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COVID – Europe
WHO: Slow vaccine roll-out prolonging pandemic
Copenhagen, 31 March 2021
As variants of concern continue to spread and strain on hospitals grows, religious holidays are leading to increased mobility. Speeding up vaccination roll-out is crucial as new cases in the WHO European Region are increasing in every age group, apart from one.
Last week saw increasing transmission of COVID-19 in the majority of countries in the WHO European Region, with 1.6 million new cases and close to 24 000 deaths. The Region remains the second most affected by SARS-CoV-2 of all the world’s regions, with the total number of deaths fast approaching 1 million and the total number of cases about to surpass 45 million.
“Only 5 weeks ago, the weekly number of new cases in Europe had dipped to under 1 million, but now the Region’s situation is more worrying than we have seen in several months. There are risks associated with the increased mobility and gatherings over the religious holidays. Many countries are introducing new measures that are necessary and everyone should follow as much as they can,” said Dr Dorit Nitzan, Regional Emergency Director for the WHO Regional Office for Europe.
Across the Region, 50 countries or territories have reported the variant of concern B.1.1.7, initially detected by the United Kingdom and now the predominant variant in the Region. As this variant is more transmissible and can increase the risk of hospitalization, it has a greater public health impact and additional actions are required to control it.
Early impact of vaccination
At the European regional level, new cases are increasing in every age group except in people 80 years and older. It is only in this most vulnerable population that we have seen a steady decline in cases and a decreasing proportion of COVID-19 deaths since the beginning of 2021, reflecting early signs of the impact of vaccination.
New data from Public Health England suggest that COVID-19 vaccines have saved, at the very least, over 6000 lives among people over 70 since vaccination started in December 2020. Similarly, data from Israel show that the Pfizer–BioNTech vaccine is around 90% effective at preventing infection, severe disease and hospitalization after the second dose.
“Vaccines present our best way out of this pandemic. Not only do they work, they are also highly effective in preventing infection. However, the roll-out of these vaccines is unacceptably slow. And as long as coverage remains low, we need to apply the same public health and social measures as we have in the past, to compensate for delayed schedules. Let me be clear: we must speed up the process by ramping up manufacturing, reducing barriers to administering vaccines, and using every single vial we have in stock, now,” said Dr Hans Henri P. Kluge, WHO Regional Director for Europe…
As the largest numbers of new COVID-19 cases are occurring in population groups that are not yet vaccinated, WHO continues to call for early action to implement public health and social measures on the basis of epidemiological and health system data while vaccination coverage continues to grow.
A total of 27 countries in the Region are in partial or full nationwide lockdown, with 21 imposing nighttime curfews. In the past 2 weeks, 23 countries have intensified restrictions while 13 have eased measures, with an additional 9 to follow suit.
Although so-called lockdowns should be avoided by timely and targeted public health interventions, they should be used when the disease overstretches the ability of health services to care for patients adequately, and to accelerate the readiness of local and national public health systems.
“The likelihood of new variants of concern occurring increases with the rate at which the virus is replicating and spreading, so curbing transmission through basic disease control actions is crucial. And today, as opposed to a year ago, we have better test and trace systems, faster information-sharing, and we know much more about how to care for the severely ill,” said Dr Nitzan.
Expanded testing, isolation, contact tracing, quarantine and genetic sequencing are the basic public health tools that must be used and continually strengthened.
Heed the danger
Vaccination together with continued public health and social measures will eventually bring an end to the pandemic. For that to happen, a scale-up of both vaccine production and vaccination is required, as well as continued adherence to public health and social measures.
“The greatest determinant of how many people get infected and how many people die in the coming weeks is what you as an individual do – or don’t do. We have seen it time and time again: virus spread can be stopped. My message to governments in the Region is therefore that now is not the time to relax measures. We can’t afford not to heed the danger. We have all made sacrifices, but we cannot let exhaustion win. We must keep reining in the virus,” Dr Kluge concluded.
European Union: Commission Amends Authorization Mechanism for Exports of COVID-19 Vaccines
(Apr. 1, 2021) On March 26, 2021, the European Commission’s Implementing Regulation (EU) 2021/521, which amends the authorization mechanism for exports of COVID-19 vaccines adopted on January 30, 2021, entered into force. The regulation adds the principles of reciprocity and proportionality as new criteria to be considered when a European Union (EU) member state authorizes exports.
EU Regulations are binding in their entirety and directly applicable in all EU member states. (Treaty on the Functioning of the European Union art. 288, para. 2.)
