belgium, which was recently so badly-off that coronavirus-positive nurses in Liège were asked to continue working as long as they were asymptomatic, the situation is slowly stabilizing after daily new infections dropped by 40 percent week-on-week.
With the approaching holiday season heightening pressure on policymakers to re-open economies by the end of the year, ensuring that the right tools are in place will prove essential if a devastating third wave is to be prevented. That said, the roll-out of reliable COVID-19 testing regimes has already proved far more difficult than health authorities may have anticipated, and a persistent onslaught of virus-related scams has thrown a further wrench into public health authorities’ attempts to control the deadly virus’s spread.
One such scandal recently surfaced from within Europe’s decimated travel industry, where a criminal gang was found to be selling fake negative COVID-19 tests to passengers departing from Paris Charles de Gaulle airport amid tighter immigration rules. The counterfeit certificates bore the names of real Parisian medical laboratories, and the scheme was only exposed after a passenger bound for Ethiopia was found to be carrying a false certificate. If Europe is to safely emerge from this latest lockdown, the independent and trustworthy verification of health information will need to be the cornerstone of any new policy.
More secure and more convenient COVID test results
Fortunately, a number of promising high-tech solutions have already popped up. Swiss company SICPA’s CERTUS MyHealthPass, for example, uses an existing blockchain-based technology to allow the universal verification of health credentials, and is currently being trialled to help both maritime crews and airline passengers.
The CERTUS solution will be a particularly welcome development for seafarers, who have struggled to go about their usual duties since the beginning of the pandemic. Many national authorities have questioned the validity of seafarers’ COVID-19 tests and taken an inordinately long time to approve their health documents, leaving seafarers often left stranded onboard months after their scheduled disembarkation. Moreover, the rejection of health and travel documents often prevents potential replacements from boarding these same vessels, damaging the mental wellbeing of the workers in limbo and bringing vital transnational operations to a grinding halt.
The airline industry, unsurprisingly, is wrestling with a similar challenge. Countries are increasingly requiring negative PCR tests for entry—while some are already planning for how to integrate coronavirus vaccination certificates into their border control procedures—but scandals like the false COVID test ring discovered at Charles de Gaulle airport have ratcheted up the need for internationally-recognised procedures like the technological solution offered by MyHealthPass. The scheme is capable of authenticating both paper documents and digital information so as to guarantee the validity of WHO-approved COVID-19 test results. Seafarers, airline staff and international travellers can then carry their authenticated digital health pass on their smartphones, allowing the re-opening of essential international services in the short-term and helping national and local authorities better anticipate and prepare for future outbreaks.
Self-isolation still falling short
In addition to ensuring that easily-verified coronavirus tests & other health information can help open borders and allow normal economic activity to resume as soon as possible, governments should also be using this time to resolve the missing links that have so far caused testing and isolation strategies to fall through. If rapid and widespread COVID-19 testing is finally beginning to take off, bolstered by more accurate blood tests to detect past infection, authorities must also be doing more to encourage—and compensate—populations which may have been exposed to the disease to self-isolate so as to allow these developments to adequately take hold.
In the months since the heady days of summer, a clearer image of Europe’s failures to control the pandemic has indeed begun to emerge. In the UK, where COVID-19 cases have exceeded 1.3 million, less than one-fifth of people who reported coronavirus symptoms complied with national self-isolation regulations, and authorities handed out a paltry handful of fines for quarantine violations when returning from a high-risk area.
Here again, countries with high marks handling the coronavirus outbreak have turned to technological solutions to both ease the burden of complying with self-isolation requirements and ensure compliance with rules in force. Taiwan, for example, has emerged as the international gold standard for COVID-19 control measures. After closing international borders and regulating travel early, Taiwan has successfully maintained a rigorous regime of contact tracing and technology-enhanced quarantine which has helped the island nation keep cases and fatalities low. In particular, the Pacific country adeptly implanted an “electronic fence system”, which uses cell phone location data to ensure that quarantined individuals stay at home. Technology also provided a solution for the practical and mental health concerns of those in quarantine, from offering easy food delivery options to a chatbot developed with popular messaging app LINE.
European authorities failed over the summer to implement the technological solutions they needed to stop a second wave in its tracks. This second round of lockdowns has given them a fresh chance to construct the pillars of a comprehensive and secure strategy for testing and quarantining which could stave off a third wave of the virus.
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.
EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated
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.|
Ukraine's capital Kyiv eases coronavirus restrictions
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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