US FDA panel recommends Covid-19 vaccine authorization

By Julia Hollingsworth, Adam Renton, Emma Reynolds, Nada Bashir, Melissa Macaya and Meg Wagner, CNN

Updated 7:50 a.m. ET, December 11, 2020
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1:30 a.m. ET, December 10, 2020

US reports record number of daily Covid-19 deaths

From CNN's Joe Sutton

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. 

See CNN's map:

1:07 a.m. ET, December 10, 2020

Japan reports record number of new Covid-19 infections

From CNN's Junko Ogura in Tokyo

A healthcare worker wearing personal protective equipment (PPE) collects a swab sample at the drive-thru coronavirus testing center in Miyoshi-machi, Saitama Prefecture, Japan, on Dec. 9.
A healthcare worker wearing personal protective equipment (PPE) collects a swab sample at the drive-thru coronavirus testing center in Miyoshi-machi, Saitama Prefecture, Japan, on Dec. 9. Noriko Hayashi/Bloomberg/Getty Images

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.

"It is better to suspend it under the current situation of virus infections. The government should restart it after the number of infections drops to gain public understanding and help the economy," Omi said at the subcommittee of the lower house.
12:35 a.m. ET, December 10, 2020

Mexico signs deal for 35 million doses of Chinese Covid-19 vaccine

From CNN’s Karol Suarez in Mexico City

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.

12:01 a.m. ET, December 10, 2020

South Korea to use shipping containers as makeshift hospital rooms to curb bed shortage

From CNN's Yoonjung Seo in Seoul

A makeshift medical facility using containers is installed on the grounds of the Seoul Medical Center in Seoul, South Korea, on Tuesday, Dec. 8.
A makeshift medical facility using containers is installed on the grounds of the Seoul Medical Center in Seoul, South Korea, on Tuesday, Dec. 8. SeongJoon Cho/Bloomberg via Getty Images

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.

9:37 p.m. ET, December 9, 2020

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

From CNN's Maggie Fox

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.

"Our team has done their initial analysis, and we do feel that preliminarily that the success criteria have been met," FDA Commissioner Dr. Stephen Hahn told CNN Tuesday.

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.

Read the full story:

8:14 p.m. ET, December 9, 2020

US hits record number of Covid-19 hospitalizations

From CNN's Haley Brink

The United States reported 106,688 Covid-19 hospitalizations on Wednesday, setting a new record high since the pandemic began, according to the Covid Tracking Project (CTP).

This is the eighth consecutive day that the US has remained above 100,000 hospitalizations.

According to CTP data, these are the highest hospitalization numbers:

  1. Dec. 9: 106,688 hospitalized
  2. Dec. 8: 104,590 hospitalized
  3. Dec. 7: 102,148 hospitalized
  4. Dec. 6: 101,501 hospitalized
  5. Dec. 4: 101,276 hospitalized
8:13 p.m. ET, December 9, 2020

Some US hospitals have only a few ICU beds left as coronavirus numbers reach all-time highs

From CNN's Jason Hanna, Madeline Holcombe and Steve Almasy

In states across the nation, officials remain concerned about the number of Covid-19 patients in the hospital and the ability of hospitals to find enough rooms.

California on Wednesday set records in cases, hospitalizations and ICU admissions. The most populous state has only about 1,500 ICU beds available.

Fresno County's Interim Public Health Officer Dr. Rais Vohra reported zero ICU capacity Tuesday.

"Whenever the ICUs get full, it's really hard to move patients through the emergency department. It's really hard for us to provide efficient services," said Vohra, a specialist in emergency medicine.

The state has mandated restrictions for five regions if ICU capacity goes below 15%. The greater Sacramento region reached the threshold Wednesday and a stay-at-home order for 3 million residents will begin late Thursday.

"I know that those who aren't in the medical field may not understand or quite grasp just how dire the situation is, but all the things you're hearing about -- how impacted our hospitals are, about how dire the situation with our ICUs is -- it's absolutely true. And that really is the reason that we want everyone to stay home as much as possible," Vohra said.

Oklahoma facilities had just 34 available ICU beds as of late Tuesday.

Other states that reported record hospitalizations Wednesday include North Carolina, Pennsylvania and West Virginia.

In the United States, Covid-19 cases, hospitalizations and deaths have soared.

The US has averaged 206,152 new cases a day over the past seven days -- the country's highest average in the pandemic so far.

And 106,688 Covid-19 patients were reported in US hospitals Wednesday, also a high for the pandemic, according to the COVID Tracking Project.

The country's average number of daily coronavirus deaths across a week -- 2,230 -- is close to the highest-ever average of 2,241 recorded on April 24, Johns Hopkins University data show. In total, more than 288,000 people in the US have died of the virus.

More than 15.3 million official Covid-19 cases have been reported, according to data from JHU, though researchers believe the actual number of infections is much higher.

Read the full story:

8:17 p.m. ET, December 9, 2020

Canada approves vaccine as US prepares decision

From CNN's Jason Hanna, Madeline Holcombe and Steve Almasy

Canada's health department on Wednesday gave emergency approval to a coronavirus vaccine, a day before the US Food and Drug Administration is due to meet about whether to do the same.

Health Canada determined the Pfizer/BioNTech vaccine for Covid-19 meets the department's safety, efficacy and quality requirements for use in Canada, the department said Wednesday. The decision comes a week after the United Kingdom authorized vaccine use there.

Canadian Prime Minister Justin Trudeau said this week that Canada would receive an initial shipment of 249,000 doses by the end of the year and expected Canada's first vaccinations to occur sometime next week.

In the United States, meanwhile, an official said Covid-19 vaccines would be distributed to vulnerable populations within days of any decision to authorize them.

The FDA will meet Thursday to discuss whether to grant emergency use authorization (EUA) for the Pfizer/BioNTech vaccine candidate in the US. A decision could come within days of that meeting, officials say.

##Vaccines

11:05 p.m. ET, December 9, 2020

China's Sinopharm vaccine has 86% efficacy against Covid-19, says UAE

From CNN's Mostafa Salem and Yong Xiong

An experimental coronavirus vaccine developed by Chinese state-owned pharmaceutical giant Sinopharm has 86% efficacy, the United Arab Emirates Health Ministry said in a statement carried by the state news agency on Wednesday.

The Health Ministry said the results for the vaccine were based on interim analysis of the late-stage clinical trials which the UAE started in July.

Though few details were provided, the statement marks the first publicly released information regarding the performance of the Chinese vaccine, developed by the China National Biotec Group (CNBG), a unit of Sinopharm. The UAE approved emergency use for frontline workers in September.

"The analysis shows no serious safety concerns," the statement said, though it did not make clear whether individual participants suffered any specific side effects, or how many volunteers were given the vaccine or a placebo.
The statement added that the "official registration" of the Covid-19 vaccine is "a major step towards combating the global pandemic." The statement did not elaborate on what official registration would entail.

The clinical trials included 31,000 volunteers across 125 nationalities in the UAE, the statement said. So far, almost 100,000 people across the Emirates have also received the vaccine as part of a voluntary program, Jamal Al Kaabi, a top UAE health official told CNN.

UAE Vice President and Prime Minister Sheikh Mohammed bin Rashid Al Maktoum was pictured receiving the jab during trials in November.

CNN has reached out to Sinopharm for more details.

Read the full story: