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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5:47 p.m. ET, December 10, 2020

CDC advisory committee will vote Sunday on Pfizer's coronavirus vaccine

From CNN's Elizabeth Cohen

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.

If the panel votes in favor of the vaccine, that’s the last step needed before shots can go into arms.

An advisory panel to the US Food and Drug Administration voted to recommend emergency use authorization of Pfizer’s vaccine on Thursday.

If the FDA does follow the advice of its Vaccines and Related Biological Products Advisory Committee – and it usually does – then it’s the CDC’s turn to review the data.

The CDC’s Advisory Committee on Immunization Practices will meet virtually Friday to discuss Pfizer’s data, according to the agenda. Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, will make a presentation to the group.

The company’s clinical trials have shown the vaccine to be 95% effective with no severe side effects.

Once the FDA issues an EUA, then ACIP – a panel of independent experts – can vote on whether to recommend it. 

“We anticipate being able to vote on the use of this vaccine on Sunday,” CDC spokesperson Kristen Nordlund told CNN.

CDC Director Dr. Robert Redfield has to sign off on ACIP’s recommendation before it’s an official recommendation.

ACIP will also vote on whether any groups should not receive the vaccine. The vaccine has not yet been studied in several groups, including children under age 16, pregnant and breastfeeding women, and people who are immunocompromised.

On Dec. 1, the panel voted that the first two groups to receive the vaccine should be health care workers, and residents of nursing home and assisted living facilities.

5:43 p.m. ET, December 10, 2020

FDA advisers vote to recommend that the agency authorize Pfizer's coronavirus vaccine

From CNN's Maggie Fox

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted Thursday to recommend the agency grant emergency use authorization to Pfizer’s coronavirus vaccine.

Seventeen members voted yes, four voted no and one abstained.

5:37 p.m. ET, December 10, 2020

FDA vaccine committee moves to vote

From CNN's Maggie Fox

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee is moving to vote.

Each member will then explain his or her vote.

5:48 p.m. ET, December 10, 2020

FAA will give priority to flights carrying Covid-19 vaccines

From CNN's Pete Muntean

UPS President of Global Healthcare Wesley Wheeler holds an example of the vial that will be used to transport the Pfizer COVID-19 vaccine as he speaks on Capitol Hill, on Thursday, December 10.
UPS President of Global Healthcare Wesley Wheeler holds an example of the vial that will be used to transport the Pfizer COVID-19 vaccine as he speaks on Capitol Hill, on Thursday, December 10. Samuel Corum/The New York Times/Pool/AP

The Federal Aviation Administration will tell its air traffic controllers that flights carrying the coronavirus vaccine should be handled as a priority.

UPS and FedEx will carry Pfizer’s vaccine by air and ground as part of Operation Warp Speed, the Trump administration’s vaccine development and distribution effort, once it is authorized.

The FAA told CNN that air carriers will provide lists of flights carrying vaccines to a command center in Warrenton, Virginia, outside Washington, DC, “which will alert air traffic control facilities in the field that these are priority flights.” 

“The Command Center will closely track the flights along their routes to ensure they are given priority to the degree possible,” the FAA said in a statement.

Air carriers say swift transportation of the coronavirus vaccine by air is critical as they could be moving the vaccine the furthest distances and need to remain at ultra-cold temperatures. 

 

5:20 p.m. ET, December 10, 2020

FDA vaccine committee discussing whether to recommend authorization of Pfizer vaccine

From CNN's Maggie Fox

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee is discussing whether to recommend that the FDA grant emergency use authorization (EUA) to Pfizer’s vaccine.

A reminder this is not full approval, and the FDA makes that decision separately from the committee vote. The FDA usually follows VRBPAC recommendations and has signaled it will grant EUA quickly. However, it is not known when the FDA would make that decision.

The VRBPAC is made up of independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative — 17 regular members and 13 temporary voting members.

5:23 p.m. ET, December 10, 2020

Pennsylvania governor announces temporary ban on indoor dining

From CNN's Ganesh Setty

Customers sit in a booth at the Penrose Diner, on Tuesday, November 17, in south Philadelphia.
Customers sit in a booth at the Penrose Diner, on Tuesday, November 17, in south Philadelphia. Matt Slocum/AP

Pennsylvania Gov. Tom Wolf announced during a news conference Thursday afternoon a slew of new temporary Covid-19 restrictions amid the state’s Covid-19 surge. 

“We all hoped it would not come to this,” the governor said. “The current state of the surge in Pennsylvania though will not allow us to wait.”

Starting Dec. 12 through Jan. 4, all indoor dining, along with indoor operation of gyms and fitness facilities, will be prohibited. Outdoor dining and takeout services will still be permitted. 

Indoor gatherings will be capped at 10 people, and outdoor gatherings at 50 people, while places of worship will be “specifically excluded,” a release from the governor’s office explained. 

In-person businesses in the entertainment industry, meanwhile, such as movie theaters, museums, and casinos will also be prohibited from operation. 

“We need to slow the spread right now in order to save lives. If we don’t, we’re going to be in big trouble,” Wolf said. 

Additionally, all in-person businesses serving the public must operate up to 50% maximum occupancy, unless an existing local rule limits occupancy further.

Finally, all K-12 sports will be paused, along with in-person extracurricular activities. 

Professional and collegiate sports may continue, albeit without in-person spectators, and in accordance with Centers for Disease Control and Prevention and state health guidance.  

By the numbers: The new restrictions come as the state health department reported a record daily increase of 248 coronavirus-related deaths earlier Thursday, along with 11,972 additional Covid-19 cases.

The statewide totals now stand at 12,010 associated fatalities and 457,289 cases, including probable ones. 

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

Pfizer's Covid-19 vaccine's warning will mention people with "history of severe allergic reactions"

From CNN's Jacqueline Howard

The fact sheet and prescribing information provided with Pfizer's Covid-19 vaccine will warn that people with a history of severe allergic reactions to any the vaccine's components should not get it, an official at the US Food and Drug Administration said on Thursday.

"Over the last couple of weeks, we have been working with Pfizer on generating fact sheets and prescribing information," Dr. Marion Gruber, director of the Office of Vaccines Research and Review in the FDA Center for Biologics Evaluation and Research, said during Thursday’s FDA Vaccines and Related Biological Products Advisory Committee meeting. 

The advisory committee is discussing a possible emergency use authorization for Pfizer's Covid-19 vaccine candidate.

"The fact sheet and the prescribing information will state that this vaccine should not be administered to individuals with known history of severe allergic reactions to any components of Pfizer’s Covid-19 vaccine and the warning statement will say appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Pfizer Covid-19 vaccine," Gruber said.

"So that has made it already in the fact sheets and prescribing information weeks ago," Gruber said. "We, however, will consider any additional information that we’re going to be receiving over the next couple of days and factoring this into our decision-making."

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.

 

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.