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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11:02 p.m. ET, December 10, 2020

US could be back to normal by next summer or fall, Fauci says -- provided everybody gets vaccinated

From CNN Health’s Shelby Lin Erdman

Dr. Anthony Fauci.
Dr. Anthony Fauci. Source: CNN

The United States could be back to normal by next summer or early fall if everyone gets a Covid-19 vaccine, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, predicted Thursday.

"It depends how quickly and how many people want to get vaccinated," Fauci told CNN’s Chris Cuomo.  
"If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality reasonably quickly into the summer and certainly into the fall." 

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted to recommend emergency-use authorization (EUA) for Pfizer’s Covid-19 vaccine Thursday. The FDA is expected to approve an EUA for the vaccine in the next couple of days.

"My hope and my projection is that if we get people vaccinated en masse so that we get that large percentage of the population, as we get into the fall, we can get real comfort about people being in schools, safe in school," Fauci said.
"That's what I hope and project we would do if we get everybody vaccinated."

10:16 p.m. ET, December 10, 2020

Japan reports record number of Covid-19 infections for second day in a row

From CNN’s Yoko Wakatsuki in Tokyo

Mask-wearing custodians clean handrails and pick up trash near Sumida River in Tokyo on Friday, December 11.
Mask-wearing custodians clean handrails and pick up trash near Sumida River in Tokyo on Friday, December 11. Hiro Komae/AP

Japan has reported a record number of new Covid-19 infections for the second straight day.

Japan’s Ministry of Health announced it recorded 2,955 new Covid-19 cases and 37 related deaths for Thursday.

That brings Japan’s total reported Covid-19 infections to 172,255 -- including 2,515 dead.

The Ministry's data shows 543 patients are in intensive care, while a further 22,272 are receiving treatment in hospitals.

The capital Tokyo posted its highest number of daily infections yet with an additional 602 cases. At least 59 patients remain in critical condition, with 1,826 more in hospital.  

Osaka counted 415 new cases. Osaka Gov. Yoshifumi Yoshimura said Thursday he was expecting the Self-Defense Forces' medical support team to be dispatched to local hospitals. 

Japan's medical expert advisory board was critical about the effectiveness of the government's prevention measures to fight the recent surge in cases. 

"It's hard to say that the measures taken so far have been effective," the chairman of the advisory board, Takaji Wakita, said in a press conference late Thursday. 
"Overall, the measures were not successful to curb the new infection cases."

9:50 p.m. ET, December 10, 2020

FDA committee vote to recommend EUA for Pfizer’s vaccine is "important," Fauci says

From CNN's Shelby Lin Erdman

Dr. Anthony Fauci.
Dr. Anthony Fauci. Source: CNN

The vote by the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee to recommend emergency use authorization for Pfizer’s Covid-19 vaccine is important, Dr. Anthony Fauci said.

It shows that the process in the US is based on decisions and recommendations made by independent bodies, the director of the National Institute of Allergy and Infectious Diseases told CNN.

“The reason I think this is so important is that we want to make sure that we impress the American public that decisions that involve their health and safety are made outside of the realm of politics, outside of the realm of self-aggrandizement and are made in essence by independent groups,” Fauci said. “So it was a very important step."

The next step is FDA consideration and decision about an EUA. Then the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide whether to recommend the vaccine for use. The Advisory Committee on Immunization Practices has meetings scheduled for Friday and Sunday.

9:17 p.m. ET, December 10, 2020

CVS says Dec. 21 is the earliest it will begin long term care facility vaccinations

From CNN's Samira Said

Cars line up for a drive-thru coronavirus test at CVS Pharmacy on May 15, in Carver, Massachusetts.
Cars line up for a drive-thru coronavirus test at CVS Pharmacy on May 15, in Carver, Massachusetts. Maddie Meyer/Getty Images

Pending Food and Drug Administration emergency use authorization of the Pfizer coronavirus vaccine, CVS is preparing to begin vaccinations in long term care facilities on Dec. 21.

“December 21 is the earliest vaccine administration can begin in long-term care facilities, as communicated to states by CDC. We’ll be in facilities that day in states that choose to begin as soon as possible,” said CVS spokesperson Ethan Slavin.

It is not clear which states have chosen to begin vaccinations immediately.

CVS will use a “hub and spoke” model, with around 1,100 CVS Pharmacy locations storing vaccines based on geographic need, Slavin said.

"Pharmacy teams will go to these locations to pick up the necessary doses on their way to long-term care facilities. We’ll know how much we need for each facility and bring extra for new residents or staff members who may not have been included in the data that was shared in advance,” he said.

The data used to determine need comes from coordination between CVS and each long-term care facility, CVS spokesman TJ Crawford said.

“More than 40,000 long-term care facilities have selected CVS Pharmacy to provide vaccinations,” Slavin said. 

Some context: An advisory committee to the US Centers for Disease Control and Prevention expects to vote Sunday whether to recommend Pfizer’s coronavirus vaccine, according to an agenda posted on the agency’s website. 

US Food and Drug Administration advisers voted Thursday to recommend the FDA issue emergency use authorization to the vaccine.

 

8:40 p.m. ET, December 10, 2020

Coronavirus model predicts 502,000 deaths in the US by April

From CNN's Shelby Lin Erdman

The influential coronavirus model at the University of Washington has projected 502,000 Americans will have died from Covid-19 by April 1, down from its prediction of 539,000 deaths last week.

