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A dose of the coronavirus disease (COVID-19) vaccination of BioNTech and Pfizer is pictured in this undated handout photo, as Britain became the first western country to approve a COVID-19 vaccine, in Mainz, Germany - Sputnik International

Live Updates: US FDA Authorizes Pfizer-BioNTech Coronavirus Vaccine for Emergency Use, Report Says

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Multiple nations have announced vaccination plans, as the recent results of phase III trials show high efficacy of the medications developed by Russia's Gamaleya Institute and Pfizer/BioNTech, while many other vaccines are also undergoing serious tests.

The number of those infected by the coronavirus continues to rise, reaching 69.5 million, while the death toll is over 1,580,000, according to Johns Hopkins University. The most affected countries are the US (over 15.6 million cases, 292,000 deaths), India (9.7 million infections, more than 141,000 fatalities), and Brazil (over 6.7 million cases, and a death toll of over 179,000).

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02:38 GMT 12.12.2020
02:33 GMT 12.12.2020
02:20 GMT 12.12.2020

The US Food and Drug Administration (FDA) has issued an authorization for the emergency use of Pfizer’s vaccine against the coronavirus, The New York Times newspaper reported citing its sources.

Millions of most vulnerable people will be vaccinated within the upcoming days, the newspaper adds.

The World Health Organization declared the COVID-19 outbreak a pandemic on March 11. To date, more than 70.1 million people have been infected with the coronavirus worldwide, with over 1.59 million fatalities, according to Johns Hopkins University.

The United States remains the worst-hit nations, with more than 15.8 million confirmed cases and over 294,000 fatalities.

01:08 GMT 12.12.2020
01:06 GMT 12.12.2020
00:37 GMT 12.12.2020
22:23 GMT 11.12.2020

The International Monetary Fund said in a statement that it has completed its third review of Armenia's Stand-By-Arrangement that will allow Yerevan to draw additional $37 million in coronavirus-related aid, bringing to $332 the total extended to the country since the start of the pandemic.

"The Executive Board of the International Monetary Fund (IMF) completed the third review of the Republic of Armenia’s performance under the program supported by the Stand-By Arrangement (SBA)," the IMF said on Friday. "The completion of the review will allow the authorities to draw SDR 25.714 million (about US$37 million), bringing total disbursements to SDR 231.7 million [about US$332 million]."

The IMF said in the statement that the impact of the measures to deal with the coronavirus outbreak was expected to force the Armenian economy to contract 7.25 percent in 2020, ending a recent period of high economic growth.

The financial support will help Armenia mitigate hardship from the measures undertaken to address the pandemic, the IMF added.

Armenia’s economic outlook was generally positive beyond the impact of the novel coronavirus, according to the IMF.

21:39 GMT 11.12.2020

The number of people, who have died of the coronavirus in Brazil, has risen by 646 to 180,411 within the past 24 hours, the national Ministry of Health said.

Within the same period of time, the number of confirmed cases has increased by 53,030 to 6,834,829.

The World Health Organization declared the COVID-19 outbreak a pandemic on March 11. To date, more than 70 million people have been infected with the coronavirus worldwide, with over 1.58 million fatalities, according to Johns Hopkins University.

Brazil comes third in terms of the number of confirmed cases, following the United States and India.

21:38 GMT 11.12.2020
21:04 GMT 11.12.2020

The worldwide number of confirmed COVID-19 cases has surpassed 70 million, Johns Hopkins University says.

The exact number of the coronavirus cases stood at 70,000,538 as of 21:00 GMT on Friday. More than 1.58 million people have died of the disease, the university added.

 The World Health Organization declared the COVID-19 outbreak a pandemic on March 11. The biggest number of cases so far have been registered in the United States, India and Brazil.

21:04 GMT 11.12.2020
20:56 GMT 11.12.2020

The Russian Direct Investment Fund (RDIF) has provided the Mexican regulator with all documents required for the launch of phase 3 clinical trials of the Sputnik V COVID-19 vaccine in the Latin American country, Russian Ambassador Viktor Koronelli said on Friday.

