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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7:59 a.m. ET, December 10, 2020

CDC now projects up to 362,000 US Covid-19 deaths by January 2

From CNN Health’s Ben Tinker

A forecast published Wednesday by the US Centers for Disease Control and Prevention projects there will be 332,000 to 362,000 coronavirus deaths in the United States by January 2. 

Unlike some individual models, the CDC’s ensemble forecast only offers projections a few weeks into the future. The previous ensemble forecast, published December 3, projected up to 329,000 coronavirus deaths by December 26.

At least 289,450 people have already died from Covid-19 in the United States, according to data compiled by Johns Hopkins University.

CNN is tracking the spread of Covid-19 in the US here:

7:52 a.m. ET, December 10, 2020

China flight attendants advised to wear diapers for Covid protection

From CNN's Lilit Marcus

Transportation officials around the world have been looking for ways to keep passengers and crew safe on planes during the pandemic.

On November 25, the Civil Aviation Administration of China (CAAC) released new guidelines for the country's airline industry, which it oversees.

The document, titled Technical Guidelines for Epidemic Prevention and Control for Airlines, Sixth Edition, contains advice about the best hygiene practices to carry out on aircraft and in airports. 

But one of those suggestions -- that personnel like flight attendants wear disposable diapers so they don't need to use the bathroom -- has raised some eyebrows.

A section on PPE advises cabin crew on flights to and from high-risk countries to wear "medical masks, double-layer disposable medical gloves, goggles, disposable hats, disposable protective clothing, and disposable shoe covers."

The next sentence reads: "It is recommended that cabin crew members wear disposable diapers and avoid using the lavatories barring special circumstances to avoid infection risks."

While such advice may seem dramatic, it's no secret that lavatories can be the germiest place on an airplane. In August, a woman traveling from Italy to South Korea contracted coronavirus during her trip, and a visit to the bathroom -- the only place where she didn't wear an N95 mask -- was named as the possible source of her infection.

Read the full story here:

7:15 a.m. ET, December 10, 2020

Indian regulators request more data before approving AstraZeneca’s Covid-19 vaccine

From journalist Manveena Suri and Esha Mitra in New Delhi

Vials of AstraZeneca’s Covid-19 vaccine are seen inside a visual inspection machine at the Serum Institute of India on November 30.
Vials of AstraZeneca’s Covid-19 vaccine are seen inside a visual inspection machine at the Serum Institute of India on November 30. Francis Mascarenhas/Reuters

India’s Central Drugs Standard Organization (CDSCO) requested more data from the Serum Institute of India (SII), which applied for emergency use of AstraZeneca’s Covid vaccine on Monday. 

The CDSCO said on Thursday that SII should submit “updated safety data of Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK- MHRA (the UK’s Medicines and Healthcare products Regulatory Agency) for grant of EUA.”

The document read that SII firm presented their application “with the interim safety data from Phase II/III clinical trial carried out in the country and the interim safety and efficacy results of Phase II/III and Phase III clinical trials carried out in the UK, other countries and India.”

The regulator tasked with reviewing the emergency authorization application from SII met on Wednesday.

CNN has reached out to the Serum Institute of India. 

The background: The AstraZeneca/Oxford vaccine candidate was found to have 70.4% efficacy in an interim analysis of Phase 3 trial results, published for the first time in a peer-reviewed journal yesterday.

But experts have raised questions after AstraZeneca's data showed the vaccine was about 62% effective in most people but 90% effective in a subset of volunteers who had a low first dose of vaccine.

Moncef Slaoui, chief adviser to Operation Warp Speed, told a news briefing Wednesday that the US Food and Drug Administration may prefer data generated from an ongoing US trial when it comes time to decide on authorizing the vaccine.

7:12 a.m. ET, December 10, 2020

Singaporean "cruise to nowhere" passenger re-tests negative for coronavirus after false positive halted voyage

From CNN’s Angus Watson

The Royal Carribean International cruise ship Quantum of the Seas is seen docked at Marina Bay Cruise Centre in Singapore on December 9.
The Royal Carribean International cruise ship Quantum of the Seas is seen docked at Marina Bay Cruise Centre in Singapore on December 9. Roslan Rahman/AFP/Getty Images

An 83-year-old Singaporean passenger aboard a "cruise to nowhere" has re-tested negative for coronavirus after a false positive halted the voyage, Singapore’s Ministry of Health said Thursday.

