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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3:23 p.m. ET, December 10, 2020

Record number of daily Covid-19 deaths reported in California

From CNN's Cheri Mossburg

California reported at least 220 Covid-19 related deaths Thursday, the highest number since the beginning of the pandemic, according to data from the state’s Department of Public Health.

The previous high was 219, set at the end of July. This brings California’s total number of deaths attributed to the virus to 20,463.

The severe spike in cases is still climbing, as the state added nearly 30,000 new infections, bringing the total to 1,450,235. That is close to 10,000 more than the daily case average over the past two weeks, which is 20,824.

Hospitalizations and intensive care unit admissions continue to reach record highs. There are at least 12,477 patients in California hospitals today, with 2,710 of those in intensive care units.

ICU capacity statewide has dropped to just under 10% availability.

By Thursday night, approximately 90% of California residents, some 36 million people, will live in areas under stay-at-home orders. About 75% of those live in three of the state’s five regions where ICU capacity has dipped below 15%, triggering a state order. The rest live in Bay Area counties that have proactively implemented health orders of their own.

Note: These numbers were released by the California Department of Public Health and may not line up exactly in real-time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project. 

3:08 p.m. ET, December 10, 2020

No serious allergic reactions among coronavirus vaccine volunteers, Pfizer tells FDA committee

From CNN’s Amanda Watts

Dr. William Gruber, left, senior vice president of vaccine clinical research and development at Pfizer, speaks to the FDA’s Vaccines and Related Biological Products Advisory Committee on December 10.
Dr. William Gruber, left, senior vice president of vaccine clinical research and development at Pfizer, speaks to the FDA’s Vaccines and Related Biological Products Advisory Committee on December 10. FDA

Pfizer officials told the US Food and Drug Administration’s vaccine advisers Thursday they saw no serious allergic reactions among volunteers who tested the company’s coronavirus vaccine. 

“Amongst the 44,000 subjects, we saw no serious allergic reactions to the vaccine,” Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, told the FDA’s Vaccines and Related Biological Products Advisory Committee.

“Within the clinical trial we've actually not seen evidence to suggest a signal related to allergic reaction to the vaccine,” he added.

“Obviously we're conscious of the report that's occurred with use in the UK,” Gruber said, but declined to comment on it. 

Two health workers who received the vaccine during the first day of rollout on Tuesday in Britain suffered allergic reactions, the National Health Service in England said.

Pfizer excluded from its clinical trial anyone with a history of allergies such as a severe adverse reaction associated with a vaccine and/or severe allergic reaction “to any component of the study intervention(s).”

2:44 p.m. ET, December 10, 2020

McConnell sees no path for bipartisan agreement over 2 main stimulus sticking points, sources say

From CNN's Manu Raju

Senate Majority Leader Mitch McConnell talks during a news conference on December 8 on Capitol Hill in Washington, DC.
Senate Majority Leader Mitch McConnell talks during a news conference on December 8 on Capitol Hill in Washington, DC. Greg Nash/Pool/AP

Senate Majority Leader Mitch McConnell’s aides told top staff in both parties Wednesday that the GOP leader doesn’t see a path to an agreement over the two main sticking points: Liability protections for businesses and aid for states and cities, sources in both parties said.

The bipartisan group of lawmakers has tried to broker a deal on those issues but has been stymied for days. McConnell does not believe any such deal on those provisions could get enough support to pass the Senate.

McConnell has publicly advocated to drop those two provisions and pass what they can agree on, an idea both Speaker of the House Nancy Pelosi and Senate Minority Leader Chuck Schumer have rejected.

McConnell’s office declined to comment.

2:19 p.m. ET, December 10, 2020

About 15.5 million US health care workers have direct patient contact, analysis finds

From CNN's Maggie Fox

A staff member sanitizes her hands in the Critical Care Unit at St. Jude Medical Center in Fullerton, CA on Tuesday, December 1.
A staff member sanitizes her hands in the Critical Care Unit at St. Jude Medical Center in Fullerton, CA on Tuesday, December 1. Paul Bersebach/MediaNews Group/Orange County Register via Getty Images

About 15.5 million health workers in the United States have direct patient contact and about 2 million people live in nursing homes and assisted living facilities – groups that should be first in line for a coronavirus vaccine – according to a new analysis released Thursday.

The US Centers for Disease Control and Prevention has said frontline healthcare workers and residents of long-term care facilities such as nursing homes should be first in line for any coronavirus vaccine.

The Kaiser Family Foundation estimated that 15.5 million staff have direct patient contact in health care settings. It found 1.2 million nursing facility residents and another 800,000 assisted living facility residents nationwide.

“These 17.6 million adults, about 7% of U.S. adults, would qualify for priority vaccinations as the first doses of vaccines are distributed to states this month, based on the CDC recommendation,” the nonprofit organization, which studies health care issues, said in a statement.

The CDC has estimated there are 21 million health care workers who would qualify in a first round of vaccine distribution, and another 3 million residents of long term care facilities.

The Kaiser analysts said they checked for the number of workers who have direct patient contact. They also checked state by state and said several states were likely to suffer a shortfall of vaccines.

“The analysis shows the share of each state’s adult population who are health care workers with direct patient contact or nursing facility residents, ranging from 4% in Washington, DC, to 10% in North Dakota,” Kaiser said. “California has the largest number of adults in these groups, more than 1.7 million, followed by Texas (1.3 million) and New York (1.2 million). Due to data limitations, our state-level estimates do not include people who live in assisted living facilities or in other residential settings." 

2:14 p.m. ET, December 10, 2020

Pfizer says it looked for safest vaccine possible while researching candidates

From CNN’s Amanda Watts

Pfizer’s Kathrin Jansen speaks to the FDA’s Vaccines and Related Biological Products Advisory Committee on December 10.
Pfizer’s Kathrin Jansen speaks to the FDA’s Vaccines and Related Biological Products Advisory Committee on December 10. FDA

Pfizer was looking for the safest vaccine it could when sorting through various candidates for a coronavirus vaccine, the senior vice president and head of vaccine research and development at Pfizer said Thursday.

“Given the enormity of our mission, clinical data were important to us in deciding on the right candidate for a Covid-19 vaccine,” Pfizer’s Kathrin Jansen told the FDA’s Vaccines and Related Biological Products Advisory Committee.  

“We evaluated not just one, but four different candidates in Phase 1 to be able to make real time scientific decisions to select the best candidate,” Jansen added.

”With regard to safety, we were looking for the most favorable safety and tolerability profile in both younger and older adults. With regard to immunogenicity, we were looking for the broadest antiviral immune responses, most likely associated with efficacy. And with regard to a rapid pandemic response we were looking for the candidate that could be developed and produced most efficiently,” she said.   

Jansen said when it comes to mRNA vaccines, “we have a deep scientific understanding of how such vaccines work.”  

She said that mRNA vaccines “can be developed and scaled up quickly,” offering “a clear advantage,” over other types of vaccines. 

12:57 p.m. ET, December 10, 2020

Pence acknowledges US facing "challenging time" in pandemic as it moves closer to getting vaccine

From CNN's Allie Malloy

Vice President Mike Pence speaks during an Operation Warp Speed event in Greenville, South Carolina, on December 10.
Vice President Mike Pence speaks during an Operation Warp Speed event in Greenville, South Carolina, on December 10. Pool

Vice President Mike Pence delivered remarks at an Operation Warp Speed event in South Carolina and acknowledged that while US Food and Drug Administration authorization of a vaccine appears imminent, the US is still facing a “challenging time.”

“While we gather here today to talk about Operation Warp Speed and what we believe will be the imminent approval of the first coronavirus vaccine for the American people in a matter of days — we recognize we’re going through a challenging time as we see cases rising in virtually every state in the country,” Pence said Thursday, before adding that America has “never been better prepared” to combat coronavirus.

Pence's comments come as President Trump has spent the past 45 hours silent on the pandemic. On Wednesday, the US had its most deadly day of the pandemic.

“I want the people of this state to know that America has never been better prepared to combat the coronavirus than we are today," Pence said. 

Pence also spoke about the vaccine and said it was important for Americans to understand that the administration “cut no corners in the development of these vaccines.”

“We’re just a few short days away from what I believe will be the beginning of the end of the coronavirus pandemic in America,” Pence said.

12:51 p.m. ET, December 10, 2020

Ellen DeGeneres says she's tested positive for Covid-19

From CNN's Lisa France

Ellen DeGeneres speaks on February 5, 2019, in Hollywood, California.
Ellen DeGeneres speaks on February 5, 2019, in Hollywood, California. Steve Granitz/WireImage/Getty Images

Ellen DeGeneres announced on Twitter Thursday that she has tested positive for Covid-19.

DeGeneres said she was feeling "fine right now," adding that she would see everyone again after the holidays.

She has been broadcasting her syndicated talk show, which is produced by Warner Bros. Television, with Covid-19 protocols in place since September. 

CNN has reached out to Warner Bros. Television, which like CNN is part of WarnerMedia, for comment.

12:10 p.m. ET, December 10, 2020

More than 289,000 have died from Covid-19 in the US

From CNN's Amanda Watts

There have been at least 15,413,913 cases of coronavirus in the US and at least 289,970 people have died, according to Johns Hopkins University's tally of cases.

So far today, Johns Hopkins has recorded 27,351 new cases and 597 reported deaths.

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

Here's a look at how deaths and cases in the US compare to other countries:

12:16 p.m. ET, December 10, 2020

Covid-19 vaccine trial participants are free to drop out of studies once one is authorized, expert says

From CNN's Jacqueline Howard

A person receives an injection during a clinical trial for a COVID-19 vaccine at the Research Centers of America in Hollywood, Florida, on August 13.
A person receives an injection during a clinical trial for a COVID-19 vaccine at the Research Centers of America in Hollywood, Florida, on August 13. Chandan Khanna/AFP/Getty Images

Volunteers who received a placebo in Covid-19 vaccine trials are free to withdraw from those studies in order to receive the vaccine once one is authorized and made available in the United States, said Dr. Steven Goodman, associate dean of clinical and translational research at Stanford University of School of Medicine. 

This could affect how vaccine trials proceed, he noted.

“Placebo-controlled trials may continue to be possible in areas or populations for whom vaccines are not available, but that is complicated for other reasons," Goodman told the FDA's Vaccines and Related Biological Products Advisory Committee during a meeting on Thursday, referring to people who aren’t yet prioritized to receive the vaccine.

The committee is meeting to discuss a possible emergency use authorization for Pfizer's Covid-19 vaccine candidate. A vote on a recommendation to the FDA is expected later today.

The vote doesn't mean the vaccine is authorized immediately. The decision comes from the FDA, which typically follows the advisory committee's recommendation.