"The RDIF recently provided the regulator with all the necessary documentation to get approval to conduct part of phase 3 clinical trials here [in Mexico]. We look forward to a positive response in the next few days, after which the matter will move into the logistics phase," Koronelli told reporters.

According to the diplomat, Mexico should either participate in phase 3 clinical trials itself — with some 500 volunteers — or receive data from the third country, which had at least 30,000 volunteers tested to get the regulator's approval for the vaccine imports.

"Mexico, like a number of other countries, will have a basket of many products, and I think Sputnik V has every chance of being in this basket along with other vaccines ... The prospects are good, although it is obvious that competition between manufacturers and laboratories is quite harsh," Koronelli noted.

In September, the RDIF said that it had reached an agreement with the Mexican Landsteiner Scientific pharmaceutical company on delivering 32 million doses of the vaccine to the Latin American country. The Mexican Embassy later told Sputnik that the agreement was of a business-to-business nature and that the Mexican government was not involved in the deal.

Mexico is also working on acquiring other COVID-19 vaccines such as the United Kingdom's AstraZeneca, the Unites States' Pfizer and China's CanSino Biologics, among others.

20:07 GMT 11.12.2020

Moscow has registered 76 deaths of patients infected with COVID-19 over the past 24 hours, bringing the Russian capital's death toll to 9,798, the city's coronavirus response center said in a statement on Friday.

"Another 76 patients, who were diagnosed with pneumonia and tested positive for the coronavirus infection, died in Moscow," the center said.

In the previous day, 77 people infected with the coronavirus died in Moscow.

19:54 GMT 11.12.2020

The White House has told US Food and Drug (FDA) Commissioner Stephen Hahn to provide emergency use authorization for the Pfizer coronavirus vaccine by the end of Friday or resign from his post, the Washington Post reported citing anonymous sources.

White House Chief of Staff Mark Meadows spoke with Hahn as the FDA deliberated on whether the approval for the vaccine given by an agency panel vouched for its safety. The FDA issued a draft report on Tuesday noting more than 20 side effects from the use of the vaccine, including death, stroke, heart attack, autoimmune disease and facial paralysis.

Earlier in the day, President Donald Trump tweeted that the FDA is "a big, old, slow turtle" in its handling of vaccines, while exhorting Hahn to "get the dam vaccines out NOW" and "stop playing games and start saving lives."

19:53 GMT 11.12.2020

The World Health Organization (WHO) is encouraged by the growth in the number of vaccines against COVID-19 that have performed well in clinical trials, although the organization remains concerned by the limited number of doses currently available, Bruce Aylward, a senior WHO adviser, said on Friday.

A handful of candidate vaccines against COVID-19 have reported efficacy levels of greater than 90 percent in clinical trials, and Aylward noted that multiple vaccine platforms have shown strong results.

"If you look week by week at the number of companies that are announcing positive results in terms of the efficacy of vaccines, that number is increasing and what's important is it's increasing not just in terms of the number of products, but also the different technology platforms that they are being built on. As we've seen now, there are three different sorts of technology platforms, as we call them, that have reported very positive efficacy and safety data," the WHO senior adviser told a media briefing.

Over the past week, US media outlets reported that Pfizer is unlikely to meet its original supply targets for its vaccine against COVID-19, which is produced in conjunction with German firm BioNTech, due to supply chain issues.

GlaxoSmithKline and Sanofi also announced earlier on Friday that their candidate vaccine will likely not be available until the end of 2021 due to disappointing trial results, and Aylward noted the WHO's concern over the actual number of available vaccine doses.

"But at the same time ... there are real challenges with volumes. These are still very, very scarce products. And just as some companies are announcing successes, there are others - and we've had two over the last few days - that have said they've had challenges with their products either in terms of the volumes they can produce or in terms of some of the trial results," the WHO senior adviser said.

At the same media briefing, WHO Director-General Tedros Adhanom Ghebreyesus expressed his belief that more countries will begin their mass coronavirus disease vaccination programs in the near future.

18:46 GMT 11.12.2020
18:15 GMT 11.12.2020

WASHINGTON, (Sputnik) - The US Food and Drug Administration has informed the Centers for Disease Control and Prevention (CDC) and the Trump administration’s Operation Warp Speed that it is working on quickly issuing emergency use authorization for the coronavirus vaccine, FDA Commissioner Stephen Hahn said in a release on Friday.

"Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization," the release said. "The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution."

Earlier on Friday, US Health Secretary Alex Azar has said the federal authorities intend to authorize the Pfizer coronavirus vaccine so that Americans may start getting vaccinated as early as next week.

An FDA advisory committee approved the Pfizer coronavirus vaccine on Thursday. However, the FDA also published a draft report on the vaccine on Tuesday acknowledging that it may cause more than 20 side effects, including seizures, strokes, heart attacks, meningitis, and others. Six people have died during the vaccine trials.

The Pfizer vaccine is expected to be rolled out as soon as Friday to healthcare workers and long-term nursing home residents via a massive mobilization effort carried out by the US Army under the Operation Warp Speed project.

People who get a coronavirus vaccine should get a second vaccine shot 21 or 28 days after the first one, according to the manufacturers.

17:21 GMT 11.12.2020
17:06 GMT 11.12.2020

GENEVA, (Sputnik) - Switzerland's health minister urged Europeans on Friday not to go to the Alpine nation for ski trips this winter as the country struggles to contain the epidemic.

"We want to call on our European friends, our neighbors, not to come for skiing this season. We have reserved this option for our own population," Alain Berset said at a press conference.

The Swiss government ordered restaurants, bars, shops and markets to close at 7 p.m. starting Sunday across most of the country. Sports lovers will be able to practice in groups of up to five. Limits will stay in place until January 22.

Berset warned that the government was ready to tighten restrictions if the existing guidelines were ignored. He said Switzerland did not yet have enough vaccine doses to immunize the population.

16:59 GMT 11.12.2020

MOSCOW, (Sputnik) - The World Health Organization (WHO) will give its assessment of Pfizer's COVID-19 vaccine dossier in a couple of weeks, WHO Chief Scientist Soumya Swaminathan said at a briefing on Friday.

"We are now going to be looking at the Pfizer dossier followed by a couple of others as they come in. We work very closely with the European Medicines Agency along with some other national regulatory agencies. So we expect that in the next couple of weeks that our committees will be reviewing the Pfizer/BioNtech dossier and coming out with their opinion," she said.

The organization will then also assess vaccines of other Western pharmaceutical companies, Swaminathan said.

"We expect also to have Moderna followed by Astrazeneca dossiers in the next few weeks and we will come with the decision, whether it is receiving an emergency use license or not," the chief scientist added.

16:53 GMT 11.12.2020
16:49 GMT 11.12.2020
16:42 GMT 11.12.2020
15:57 GMT 11.12.2020

MADRID, (Sputnik) - Spain urges the European Commission to conduct COVID-19 vaccination in the bloc simultaneously, with the start dates no farther than one week apart, Prime Minister Pedro Sanchez said on Friday after the EU leader summit.

European Union leaders gathered on Thursday and Friday in Brussels for the last two-day summit planned for this year. One of the main issues discussed was the vaccination strategy that the European Union will adopt after the European Medicines Agency (EMA) approves the first doses to immunize European citizens against COVID-19.

"One of the conclusions is to try to strengthen coordination in the vaccination strategy. There have been a number of countries, including Spain, that have asked the European Commission and member states to start vaccination in on the same week, if not on the same day. Because it is very important to share information about the vaccination process and inform the citizens of Spain and all European citizens," Sanchez said after the summit of EU leaders at a press conference in Brussels, which was broadcast by 24 Horas TV channel.

Spain has ordered 140 million doses of vaccines through the EU distribution system, enough for the vaccination of 80 million people, over and above Spain's population of 47 million people. The authorities expect that 15-20 million Spaniards will be vaccinated by May-June.

Vaccination in Spain is to start in January and will be conducted in three stages. At the first stage, about 2.5 million people will be vaccinated, among them residents and employees of nursing houses and centers for people with disabilities and medical workers. The second stage is expected to last from March to June. At the third stage, the Ministry of Health expects all population groups to get the vaccine.

