2012. XII. 12. COVID-19 elleni oltásokba kezdett Nagy-Britannia, s az Egyesült Államok is hirtelen. Utóbbi sürgősségi engedélyezéssel. Ha a Brexit időpontjának közeledtére, illetve elnökválasztási kampányra, s annak eredményeire tekintünk, nyilvánvaló, hogy az oltóanyag rendelkezésre hozatalának a politikai propaganda is sürgős szükségét látta. A gyártók által ténylegesen, véglegesen kikísérletezett s államilag jóváhagyatott oltóanyag azonban még világszerte nem áll rendelkezésre. Ami oltóanyagot sürgősséggel mégis bevetnek a britek s az Államokban, máshol, annak mennyisége jócskán korlátozott. Ez előrevetíti, hogy a piacon végül megjelenő, szavatolt oltóanyag a különböző érdekeknek, rendeléseknek megfelelő szétosztásban, kis mennyiségben jut majd el sok államhoz eleinte, így hozzánk is. S mérlegelni kell majd, hogy elsőnek az egészségügyben dolgozóknak s idős-otthonokban élőknek jusson-e, s kinek még, aki igényli, hogy legalább számukra legyen elég mennyiség az oltóanyagból. Időközben a Sanofi francia gyógyszergyártó cég bejelentette, hogy hatalmas nagyságrendben ígért oltóanyaga előállítása késni fog majd egy évet. Svájci vezető gyógyszeripari vállalat vezetője pedig sajnálatosnak tartja, hogy illetékesek fölös reményeket keltenek a még jó ideig kísérleti fázisban lévő, elvártan hatékony, szavatolt oltóanyagok tömeges s mihamarabb rendelkezésre állása vonatkozásában.
Mára már több mint 72 millió világszerte a bizonyítottan fertőzöttek száma, azaz a több mint 7 milliárd nyolcszáz milliós emberiségnek még csak kevesebb mint egy százaléka fertőzött. Ám már elhunytak több mint 1 610 000-en (egymillió hatszáztíz ezren) világszerte - azaz 100 000 (százezer) emberből 20-an. Itthon, a közel tíz milliós lakosú országunkban is majdnem hasonlóan tömeges a bizonyítottan fertőzöttek száma - 280 000-en (kétszáznyolcvanezren) vannak, ez hamarosan a lakosságszám mintegy 3 (három) százaléka. Mára 6965 (közel hétezer) az elhunytak száma - 100 000 (százezere) lakosra átszámítva 69 (hatvankilenc) a világjárványos halottunk. Az utóbbi hetekben az új fertőzöttek napi átlagban számosabban voltak a ma közölt 4153-nál - 100 000 lakosból több mint 40-en. A kórházba utalt fertőzöttek száma több mint 7600 (hétezer hatszáz) s a legutóbbi napon is az elhunytaké 181 (száznyolcvanegy). Az ellátói egészségügyi 'kapacitáshoz' (befogadóképességhez, kellő szakértelem rendelkezésre állásához) képest máris tömegei vannak világjárványos betegeinknek a hazai kórházakban, az alig 3%-os országos átfertőzöttség mellett.
A tömeges, országos védettséghez ('nyáj-immunitáshoz') a lakosság 60-70%-ának 'immunissá' válására lesz szükség, szakemberek állításai szerint. Ennek elérését célszerű oltóanyaggal lehetne időben megvalósítani. A lakosságot csak egymás átfertőzésére hagyva az elhúzódó idő miatt az esetszám, - így az áldozatok száma is - növekszik. Ma még nem áll megfelelő oltóanyag, terápia kellően rendelkezésre, ezért az eddigi országos intézkedések lakossági betartása mellett további intézkedések meghozatalára lenne máról holnapra sürgős szükség.
Napi megnyilatkozásra kényszerülő illetékesek indokoltan figyelmeztetnek a maszkviselés-távolságtartás-kézmosás háromságára. Szinte pótcselekvés-szerűen emlegetik a 'vak cinát' (magyarán: oltóanyagot), - ami nem áll rendelkezésre. Ezekhez képest a legsürgetőbb, helyzetfelismerő mérleglés lenne kívánatos e napokban is. Budapest számára is életbevágó, hogy a nem létszükségleti cikkeket árusító helyeket be kellene zárni, csak élelmiszerüzleteket, gyógyszertárakat, postát nyitva tartatni, legalább új év első napjaiig.
Ennek indokát képezi az, hpgy az előző évekbeli, védőoltásokkal bíró gyönyörű megszokás munkál, miközben a rettenet kopogtat. Tömegek a boltokban, bevásárló központokban, hetek óta, Karácsony előtt. A járvány pedig, mint a tengerfelszín, alulnézetből - egyik hullám követi a másikat. Nem csak első, második hullám önt el, de annyi, ahány kiváltó oka van. Ennek a megszokott tömeges, decemberi boltjárásnak - kiváltó oknak - további nagy járvány-hullám(okat) keltő hatása lehet.
