December 12 coronavirus news

By Ben Westcott, Brett McKeehan, Amy Woodyatt, Fernando Alfonso III and Alaa Elassar, CNN

Updated 12:07 a.m. ET, December 13, 2020
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11:50 a.m. ET, December 12, 2020

Coronavirus vaccines will go to 145 US sites Monday, Operation Warp Speed official says

From CNN's Maggie Fox

Doses of Pfizer’s Covid-19 vaccines will start moving out within 24 hours, Gen. Gus Perna, chief operating officer of Operation Warp Speed, said Saturday.

“They will begin moving vaccine from the Pfizer manufacturing facility to the UPS and FedEx hubs, and then it will go out to the 636 locations nationwide, which were identified by the states and territories,” Perna told a news conference Saturday. “We expect 145 sites across all the states to receive vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday, which will complete the initial delivery of the Pfizer orders for vaccine." 

The US Food and Drug Administration issued emergency use authorization for the Pfizer vaccine Friday evening.

“At the sites, the vaccine will marry up with the ancillary kits that we've already distributed. These kits include needles syringes, dilutant and other supplies necessary to administer the shots," Perna said.

No vaccines were pre-positioned, Perna said.

“We did not want to presume EUA (emergency use authorization),” he said.

12:03 p.m. ET, December 12, 2020

Federal Aviation Administration clears Pfizer vaccine for pilots

From CNN's Gregory Wallace and Pete Muntean

The Federal Aviation Administration said it has cleared pilots to receive the Pfizer coronavirus vaccine. 

There is a 48-hour waiting period after each dose of the vaccine before a pilot may resume duties.   

Until now, the FAA has required that vaccines and medications be approved for use by medical certificate holders. 

Earlier this week: The FAA told CNN it would quickly review the safety of each coronavirus vaccine following FAA authorization.   

This does not mean that pilots are actively in line to receive the vaccine imminently. Industry organizations and unions this week urged the Centers for Disease Control and Prevention to put airline workers on priority lists for vaccination. 

11:25 a.m. ET, December 12, 2020

CDC committee meeting on Pfizer and BioNTech's Covid-19 vaccine begins

From CNN's Jamie Gumbrecht

Erik S Lesser/EPA-EFE/Shutterstock
Erik S Lesser/EPA-EFE/Shutterstock

A virtual meeting of the US Centers for Disease Control and Prevention's Advisory Community on Immunization Practices has begun.

During the meeting, ACIP members will discuss the Pfizer/BioNTech Covid-19 vaccine and there will be a public comment period.

The agenda says the group will vote on whether to recommend the vaccine at 2:30 p.m. ET. 

12:49 p.m. ET, December 12, 2020

Covid-19 vaccine shipments to begin leaving Pfizer's Kalamazoo facility on Sunday

From CNN's Greg Wallace

Pfizer manufacturing facility in Kalamazoo, Michigan.
Pfizer manufacturing facility in Kalamazoo, Michigan. Pfizer

Pfizer has told reporters covering its rollout that it expects the first shipments of its Covid-19 vaccine to leave the Michigan facility Sunday morning.

The company originally predicted trucks rolling “within 24 hours” of Food and Drug Administration authorization.

The company did not provide an explanation for the later timeline.

 

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

FDA is "comfortable" with Pfizer/BioNTech vaccine’s safety for 16- and 17-year-olds

From CNN's Jamie Gumbrecht

The US Food and Drug Administration says the potential benefits of the Pfizer/BioNTech vaccine outweigh the risks for 16- and 17-year-olds, Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said during a news briefing on Saturday.

FDA has a long history of evaluating pediatric vaccines and extrapolating data from adults to children, he said.

“Based on everything we saw from looking at the data, we're very comfortable that the safety profile that was observed in 17- and 16-year-olds was acceptable,” Marks said, even if the study group wasn’t as large as it was for older people.

Although teens rarely become seriously ill from Covid-19, Marks acknowledged some do become very sick and die. And, teens are able to transmit the virus “quite easily” – even if they’re asymptomatic.

“Since some of those 16- and 17-year-olds, at least that I know of, are out there as checkout people, or interacting with communities, it may be wise that we are able to vaccinate them,” Marks said. “So we think the known and potential benefits outweigh the known and potential risks.”

It will take a few months before it’s clear how the vaccine impacts transmission of the virus, Marks said.

On pregnant women: Decisions about whether pregnant women should take Pfizer and BioNTech’s Covid-19 vaccine should be considered on an individual basis, Marks said. 

