EU regulator to approve BioNTech's COVID-19 vaccine on Dec. 23 - source

The headquarters of the European Medicines Agency (EMA), is seen in London
The headquarters of the European Medicines Agency (EMA), is seen in London
By Andreas Rinke

By Andreas Rinke

BERLIN (Reuters) -The European Medicines Agency (EMA) is set to issue a positive verdict on the first COVID-19 vaccine on Dec. 23, a German government source told Reuters on Tuesday, putting EU countries on track to catch up with the United States and Britain, where immunisation campaigns are underway.

"Yes, the EMA will be done on December 23," the source said, referring to the watchdog's review of Pfizer BioNTech's vaccine.

German Health Minister Jens Spahn also told a news conference that he hoped European Union approval for the vaccine would be in place before Christmas, clearing a path for innoculations before the end of the year.

EMA said in early December it planned to issue its view on the BioNTech/Pfizer vaccine by Dec 29, and on another inoculation developed by Moderna by Jan. 12.

The vaccine is already being rolled out in countries including the United States, Britain and Canada, following positive verdicts by regulators there.

A spokeswoman for EMA reiterated that the watchdog would rule on the compound by Dec. 29 at the latest under the ongoing rolling review of a request for conditional marketing approval.

BioNTech was not immediately available to comment.

EMA's mandate is to issue recommendations on new medical treatments. The European Commission has the final say on approval and typically follows EMA's advice.

German newspaper Bild earlier reported that a positive EMA verdict was slated for Dec 23, citing government and European Commission sources. Bild added that Dec. 26 was seen a possible launch day for vaccinations in Germany.

(Additional reporting by Thomas Seythal, Ludwig Burger and Patricia Weiss; editing by Thomas Escritt)

Latest Stories

  • Biden coughs his way through first speech since being confirmed as president-elect: ‘Hand him a glass of water!’

    President-elect Biden blamed his throat clearing and coughing on a little cold

  • Hunter Biden Email Reportedly Shows $400,000 in Unreported Income from Burisma

    Hunter Biden failed to report “approximately $400,000” in income he received from his role on the board of Ukranian natural gas firm Burisma Holdings upon joining in 2014, according to a new report.Hunter Biden’s former business partner Eric Scherwin, then-president of Rosemont Seneca, told the president-elect’s son he would need to “amend” his 2014 returns to include the “unreported” income, according to NBC News. "In 2014, you joined the Burisma board and we still need to amend your 2014 returns to reflect the unreported Burisma income," Scherwin reportedly wrote to Hunter Biden in a January 16, 2017 email.  "That is approximately $400,000 extra so your income in 2014 was closer to $1,247,328."NBC reported that the emails were made available by Rudy Giuliani’s attorney Robert Costello, who said he was given a copy of one of Hunter Biden’s hard drives from the owner of a computer repair shop in Delaware. It was unable to confirm the email’s authenticity, as was Fox News, which also viewed the email.The report comes after Biden last week confirmed he was under federal investigation for his “tax affairs.”Scherwin said in the email that in 2013 Biden’s taxes reported “$833,614 in income,” in 2014 “your taxes reported $847,328 in income. (To be amended at $1,247,328),” and in 2015 reported $2,478,208 in income.”Scherwin wrote that 2013 and 2014 were “normal years” when Hunter Biden's income “was based pretty much solely on income from Rosemont Seneca and Boies.”He detailed Hunter Biden’s “increased income in 2015,” noting that he received “$166,666 from Burnham (for RSA), $216,000 from Boies, $365,403 from Owasco (for RSA), $300,000 one time payment from Eudora (for the 1/3 of CitizensRx).”“The above represents all the cash you received directly,” Scherwin wrote. “In addition, you reported $1,000,000 of income that all went to RSB and you reported $188,616 in income that also went to RSB.” He continued: “You didn’t receive this in cash and it is in reality 'phantom income.'” “Since you couldn’t have lived on approximately $550,000 a year, you ‘borrowed’; some money from RSB in advance of payments," he added.The email appeared to be part of a discussion between Scherwin and Hunter Biden regarding his divorce, according to Fox News.Last week Hunter Biden said in a statement that he had learned "for the first time that the U.S.  Attorney’s Office in Delaware advised my legal counsel" of an investigation into his tax affairs.“I take this matter very seriously but I am confident that a professional and objective review of these matters will demonstrate that I handled my affairs legally and appropriately, including with the benefit of professional tax advisors," he said.The Biden-Harris transition team said in a statement last week that “President-elect Biden is deeply proud of his son, who has fought through difficult challenges, including the vicious personal attacks recent months, only to emerge stronger.”Hunter Biden has been a subject/target of the grand jury investigation, according to Fox News. A "target" means that there is a "high probability that person committed a crime," while a "subject" is someone you "don't know for sure" has committed a crime.