Berlin a mai példa, ez: a novemberi korlátozások dacára a fertőzésszám Németországban vészesen nő - 100 000 (százezer) lakosból már napi 26 fertőzött (azaz országosan napi közel 22 000). Ezért további szigorító intézkedéseket hoznak. Három nap múlva az iskolákat bezárják, a nem élelmet forgalmazó üzleteket szintén, egyes szolgáltatásokat - például fodrászatokét - szüneteltetik. Éttermekből rendelésre lehet étket szállítani. Ötre korlátozzák a zárt térben lévők megengedett számát. Nem forgalmazható tűzijáték, tiltják a szilveszteri összejöveteleket. A német pénzügyminiszter közölte: további segítséget nyújtanak a lezárás miatt érintett vállalkozásoknak, 11,2 milliárd euro összegben. A munkáltatókat kérni fogják, hogy ahol lehetséges, egy hónapra tegyék lehetővé dolgozóik számára a távmunkát. Az egyházi szertartásokat megengedik, ha a résztvevők közti távolság-tartás biztosított, viselnek maszkot - az éneklést azonban nem engedélyezik. Az idős-otthonokban dolgozókat heti több alkalommal tesztelik, a rokonlátogatóktól kérik az érvényes negatív teszt kimutatást. Több tartományi miniszterelnök támogatólag szorgalmazott további, bevezetendő részintézkedéseket. Legsúlyosabb helyzetben Drezda és környéke van, ott az egészségügyi létesítmények a befogadó képességeik határán működnek, a megfáradt ápolók és orvosok testi és szellemi igénybevétele maximális. A 83 000 000 (nyolcvanhárom millió) lakosú Németországban az idei koronavírusos világjárványnak eddig 22 000 ( huszonkétezer) halottja van.
10 Dec 2020 Decomposing mink buried in mass graves in Denmark after being culled because of coronavirus fears may have contaminated the groundwater. Authorities buried tens of thousands in shallow 2-metre pits in a military training area in West Jutland. The ministry of food, agriculture and fisheries has also conceded it could not say with certainty where or how 4,700 tonnes – or about 1.5 million – dead mink had been disposed of. The Danish veterinary and food administration has been charged with disposing of 31,000 tonnes of slaughtered mink. equating to roughly 11 million bodies. (Source: TheGuardian)
11 December 2020 Drugmakers Sanofi and London-based GlaxoSmithKline said today that their potential COVID-19 vaccine won’t be ready until late next year because they need to improve the shot’s effectiveness in older people. The companies said early trials showed the vaccine produced an “insufficient” immune response in people over 60 because it didn’t contain enough of the material that triggers the production of disease-fighting antibodies. They said they plan to reformulate the vaccine and do more testing, which is likely to delay approval to the fourth quarter of 2021 from the middle of the year. GSK and Sanofi plan to produce up to 1 billion doses of their COVID-19 vaccine annually, and they have signed agreements to supply millions of doses to the U.S., European Union, Canada and developing countries. Sanofi is a leading producer of flu vaccines and has large-scalemanufacturing capacity. Sanofi and GSK confirmed that volunteers in their study received less of the vaccine than intended because of incorrect readings produced by two of the commercial compounds used to test the amount of active ingredient in each dose. In adults 18 to 49, the vaccine produced an immune response comparable to patients who had recovered from COVID-19, the companies said, citing results from the early stage trials. In addition, Sanofi and GSK have now tested a reformulated version of the vaccine on non-human primates. Those tests showed that the vaccine protected against lung damage and reduced the amount of virus in the nose and lungs in two to four days. The companies plan to start a new early-stage trial of the vaccine in February. (Source: France24 / AP)
December 13, 2020 Existing restrictions imposed in November had failed to significantly reduce the number of new infections. The seven-day rolling average of daily new cases in Germany has risen over the past two weeks from 21.23 new cases per 100,000 people on Nov. 28 to 26 new cases per 100,000 people on Dec. 12. Starting December 16 schools nationwide will be closed or switch to home schooling; most non-food stores will be shuttered, as will businesses such as hairdressers. Restaurant takeout will still be permitted. With the exception of Christmas, the number of people allowed to meet indoors will remain restricted to five, not including children under 14. The sale of fireworks traditionally used to celebrate New Year’s will also be banned, as will public outdoor gatherings on New Year’s Eve. Germany has had about 22,000 virus deaths. Finance Minister Scholz said the government would provide further financial support for businesses affected by the lockdown. The additional sums amounted to 11.2 billion euros. Employers will be asked to let staff work from home, where possible, for the next month. Religious services will be permitted, provided minimum distancing rules are in place and masks are worn, although singing will be banned. Staff in nursing homes will be required to take COVID-19 tests several times a week and visitors to the homes will have to provide a negative test result before being able to see relatives. Hospitals in the hard-hit eastern region around Dresden have appealed for people to responsibly follow social distancing and mask-wearing, saying medical facilities were about to hit full capacity. Nurses and doctors are already at their physical and psychological limits. (Source: AP)
11 December 2020 NHS commercial terrifies children by showing Santa dying of COVID. The advert “celebrates NHS staff and volunteers” by showing them nursing Father Christmas back to full health so he can deliver presents. (Source: summit.news)
See also: /video - 13 442 views/ (Source: YouTube): https://tinyurl.com/y5lm3lpn
9 Dec 2020 People with a history of significant allergic reactions should not receive the Covid vaccine, the medicines regulator has said, after two NHS workers experienced symptoms today. Both of the NHS staff carry adrenaline autoinjectors, of which the best-known brand is the EpiPen, suggesting they have suffered reactions in the past. These administer a swift adrenaline boost to counter allergic reactions that occur when some people, for instance, eat nuts. The patient information leaflet with the Pfizer/BioNTech vaccine says it should not be given to people allergic to any substance in the vaccine, raising questions about the wisdom of NHS trusts selecting those staff members to be vaccinated. “Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue,” says the leaflet. The Medicines and Healthcare products Regulatory Agency (MHRA) advice states: “Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer/BioNtech vaccine. Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.” The NHS workers are said to have developed symptoms of “anaphylactoid reaction” shortly after receiving the vaccine, and both have recovered after treatment. (Source: TheGuardian)
