US FDA panel recommends Covid-19 vaccine authorization

Hackers targeting the European medical regulator “unlawfully accessed” documents related to the Pfizer and BioNTech vaccine submission, the companies said in a statement.

The US drug giant and German firm said their own systems -- including personal data of participants -- had not been breached.

The company stressed that no BioNTech or Pfizer systems had been breached and they were “unaware that any study participants have been identified through the data being accessed.” 

“At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law,” the statement said.

“EMA has assured us that the cyber attack will have no impact on the timeline for its review,” it added. 

The EMA on Wednesday said it had launched a full investigation into the cyberattack and was in “close cooperation” with law enforcement officials and other relevant entities. 

Neither the BioNTech nor EMA statement gave any further details on how the cyberattack took place or who was responsible.

A green light for a Covid-19 vaccine could come any day now in the US, but leading health experts warn the nation is only at the start of a winter that's projected to be one of the most difficult in the nation's history.

December has already proved devastating. Wednesday recorded more than 3,100 Covid-19 deaths -- the highest daily death toll ever since the pandemic's start, beating a record set just days ago. There are now more than 106,600 Covid-19 patients nationwide, the most ever, according to the COVID Tracking Project. And the country's average of daily new cases is now more than 200,000 -- and that's as experts are soon expecting another surge to kick off, one fueled by the Thanksgiving travel and gatherings that took place last month.

Covid-19 vaccines are a "really significant light at the end of the tunnel," Sebelius said, but in the coming months it's crucial that Americans stay vigilant and follow safety guidelines, like wearing face masks, social distancing and staying away from indoor gatherings.

Her warning has in the past week been echoed by other leading health officials and experts who warn that while a vaccine may be almost here, the country will likely not see any meaningful impact until well into 2021 -- and that's if enough people get vaccinated.

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A vaccine could soon get the green light, but Americans need to stay vigilant to avoid 'unthinkable death toll,' expert says

Americans could get the first real glimmer of hope that there will be an end to the pandemic that has upended their lives Thursday, when a key advisory panel takes a vote that could clear the way for the US Food and Drug Administration to greenlight a Covid-19 vaccine within days.

The FDA advisory panel will meet Thursday to discuss whether the agency should authorize emergency use of the Pfizer and BioNTech vaccine at a dark moment in the pandemic, when the US recorded the highest single day tally of more than 3,000 deaths -- and some communities continue to resist precautionary measures like mask mandates as a vocal few falsely claim that the pandemic does not exist.

These times cry out for leadership from the White House. Instead, President Donald Trump is pursuing a new round in his quixotic bid to overturn the November election by attempting to intervene in a lawsuit filed with the Supreme Court.

The contentious transition he has forced with President-elect Joe Biden's team has magnified the giant hurdles that loom for government officials as they try to ensure the smooth delivery of millions of vaccine doses within the 50 states, as they try to ensure smooth delivery of millions of vaccines doses to states and cities with different ideas about the best way to administer them.

With the reality of shots in arms coming ever closer, the crucial question is whether Trump and his administration are equipping the incoming Biden administration with the knowledge and tools they need to carry out an unprecedented vaccination operation as Trump's White House grudgingly passes the baton.

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Analysis: Vaccine meeting offers glimmer of hope for the future while Trump harps on the past

Germany reported 440 coronavirus-related deaths Thursday, according to the Robert Koch Institute, the country's disease control and prevention agency. 

The day before, the country reported its highest number of Coivid-19 deaths in a single day, with 590 fatalities reported Wednesday.

At least 20,372 people have died of Covid-19 in Germany, the public health agency's data showed.

The RKI recorded 23,679 Covid-19 infections on Thursday, bringing the total caseload to 1,242,203.

Germany is struggling to contain a surge in new coronavirus infections. Speaking in the German parliament Wednesday, Chancellor Angela Merkel warned that nationwide restrictions brought in on Nov. 2 had not proven effective enough, with too many people now dead or in intensive care units with Covid-19.