The model from the Institute of Health Metrics and Evaluation predicts a new coronavirus vaccine can save 25,000 or more lives. And if 95% of Americans wore masks, the death count would drop by 56,000 by April 1 compared to the “most likely” scenario.

On the other hand, if states ease coronavirus mandates, the model projects 598,000 cumulative deaths by April 1.

“Moreover, the impact of vaccinations is greater as well because of the detailed information in the Pfizer FDA filing, showing approximately 50% protection after the first dose, and data on a larger number of doses available sooner in the US,” IHME said.

The model projects 25,200 lives will be saved by the vaccine rollout and if the distribution occurs rapidly, 44,500 lives could be saved compared to a no-vaccine scenario.

The Covid-19 epidemic in the Midwest is leveling off but is increasing on the West Coast and in the Northeast, IHME said. 

8:15 p.m. ET, December 10, 2020

Canada will start vaccinations early next week as lockdowns fail to get infections under control

From CNN's Paula Newton

There was sobering news for Canadians Thursday as public health officials in several provinces said they were coping with an increase in infections despite new restrictions and lockdowns. 

Prime Minister Justin Trudeau underscored the need to keep up with public health protocols as he announced that vaccines would arrive in Canada by Monday.

“The first 30,000 doses are expected to arrive on Canadian soil in just a few days. To all Canadians, if you’re feeling relieved and hopeful, you’re not alone, this is the good news we all need but remember this is only the first step in what will be a massive project over a long winter,” said Trudeau during a news conference in Ottawa Thursday evening. 

Canada is not disclosing logistics or tracking information on the Pfizer/BioNTech vaccine as it enters the country because of what officials say are "credible" security concerns.  

But Trudeau stressed he does not believe there will be any disruptions as the vaccines make their way from Belgium to Canada. 

The timeline on vaccines in Canada comes as several provinces, including Canada’s two largest, Quebec and Ontario, logged record-setting new cases of Covid-19 in recent days with officials saying that lockdowns in both Toronto and Montreal are having little effect on the rise in new cases.  

The province of Ontario broke another record for the highest number of Covid-19 cases reported in a single day, with Toronto and its suburbs logging most new cases. 

Ontario released new modeling Thursday and confirmed that according to mobility data throughout the province, people are traveling outside their homes at close to normal levels and likely not limiting contacts as much as needed to stop the spread of the virus.  

Montreal broke a single-day record Thursday with 648 new cases of Covid-19, a growth rate the city’s public health director called "alarming."

“I know we’re all tired, but we need to make an effort,” said Dr. Mylène Drouin, Montreal’s public health director, during a news conference Thursday.

7:06 p.m. ET, December 10, 2020

FDA calls committee vote "an important step"

From CNN’s Jen Christensen

The US Food and Drug Administration said Thursday’s vote by its vaccine advisers to recommend emergency use authorization of the Pfizer Covid-19 vaccine was an “important step” in the review process.

The FDA said its Vaccines and Related Biological Products Advisory Committee, made up of independent scientists and public health experts, provides “valuable advice and input” for the agency to help make its decision on the vaccine.

“Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials,” the agency said in a statement.

“In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. However, they know that they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect,” FDA Commissioner Dr. Stephen Hahn said in the statement.

“The whole of the FDA—myself included—remains committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, Americans can have trust and confidence in receiving the vaccine for their families and themselves.”

7:03 p.m. ET, December 10, 2020

US reaches record number of Covid-19 hospitalizations

From CNN’s Haley Brink

Medical staff member Alan Araiza checks of an IV for a patient in the Covid-19 intensive care unit at the United Memorial Medical Center on December 7 in Houston.
Medical staff member Alan Araiza checks of an IV for a patient in the Covid-19 intensive care unit at the United Memorial Medical Center on December 7 in Houston. Go Nakamura/Getty Images

The United States reported 107,248 Covid-19 hospitalizations on Thursday, setting a new record high since the pandemic began, according to the Covid Tracking Project (CTP).

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

The following, according to CTP data, are the highest hospitalization numbers:

  1. Dec. 10: 107,248 hospitalized
  2. Dec. 9: 106,671 hospitalized
  3. Dec. 8: 104,590 hospitalized
  4. Dec. 7: 102,148 hospitalized
  5. Dec. 6: 101,501 hospitalized
6:51 p.m. ET, December 10, 2020

Members of FDA advisory committee explain why they recommended vaccine authorization

From CNN's Adrienne Vogt

Three members of the Food and Drug Administration vaccines advisory committee explained why they voted to recommend the agency grant emergency use authorization to Pfizer/BioNTech's coronavirus vaccine.

“I think the data was pretty compelling that the benefits greatly outweigh the risks. I wish there could have been slightly more enrollment of minorities in the trial. But I think the numbers were sufficient to make a decision,” Dr. James Hildreth said.

He also said he feels comfortable with the mRNA technology used with the vaccine.

Dr. Paul Offit said the vaccine is highly effective.

“We know at least in tens of thousands of people followed for two months, it doesn't have any serious, adverse events. … I think we know enough now to say that this appears to be our way out of this awful, awful mess,” he said.

Dr. Ofer Levy also said “the efficacy looked very, very good.” He expects the FDA to accept the recommendation in a matter of days. 

Noting the beginning of Hanukkah, Levy said, “It's the Festival of Lights, and we’re hoping we now have light at the end of the tunnel.”

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