11 Dec 2020 The world needs a transparent and independent WHO, which ultimately focuses on the people. The World Health Organization has been accused of conspiring with the Italian health ministry to remove a report revealing the country’s mismanagement at the beginning of the coronavirus pandemic - the publication of which was intended to prevent future deaths. The report, produced by the WHO scientist Zambon and 10 colleagues across Europe, was funded by Kuwait’s government with the objective of providing information to countries yet to be hit. Called An Unprecedented Challenge: Italy’s First Response to Covid-19, the document was published on the WHO website on 13 May before being taken down the next day. The 102-page report said Italy’s pandemic plan had not been updated since 2006 and that, due to being unprepared, the initial response from hospitals was “improvised, chaotic and creative”. It took time for formal guidance to become available, the report added. The document was allegedly removed at the request of Guerra, the WHO’s assistant director general for strategic initiatives. Guerra was the director general for preventive health at the Italian health ministry between 2014 and late 2017, and was therefore responsible for updating the pandemic plan as per new guidelines laid out by the WHO and European Centre for Disease Prevention and Control (ECDC). Guerra is among the scientists on the Italian government’s Covid-19 taskforce. The outdated plan is a crucial element in the preliminary investigations being carried out by prosecutors in Bergamo - the Lombardy province hardest hit during the first wave of the pandemic - into possible criminal negligence by authorities. Covid-related deaths in Italy surpassed 60,000 in December 6, the highest toll in mainland Europe. Investigators are also using a report compiled after the first wave by a retired army general, Lunelli, which concluded that as many as 10,000 deaths may have been attributed to the lack of sufficient anti-pandemic protocols. Zambon, who is based at the WHO’s office in Venice, has been summoned three times to speak to prosecutors but has been prevented from doing so by the WHO, which has insisted he and the other 10 researchers involved in producing the report should have immunity from testifying. Only Guerra was heard by prosecutors in early November. Zambon’s latest summons was on 10 December, but again he was blocked from going despite requesting permission. Zambon claims that a month before publication he sent an outline of the findings to Guerra, who shared it with Italy’s health minister, Speranza. Emails sent in May to Zambon by Guerra and Kluge, the WHO’s Europe director - who also wrote the introduction of the removed document - appear to reflect a pact made with the Italian health ministry to keep the report under wraps and formed part of a recent documentary by Report, an investigative programme on the state TV channel Rai. If Bergamo prosecutors find that Italy had failed to update its pandemic plan, then all health ministers and prime ministers since 2013 risk facing trial. Chiappani, the chief prosecutor, told this week: “Italy was unprepared for Covid, there was a lot of improvisation … we need to find out why there are so many victims compared to elsewhere.” Di Maio, Italy’s foreign minister, sent out a strong signal to the WHO this week when he said he was “against immunities”. Zambon said he was ready to collaborate with prosecutors, who have so far interviewed the prime minister, Giuseppe Conte, and Speranza. He added that the reference to the report being “full of inaccuracies” was defamatory and that it had gone through all the required stages of checks. “I do this because I strongly believe that the world needs a transparent and independent WHO, which ultimately focuses on the people,” Zambon said. (Source: TheGuardian)
December 11, 2020 Turkish President Erdogan was guest of honor at Azerbaijan’s military parade in December 10, to mark its victory with Ankara’s help over Moscow ally Armenia. Erdogan watched about 200 of his troops join Azerbaijani forces in the center of the capital, Baku, who paraded Turkish-made drones that were decisive in defeating Armenia during the 44-day war over the disputed region of Nagorno-Karabakh. From Azerbaijan to Syria to Libya, Erdogan’s drive to rebuild Turkey’s influence as a regional power has forced Russia to roll back its ambitions. Even as Erdogan increasingly positions himself as a check on the Kremlin’s geopolitical reach, Putin has nothing but warm words for his Black Sea neighbor in public. While Ankara has been telling Western partners that its growing footprint in the ex-Soviet arena and the Middle East is a bulwark against an expansionist Russia, that doesn’t mean Turkey’s on the same page with them. U.S. plans approved by President Trump, who’s boasted of his warm relations with Erdogan, to sanction Turkey over its purchase of a Russian S-400 missile-defense system will only further complicate the Turkish leader’s efforts to rebuild links with Washington. Russia has experience of managing a volatile economic and political relationship with Turkey, even as Erdogan has sent Turkish forces and proxies to thwart Putin in regional hotspots. In 2015 Russia slapped crushing sanctions on Turkey after it shot down a Russian fighter jet on the border with Syria. On Wednesday, December 9, it barred imports of tomatoes from Azerbaijan, the country’s biggest export after oil and gas. Turkey is also a major energy customer for Russia, but even here it has proven problematic. Once Moscow’s top customer outside the former Soviet Union, Turkey has reduced gas purchases in recent years by turning to rival suppliers like Azerbaijan. Putin in public praises Erdogan for his independence in doing energy and weapons deals with Russia despite opposition from its NATO allies. “It’s not just nice to work with that kind of partner, it’s reliable,” Putin said in October. As for differences between them, Russia needs to “be patient” and “seek compromise,” he said. (Source: Bloomberg)
December 11, 2020 The Vladimir Monomakh Russian new Borei-class nuclear submarine of the Pacific Fleet today successfully test-fired four Bulava intercontinental ballistic missiles in quick succession from an underwater position in the Sea of Okhotsk in a show of readiness of Moscow’s nuclear forces. Their dummy warheads hit their designated targets on the Chiza shooting range in the Arkhangelsk region in northwestern Russia more than 5,500 kilometers away. As part of large-scale drills of Russia’s strategic nuclear forces that began in December 9, another Russian nuclear submarine also performed a practice launch of an intercontinental ballistic missile from the Barents Sea, a ground-based ICBM was launched from the Plesetsk facility in northwestern Russia and Tu-160 and Tu-95 strategic bombers fired cruise missiles at test targets at an Arctic range. The series of missile launches comes less than two months before the New START U.S.-Russian arms control treaty signed in 2010 - the only remaining nuclear arms control deal between the two countries still standing - expires in early February. (Source: AP)
11 Dec 2020 UK and Russian scientists are to test whether combining shots of the Oxford/AstraZeneca and Sputnik V coronavirus vaccines could result in better protection than two doses of the same one. Trials will start by the end of the year, the Russian Direct Investment Fund (RDIF), which funded the development of the Sputnik V vaccine by Russia’s Gamaleya Institute, said today. “The decision by AstraZeneca to carry out clinical trials using one of two vectors of Sputnik V in order to increase its own vaccine’s efficacy is an important step towards uniting efforts in the fight against the pandemic,” said Dmitriev, chief executive of RDIF. AstraZeneca confirmed that it was considering how it could assess combinations of different vaccines, and would soon begin exploring with the Gamaleya Institute whether their two vaccines could be successfully combined. Mixing and matching different vaccines may provide a solution. This concept is known as a heterologous prime-boost, and has been used in vaccination programmes against other diseases. Russia is likely to see the move as a vote of confidence by a western manufacturer in Sputnik V, which is already being used to immunise medical workers, teachers and social workers. Unlike AstraZeneca’s vaccine, Sputnik V uses two different human adenovirus vectors to try to trigger a stronger and longer-term immune response. It is not yet clear which of these components will be tested alongside the AstraZeneca vaccine. Like the Oxford/AstraZeneca vaccine, the Russian Sputnik V shot is based on a modified version of adenovirus, a common cold virus. This “vector” is stripped of any disease-causing genes and modified to carry genetic instructions for making the coronavirus spike protein, which it passes to human cells. The manufactured coronavirus spike protein then triggers an immune response that protects against the Covid-19 disease. A potential problem with such vaccines, however, is that of “anti-vector immunity”, where if the immune system has previously encountered the type of adenovirus used in the vaccine, it may destroy it before the vaccine can trigger an immune response. This is why the Oxford University group chose to use a chimp adenovirus, rather than a human one. Earlier this week, the outgoing chair of the UK’s vaccine taskforce, Bingham, announced that a trial of AstraZeneca’s vaccine in combination with the Pfizer shot was likely to begin in January. (Source: TheGuardian)
11-Dec-2020 The head of Russia's consumer safety watchdog Rospotrebnadzor, Popova, warned that anyone getting Russia's Sputnik V COVID-19 vaccine should give up alcohol for almost two months. Drinking alcohol would reduce the body's ability to build up immunity against the virus. She said that people should refrain from drinking alcohol at least two weeks before getting the first of two inoculations – and then for a further 42 days after. The guidance has caused uproar in large parts of Russia. Sputnik published a contradicting message in response to Popova's advise. It posted a picture of Hollywood actor DiCaprio raising a glass of champagne on its Twitter channel with a quote from the vaccine's developer Gintsburg that said: "One glass of champagne won't hurt anyone, not even your immune system." People should refrain from drinking alcohol three days before and three days after both jabs, Gintsburg said, adding that the advice was the same for getting vaccinated around the world and not specific to Russia or Sputnik. Meanwhile, a spokesman for Pfizer – the vaccine produced by which was rolled out in the UK earlier this week – said regulators had not mentioned any warnings about alcohol consumption relating to the jab. (Source: cgna / Reuters)
December 10, 2020 Russia saw 138,325 excess deaths between the start of the pandemic in March and the month of October, reports the Federal Statistics Service (Rosstat). Russia’s leading regions in terms of excess deaths are Moscow (3,254 people), the Samara region (2,269 people), the Rostov region (2,240 people), the Chelyabinsk region (2,145 people), and the Altai Krai (1,780 people). In October 2020, 47,777 people died in Russia - 30.3 percent more than the number who died during that same month last year. According to Rosstat’s data, 15,607 of those deaths were due to the coronavirus or its consequences. In 90 to 100 percent of cases, these excess deaths in Russia are linked to the coronavirus infection in some way or another, as evidence by reports from the few regions where the data on excess mortality has been analyzed in detail (for example, the Moscow Health Department has been working on this since April). Rosstat obtains its data on excess death from local registry offices, where death certificates are issued to relatives of the deceased. While this data is believed to be the most accurate, it’s published 35-40 days after the end of each month. /map/ (Source: meduza.io): https://tinyurl.com/y3knvk4j