15:08 GMT 11.12.2020
14:59 GMT 11.12.2020
13:39 GMT 11.12.2020

WASHINGTON, (Sputnik) - US Health Secretary Alex Azar has said on Friday the federal authorities intend to authorize the coronavirus vaccine produced by Pfizer and Americans may start getting vaccinated as early as next week.

"Just a little bit ago the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccines, so in the next couple of days probably as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately we should be seeing the authorization of this first vaccine," Azar said. "[W]e will work with Pfizer to get that shipped out and so we could see people getting vaccinated Monday, Tuesday of next week."

Azar said some 20 million Americans may be vaccinated in the next coming weeks and up to 50 million by the end of January.

"We believe we could have 100 million vaccinations in arm by the end of February," Azar added.

On Thursday, a Food and Drug Administration (FDA) advisory panel approved Pfizer's coronavirus vaccine. However, the FDA also published a draft report the vaccine on Tuesday acknowledging that it may cause more than 20 side effects, including seizures, strokes, heart attacks, meningitis, and others.

The Pfizer vaccine is expected to be rolled out as soon as Friday to healthcare workers and long-term nursing home residents under a massive mobilization effort carried out by the US Army under the Trump administration "Operation Warp Speed" project.

People who get one of the two coronavirus vaccines should get their second shot 21 or 28 days after the first one, according to the manufacturers.

13:29 GMT 11.12.2020

MOSCOW (Sputnik) - Russia's Vector Centre plans to introduce 10,000 doses of its vaccine EpiVacCorona into civil circulation every remaining week in December, and found an industrial partner to scale up production, the centre's director, Rinat Maksyutov, said on Friday.

“In the future, every week before the new year, we expect to introduce into civil circulation 10,000 doses of vaccine every week”, Maksyutov told reporters.

He specified that an industrial partner, Geropharm, would help to scale up production, one of the key components of the vaccine will be produced there.

Vector has already produced 50,000 doses of coronavirus vaccine EpiVacCorona, 7,800 have been introduced into civil circulation and delivered to regions, Maksyutov also said.

The vaccine was delivered to Moscow, St. Petersburg, Rostov-on-Don, Tula, he added.

13:04 GMT 11.12.2020
12:47 GMT 11.12.2020

MOSCOW (Sputnik) - Darknet vendors are selling products they claim to be vaccines against COVID-19 for up to $250, the Check Point Software Technologies company said in a blog post on Friday.

The software firm said that it had been in touch with several Darknet vendors, who are asking to be paid in Bitcoin for unspecified vaccines against the coronavirus disease. The seller also allegedly said that 14 doses of the vaccine were required, despite most manufacturers offering vaccines against COVID-19 in two shots.

"The range of medicines advertised by these vendors is extensive, from 'available corona virus vaccine $250' to 'Say bye bye to COVID19=CHLOROQUINE PHOSPHATE' to 'Buy fast.CORONA-VIRUS VACCINE IS OUT NOW'", Check Point said in the blog post.

12:30 GMT 11.12.2020

Russia’s state centres for genetic research were asked to use gene technology to create new coronavirus diagnostics, treatments and vaccines, the deputy prime minister’s office said Friday.

"At the president’s order, the presidium of the Council [for Genetic Technology] approved changes to agendas of genetic centers", the office of Tatyana Golikova, a former Russian health minister, said in a press release.

The centre specialising in genome editing has been asked to produce cellular and animal models for testing potential vaccines and medicines against COVID-19 as well as methods to detect the virus.

"The centre has already developed, certified and started producing a testing system called Coronapass that detects antibodies in recovered COVID-19 patients, and has created a new line of transgenic mice for testing vaccines and treatments", the release read.

Centres will study whole-genome sequencing of SARS-CoV-2 strains circulating in Russia. The Kurchatov genome centre was tasked with making a rapid coronavirus test within a year based on an enzyme they created.