In announcing the new regulation, the President of the European Commission, Ursula von der Leyen, remarked: “[O]pen roads should run in both directions. . . . The EU has an excellent portfolio of different vaccines and we have secured more than enough doses for the entire population. But we have to ensure timely and sufficient vaccine deliveries to EU citizens. Every day counts.”…
Global Legal Monitor
Author: Jenny Gesley
Date: April 1, 2021
COMMISSION IMPLEMENTING REGULATION (EU) 2021/521 of 24 March 2021 …making specific arrangements to the mechanism making the exportation of certain products subject to the production of an export authorisation
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March 2015 on common rules for exports(1), and in particular Article 5 thereof,
(1) On 30 January 2021, the Commission adopted Implementing Regulation (EU) 2021/111(2) making the exportation of COVID-19 vaccines as well as active substances, including master and working cell banks, used to manufacture these vaccines, subject to the production of an export authorisation, pursuant to Article 5 of Regulation (EU) 2015/479. At the end of the six weeks period following the date of entry into force of these measures, the Commission adopted Implementing Regulation (EU) 2021/442(3) making the exportation of the same products subject to an export authorisation until 30 June 2021, pursuant to Article 6 of Regulation (EU) 2015/479.
(2) The global shortage of supply of COVID-19 vaccine persists and is even increasing in view of the delays of production.
(3) In accordance with Implementing Regulation (EU) 2021/442, export authorisations are to be refused by the Member States where the exports concerned pose a threat to the execution of the Advanced Purchase Agreements (APAs) between the Union and vaccine manufacturers in view of their volume or other relevant circumstances, such as the volume of vaccines delivered to the Union at the time of the request.
(4) There is still a lack of transparency as well as persisting constraints on production of COVID 19 vaccines and delays in their delivery in the Union, which may pose a threat to the security of supply within the Union of the goods covered by Implementing Regulation (EU) 2021/442. Additional elements should therefore also be considered in the decision to grant or refuse an export authorisation.
(5) The information collected by the Commission through the export authorisation mechanism put in place by Implementing Regulation (EU) 2021/111 and continued by Implementing Regulation (EU) 2021/442 and through customs data has shown that exports which are subject to the authorisation mechanism may be channelled via countries so far exempted from the export authorisation requirement, thereby not allowing for the required level of transparency. These exemptions should therefore be temporarily suspended.
(6) The exemption should be maintained for some of the countries and territories mentioned Article 1(9)(a) of Implementing Regulation (EU) 2021/442, namely those which have a particular dependency on the metropolitan supply chains of the Member States to which they are attached or on the supply chains of neighbouring Member States, respectively.
(7) The information mentioned in recital (5) has also shown that Union manufacturers have exported large quantities of goods covered by the export authorisation mechanism to countries which have a large production capacity of their own, while those countries restrict their own exports to the Union, either by law or through contractual or other arrangements concluded with vaccine manufacturers established in their territory. This imbalance leads to shortages of supply within the Union. ENOfficial Journal of the European Union L 104/52 25.3.2021
(8) Furthermore, the same information has shown that Union manufacturers have exported large quantities of goods covered by the export authorisation mechanism to certain countries without production capacity, but which have a higher vaccination rate than the Union or where the current epidemiological situation is less serious than in the Union. Exports to those countries may thus threaten the security of supply within the Union.
(9) Member States should refuse export authorisations accordingly.
(10) The Commission should take the same additional elements into consideration when conducting its assessment of the draft decision notified by the competent authority of the Member State pursuant to Article 2(4) of Implementing Regulation (EU) 2021/442.
(11) Due to the urgency of the situation, the measures provided for in this Regulation should be taken in accordance with Article 3(3) of Regulation (EU) 2015/479.
(12) This Regulation should enter into force immediately. Having regard to Article 5(5) of Regulation (EU) 2015/479, the measures provided for in this Regulation should apply for six weeks,
HAS ADOPTED THIS REGULATION:
Article 1 The application of point (a) of Article 1(9) of Implementing Regulation (EU) 2021/442 is suspended. However, the suspension shall not apply to the following countries and territories: — Andorra, — the Faroe Islands, — San Marino, — Vatican City, — the overseas countries and territories listed in Annex II to the Treaty on the Functioning of the European Union, — Büsingen, — Helgoland, — Livigno, — Ceuta and Melilla.
Article 2 1.The competent authority of a Member State shall grant an export authorisation requested pursuant to Implementing Regulation (EU) 2021/442 provided that:
(a) the export authorisation fulfils the condition of Article 1(7) of Implementing Regulation (EU) 2021/442;
(b) the authorisation does not otherwise pose a threat to the security of supply within the Union of the goods covered by Implementing Regulation (EU) 2021/442.