December 9, 2020 Physicians in outpatient facilities have to tend to those who were self-isolating at home with mild or moderate symptoms and needed to take a test or get treatment recommendations. Often, the Russian medical workers have had to go on foot, as their clinics don’t have enough cars to go around. In Irkutsk in October a group of volunteers came to the rescue, offering the simple service of driving medical workers to their home visits. Doctors were able to visit 70% more patients when they had someone to drive them than when they went on foot. Within about two weeks, there were 22 cars and over 100 volunteers in Irkutsk helping local doctors with house calls. By December, the project called Let’s Help Doctors Together had grown to involve more than 3,000 volunteers in 10 Russian regions. In Irkutsk alone, more than 500 volunteers have helped with 10,000 house calls since October. Doctors come in full protective gear and spray their protective suits with disinfectants after every visit before getting back into the cars. Volunteers wear masks and other protective equipment, too. Doctors are grateful, of course, and happy to get help. They do need it, because they have been working at such a pace for a long time already. (Source: AP)
December 9, 2020 The Kremlin-friendly REN-TV television channel reported earlier this week that radio equipment was taken from an Il-80 plane that was undergoing maintenance at Taganrog. The port city of Taganrog, more than 1,100 kilometres south of Moscow, is home to Beriev Aircraft Company, a struggling state-controlled enterprise. The interior ministry said police in the southern city of Taganrog had been alerted, that one million rubles worth of equipment had been stolen from an Ilyushin Il-80 plane at an airfield. The Kremlin today sounded the alarm over the theft of sensitive equipment from a “doomsday plane” designed to shield top command from the effects of a nuclear explosion. The robbed plane is one of four highly-classified flying command centres built to evacuate the president and other top officials in case of a nuclear explosion. (Source: AFP)
December 9, 2020 The Russian military today conducted drills of its strategic nuclear forces that featured several practice missile launches. The maneuvers included the test launch of an intercontinental ballistic missile from the Karelia nuclear submarine in the Barents Sea. A ground-based intercontinental ballistic missile was also launched from the Plesetsk facility in northwestern Russia and Tu-160 and Tu-95 strategic bombers fired cruise missiles at test targets. Russia has expanded its military drills in recent years amid tensions with the West. The New START U.S.-Russian arms control treaty expires in early February. Moscow and Washington have discussed extending the pact, but differences have remained. New START was signed in 2010 by then-U.S. President Obama and then-Russian President Medvedev. It limits each country to no more than 1,550 deployed nuclear warheads and 700 deployed missiles and bombers, and envisages sweeping on-site inspections to verify compliance. Both Moscow and Washington withdrew from the 1987 Intermediate-Range Nuclear Forces Treaty last year. New START is the only remaining nuclear arms control deal between the two countries still standing. (Source: AP)
December 10, 2020 EU regulator rejects need for emergency authorization of coronavirus vaccine. The head of the European Medicines Agency is standing by the EU's decision to wait for a conditional marketing authorization (CMA) before using coronavirus vaccines on the public. ‘While speed is of the essence, safety is our No. 1 priority,’ Cooke, the agency's new executive director of the European Medicines Agency (EMA) chief told the European Parliament's health committee today. "These vaccines will be given to millions of people in the EU, and we are keenly aware of the huge responsibility we have to get these recommendations right to protect the European population." She noted the agency is "aware of" the decisions by the U.K. and Canada to approve the BioNTech/Pfizer vaccine with the faster process of an emergency authorization "with great interest," but she stressed that such emergency authorizations are "for temporary use of unlicensed vaccines - these are not marketing authorizations as such." The U.S. could follow suit later today. A CMA, however, ensures safety and allows all EU countries to roll out vaccines at the same time, Cooke said. Regulators will only issue one when the data proves the benefits of a vaccine outweigh the possible risks, following two independent scientific assessments that are then confirmed by a scientific committee with representatives from all EU member states. Any EU country can issue an emergency authorization, putting a medicine on the market before it's received a full authorization, but EU countries and Cooke have stood by the CMA process. The EMA's scientists will reach a decision by December 29 at the latest for the BioNTech/Pfizer vaccine and January 12 for Moderna, but "of course [those dates] could change," Cooke said. (Source: Politico)
December 10, 2020 EU leaders unblock EU budget, recovery fund in deal with Poland, Hungary. European Union leaders unblocked today a 1.8 trillion euro financial package to help the economy recover from the pandemic-induced recession after reaching a compromise with Poland and Hungary, the chairman of EU leaders Charles Michel said. Our landmark recovery package will drive forward our green & digital transitions, Michel said on Twitter. (Source: Reuters)
December 10, 2020 “Merkeled” - in German, that neologism means to hedge, delay, dilute and fudge. The compromise was struck between Merkel's government, which currently holds the EU’s rotating presidency, and two other member states, Hungary and Poland. They’ve been threatening to veto the bloc’s seven-year budget and a pandemic recovery fund, worth a combined 1.8trillion euros. Budapest and Warsaw were holding the package hostage because they wanted to remove a mechanism that ties EU funds to observance of the rule of law. Here’s the fudge: the mechanism is still there in the text, unaltered, so the EU can say it stayed firm. But it’s been been neutered with additional “interpretations” so that it’ll almost certainly never be applied. That in turn allows Hungary and Poland to declare victory and let the EU’s money flow - not least, to them. The background is that Hungary for a decade and Poland for half as long have been whittling away at fundamental principles of liberal democracy, to which they acceded when they joined the EU in 2004. Stealthily and cynically, their governments have been infringing on judicial independence and more - enough for Brussels to launch formal proceedings against them under Article 7 of the European treaties. That process, however, is notoriously toothless, because sanctions against any