Should Investors Be Worried About Pfizer and BioNTech's Coronavirus Vaccine Rollout?

In this video from Motley Fool Live, recorded on Dec. 21, Corinne Cardina, bureau chief of healthcare and cannabis, and Fool.com contributor Brian Orelli discuss the launch of Pfizer (PFE 2.40%) and BioNTech's (BNTX 0.74%) coronavirus vaccine. The rollout has been slower than expected, but the bigger concern might be the allergic reactions caused by the vaccine. The duo also discuss the mystery of additional doses in each vial.

Corrine Cardina: Let's talk about the vaccines that have been rolled out. Last week, of course, Pfizer and BioNTech's vaccine had their first full week of doses being administered, and probably to be expected, but there was no shortage of drama. As of Sunday afternoon, yesterday, almost half a million people had received a dose of the vaccine in the United States, that's according to the CDC. As of Friday night, there were about five incidents that potentially involved allergic reactions and are under investigation according to the FDA. Are these allergic reactions concerning or are they par for the course with any vaccine?

Brian Orelli: There are sort of two reactions that we could think about. One is an allergic reaction, and that would be a reaction to the components of the vaccine. We definitely need to figure those out. The two main components of both of the vaccines, Moderna's (MRNA -0.58%) and Pfizer's, is there's an RNA, that's the mRNA part and everybody has RNA in their bodies, so probably the patients aren't reacting to the RNA and then that's surrounded by a set of fat molecules, it's very similar to membranes of a cell and that's actually how the RNA gets into the cell. That fat molecule fuses with the cell and then releases the RNA into the cell, so we could be getting reactions to that, but it seems unlikely. Maybe it's a preservative in the vaccine that people are reacting to. That's concerning, but it's going to be a small number of people. We have to figure out what it is. We've got 20, 40, 50,000 people were tested in the clinical trials, so it's a small number even if it is.

The other issue is that people are going to have immune reactions, and so that's not reacting to the components of the vaccine, but reacting to the coronavirus protein that's produced by the mRNA in the patients' cells. That's definitely less concerning in my view because it means the vaccines working if you're reacting to the protein. It's more likely to happen on the second dose than it is on the first dose because you've been primed to react to it. But you could react to it on the first dose, especially if you've already developed antibodies to that particular sequence of proteins, because maybe you're exposed to a different coronavirus that have that sequence. It's not a huge issue, but obviously if people are overreacting, then that's a problem and maybe they're going to get some drugs to help their immune system tolerate the vaccine.

Cardina: Yes. There is actually just news this morning that the National Institutes of Health are devising a study to identify what part of the Pfizer vaccine is probably responsible for this anaphylactic reaction. So they are trying to get an answer to what we're seeing here. Hopefully, they can get their arms around that. Although it will be a complicated study, because they are going to be looking for people who have a history of allergic reactions. They are on top of it. They definitely are not ignoring this problem. Again, it should definitely not be a reason to not get the vaccine unless you do have a history. They've put out some guidance about if you do have a history of allergic reactions related to vaccines, you probably should not get this. But other than that, it should not be a cause to avoid it.

Some other interesting things that have gone on with the Pfizer vaccine rollout is that Pfizer and the federal government, we're going back and forth last week because the rollout was slower than expected in terms of volume of doses. Are we just now seeing the start of distribution and communication challenges with trying to get the U.S. vaccinated. What is going on here?

Orelli: Yeah, I mean the states aren't getting allotments as expected, but we're not real sure whether the issue was that they were expecting to. The federal government had told them they're expecting too much or if there was some issue with Pfizer or whatever, the federal government took some responsibility, I heard. There seemed to be some issue with the federal government had assumed, after you manufacture a vaccine, it gets tested to make sure its really what they think they made. Then they thought that they'd be able to ship immediately after that. But apparently it takes two days to process paperwork. Then Pfizer's could ship it out. That seems to be some of the issue.

But there were some other issues. There are some other reports its said Pfizer had vaccine ready to be distributed without instructions. That clearly isn't the two day issue. Then it's not a big surprise. They didn't have a whole lot of time to plan this and they're trying to roll it out as quickly as possible. I'm sure these things happen all the time with launches and we just don't care about them because they're not major news events.

Cardina: Yeah, there's a lot of attention on every small step of this rollout. Another headline was that it turns out there are more doses in each vial of the Pfizer vaccine than originally thought. Can you explain what's going on there?

Orelli: Yes. The vaccine comes as a concentrated solution that's frozen and then you thaw it out. Then the doctor, the nurse adds additional solutions to that to get it to the right concentration. Ultimately, it's supposed to be five doses in each vial. Obviously you want a little bit extra. As they're pulling it out there than maybe some loss or if you have to get an air bubble out of the needle that you have to lose some there. But even with those factors, it seems like each vial had enough for six-plus doses. The doctors were sort of wondering whether they should use the sixth dose because whoever you vaccine, now you also have to have another vaccine in 21 or 28 days to give them the second dose. The FDA says its fine to use the second -- any extra dose, but don't combine between vials.