The man had initially tested positive for the virus while aboard the Quantum of the Seas, operated by Royal Caribbean International, and was transported to a nearby hospital. 

That test has now been re-classed as negative, Singaporean authorities said in a statement.

How the story unfolded: The ship had been hosting a three-night, four-day “cruise to nowhere” itinerary around Singapore, as part of a program to reinvigorate domestic travel in Singapore amid the global coronavirus pandemic. 

Close contacts of the individual in question were quarantined while a number of other passengers and crew members were forced to stay on board while contact-tracing took place.

“We have rescinded the Quarantine Orders of his close contacts, who had earlier been placed in quarantine as a precautionary measure while investigations were ongoing,” the statement read.

According to the Singapore Tourism Board, all 1,680 passengers and 1,148 crew members had tested negative for coronavirus when the cruise ship departed on December 7. 

In a statement, Royal Caribbean International said the cruise line has worked closely with the government to develop a “thorough system” to test and monitor all guests and crew, and maintain public health best practices.

"That we were able to quickly identify this single case and take immediate action is a sign that the system is working as it was designed to do," a Royal Caribbean representative said. 

Under new protocols, the cruise had been operating with reduced occupancy, with mandatory universal testing and mask wearing enforced, as well as physical distancing and enhanced cleaning practices. 

Only Singaporean citizens were allowed to buy tickets for the cruise, and crew members from around the world spent 14 days quarantining in the city-state in order to be cleared for working.

6:42 a.m. ET, December 10, 2020

San Francisco could run out of intensive care beds in 17 days, say health officials

From CNN's Christina Maxouris

Intensive care unit capacity could run out by December 27 if Covid-19 numbers continue to climb as fast as they are now, health officials project.

That is "in just 17 days," the city's health director Dr. Grant Colfax said Wednesday. "And that's if things don't even get worse, but they very well may." 

There are 123 Covid-19 patients across San Francisco, Colfax said, a number higher than ever before that shows "no signs of going down." Thirty of those patients are in intensive care units. 

This number is climbing, and climbing rapidly. Now, not only by the day, but by the hour," he added.

The city is experiencing by far its worst surge to date, Colfax said, adding the virus was "everywhere in our city right now."

"Even lower-risk activities now carry substantial risk because there's more virus out there than ever before," he said.

The surge has also been fueled by the gatherings that took place over the Thanksgiving holiday. Since then, at least 167 people are testing positive for the virus daily, and the average case rate per 100,000 has skyrocketed since Thanksgiving week -- from 15 to 30. 

"The reality is unfortunately proving to be as harsh as we expected," Colfax said.

Read the full story here:

6:17 a.m. ET, December 10, 2020

A Reno hospital turned its parking garage into a new wing to treat coronavirus patients

From CNN’s Madeline Holcombe and Sara Sidner

Hospital beds are pictured inside Renown Regional Medical Center's parking garage, which has been transformed into an alternative care site for Covid-19 patients, in Reno, Nevada, on November 11.
Hospital beds are pictured inside Renown Regional Medical Center's parking garage, which has been transformed into an alternative care site for Covid-19 patients, in Reno, Nevada, on November 11. Lucia Starbuck/KUNR Public Radio/Report for America/AP

As the number of coronavirus cases across the United States continues to surge, one hospital in Reno, Nevada has turned its parking garage into a specialist wing for coronavirus patients. 

Renown Regional Medical Center has come under increased pressure with Washoe County — the region Renown serves — now registering 10 times the number of cases that it did a couple of months ago. 

"It's scary, you know, you don't expect to go to work and be working out of a parking garage," said Janet Baum, nursing manager of the site. "We've made it a hospital, so we don't consider it a garage anymore."

According to hospital CEO Anthony Slonim, the building went from garage to health center in about 10 days and now houses 700 hospital beds. Among those receiving care at Renown is Rosalia Martinez and her husband of 35 years, Luis. 