member state would require a unanimous vote by the other 26, and Budapest and Warsaw have each other’s back. So the Netherlands and a few countries, as well as the European Parliament, insisted on an additional mechanism to be included in a historic budget-cum-stimulus deal struck in July. Almost as soon as that clause was written, the usual haggling broke out about what it could mean. Euro-hawks claimed it was straightforward: no rule-of-law, no money. Hungary and Poland threatened to sink the whole deal. So the merkeling started. In a first round of compromise, the wording was diluted so that the mechanism became almost useless. It now applies only to those rule-of-law breaches that directly corrupt the use of money from Brussels. It no longer has any bearing on all other violations, from cherry-picking judges to harassing journalists, academics or opponents. Even this gesture from Brussels, astonishingly, wasn’t enough to appease Budapest and Warsaw. Hence Merkel’s final fudge: On top of the mechanism’s previous dilution, there’s now also the prospect of indefinite delay. The clause won’t kick in until Hungary and Poland get a chance to take it to the European Court of Justice in Luxembourg. Those judges will take their sweet time, and a decision isn’t expected until mid-2022. Conveniently, this will come after Hungary’s parliamentary election, slated for early 2022. Some reports suggest that there may have been additional understandings in the compromise. Even after the Luxembourg court approves the rule-of-law mechanism, Hungary and Poland can probably appeal or deflect decisions, thus stretching them out forever. Portugal, which will take over the EU presidency on Jan. 1, may also bring the separate Article 7 proceedings to an official close. Viktor Orbán, Hungary’s prime minister, can therefore keep playing his cynical game of pocketing the European cash that buoys his economy while running a quasi-autocracy. His country is a big net beneficiary of the EU budget, and stands to get another 6.2 billion euros from the pandemic stimulus fund he’s so graciously allowing now. Poland can expect even more: It’s the single biggest net recipient of European money, and would get 23.1 billion euros on top from the stimulus. (Source: Kluth / Bloomberg)
10.12.2020, After long-haul negotiations, the EU leaders have reached a consensus on the budget package and the rule of law mechanism conditioning it, as Charles Michel, the President of the European Council announced on Twitter. A compromise was possible because the mechanism in question was combined with specific guidelines and conditions regarding its use. This allowed Poland and Hungary to withdraw their objection. In the conclusions from the summit it was stressed that the purpose of the conditionality rules was to protect the EU budget from fraud, corruption and conflict of interest. It was also mentioned that the mere finding of a violation of the rule of law is not a reason to trigger the conditionality mechanism. Furthermore, according to the arrangements of the summit, the mechanism cannot be launched before the Court of Justice has assessed compliance or non-compliance with EU law. Polish authorities refer to the summit conclusions as a guarantee mechanism for a regulation making the payment of EU funds dependent on the rule of law. The proposals are not legally, but politically binding. The entire financial package, comprising the Union budget for 2021-2027 and the pandemic recovery fund, amounts to almost EUR 2 trillion. Approximately EUR 123 bn in subsidies has been planned for Poland, including EUR 27 bn from the reconstruction fund. In addition, Poland can count on nearly EUR 32 bn in cheap loans from the fund. Earlier, Polish PM Mateusz Morawiecki and his Hungarian counterpart Viktor Orbán threatened to veto the EU's 2021-27 budget and the EUR 750bn post-pandemic recovery fund should the rule-of-law requirement be linked to the payments. Both states opposed the introduction of the rule-of-law principle, arguing it infringes upon their national sovereignty and their right to carry out judicial reforms. (Source: polandin / PAP)
2020. 12. 11. Az Európai Unió hosszú távú költségvetéséről és a koronavírus-járvány okozta károk helyreállítását célzó pénzalapról júliusban elfogadott megállapodás tegnap elért megerősítése mérföldkő a járvány elleni védekezés sikerében – jelentette ki a kormányfői fórum munkáját irányító Michel Charles, az Európai Tanács elnöke Brüsszelben, az uniós tagországok vezetőinek kétnapos tanácskozását követően, ma. Az elfogadott zárónyilatkozatba foglalt megállapodások és döntések az EU egységét, összetartozását és bizalmát mutatják és erősítik. Az elnök közölte: az EU-nak az oltóanyagok tagországok közötti méltányos és igazságos elosztásának kulcsfontosságú feladatára kell összpontosítania figyelmét. Az uniós tagállamok vezetői új éghajlatpolitikai célkitűzésekről egyeztek meg. A transzatlanti kapcsolatokban azonosítani kell azokat a területeket, amelyeken szorosabb szövetség alakítandó ki a közös értékeket valló országgal. A Földközi-tenger keleti medencéjében kialakult, illegális török szénhidrogén-kitermelés miatti konfliktussal kapcsolatban úgy határoztak: márciusig elkészülő jelentés alapján döntenek majd a következő lépésekről. Az EU továbbra is a szíriai menekültek befogadásához hajlandó pénzügyi segítséget nyújtani. Felszólították a török kormányt a migráció felelősségteljes kezelésére, az embercsempész-hálózatok elleni küzdelem fokozására. Von der Leyen, az Európai Bizottság elnöke közölte: az uniós források felhasználásához kötött jogállamisági feltételrendszer mechanizmusa 2021. január 1-től alkalmazandó, az Európai Bizottság ekkortól vizsgálja az idevágó eseteket. A tagállamok az Európai Uniós bírósághoz fordulhatnak a rendelet jogszerűségének ellenőrzésére. A bizottságnak időre lesz szüksége a feltételességi mechanizmus iránymutatásainak kidolgozásához. Beszélt arról, hogy az Egyesült Királysággal a megállapodás kilátásai rosszak, az egyezség elmaradásának nagyobb a valószínűsége. December 13.-ig derül ki, lehetséges-e megállapodásra jutni; a halászat szabályozása továbbra is kiemelkedő kérdés, nézetkülönbségek vannak. Merkel Angela, az Európai Unió Tanácsának soros elnökségét betöltő Németország kancellárja elmondta: a költségvetésről és a helyreállítási alapról szóló vita a kölcsönös bizalom légkörben zajlott, ami azt bizonyítja, hogy a tagállamok között húzódó, gyakran mély ellentétek ellenére - nyílt párbeszéd mellett – minden álláspont érvényesülhetett. Az éghajlatpolitikai célokról szóló egyezséget illetően arra hívta fel a tagállamok figyelmét, hogy a munka nagy része még hátra van, most a célok megvalósítását segítő nemzeti stratégiák kidolgozásának ideje kezdődik. Macron, francia elnök üdvözölte a Törökország elleni szankciók előkészítését. A csúcstalálkozón az Unió megmutatta cselekvőképességet, hiszen a legfontosabb területeken jelentős döntéseket hozott. Costa António portugál kormányfő ma kiemelte: a helyreállítási terv végrehajtása a január elsejétől hivatalba lépő soros portugál EU-elnökség egyik fő prioritása lesz. (Forrás: MTI)
