By Ben Westcott, Brett McKeehan, Amy Woodyatt, Fernando Alfonso III and Alaa Elassar, CNN
From CNN's Greg Wallace
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.
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.
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:
From CNN's Jamie Gumbrecht
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.”
From CNN's Lauren Mascarenhas
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:
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:
From CNN's Jamie Gumbrecht
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 there’s “been a lot of noise” about the protection provided by one dose of Pfizer/BioNTech’s coronavirus vaccine and whether that could help extend the vaccine supply.
The FDA’s stance is that people should take two doses.
“The way the regimen was studied was that everyone, ultimately, or almost everyone received two doses of the vaccine, so we only know how people were protected with two doses of the vaccine,” Marks said. “We spent so much time carefully reviewing the data and basing our decisions on science, right, that it seems pretty foolhardy to just conjecture that one dose might be OK without knowing.”
Marks added: “So at least from the FDA perspective, we would be recommending that people complete the two-dose series so we actually know that they're truly protected at the rate of approximately 95% of efficacy."
Watch:
From CNN's Gregory Wallace and Pete Muntean
Months of planning culminate this weekend with the first deliveries of Pfizer coronavirus vaccine doses – and the UPS executive overseeing his company’s efforts says it is an emotional experience.
“Oh, probably the equivalent of going to your daughter's wedding, I guess,” said Wes Wheeler, the president of UPS Healthcare, told CNN. “It's been a lot of planning. A lot of a lot of phone calls, a lot of technology, a lot of alignment ... As an engineer, I like to do a lot of planning, so that when day one comes, it comes smoothly.”
Wheeler said the process that soon gets underway at the Pfizer facility in Kalamazoo, Michigan, will be highly choreographed.
“We have people embedded at the Pfizer location in Michigan, and they will be helping Pfizer to dispatch packages,” he explained. “They will be loaded onto a trailer, a dedicated trailer, with an escort. They will drive five hours to Louisville, Kentucky, and then there'll be dispatched around to the states that we’re assigned.”
In Louisville, many of the shipments will be loaded onto UPS planes. Wheeler said the company’s extensive delivery network means it can ship doses overnight for delivery by 10:30 the next morning. UPS is handling delivery to sites on the Eastern side of the U.S.
The company is also creating 24,000 pounds of dry ice daily that are packed into special Pfizer containers to keep the vaccine at the required sub-zero temperature.
“The day after the vaccines arrive, we deliver 40 pounds of dry ice to replenish what is sublimating from the box,” Wheeler said. “The Pfizer package is good for 10 days with it with the 50 pounds of dry ice in it. And with the 40 pounds that we send the following day. It'll give you another several days if necessary so the box becomes the storage medium at the dosing center.”
More details: Tracking devices on each container and truck send real-time information back to the UPS command center in Louisville.
The tracking tags have four radios and a Bluetooth device that transmit data including GPS location, “atmospheric pressure, motion detection, light detection, and of course temperature,” he said. That data gives the company insight into the condition of each package and the dry ice inside of it.
“We have eyes on these shipments all the way from origin to the final dosing destination,” he explained.
From CNN's Jacqueline Howard
Now that the Pfizer and BioNTech's Covid-19 vaccine has been authorized in the US, clinical trial participants can find out whether they received the vaccine or placebo, Dr. Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, said during a virtual news conference on Saturday morning.
"We have to balance the amount of blinded data that we received with the need to protect people," Marks said.