12:12 GMT 11.12.2020
11:43 GMT 11.12.2020

Almost half of adults in the United Kingdom say their mental health has been affected by the coronavirus pandemic, with the trend is especially pronounced among those with prior experience of depression and anxiety, the Office for National Statistics (ONS), a non-ministerial body that reports to the country's parliament, said Friday.

The ONS published the latest data from its Opinions and Lifestyle Survey on Friday, including data on the pandemic's impact on mental health. The most recent dataset on those issues was collected in three stages between 11 and 29 November and includes 12,426 adults. The data were weighted based on the November 2020 population estimates.

"Almost half of adults (48%) reported that their well-being was being affected by the pandemic; this increased to 81% for those who had experienced some form of depression and/or some form of anxiety", the ONS said in a statement.

According to the ONS analysis, in November, 19 percent of adults suffered from some kind of depression, while 17 percent of adults experienced anxiety.

"It’s also interesting to see that since late October, more adults say they believe life will return to normal within six months. However a lower proportion of adults experiencing some form of anxiety and/or depression felt this was the case", ONS Principal Research Officer Tim Vizard said.

Opinions and Lifestyle Survey is an omnibus survey that is conducted eight months a year and covers a variety of topics

11:21 GMT 11.12.2020
11:21 GMT 11.12.2020

Russian Prime Minister Mikhail Mishustin pledged on Friday that the country would start COVID-19 vaccination in the end of the week and authorities would not miss the deadline.

"I can say today that we meet the deadline. The first batches of the vaccine have already been sent to regions, we are gradually nearing the output targets", Mishustin told coronavirus vaccine producers.

Russian President Vladimir Putin has ordered that mass vaccination be launched this week. On Thursday, Moscow Mayor Sergei Sobyanin said that over 6,000 residents of the Russian capital had already been vaccinated. Doctors, teachers and social services staffers are the first in line to receive the vaccine.

11:12 GMT 11.12.2020

WARSAW (Sputnik) - Poland expects to vaccinate about 500,000 people against the coronavirus with the vaccine jointly developed by Pfizer and BioNTech in January, the head of the Polish Prime Minister's Chancellery, Michal Dworczyk, told Polskie Radio on Friday.

"Pfizer, the company that has the chance to be the first to register its vaccine, says that in September, about 1,100,000 doses of the vaccine may be delivered to Poland", Dworczyk said, adding that if successful, Poland "can vaccinate about 500,000 people in January”.

The official added that the number of COVID-19 vaccine doses delivered to Poland by Pfizer and other vaccine producers would increase every month. Starting February, the country is set to receive an average of 2-2.5 million doses of the vaccine every month.

11:07 GMT 11.12.2020
11:06 GMT 11.12.2020

"I can say today that we meet the deadline. The first batches of the vaccine have already been sent to regions, we are gradually nearing the output targets", Mishustin told coronavirus vaccine producers.

10:57 GMT 11.12.2020

"Every week counts ... many EU leaders have supported me in this", Poland's Prime Minister Mateusz Morawiecki stated.

10:52 GMT 11.12.2020

ATHENS (Sputnik) - Greece has decreased the mandatory quarantine for people coming to Greece from abroad for the Christmas holidays starting 18 December from ten days to three, government spokesman Stelios Petsas said on Friday.

The ten-day quarantine was announced by Greece on Monday.

"The obligatory preventive quarantine for all travelling to Greece from foreign countries and entering the country starting 18 December 2020, to 7 January 2021, has been limited from ten days to three days", Petsas said at a briefing.

10:16 GMT 11.12.2020

"We aim to authorise the BioNTech/Pfizer vaccine by the end of the year, subject to [European Medicines Agency] EMA's opinion. EMA's opinion on the Moderna vaccine should come before mid-January, and rolling review of data for AstraZeneca/Oxford and Johnson& Johnson's vaccines is ongoing", von der Leyen told a press conference following an EU summit.

10:00 GMT 11.12.2020

Prominent South Korean film director Kim Ki-duk died in Latvia from coronavirus complications, Latvian media reported on Friday.

According to Delfi news portal, the winner of Cannes, Berlin and Venice international film festivals arrived in Latvia on 20 November, and on Friday it was revealed that he died from the COVID-19-related complications.