Dec 10, 2020 Over the past year, Turkey has reinforced the Tripoli-based Government of National Accord with militia forces recruited in Syria, sent military trainers and shipped large quantities ofhardware to prop up the administration. The United Nations has called on all sides in the conflict to expel foreign militias and comply with embargoes to cease resupplying the country’s many militias. Turkey recently shipped large quantities of weapons to Libya in possible breach of arms embargoes. The UN maritime mission to halt illegal weapons shipments to Libya have stopped and searched Turkish ships. Last month, Operation Irena, the UN mission to enforce an arms embargo on the conflict-riven nation, authorised the German navy to search the Turkish cargo ship Rosaline A. Turkey managed to stop German commandos from boarding the ship, claiming that it was simply an aid shipment. Now it appears Ankara is flying in equipment despite peace talks. Flight data suggests ongoing Turkish military air bridge to Libya. Flight tracking service Flight24 shows that Turkish military airlifts are ongoing to the Tripoli government, overflying and avoiding naval Operation Irena. On December 4, an Airbus A400M Atlas – a large cargo plane capable of carrying 116 fully equipped soldiers, landed at Tripoli airport. Open-source satellite imagery analysis account Observer IL has suggested that Turkey may have used the A400 to fly “MRAPs,” or Mine Resistant Armoured Personnel carriers, to GNA forces. Satellite imageries from 30.11.20 and 04.12.20 show the arrival of 26 Infantry Vehicles (Possibly MRAP's). Internationally supported peace talks, held remotely, are ongoing and there are now plans to hold national elections, which could herald a lasting political settlement. But the recent evidence of Turkish arms transfers to the GNA will raise fears that rival groups are preparing for the possibility that talks will fail. In December 7, there were reports that GNA forces were manoeuvring near the city of Sirte, located on the war's now frozen front line. (Source: thenationalnews) /UAE/
United Arab Emirates
December 9, 2020 UAE announced the official registration of Beijing Institute of Biological Product’s inactivated COVID-19 vaccine. The UAE’s Ministry of Health and Prevention (MOHAP) in collaboration with Department of Health Abu Dhabi (DOH) have reviewed Chinese Sinopharm CNBG’s interim analysis of the phase III trials which shows Beijing Institute of Biological Product’s inactivated vaccine to have 86% efficacy against COVID-19 infection. The analysis also shows the vaccine to have 99% seroconversion rate of neutralizing antibody and 100% effectiveness in preventing moderate and severe cases of the disease. Furthermore, the analysis shows no serious safety concerns. This vaccine was granted Emergency Use Authorisation (EUA) since September by MOHAP to protect frontline workers most at risk of COVID-19. The UAE is conducting Post Authorisation Safety Study (PASS) and Post Authorisation Efficacy Study (PAES) of its EUA programme. These ongoing studies show similar safety and efficacy profiles as the interim analysis. The EUA vaccination programme has effectively safeguarded the UAE frontline workers. (Source: gulftoday)
Dec 11, 2020 The federal Liberals have announced financial support for anyone who suffers an 'adverse reaction' from a COVID-19 vaccine approved by Health Canada. t’s unclear what the program might actually look like, but Trudeau told reporters it would be to support those who experience an “adverse reaction.” As the government points out, adverse reactions from vaccines are incredibly rare. For example, anaphylaxis or a severe allergic reaction, occur in one in 760,000 vaccinations, according to an article in the Canadian Medical Association Journal. Mild reactions - such as swelling around the injection site - are common, as the body reacts to build immunity, says the Public Health Agency of Canada in the news release. Quebec is the only province in Canada that already has a vaccine compensation program. Between 1985 and 2018, the province disbursed $5.4 million in 43 cases; there had been 228 claims, 187 of which were deemed likely enough to be evaluated. (Source: nationalpost)
Dec. 9, 2020 “Long-haulers” continue to suffer the consequences of the disease months later or whether the symptoms will stay with them for the rest of their lives. But public health experts say it’s increasingly clear that many thousands of patients face long-term effects from the virus. A Canadian woman has been sick with COVID-19 for nearly 9 months. Canadian criminal attorney Antonio, 35, with no underlying conditions contracted COVID-19 in late March. Her best guess is that she caught the virus on a run to the grocery store, and began feeling symptoms around March 25. She did not have a cough, which doctors and health experts then said was one of COVID-19′s main symptoms. She fought against the common symptoms that come with most cases: fever, body aches, fatigue, headaches. She’d manage her symptoms at home and eventually overcome them. The symptoms never really went away - they intensified. She has been in and out of the hospital four times in almost nine months. Every time she thought she was recovering, symptoms would return. In the next three months, old symptoms and new, graver ones left Antonio tied to her couch. The fatigue was so bad she could only shower a couple of times a week. Her blood oxygen levels would drop dangerously low whenever she took short steps. One day, her brain was so foggy that she could not remember how to hold a glass. It wasn’t until mid-May when she was taken to the emergency room for the first time. Alone in her bedroom and fighting a high fever, Antonio began hallucinating. Then, she could not feel half of her body nor her face. The hospital tested her for COVID-19, but her results came back