DETROIT – Officials from the Food and Drug Administration held a press conference Saturday after granting emergency use authorization for the Pfizer COVID-19 vaccine.
It is the first COVID-19 vaccine to be authorized in the United States.
FDA Commissioner, Dr. Stephen M. Hahn, and FDA Biologics Director, Dr. Peter Marks, took questions from reporters during the press conference.
Dr. Marks advised pregnant and breastfeeding women, Americans with a history of significant allergic reactions and those who are on immunosuppressive therapies to consult with a physician before taking the vaccine.
Pfizer vaccine and allergic reactions
One major concern about the vaccine is the contraindication in people with a history of allergic reactions.
Those with a food allergy should consult with a doctor, advised Dr. Marks.
“So if you’ve had a history of allergic reactions obviously you should talk to your doctor about those but the vaccine, really is one that we’re comfortable giving to patients who have had other allergic reactions besides those other than severe allergic reactions to a vaccine, or one of its components,” Marks said.
“So obviously, you’ll need to tell your doctor if you’ve had allergic reactions, they’ll help determine knowing what’s in the vaccine if you might be allergic to one of those components, but we are making sure that sites where this vaccine is being administered have the ability to treat allergic reactions.”
Regarding including additional warnings about allergic reactions on the vaccine, Marks noted that about 1.6% of the American population has had a severe allergic reaction of some sort or another to a food or some environmental aspect.
“We would really not like to have that many people not be able to receive the vaccine, so we look very closely at the databases, and we feel comfortable, and we’re telling people that unless they’ve had a severe allergic reaction to the vaccine, or one of its components, they can receive it,” said Marks.
“Now, we’ll obviously be monitoring, we have very good safety surveillance systems in place, in conjunction with the Centers for Disease Control and Prevention, and we may have to modify things as we move forward. But for right now we’re comfortable with this and the extra, the extra piece of this is that centers will have the ability to treat allergic reactions. I think that’s an extra precaution.”
Breastfeeding or pregnant women
FDA officials also talked about considerations for women who are pregnant and breastfeeding in addition to those who are on immunosuppressive therapies.
Marks talked abut how the agency considered the recommendations for those groups since they were not included in the trials.
“Yeah, so there were not enough pregnant women in the trials or women who became pregnant in the trials to actually know and make any statement about that...We don’t have data at this point, but for pregnant women and the immunocompromised at this point, it will be something that providers will need to consider on an individual basis for patients, or for people,” said Marks.
FDA chief denies being pressured to approve vaccine
This week there were reports that the White House had threatened to fire Dr. Hahn if they agency did not grant emergency use authorization for the Pfizer vaccine fast enough.
During the press conference Dr. Hahn addressed the reports.
“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. So just want to put that on the record and I’ve been clear with that and in our response to those press reports,” he said.
US says COVID-19 vaccine to start arriving in states Monday
US officials say the nation’s first COVID-19 vaccine will begin arriving in states Monday morning.
Army Gen. Gustave F. Perna said Saturday that shipping companies UPS and FedEx will deliver Pfizer’s vaccine to nearly 150 state locations. Another 450 sites will get the vaccine on Tuesday and Wednesday.
Perna is with Operation Warp Speed, the Trump administration’s vaccine development program. He says the vaccine was timed to arrive Monday morning so that health workers would be available to receive the shots and begin giving them.
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.
Challenges could emerge in ramping up production of vaccines on a big scale. The FDA will be working with federal partners to help identify potential capacity and competitive potential supply that might help in the increased production of the vaccines.