Merkel urged federal state leaders to start the Christmas holidays sooner, on Dec. 16 rather than Dec. 19, to help people limit contact with others and allow them to isolate for longer before seeing older relatives.

The United States reported 3,124 coronavirus-related deaths Wednesday, the highest single-day total of the pandemic, according to Johns Hopkins University.

That brings the total number of Covid-19 fatalities recorded in the country to at least 289,373.

Another 221,267 cases were also reported on Wednesday, bringing the country's total to at least 15,386,562, according to JHU's tally.

The totals include cases from all 50 states, the District of Columbia and other US territories, as well as repatriated cases. 

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Tracking Covid-19 cases in the US

Japan added 2,810 new coronavirus cases in the past 24 hours -- a record-high since the outbreak began, according to figures from the country's Health Ministry on Thursday.

That brings Japan's total number of reported cases to 169,285.

The ministry also added 45 fatalities from Wednesday, bringing the death toll to 2,478.

The number of people in intensive care continues to rise in the country, with 555 people on respirators as of Wednesday, up 19 from the previous day.

The capital Tokyo reported 572 new cases on Wednesday, its second highest daily increase since the start of the pandemic. Tokyo's total number of reported infections now stands at 44,927.

Call for travel scheme pause: On Wednesday, Shigeru Omi, the head of the government’s panel on virus countermeasures, said the domestic "Go To Travel" subsidy program should be suspended in areas of the country that have seen a rapid spread of infections.

Mexico’s Health Ministry has signed a deal to buy 35 million doses of China’s CanSino Biologics vaccine, according to Mexico’s Secretary of Foreign Affairs Marcelo Ebrard in a tweet posted late Wednesday. 

Ebrard had said previously that Mexico hoped to make the deal official this week.

Mexico has confirmed nearly 1.2 million coronavirus cases, according to Johns Hopkins University. The country has reported the word's fourth-highest death toll from the virus, with more than 111,000 fatalities.

South Korea will use 53 shipping containers as makeshift hospital rooms to curb bed shortages in Seoul, according to the city's government.

A total of 150 beds will be installed in the shipping containers, Seoul city government official Song Eun-chol said. Of those, 48 beds will be installed at Seoul Medical Center by Dec. 10.

Seoul disease control official Park Yoo-mi said in a news briefing Thursday that 83% of the city's available beds for coronavirus patients are in use and only three remain for those in a serious condition.

Seoul reported 251 new coronavirus cases from Wednesday, Park said, bringing the South Korean capital's total to 11,175.

Military help: South Korea's Ministry of Defense says it plans to dispatch 362 army officers beginning Friday to help with case tracing in greater Seoul. They will work at 81 public health centers after receiving training from the Korea Disease Control and Prevention Agency, the Defense Ministry statement Thursday said.

South Korea reported an additional 682 Covid-19 cases from Wednesday, bringing the nationwide total to 40,098. The death toll is 564.

There's not much suspense going into Thursday's meeting of the US Food and Drug Administration's vaccine advisers, who will discuss emergency use authorization for Pfizer and BioNTech's coronavirus vaccine.

The EUA is widely expected and has been telegraphed with unusual frankness from the top of the FDA on down.

But the FDA has promised to listen to the advice of its Vaccines and Related Biological Products Advisory Committee, made up of independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative -- 17 regular members and 13 temporary voting members. The meeting begins at 9 a.m. ET Thursday, and a committee vote could come in the afternoon.

The only real questions will be about whether the advisers recommend restrictions to the EUA -- perhaps leaving children off the list for now, for example. They'll also discuss how to conduct the post-EUA safety surveillance and whether to offer the shot to clinical trial volunteers who got placebo doses.

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Key committee meets Thursday to consider FDA authorization for Pfizer/BioNTech Covid-19 vaccine