negative so she was sent home. About a week later, she was back. She would return two more times in the following months. In June, she tested positive for COVID-19 antibodies. In July, doctors at a clinic for coronavirus survivors diagnosed her with arthritis and a condition that causes her heartbeat to raise significantly when standing. Joining a Facebook group she learned, for example, that she wasn’t alone in smelling cigarettes when no one was smoking near her. Other people experienced random smells too, they told her. "It was very comforting to know that I wasn’t alone.” “I had a lot of questions and the doctors didn’t have a lot of answers. It was all so new to everyone,” Antonio said. in August, she voluntarily returned to the law firm where she works. Some days, she feels OK. But the increased heart rate, shortness of breath, joints pain and headaches are usually daily ailments. She also still suffers from a blurry vision and gets skin rashes. Her doctors have now told her it’s possible that her long-term symptoms will come and go for the rest of her life. Clinicians have learned the long-term effects can impact both the old and the young, regardless of whether the case was mild or required hospitalization. (Source: SeattleTimes)
Dec 12, 2020 The Food and Drug Administration (FDA) last night announced it has issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, allowing shipments to begin across the country - the emergency use authorization allows the vaccine to be distributed in the U.S. The FDA typically follows the recommendations of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The FDA's review of the vaccine doesn't end with the EUA and that it will continue to comb through the data and collaborate on safety monitoring as the company seeks full approval for the vaccine. The FDA EUA approval sets the stage for immunization to begin with the first doses, which will target healthcare workers and nursing home residents. This afternoon, the vaccine advisory group of the Centers for Disease Control and Prevention (CDC) is meeting in an emergency session and will vote on whether Americans should receive the vaccine. (Source: CenterforInfectiousDiseaseResearch / UniversityofMinnesota)
12/12/2020 Trucks will roll out tomorrow, Sunday morning as shipping companies UPS and FedEx begin delivering Pfizer’s vaccine to nearly 150 distribution centers across the states, said Army Gen. Perna of Operation Warp Speed, the Trump administration’s vaccine development program. An additional 450 or so facilities will get the vaccine between December 15 and 16. The first shipments are expected to leave Pfizer’s manufacturing plant in Kalamazoo, Michigan, via truck and then be flown to regional hubs around the country. Medical distributor McKesson and pharmacy chains including CVS and Rite-Aid also are involved in local rollout. Initially, about 3 million shots are expected to be shipped nationwide. A similar number of shots will be held back for those recipients’ second dose, which is needed for full protection from COVID-19. Distribution locations include hospitals and other sites able to meet the ultra-cold storage requirements. Within three weeks, vaccines should be delivered to all vaccination sites identified by state governments, such as local pharmacies, Perna said. The Trump administration pressured the agency up until the final announcement. A top White House official even threatened to remove FDA chief Hahn if a ruling did not come before today. Concerns that a shot was rushed out could undermine vaccination efforts in a country with deeply ingrained skepticism about vaccines. The Trump administration contends the current orders plus those in the pipeline will be enough to accommodate any American who wants to be vaccinated by the end of the second quarter of 2021. (Source: France24 / AP)
Dec. 10, 2020 The Vaccines and Related Biological Products Advisory Committee, a key Food and Drug Administration advisory panel voted 17 to 4 with one member abstaining today to recommend the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use. The committee recommended emergency authorization of the vaccine for people who are 16 years old and older. An EUA isn’t the same as a full approval, which can typically take months. The FDA could grant emergency use authorization which generally allows a drug or vaccine to be administered to a limited population or setting, such as to hospitalized patients, as the agency continues to evaluate safety data. The FDA said today that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems. Prior to the vote, some experts in the meeting argued to limit its recommendation to people who are at least 18, saying the safety data on 16- and 17-year olds was “thin.” FDA vaccine reviewer Dr. Wollersheim noted the trial data showed a “numerical imbalance” in cases of Bell’s palsy, a condition that causes a temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. While the frequency of cases was not above that of the general population, the FDA recommended further surveillance if the vaccine is authorized for more broad use. Pfizer has submitted only two months of follow-up safety data, but the agency usually requires six months for full approval. U.S. officials say they are prepared to distribute the vaccine within 24 hours of authorization. Initial doses will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. Pfizer has said it plans to ship 50 million vaccine doses this year, enough to inoculate 25 million people. The vaccine is expected to be distributed in phases, with the most critical U.S. workers and vulnerable people getting it first. The Centers for Disease Control and Prevention has provided states with an outline that recommends prioritizing health-care workers and nursing homes first, but states can distribute the vaccine as they see fit. U.S. officials plan to continue watching for any adverse reactions to Pfizer’s vaccine in the health-care workers and nursing home residents who receive it. President Trump’s coronavirus vaccine czar, Dr. Slaoui, has said the U.S. should be able to distribute enough coronavirus vaccine doses to immunize 100 million Americans, nearly a third of the U.S. population, by the end of February. He has said the entire U.S. population could be vaccinated against Covid-19 by June. Pfizer said last week its full-scale production lines in the U.S. and Europe are now complete and it is “confident” it will be able to supply the targeted doses. (Source: CNBC)