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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4:50 p.m. ET, December 10, 2020

FDA vaccine advisers worry about UK allergic reactions to Pfizer vaccine

From CNN’s Amanda Watts

A phial of the Pfizer/BioNTech COVID-19 vaccine concentrate is prepared for administration at Guy's Hospital on December 8 in London.
A phial of the Pfizer/BioNTech COVID-19 vaccine concentrate is prepared for administration at Guy's Hospital on December 8 in London. Victoria Jones/Pool/Getty Images

Vaccine advisers to the US Food and Drug Administration say they are worried about how the US public will react to reports about severe allergic reactions in Britain to Pfizer’s coronavirus vaccine. 

“I'm worried about these severe anaphylactic reactions,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said during discussion ahead of the committee’s vote.

On Wednesday, reports emerged out of the United Kingdom about two health care workers with a significant history of allergic reactions having reactions following Covid-19 vaccination. The health workers have since recovered.

“We don't know the details of those two cases. We don’t know specifically what it was they were allergic to, or what their history with severe allergies was,” Offit said during the meeting of the Vaccines and Related Biological Products Advisory Committee.

Offit, a voting member of the committee, said he was concerned Americans with allergies might be afraid to get vaccinated. Public Health officials in Britain are now telling people with a history of severe allergies not to get the vaccine, Offit said.

“There are tens of millions of people in this country who carry EpiPens with them — because they have peanut allergies, because they have egg allergies — who are going to believe now that they can't get this vaccine,” Offit said. “That's a lot of people.”

Pfizer earlier reported it saw no serious allergic reactions to the vaccine in its Phase 3 trial involving 44,000 volunteers, but people with a history of allergic reactions to vaccines were excluded from the trial.

Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer said, “the nature of what was actually excluded from the trial was really restricted to those individuals who had had a severe allergic reaction to a vaccine — any vaccine — previously, or obviously during the course of the trial if they’d gotten the first dose, and they had a significant type one hypersensitivity response, then that would preclude giving a second dose.” 

Gruber said during the trial, Pfizer’s investigators did not encounter anyone who had to be excluded from getting the second dose of vaccine.

5:25 p.m. ET, December 10, 2020

Maryland reports highest number of Covid-19 patients hospitalized since start of pandemic

From CNN’s Rebekah Riess

Maryland reported 1,720 Covid-19 patients hospitalized Thursday, the state’s highest total ever during the pandemic, Gov. Larry Hogan announced. 

Those hospitalized include 416 individuals in intensive care units, the state’s highest level since June 6. Eighty-eight percent of staffed acute beds in the state are currently occupied and 87% of ICU beds are currently occupied, the governor said.

Maryland reported a total of 225,855 Covid-19 cases, including 20 straight days with more than 2,000 daily cases. There have now been 4,850 Covid-19-related deaths in the state, Hogan said.

Note: These numbers were released by the state’s public health agency, and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.

4:05 p.m. ET, December 10, 2020

FDA advisory committee meeting resumes with discussion and vote on Pfizer's Covid-19 vaccine

From CNN's Jacqueline Howard

A meeting of the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee has resumed after taking a short break. The committee is now holding discussions, and there will be voting after.

The FDA advisory committee is convening to discuss a possible emergency use authorization for Pfizer's Covid-19 vaccine candidate. The committee discussion and voting is scheduled to be a more than two-hour-long process.

Here is the wording of the questions being discussed: 

  1. Pfizer and BioNTech has proposed a plan for continuation of blinded, placebo-controlled follow-up in ongoing trials if the vaccine were made available under EUA. Please discuss Pfizer’s plan, including how loss of blinded, placebo-controlled follow-up in ongoing trials should be discussed.
  2. Please discuss any gaps in plans described today and in the briefing documents for further evaluation of vaccine safety and effectiveness in populations who receive the Pfizer-BioNTech Vaccine under and EUA.

There will be a second round of discussions before this vote.

Remember: The panel is expected to vote on a recommendation to the FDA on an emergency use authorization for Pfizer’s Covid-19 vaccine. The vote doesn't mean the vaccine is authorized immediately. The decision comes from the FDA, which typically follows the advisory committee's recommendation.

The FDA will then decide on whether or not to issue an emergency use authorization for the vaccine. The FDA EUA allows shipping to begin, but shots still can’t be administered until the US Centers for Disease Control and Prevention advisory committee recommends the vaccine.

In anticipation of an EUA, the CDC's Advisory Committee on Immunization Practices has scheduled emergency meetings for Friday and Sunday. This committee — which is separate from FDA's advisory committee — will recommend whether the CDC should offer the vaccine to the American public. After the CDC accepts that recommendation, Pfizer shots may start to be administered.

3:43 p.m. ET, December 10, 2020

The FDA's vaccine committee will discuss these key items before voting 

From CNN’s Amanda Watts

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss several items before they vote on emergency use authorization for the Pfizer Covid-19 vaccine, Dr. Susan Wollersheim with the US Food and Drug Administration said on Thursday. 

“The first of which is that Pfizer has proposed a plan for continuation of blinded, placebo-controlled follow-up in ongoing trials if the vaccine were made available under the EAU. Please discuss Pfizer’s plan, including how loss of blinded, placebo-controlled follow-up in ongoing trials, should be addressed,” she said. 

“The second item to discuss, is to discuss any gaps and plans described today and in the briefing documents, for further evaluation of vaccine safety and effectiveness and population to receive the Pfizer-BioNTech vaccine under EUA.”

Wollersheim said the final question is a yes/no vote, “Based on the totality of the scientific evidence available do the benefits of the Pfizer-Bio:Tech Covid-19 vaccine outweigh its risks for use in individuals 16 years of age and older?”

The VRBPAC committee will soon conduct a two-hour discussion, followed by a vote whether to recommend that the FDA issue emergency use authorization for the vaccine.

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

3:42 p.m. ET, December 10, 2020

FDA confirms Pfizer's coronavirus vaccine efficacy is "uniformly high" across trial subgroups

From CNN’s Amanda Watts

A health worker works in a lab during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, on September 9.
A health worker works in a lab during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, on September 9. Eva Marie Uzcategui/Bloomberg/Getty Images

The US Food and Drug Administration said its primary analysis confirms the Pfizer coronavirus vaccine shows a 95% efficacy seven days after the second dose. 

The FDA’s Dr. Susan Wollersheim ran through the FDA’s analysis of Pfizer’s data from its Phase 3 trial involving 44,000 volunteers. The FDA checks the company’s primary data and odes not rely on the company’s summaries of what it found.

With 170 Covid-19 cases in the group, “eight in the vaccine group, and 162 in the placebo group — giving a vaccine efficacy of 95% for the prevention of Covid-19 from seven days after dose two,” Wollersheim told Thursday’s FDA Vaccines and Related Biological Products Advisory Committee meeting.

Among subgroups — such as age, comorbidities and sex — results show that “the vaccine efficacy was consistently high across different subgroup analyses,” she said.  

Wollersheim did note that were some limitations in the “adolescent age because of small numbers of cases and participants, as compared to the adult population.” Additionally, another exception was “participants identifying as multiracial.” There were too few Covid-19 cases among multiracial volunteers to interpret the data. 

The committee will vote later Thursday on whether to recommend that the FDA issue emergency use authorization for the vaccine.

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."