Archive for April, 2021

European Union – EU

April 30, 2021

Political and Economic Updates:

ECB – reference rate – currencies quoted against the Euro: 30.04.2021

USD/US dollar – 1,2082, JPY/Japanese yen – 131,62, GPD/Pound Sterling – 0,86863, CHF/Swiss Franc – 1,0998, CNY/Chinese yuan renminbi – 7,8134.

30.04.2021 – Gold US$ OZ – $1.768,91, 29.04.2021 WTI Crude Oil – $65,01/Brent Crude Oil – $68,56 (Barrel)

The European Union expects the Pfizer/BioNTech covid-19 vaccine to be approved for use by the EMA by December 23, 2020, and the vaccine roll-out in Germany could start already December 27, 2020. Germany closed down from December 16, 2020 to January 10, 2021, imposing a strong lock-down, as covid-19 infections are still rising; France, Italy and Spain are taking similar drastic measures. The EU Commission granted a conditional market approval for the BioNTech/Pfizer vaccine, expecting vaccine roll out to start on December 27, 2020. The BioNTech/Pfizer vaccine is the first to receive an emergency use authorization by the World Health Organization/WHO. U.K. approved the use of the Oxford-AstraZeneca Covid-19 vaccine. The U.S. developed Covid-19 vaccine of Moderna is the second vaccine authorized for use in the 27-nation bloc, after getting conditional approval from the E.U.’s medical watchdog. Vaccine shortage hit the E.U. in a set back for its immunization race; AstraZeneca feels not obliged to deliver because of a ‘best effort’ agreement, saying the E.U. it is ‘neither correct nor acceptable’, negotiations will continue; the European Medicines Agency will take a decision on whether to approve the vaccine for use in the 27-member bloc on Friday, January 29, 2021; EMA authorized the AstraZeneca vaccine for use in the E.U.. The E.U. introduced tighter rules on vaccine exports allowing countries to halt exports of corona-virus vaccines that the E.U. says belong to its citizens; the World Health Organization has criticized the move; the new mechanism allows to monitor and in some cases block corona-virus vaccine exports out of the bloc. As part of a recently penned collaboration, Bayer will help manufacture German compatriot CureVac’s mRNA based corona-virus vaccine, CVnCOV, in addition to contribute in R&D, regulatory affairs, supply chain management and potential market operations, Bayer said; to that end Bayer plans to make 160 Million CureVac doses in 2022, with the first commercial product expected to be made available at the end of this year; the vaccine entered phase 3 testing in December 2020. Europe’s health organization/EMA said it had started a real-time review of Regeneron Pharmaceuticals Inc.’s antibody therapy for the treatment and prevention of Covid-19, produced with the Swiss company Hoffmann-La Roche; preliminary results indicated that the REGN-COV2 antibody helped reduce the amount of virus in the blood of non-hospitalized patients with Covid-19. A Russian interim report from a phase 3 trial of the Sputnik V Covid-19 vaccine was published by the British scientific magazine The Lancet, saying the vaccine appears to be secure and effective and that no serious adverse events considered related to the vaccine were recorded; the vaccine efficacy, based on the numbers of confirmed cases from 21 days after the first dose of vaccine, is reported to reach 91,6% and the suggested lessening of disease severity after one dose seems to be particularly encouraging for current dose-sparing strategies. Within a new exclusive co-development agreement CureVac and the British pharma giant GlaxoSmithKline/GSK will develop next generation mRNA vaccines for Covid-19; companies aim to develop a multivalent candidate, vaccines to address emerging variants for pandemic and endemic use; development to begin immediately targeting vaccine availability in 2022, subject to regulatory approval; GSK will also support manufacture of up to 100 Million doses of CureVac’s first generation Covid-19 vaccine CVnCoV in 2021. Over concerns about a lack of data on the effectiveness of the vaccine for over 65s, Austria’s national vaccination board has joined France, Germany, Belgium, Sweden and Switzerland in recommending the AstraZeneca vaccination for people aged under 65, and Poland recommends it for those younger than 60; Italy goes one step further and only recommends it for those under 55; Spain’s health authorities have decided not to give the AstraZeneca vaccine to those over 65 and may be even lower to the age threshold to those under 55. South African health officials said they’re pausing the country’s rollout of AstraZeneca’s corona virus vaccine after a study showed it offered reduced protection from the Covid-19 variant first identified there; the country will move forward with the deployment of vaccines made by Pfizer/BioNTech and Johnson & Johnson. AstraZeneca has enlisted Germany’s IDT Biologika as a contract manufacturer of its covid-19 vaccine, as Germany and the European Union seek to boom a delayed immunization campaign; IDT Biologika is a contract development and manufacturing company that produces viral vaccines and other biological products for pharmaceutical companies across the world; Russian developers had reached out to IDT Biologika to discuss producing Sputnik Vat a facility in eastern Germany; German officials said if IDT Biologika wants to produce the Russian vaccine and it would be approved in the European Union, the state government would do anything to help the company. WHO vaccine experts said the AstraZeneca-Oxford covid-19 vaccine could be used for people over the age of 65 and also in settings where variants of the virus are circulating. EMA’s human medicines committee has started a rolling review of CVnCoV, a covid-19 vaccine being developed by CureVac AG. WHO authorized AstraZeneca’s COVID-19 vaccine for emergency use. The European Medicines Agency has to date (10.02.2021) not received an application for a rolling review or a market authorization for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-COVID-Vac), despite reports stating the opposite; the developers have received scientific advice from EMA providing them with the latest regulatory and scientific guidance for the development of their vaccine; in line with the Agency’s transparency policy the vaccine is included in the list of COVID-19 medicines and vaccines that have received scientific advice from the Agency. Johnson & Johnson requests EU approval for its covid-19 vaccine, which has been under rolling review since December 1, 2020; the other three vaccines currently authorized for use across the EU are those developed by AstraZeneca, Pfizer/BioNTech and Moderna; EMA’s committee could issue an opinion by the middle of March 2021, providing the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust. Johnson & Johnson has also asked U.S. regulators for emergency use authorization in the United States. The FDA approved Johnson & Johnson’s Covid-19 vaccine for emergency use in the United States. the European drug regulator started a rolling review of Russia’s Sputnik V corona-virus vaccine; the application of Sputnik V, developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology was submitted by its E.U. partner R-Pharm Germany GmbH; so far three Covid-19 vaccines developed by BioNTech-Pfizer, Moderna y AstraZeneca have been authorized by the E.U.; another one produced by Janssen (Johnson & Johnson) is under evaluation at E.M.A.; E.M.A. will evaluate data of Sputnik V as they become available to decide if the benefits outweigh the risks; the rolling review continues until enough evidence is available for formal marketing authorization application. A Swiss-based pharma-group to produce Sputnik V vaccine in Italy; the Lugano-headquartered Adienne pharma company has agreed to produce the Russian Sputnik V Covid-19 vaccine in its northern Italy plant, needing still the approval by Italian authorities; Sputnik V is being reviewed by European Union regulators, but has not been approved for use in the bloc; Russia has complained that the E.U. keeps pushing back the approval process, while acknowledging that the vaccine is already authorized in 46 countries worldwide. There is no indication that the Oxford-AstraZeneca vaccine is linked to an increased risk of blood clots, the EMA’s medicines regulators says, after a number of countries, including Denmark, Norway, Island and Italy suspended the use of the jab, after a small number of people had developed clots after receiving that vaccine; insisting EMA that there is no indication that vaccination has caused these conditions which are not listed as side effects with this vaccine; the vaccine’s benefits continue to outweigh its risk and the vaccine can continue to be administered , while investigation of cases of thromboembolic events is ongoing, EMA is saying. The Covid-19 vaccine Janssen (Johnson & Johnson) is now authorized across the E.U. after EMA’s recommendation, granting a conditional marketing authorization for this Covid-19 vaccine to prevent Covid-19 in people from 18 years of age; it’s the fourth vaccine authorization for use in the E.U., after the approval of the BioNTech/Pfizer, Moderna y AstraZeneca vaccine. Germany and France also paused use of AstraZeneca vaccine due to concerns over blood clots found in people who received the jab. Denmark the first country in the world to suspend definitively the use of AstraZeneca’s Covid-19 vaccine over blood clots concerns.

Brexit: British companies are preparing for a no-deal Brexit. Britain and EU strike pessimistic tone in post-Brexit trade talks. Britain and the E.U. reach finally a last minute landmark deal on Brexit, after months of negotiations, and still leaves critical details to be worked out; the hard-fought trade agreement must be ratified by the British and European parliaments. New era for Europe as U.K. and E.U. complete Brexit separation; the United Kingdom has finally completed its economic separation from the European Union embarking on an era of greater freedom but heightened isolation from its continental neighbors; Thursday 31.12.2020 marked the end of a transition period in which the U.K. followed all the E.U.’s rule and regulations.

The German Government cuts grows forecast for 2021 from 4,4% to 3%, after its economy shrank by 5% in 2020. Armin Laschet, 59, a Merkel Loyalist, elected as new leader of Germany’s ruling Christian Democrats, putting him into a good position to succeed Angela Merkel as Chancellor, when she steps down as German Chancellor in September 2021, after 16 years if office; Germany goes to the polls in September 2021. German inflation dropped 0,3% from a year earlier in December 2020, but increased 1% year-on-year in January 2021 and 1,3% in February 2021, (Euro-zone 0,9% inflation in February 2021). Germany’s debt level stood at 59,8% of GDP at the end of 2019 and Germany reported a general government budget surplus of 1,4% of GDP in 2019, expecting government debt will rise to about 75% of GDP in 2020, planning a general government budget deficit of about 7% of GDP, due to the sizeable measures adopted in response to the Covid-19 pandemic. Germany’s trade surplus 2020 suffered a decline due to the corona virus pandemic, reaching € 179 Billion, dropping exports 9,3% to € 1.205 Billion and declining imports 7,1% to € 1.026 Billion, remaining China Germany’s most important trading partner. Germany’s jobless rate stood at 6,3% in February 2021, the same level as in January 2021.

Mario Draghi, former ECB chief, formally accepts president’s offer after securing broad support across, to become Italy’s new Prime Minister.