In this video from Motley Fool Live recorded Dec. 14, Corinne Cardina, head of the health care and cannabis bureau, and Fool.com contributor Brian Orelli discuss the launch of the first coronavirus vaccine since Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). While the Food and Drug Administration approved the vaccine, there were some unanswered questions from the advisory committee meeting. They also talk about how difficult it is for investors to estimate the manufacturing side of their spread.
Corinne Cardina: Let ‘s start with the COVID-19 vaccine news. As I’m sure everyone, Pfizer and BioNTech know, their vaccine candidate was authorized by the FDA last week. Today, the first American received the vaccine, obviously, outside of tests, and that was an emergency care nurse in New York. Brian, when the FDA panel, their advisory committee, came in when they convened last week, is there anything that came out of that panel that is of particular interest to investors?
Brian Orelli: Yes. I think there were actually three things. First, the one-picture debate is against two-pictures. So there was a circling graph that was in the FDA information documents. When they measured their effectiveness, they started a week after the second dose, but the FDA provided a graph that showed starting from the first dose. So you would expect the vaccine and the placebo group to monitor each other for the first time during the second dose or even a week after the second dose, and then they would crack, but they largely separated after the first dose. So at least the first dose seems to offer some protection, but Pfizer was reluctant to say that they could only do one dose just because that ‘s not the way it was. set up a lawsuit, so it looks back, not -driven hypothesis, so they were not interested in a formal decision to go into a single dose, and to Surprisingly, the FDA decided to approve the two-dose regimen.
Second, there is a great deal of debate about 16-year-olds versus 18-year-olds as the minimum where the thresholds should be on who the authorization should be for. I think there were some – there were not four votes, and I heard that at least some of the people after that said that the reason they did not vote at all was because they thought that he should be 18 against 16.
Then the third thing, and I’m not sure what weight this got during the meeting, but it was in the information documents. There was some evidence of reactions. So there were, as, more than 1,000 people in the trial who had COVID-19 before and then 19 of them developed COVID-19, and there were 10 in the vaccine group and nine in the placebo group, and her -all but one of these between dose one and dose two. So there may not be much protection, but there is definitely a reversal. and I think it could depend on how sick you get the first time. So if you are asymptomatic the first time, you may not develop enough antibodies and then you will get an immunosuppressant.
Cardina: Of course. Health and Human Services Secretary Alex Azar said he went on Fox Business last week, saying there are a lot of different things including his intention to have a common vaccination for the public. These high-priority groups will be released in late February, early March, and by the second quarter of 2021, it will be possible for everyone who wants to get vaccinated in the U.S.. Brian, do you think that this is an exaggerated view, or is it something that could actually happen?
Orelli: I mean, I think it depends on manufacturing, it also depends – I mean, apparently, we will have two vaccines at that time because Moderna (NASDAQ: MRNA) it looks like he’ll get permission this week. But from an investor’s point of view, I think it’s very difficult to say because only the company provides how many doses are expected to be issued in all 2021, and so it is difficult to know how much of that is coming in the first months against all year round. I think it may not be linear – divide that number by 12 and that’s the number you get in January. It may be less than that.