  • Turkey condemns 'unjust' U.S. sanctions, threatens response

    Turkey on Monday condemned U.S. sanctions over its purchase of Russian S-400 missile defences as a "grave mistake" and threatened to retaliate over a move it said would harm ties between the NATO allies. Washington imposed the long-anticipated sanctions on Turkey's top defence procurement and development body, its chairman and three other employees. Turkey's Foreign Ministry called the decision "inexplicable" given that Washington repeatedly rejected Ankara's offer to form a joint working group to allay U.S. concerns that the S-400s threatened NATO defences.

  • Russian report claims Putin is secretly working at a duplicate office in seaside resort

    Russian President Vladimir Putin has been a visible presence during Russia's COVID-19 pandemic, but only on TV, shown working from his office at his official residence outside Moscow. Few people have seen Putin in person since March, and those who are allowed into his office have to first quarantine for two weeks then walk through a tunnel that sprays a fine mist of antiseptics, Russian journalists say. But the investigative news organization Proekt reported last week that Putin's isolated workaholism isn't all that it appears.Putin, a former spy, has actually been working at an identical office set up at his residence in Sochi, a resort town and popular vacation destination on the Black Sea, Proekt reports, citing anonymous sources plus presidential plane flight logs and other circumstantial evidence. Putin's office denied the report, The New York Times notes. "The president has many offices and no identical offices," Putin spokesman Dmitry Peskov told journalists last week, claiming that the Proekt report and other exposés about Putin's personal life are an "information campaign, an information attack."Opposition figure Alexei Navalny, recovering in Germany from a nerve agent poisoning believed to have been ordered by Putin, said the Proekt report about the president working at a secret duplicate office at the seashore "is absolutely Putin's style — to lie even in the little things." Ekaterina Schulmann, a political commentator for the Echo of Moscow radio station, said the recent spate of leaks about the personal life of Putin's family and inner circle are probably tied to competing factions within the government trying to embarrass rivals as their children vie for plum jobs in government and state-run corporations.More stories from theweek.com Fauci: Americans without underlying conditions could get COVID-19 vaccine by late March, early April Donald Trump's defeat is good. Why does it feel so bad? Top Senate Republicans acknowledge Biden's win after Electoral College vote, but not Mitch McConnell

  • Hillary Clinton calls for Electoral College to be abolished after casting first vote in New York for Biden

    Following 2016 loss, former Democratic presidential candidate casts first vote in New York as electors affirm Trump’s loss

  • Roadside bomb wounds 23 near Pakistan police station

    A roadside bomb exploded near a police station in the Pakistani garrison city of Rawalpindi on Sunday, wounding at least 23 people, police said. Initially police said a hand grenade was thrown near a water filtration plant across the road from the police station, but a senior Rawalpindi police officer Ahsan Younas later confirmed the blast was from a device planted on the side of the road. The Pakistani military’s headquarters and the offices of the country’s spy agencies are located in Rawalpindi, about 15 kilometers (9 miles) south of the capital, Islamabad.

  • China urges EU to stop 'irresponsible remarks' after statement on Bloomberg employee

    BEIJING (Reuters) -China said on Monday the European Union should stop making "irresponsible remarks" after it called for the release of all those arrested for reporting in China in a statement on a detained Chinese national working for Bloomberg News. China's foreign ministry said on Friday authorities had detained Haze Fan, who works for the Bloomberg bureau in Beijing, on suspicion of endangering national security. The European Union called for authorities to grant Fan "medical assistance if needed, prompt access to a lawyer of her choice, and contacts with her family."