“Covid-19 in a pregnant woman is not a good thing, so someone might decide that they would like to be vaccinated, but that's not something that we're recommending at this time. That's something we're leaving up to the individual,” Marks said.

Marks said that the clinical trials of the vaccine, which did not enroll pregnant women but included women who became pregnant during the trials, did not yield enough data to make a determination for that population.

“For pregnant women and the immunocompromised – just at this point – it will be something that providers will need to consider on an individual basis for patients,” said Marks.

 

11:31 a.m. ET, December 12, 2020

Pfizer Covid-19 vaccine’s benefits outweigh its risks, FDA commissioner says

From CNN's Lauren Mascarenhas

The benefits of the Pfizer and BioNTech vaccine outweigh its risks, US Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn said Saturday.

“We held a public advisory committee on Thursday about the Pfizer and BioNTech application,” Hahn said during a news conference. “The committee overwhelmingly agreed that the vaccine’s benefits outweighs its risks.”

Hahn said the FDA has been transparent about the data.

“We've also posted important information to help healthcare providers understand the benefits, risks and proper use of this FDA authorized vaccine,” Hahn said. 

CNN health reporter breaks down FDA's comments: 

11:24 a.m. ET, December 12, 2020

FDA is convinced Pfizer/BioNTech vaccine’s extreme cold temps can be maintained

From CNN's Jamie Gumbrecht

The room where coronavirus vaccines will be kept in super-cold storage at Cedars-Sinai Medical Center in Los Angeles, California.
The room where coronavirus vaccines will be kept in super-cold storage at Cedars-Sinai Medical Center in Los Angeles, California. Cedars-Sinai via AP

Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a news briefing on Saturday that FDA is “pretty convinced” the extreme cold conditions required for the Pfizer/BioNTech vaccine can be maintained, based on planning and past experience.

Some background: The Pfizer/BioNTech vaccine needs to be stored at about minus 75 degrees Celsius – far colder than any vaccine currently used in the United States.

The vaccines are using specially designed shippers with dry ice, and they can remain refrigerated for a few days once thawed.

FDA made clear in the labeling how the vaccine will need to be handled, Marks said, and the US Centers for Disease Control and Prevention and Operation Warp Speed “are making sure that things are in place to make sure that the cold chain is maintained.” 

10:42 a.m. ET, December 12, 2020

FDA is "very concerned" about vaccine hesitancy, commissioner says

From CNN's Lauren Mascarenhas

FDA Commissioner Dr. Stephen Hahn speaks during a news conference on Saturday, December 12.
FDA Commissioner Dr. Stephen Hahn speaks during a news conference on Saturday, December 12. Pool

Food and Drug Administration Commissioner Dr. Stephen Hahn said that the organization "is very concerned about vaccine hesitancy."

“We are also aware that some feel that the speed with which this development and then regulatory process took place might give them concerns about the vaccine,” Hahn said during an FDA news conference Saturday.

The FDA has addressed the hesitancy, Hahn said, by being transparent about the science behind Pfizer and BioNTech’s Covid-19 vaccine and the process for authorizing it.

Hahn said that the FDA believes in "transparency" and "the rigorous scientific review that we've done."

Watch:

10:06 a.m. ET, December 12, 2020

FDA commissioner denies political pressure led to quick FDA authorization of Pfizer vaccine

From CNN's Maggie Fox

US Food and Drug Administration Commissioner Dr. Stephen Hahn denied on Saturday that political pressure led to a quicker than normal decision to issue emergency use authorization for Pfizer’s coronavirus vaccine.

The FDA issued the EUA Friday evening, a day after its Vaccine and Related Biological Products Advisory Committee voted to recommend the authorization. But as the FDA considered the vote, Hahn was summoned to the White House.

“First of all, the representations in the press that I was threatened to be fired if we didn’t get it done by a certain date is inaccurate,” Hahn said at a news conference held jointly Saturday with Dr. Peter Marks, who heads the FDA’s vaccine and biologicals branch. Dr. Marks and I have been very clear from the beginning that we are going to maintain the integrity of the scientific process. We are going to let our scientists do their job and review and go through the fairness of that review – the gold standard, if you will." 

The FDA said it reviewed not just Pfizer and BioNTech’s summary of their clinical trial involving around 40,000 volunteers, but went through to original source data. It showed the vaccine was safe and provided 95% protection.

“Our incredible team, heroic efforts, night and day worked to get this out the door,” Hahn said. “As Dr. Marks said, thousands of people are dying a day."

Hear FDA commissioner's answer when asked about political pressure: