Transcript for Pfizer and BioNTech asking for emergency authorization for COVID-19 vaccine
Pfizer is asking for emergency use authorization for the vaccine it has developed and ABC's elwyn Lopez is at CDC headquarters in Atlanta. Elwyn, good morning to you Reporter: Good morning, Dan. Here at the CDC a panel will be meeting on Monday to discuss who will get the first round of covid-19 vaccines. This as two major drug companies near the finish line. This morning, a light at the end of the tunnel. Pfizer's covid-19 vaccine becoming the first to seek emergency use authorization from the fda. We will continue the work already under way to make sure we can begin shipping the vaccine immediately after authorization or approval. Reporter: Moderna says its vaccine isar behind and both drug giants claim their candidates are about 95% effective. The date to circle on the calendar, December 10th. That's when a panel of advisers will take a look at pfizer's trial data. After that they will make a recommendation on how to move forward. If approved, arm to needle could come before Christmas. Be prepared for serious help that we will get from the vaccines. Reporter: Delivering and supplying pfizer's vaccine comes with a challenge. Interesting requires a minus 81 degree celsius, in other words, really cold. Reporter: Medical gra freezers like this one in las Vegas hard to come by. The second major step only made possible through volunteers. I was really enthusiastic to participate. The trials are rigorous. The procedures are very detailed. Reporter: Those who rolled up their sleeves first in clinical trials, an essential part in the fight against coronavirus. Both pfizer and modern reported no serious side effects in their clinical trials, both requiring two doses of the vaccine. If authorized for emergency use, up to 20 million Americans could get vaccinated by the end of the year. Eva? Elwyn Lopez for us, thank you. Joining us is Dr. Paul offit, a member of that advisory panel and a vaccine expert at the children's hospital of Philadelphia. Thank you for being with us. This emergency use authorization request by pfizer for its vaccine, kind of walk us through. What does it entail and how long will it take? Right, so what is happening now, pfizer has submitted to the fda approval through emergency use authorization. So the fda will take a couple weeks to look through all those data, and it's massive amounts of data. Then they'll turn to the fda's vaccine advisoryommittee and say do you agree this vaccine should be approved through an eua. We'll meet on December 10th and make that decision. Assuming that decision is, yes, to approve it then it goes to the CDC's advisory committee called the advisory committee for immunization practices and it will be an independent group that will look independently at the data and then make a recommendation for whether the vaccine should be given and to whom and how should it be administered. Who would be the first, second, third, et cetera. We still are hearing a lot of people having skepticism about this vaccine, any vaccine. Does the fast pace of the vaccine authorization worry you at all? No. I think the key thing is that you do a phase 3 trial. When we saw what happened hydroxychloroquine where drugs were approved without any clear evidence that they worked, I think that shook people up and it's understandable. This is different. All these vaccines are being subjected to a phase 3 trial meaning the case of modern, 30,000 people get the vaccine or get placebo. In the case of pfizer, 44,000 get vaccine or placebo. That's true of vacci. That's fine. The only reason they're not licensed as compared to through emergency use authorization is the length of time they're studied. With pfizer you'll know they're protected for a couple of months. Typically the fda wouldn't license a product that's only gone that period of time. So then the question becomes if you're protected for a couple months is it likely you would be protected for six months or a year and the answer to that question, I think, yes although there may be some erosion in percent effectiveness, it wouldn't be much. It is faster than typical and I think we mitigated a lot of risks associated with the vaccine. So then the next question is what are the hurdles of getting this vaccine to where it has to go to people? Right, and that's going to be a challenge. Especially pfizer's vaccine which requires storage and shipment at minus 70 to minus 80 degrees centigrade is part of it.what happens is once you then thaw the product it only has a 24-hour life in the refrigerator and it is a concentrated product in five to ten-dose vials so needs to be reconstituted with saltwater, saline and then it only has a six-hour life after that. You have to line peoplep and make sure they all get it. It will require centers specifically designed to look after this vaccine and give it so it will be challenging. Dr. Offit, thanks for being with us this morning. We always appreciate you.
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