Feds Avow Safety, Availability of COVID Vaccine

WASHINGTON — Now that the FDA has authorized a COVID-19 vaccine for emergency use, federal officials spent Saturday morning reassuring Americans that the vaccine is safe and that it will be efficiently distributed to them.

“Some feel the speed with which this development and regulatory process took place might give them concerns about vaccine,” FDA Commissioner Stephen Hahn, MD, said at a rare FDA Saturday morning press conference. “That’s why we’ve been very transparent … about the processes and the science and the data.”

“I know the meticulousness of the review the FDA has done,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, which evaluated the vaccine. “I will absolutely take this COVID-19 vaccine … because I have complete trust and confidence in the FDA’s career staff’s evaluation.”

The FDA issued an emergency use authorization (EUA) for the vaccine late Friday, a day after an FDA advisory committee voted 17-4, with one abstention, to recommend approving an EUA. But the process was not without its share of drama, with the Washington Post reporting earlier on Friday that Hahn was told by the White House that he had to authorize this vaccine on Friday or resign. On Saturday, Hahn denied that he had been pressured in that manner. “Representations in the media that I was threatened to be fired by a certain date is inaccurate,” he said.

Gen. Gustave Perna, chief operating officer at Operation Warp Speed, the Trump administration’s project to speed up development of vaccines and therapeutics, said he expected the first shipments of Pfizer’s COVID-19 vaccine to arrive at their destinations on Monday morning. “We worked with Pfizer, McKesson, UPS, FedEx, and federal and law enforcement agencies to ensure the safety and security of the vaccine,” he said during a separate press conference. “We are not done until every American has access to the vaccine, until every American that wants it, receives it.”

Perna said that as he was speaking “boxes are being loaded and packed with the vaccine, with the emphasis on quality control. It will be moved to UPS and FedEx hubs in the next 24 hours and go out to 636 locations nationwide.” A total of 145 sites across all the states will receive their allocation of the first batch of vaccine on Monday, another 425 will get it on Tuesday, and the remaining 66 will get it on Wednesday, he said. “The vaccine will marry up with kits we’ve already distributed with needles, syringes, dilutant, and the other supplies necessary to deliver the shot.”

Each week, more doses will become ready for allocation and distribution, “and we’re also posturing to phase in the Moderna vaccine if they receive an EUA,” Perna said. “We want to ensure the vaccine arrives safely and can be effectively administered once arrival occurs. It’s important all vaccines are utilized as a shot in the arm, and that nothing is wasted.”

During a question-and-answer session, Perna was asked about the possibility that some spoilage of vaccines might occur; the Pfizer vaccine in particular must be kept at about -80° C. at all times while in transit. “We’ve taken extreme precaution on the execution and delivery of the vaccine,” he said. “We identified early on that the way to mitigate that was to bring in the ultimate professionals in execution,” including Pfizer, Moderna, McKesson, FedEx, UPS, and pharmacies. “They know how to deliver and distribute the vaccine prior to administration. Do I think something is going to occur? I do. Hence the reason why I maintain some reserve stocks.”

In addition to the reserve stocks, Perna said that — at least initially — he will be saving enough vaccines for a second dose for those who received their first dose. “Holding the second dose until we have ultimate confidence and build up stocks to make sure we can get the American people a second dose,” he said. ” We have a moral responsibility and obligation to make sure the second dose is available for the American people.”

At the FDA press conference, officials were asked about reports of anaphylactic reactions in two people in the U.K. who received Pfizer’s COVID-19 vaccine after it was authorized there. “Though there were [anaphylactic] reactions in Great Britain, they were not seen in the original clinical trial datasets,” said Marks, adding that people who are planning to get the vaccine should inform their doctor if they have had such reactions to previous vaccines.

“We’re making sure sites where this is being administered, that they have the ability to treat allergic reactions,” he said. “We considered the potential allergic reactions pretty carefully here.” CDC, which is helping with the vaccine rollout, “is making sure all sites have basic supplies to take care of allergic reactions,” such as epinephrine pens, Benadryl, and hydrocortisone, he said.

One issue the FDA is still getting data on is shedding and transmission of the virus. “Those studies are going to be conducted during the coming months,” Hahn said. Officials also were asked about the EUA including use in those ages 16-17 years, which was a heated topic at Thursday’s advisory committee meeting. “We at FDA … approve a lot of vaccines in the pediatric age range and we’re very used to extrapolating data from older to younger children,” said Marks. “Based on what we saw looking at the data, we were confident the data was acceptable,” and since some 16- and 17-year-olds work as checkout clerks at stores where they interact with much of the community, “it may be wise to vaccinate them.”

Last Updated December 12, 2020