  • Iran's president says country would rejoin nuclear deal within an hour of U.S. signing on

    Iranian President Hassan Rouhani on Monday said if the United States returns to the Iran nuclear deal, his country will follow within an hour.The deal was made during the Obama administration in 2015, lifting sanctions on Tehran in exchange for Iran reducing its uranium stockpile and dismantling its centrifuges. Rouhani said he will not discuss any changes to the accord or restrictions on Iran's ballistic missile program, The Guardian reports. President Trump withdrew from the deal in 2018, and Rouhani made his comments on the same day the Trump administration sanctioned two Iranian intelligence officials for allegedly playing a role in the 2007 disappearance and presumed death of retired FBI agent Robert Levinson. President-elect Joe Biden has said he will rejoin the deal, believing it is one way to avert a nuclear crisis in the Middle East.More stories from theweek.com Fauci: Americans without underlying conditions could get COVID-19 vaccine by late March, early April Donald Trump's defeat is good. Why does it feel so bad? Top Senate Republicans acknowledge Biden's win after Electoral College vote, but not Mitch McConnell

  • Newsom could face recall, as resistance to California governor is growing

    An effort to recall California Gov. Gavin Newsom is gaining momentum, partly fueled by outrage over the Democrat dining with friends at an opulent restaurant while telling residents to stay home.

  • Army Cancels 3rd Cavalry’s Rotation to NTC in Response to Fort Hood Review

    The move is to allow it time to rebuild unit cohesion, a problem identified in the independent review of Fort Hood.

  • Georgia man who lied to employer about having Covid pleads guilty

    The claim prompted the company to shut down the facility for cleaning, causing a loss of around $100,000, prosecutors said.

  • U.S. Sanctions Iranian Intel Officers for Kidnapping Ex-FBI Man Who Died in Their Custody

    The Treasury Department says it knows the Iranian intelligence officers who kidnapped the former FBI agent Robert Levinson who died in their custody. U.S. officials announced on Monday that two members of Iran’s Ministry of Intelligence and Security (MOIS) would be sanctioned for their alleged role in Levinson’s kidnapping and detention.“Senior Iranian officials authorized Levinson’s abduction and detention and launched a disinformation campaign to deflect blame from the Iranian regime,” the statement reads.Trump Says He ‘Won’t Accept’ That Ex-FBI Agent Robert Levinson Died in Iran, Despite Family’s StatementThe Treasury Department identified Mohammad Baseri and Ahmad Khazai as senior Iranian intel officials involved in Levinson’s kidnapping and disappearance. Baseri is allegedly a “high-ranking MOIS officer involved in counterespionage activities in and outside of Iran” who has “worked directly with intelligence officials from other countries in order to harm U.S. interests,” according to the Treasury statement. Khazai is a “high-ranking member of the MOIS” who has allegedly worked with Iran’s intel program in foreign countries.In a statement released alongside the sanctions designation, FBI Director Christopher Wray accused Iran of lying about its role in Levinson’s disappearance in 2007. “The government of Iran pledged to provide assistance in bringing Bob Levinson home, but it has never followed through. The truth is that Iranian intelligence officers—with the approval of senior Iranian officials—were involved in Bob’s abduction and detention.”Levinson, a former FBI agent, flew to Kish Island off the southern Iran coast while ostensibly pursuing an investigation into counterfeit cigarettes on behalf of a tobacco company at a meeting with Dawud Salahuddin. Salahuddin, an American convert to Islam, fled to Iran after killing an Iranian diplomat from the shah-era government who had become a dissident.U.S. law-enforcement officials had reached out to Salahuddin after the 1993 World Trade Center bombing in an attempt to learn more about global terrorism and began a back-channel dialogue, during which Salahuddin discussed the possibility of returning to the U.S. and facing criminal charges.As the AP later reported, Levinson’s cigarette-counterfeiting investigation was a cover for his work as a contractor at the CIA, and his meeting with Salahuddin was part of an attempt to turn him into an informant for the agency. Levinson disappeared after the meeting, only to surface in proof-of-life videos and a photograph received in 2010 and 2011.In the images, a gaunt Levinson pleads for help from the U.S. government to “answer the requests of the group that has held me for three and a half years” while making no mention of the “group” holding him or his whereabouts. In the subsequent photos, Levinson appeared in an orange prison jumpsuit holding signs with “help me” and “why you can not help me” printed on them.Iran Can’t Find an American Hostage, U.S. Officials SayLevinson’s family waged a 13-year search for him until the Trump administration told family members in 2020 that intelligence indicated Levinson had likely died in Iranian custody at some point prior to the COVID-19 pandemic, The New York Times reported.Iran has denied holding Levinson in detention or any connection to Levinson’s disappearance.Read more at The Daily Beast.Got a tip? Send it to The Daily Beast hereGet our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

  • The Trump administration turned down more vaccine doses 'as recently as November,' former FDA commissioner says

    "There were multiple conversations with the US government about taking more supply in the second quarter," said Scott Gottlieb, a Pfizer board member.

  • Trump demands names of Congressional Republicans who have acknowledged Biden’s election victory

    ‘I am surprised there are so many. We have just begun to fight’

  • 'We have no oxygen': First journalist to access Yemen after Covid discovers major cover up in country of her birth

    Like many others in March I was spending my days locked down in my London flat, listening to reports about how overwhelmed the NHS was and the struggle to get essential supplies. However where I differed is that all I could think about was Yemen. I am British, but I’m originally Yemeni, and regularly report from it for BBC News and the World Service. If the UK was struggling to cope, I thought to myself, just how would the authorities in Yemen fare? I was terrified for them: my family, my friends, the nation. But I mainly feared for my grandmother. She is in her late 70’s and ticked all the vulnerable categories. I began calling my sister who lives in northern Yemen every day asking her if there were any cases. But while I was terrified, she, like so many others in the war-torn country was oblivious to the threat. The Houthi authorities in the north hadn’t announced a single case. From London I set about trying to find out what was truly happening, but it was near impossible. The Houthis had imposed a blanket restriction on all Covid reporting from areas they control.

  • Brazil cops nabbed after images capture arrest of two men later found dead

    Two Brazilian police officers have been arrested in Rio de Janeiro after security camera images showed them shooting at two young men on a motorbike, before taking them away in a car. Saturday's incident in the poor Rio suburb of Belford Roxo shines a fresh light on aggressive tactics of Brazilian police, who critics allege often target poor young Black men in deadly raids. Critics say Brazilian President Jair Bolsonaro, a far-right former army captain, has empowered police to be more aggressive than ever, offering them his full support to take out criminals in the country's drug-riddled slums.

  • Army Suspends Battalion Commander, Sergeant Major in Korea Amid Racism Allegations

    The Army has suspended a battalion commander and command sergeant major in South Korea while an investigation is being conducted into allegations of racism, bigotry and discrimination.

  • Head of White House security office has his right foot amputated because of severe COVID-19 and is facing 'staggering medical bills,' new report says

    Crede Bailey has been hospitalized with COVID-19 for three months but is said to be recovering, according to Bloomberg.

  • Bipartisan senators split their coronavirus proposal into 2 bills, both without stimulus checks

    After months of negotiations, a bipartisan group of centrist senators is preparing to unveil its COVID-19 stimulus proposal on Monday. The group is set to split its proposal into two bills: a $748 billion package containing universally popular measures, and a $160 billion bill that is more controversial, The Washington Post reports.The bigger package would renew unemployment benefits that are set to expire at the end of the year, extend a new round of small business aid, and boost funding for vaccine distribution, transportation, and education. The smaller one includes state and local aid, as well as a so-called "liability shield" for employers that every Democrat except Sen. Joe Manchin (D-W.Va.) has opposed. The shield would protect businesses from being sued over coronavirus-related medical problems.But whatever they come up with, another, much smaller group of bipartisan senators might prove problematic. Sens. Bernie Sanders (I-Vt.) and Josh Hawley (R-Mo.) are demanding the bill include another round of stimulus checks. Sanders told Politico he'll urge House Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Chuck Schumer (D-N.Y.) to reject the bipartisan bill over its failure to do so, pointing out that Democrats had pushed for $3.4 trillion in new relief funding, but the bipartisan bill includes just $188 billion in new spending. It largely repurposes unused funding from previous bills.Sanders' progressive allies have refused to vote for a bill without stimulus payments, and Hawley has pushed the White House to adopt them as well. > This is what Democrats and Republicans did unanimously in March through the CARES Act. This is what we have to do today.> > -- Bernie Sanders (@BernieSanders) December 14, 2020More stories from theweek.com Fauci: Americans without underlying conditions could get COVID-19 vaccine by late March, early April Donald Trump's defeat is good. Why does it feel so bad? Top Senate Republicans acknowledge Biden's win after Electoral College vote, but not Mitch McConnell

  • Trump signs executive order making Christmas Eve a federal holiday in 2020

    All federal employees will be excused from duty on 24 December