2.To determine whether the condition in point (b) of paragraph 1 is fulfilled, the competent authority of the Member State shall assess the following factors:
(a) whether the country of destination of the export restricts its own exports to the Union of goods covered by Implementing Regulation (EU) 2021/442, or of the raw materials from which they are made, either by law or by any other means, including through the conclusion of contractual arrangements with the manufacturers of those goods;
(b) the relevant conditions prevailing in the country of destination of the export, including the epidemiological situation, the vaccination rate and the existing availability of goods covered by Implementing Regulation (EU) 2021/442. ENOfficial Journal of the European Union 25.3.2021 L 104/53
3.When the Commission assesses the draft decision notified by the competent authority of the Member State pursuant to Article 2(4) of Implementing Regulation (EU) 2021/442, it shall also evaluate whether the condition in point (b) of paragraph 1 of this Article is fulfilled, having regard to the factors listed in its paragraph 2.
Article 3 This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply until six weeks from its entry into force.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 March 2021. For the Commission The President Ursula VON DER LEYEN EN Official Journal of the European Union L 104/54 25.3.2021
(1)OJ L 83, 27.3.2015, p. 34.(2)Commission Implementing Regulation (EU) 2021/111 of 29 January 2021 making the exportation of certain products subject to the production of an export authorisation (OJ L 31 I, 30.1.2021, p. 1).(3)Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation (OJ L 85, 12.3.2021, p. 190).
COVID-19 Origins – WHO International Team Report
WHO calls for further studies, data on origin of SARS-CoV-2 virus, reiterates that all hypotheses remain open
30 March 2021 News release Geneva, Switzerland
The report of the international team on their Wuhan field visit, from 14 January -10 February 2021, was published today as WHO Director-General Dr Tedros Adhanom Ghebreyesus called for further studies.
The report stems from a Member State resolution adopted by consensus at the World Health Assembly in May 2020 and calling on WHO “to identify the zoonotic source of the virus and the route of introduction to the human population, including the possible role of intermediate hosts, including through efforts such as scientific and collaborative field missions.”
In remarks to Member States today, Dr Tedros, who received the full report on the weekend, thanked the team for their tireless work. He said it advances our understanding in important ways, while raising questions that will need to be addressed by further studies, as noted in the report. “As far as WHO is concerned, all hypotheses remain on the table. This report is a very important beginning, but it is not the end. We have not yet found the source of the virus, and we must continue to follow the science and leave no stone unturned as we do,” said Dr Tedros. “Finding the origin of a virus takes time and we owe it to the world to find the source so we can collectively take steps to reduce the risk of this happening again. No single research trip can provide all the answers.”
The report is available on this webpage:
Below is the full text of the Director-General’s remarks that can be found here:
From the very beginning of the pandemic WHO has stressed the need to understand the origin of the virus in order to better understand the emergence of new pathogens and possible exposures.
Only a few weeks into the outbreak, the IHR Emergency Committee of independent experts recommended that WHO and China pursue efforts to identify the animal source of the virus.
Throughout 2020, WHO continued to discuss with China and other Member States the need to study and share information around the virus origins.
The World Health Assembly resolution of May 2020, which was adopted by all Member States, cited a need “to identify the zoonotic source”:
WHA73.1 from 19 May 2020: 9. (6) to continue to work closely with the World Organisation for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO) and countries, as part of the One-Health Approach to identify the zoonotic source of the virus and the route of introduction to the human population, including the possible role of intermediate hosts, including through efforts such as scientific and collaborative field missions, which will enable targeted interventions and a research agenda to reduce the risk of similar events occurring, as well as to provide guidance on how to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-COV2) in animals and humans and prevent the establishment of new zoonotic reservoirs, as well as to reduce further risks of emergence and transmission of zoonotic diseases;
In July 2020 WHO sent a small team to China to plan a joint study comprising Chinese and independent international scientists.
It was agreed that WHO would select the international scientists. The Terms of Reference for the Virus Origins Study were completed by fall 2020.
Terms of reference of the Global Study of the Origins of SARS-COV2
The team of scientists came from around the world: Australia, China, Denmark, Germany, Japan, Kenya, Netherlands, Qatar, the Russian Federation, the United Kingdom, the United States of America and Viet Nam. The joint international team comprised 17 Chinese and 17 international experts from 10 other countries as well as the World Organization for Animal Health (OIE); and WHO. Find the list of the members of the international team here.
From the outset, this study was designed as one step on the path of understanding the origins of COVID-19 reflecting the specific scope and mandate as outlined by Member States in the World Health Assembly resolution and negotiated Terms of Reference.