"When I found out she was sick; I cried. I thought she was going to die," Luis Martinez said. Now, he is recovering from the virus as well, four beds down.

He coughs at nighttime, I can hear him. And if I yell, he can hear me," Rosalia said. "He knows that I'm still alive."

Though coronavirus patients in parking spaces may sound odd, Luis Martinez said he feels safe there. The space is clean, and the staff are working hard to make sure their patients are all attended to, he said.

On Wednesday, Nevada registered a total of 176,334 coronavirus cases and 2,384 deaths, according to Johns Hopkins University's tally of cases in the United States.

Read the full story here:

5:40 a.m. ET, December 10, 2020

Germany's Covid-19 numbers are "rising and that is worrying," say health officials after record cases

From CNN's Nadine Schmidt in Berlin

Lothar Wieler, President of the Robert Koch Institute, speaks to the media on December 10, in Berlin, Germany.
Lothar Wieler, President of the Robert Koch Institute, speaks to the media on December 10, in Berlin, Germany. Sean Gallup/Getty Images

Germany's coronavirus situation remains ''very tense,'' the head of the country's infectious disease agency said Thursday, adding that infections are “rising and that is worrying.''

Lothar Wieler, president of the Robert Koch Institute (RKI), told journalists “we need people to reduce contacts by more than 60%" or “other measures” will have to be considered.

He warned that after plateauing for a few weeks, infections could again spill over into exponential growth.  

Worrying figures: Germany on Thursday reported a daily record of 23,769 new Covid-19 infections within the past 24 hours. It reported 440 coronavirus-related deaths, a day after hitting a record 590 daily fatalities.

Wieler said that some regions were containing the virus better than others, which showed that ''these measures are working” if implemented correctly.

The head of RKI's surveillance unit, Ute Rexroth, warned: ''It is very likely that we will see rising numbers of infections and deaths in the coming weeks."

''We are seeing double the amount of infection numbers in care homes than in spring this year," he added.

This comes a day after German Chancellor Angela Merkel said that rising infection numbers mean tougher measures are urgently needed. 

In an unusually impassioned speech, Merkel asked the public to limit their social contact or risk losing more lives. 

"If we have too many contacts now before Christmas, and that ends up making it the last Christmas with the grandparents, then we will have failed. We should not do that,” she told lawmakers in parliament.

Merkel warned that nationwide restrictions brought in on November 2 had not proven effective enough, with too many people dying of Covid-19 or admitted to intensive care.

She called for a full lockdown to be implemented for several days -- possibly for as long as two weeks -- after Christmas in order to bring down infection rates.

5:10 a.m. ET, December 10, 2020

Hackers access Pfizer/BioNTech vaccine documents in cyberattack on European regulator

From CNN's Fred Pleitgen in Mainz, Germany and Zahid Mahmood in London

A phial of Pfizer-BioNTech Covid-19 vaccine is pictured at a vaccination center in Cardiff, Wales, on December 8.
A phial of Pfizer-BioNTech Covid-19 vaccine is pictured at a vaccination center in Cardiff, Wales, on December 8. Justin Tallis/Pool/Getty Images

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.

“We were informed by the European Medicines Agency (EMA) that the agency has been subject to a cyber attack and that some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed,” a statement from BioNTech said Wednesday.

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.

4:59 a.m. ET, December 10, 2020

Americans need to stay vigilant to avoid "unthinkable death toll," expert says

From CNN's Christina Maxouris

Medical staff members zip up a body bag which contains a deceased patient in the Covid-19 intensive care unit (ICU) at the United Memorial Medical Center in Houston, on December 6.
Medical staff members zip up a body bag which contains a deceased patient in the Covid-19 intensive care unit (ICU) at the United Memorial Medical Center in Houston, on December 6. Go Nakamura/Getty Images

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.

"We are in a totally unprecedented health crisis in this country. The disease is everywhere -- Midwest, West Coast, East Coast, North, South. Health care workers are exhausted, hospitals are totally full," former Health and Human Services Secretary Kathleen Sebelius told CNN Wednesday night.

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.

"We've got to take what we've learned in the last eight months and really put it into practice, so we don't continue to have this unthinkable death toll and disease toll," she said.

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.

Read the full story: