US FDA panel recommends Covid-19 vaccine authorization

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. 

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.

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. 

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. 

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.

"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.

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.

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.

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.

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: 

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.

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.

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.