Delfi reported that the filmmaker, aged 59, wanted to purchase a house in Jurmala and obtain a residence permit, but did not appear at a scheduled meeting, after which his worried colleagues started searching for him in hospitals across Latvia, which was quite complicated due to personal data protection regulations.

09:57 GMT 11.12.2020

 Saudi Arabia's Food and Drug Agency (SFDA) said that it had approved the registration of the COVID-19 vaccine developed by the US' Pfizer and Germany's BioNTech pharmaceutical companies for use in the Arab country.

"Following thorough discussion of all technical and scientific parameters, it was decided to authorise the registration of the vaccine by Pfizer and BioNTech and its use", the agency said on Thursday in a statement, as cited by the official Saudi Press Agency.

The timeframe for the deliveries of the vaccine will be announced later, the SFDA added.

In November, the authorities said that the vaccination would be free of charge for all citizens of the kingdom and is projected to start in late 2020 or early 2021.

09:55 GMT 11.12.2020

Kremlin spokesman Dmitry Peskov said on Friday that some countries and major pharmaceutical companies are trying to prevent market entry of the Russian coronavirus vaccine Sputnik V through "dirty" methods, while politicisation of the matter is inadmissible.

"This is fine as long as this is fair competition, but I believe there should not be much competition in this market. Politicised competition and dirty methods for discrediting our vaccine are a different thing", Peskov noted.

Sputnik V is the world's first registered vaccine against COVID-19, the Kremlin spokesman recalled, praising it as "safe, reliable and in demand."

"Some countries and their pharmaceutical giants try to prevent our vaccine's market entry, and they indeed resort to some unpleasant methods sometimes. This is common knowledge", Peskov added.

Earlier in the day, the Russian Defence Ministry's spokesman, Igor Konashenkov, said that foreign nations were allocating funds to discredit Russia's Sputnik V vaccine through pseudo-analytical investigations. When asked if the Kremlin agrees with Konashenkov's statement, Peskov said "these aspirations stand out a mile" and also admitted "tough competition" in vaccine development.

09:44 GMT 11.12.2020
09:23 GMT 11.12.2020
08:45 GMT 11.12.2020

"The only chance to regain control of the situation is a lockdown, but this must happen immediately. If we wait until Christmas, we'll have to struggle with high numbers for months", Interior Minister Horst Seehofer told the magazine Der Spiegel.

08:26 GMT 11.12.2020
07:44 GMT 11.12.2020

Russia has registered 28,585 COVID-19 cases in the past 24 hours, up from 27,927 the day before, bringing the total to 2,597,711, the federal response centre said on Friday.

"In the past 24 hours, Russia has confirmed 28,585 COVID-19 cases in 84 regions, of which 4,600 (16.1 percent) were detected with people showing no clinical symptoms", the response centre said, adding that the case count has reached 2,597,711.

Moscow confirmed 7,215 new coronavirus cases over the given period, up from the 6,730 the day before. The Russian capital was followed by St. Petersburg with 3,779 cases, up from the 3,774 the day before, and the Moscow Region with 1,370 new cases, up from the 1,351 the day before.

No new cases were registered in the Chukotka Autonomous Region.

The response centre reported a new record of 613 coronavirus fatalities, up from 562 the day before, raising the country's death toll to 45,893.

As many as 26,171 coronavirus patients were confirmed to have recovered, up from 25,877 the day before, bringing the total to 2,059,840.

07:07 GMT 11.12.2020
06:23 GMT 11.12.2020

"Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine programme to improve immune response in older adults", a statement from the French and British companies read.

06:12 GMT 11.12.2020
05:21 GMT 11.12.2020

"Doctors planning to leave for military service, crews on Navy vessels, flight personnel from the Russian Aerospace Forces, combat crews from the Strategic Missile Forces and command posts of all levels, and commanders of armed forces' units are the first in line to receive the vaccine", Russian Defence Ministry spokesman Maj. Gen. Igor Konashenkov said.

05:11 GMT 11.12.2020
05:00 GMT 11.12.2020
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