In this video from Motley Fool Live, recorded on December 21, Corinne Cardina, head of healthcare and cannabis, and Brian Orelli, contributor to Fool.com, discuss the launch of Pfizer (NYSE: PFE) and BioNTechsay (NASDAQ: BNTX) coronavirus vaccine. The development was slower than expected, but the biggest concern may be about the allergic reactions caused by the vaccine. The duo also discusses 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 administered their first full week of doses, and probably to be expected, but there was no shortage of drama. Sunday afternoon, yesterday, nearly half a million people received a dose of vaccination in the United States, according to the CDC. As of Friday night, there were about five incidents that could possibly include allergic reactions and are being investigated according to the FDA. Do these allergic reactions apply to or is it equivalent to any vaccine?
Brian Orelli: There are two reactions we can think of. One is an allergic reaction, and it is a reaction to the ingredients of the vaccine. We definitely need to figure it out. The two main components of both vaccines, Modernsay (NASDAQ: MRNA) and Pfizer’s, there’s an RNA, it’s the mRNA part and everyone has RNA in their bodies, so most likely the patients do not respond to the RNA and then it’s surrounded by a set of fat molecules, it’s very similar to membranes of a cell and this is actually how the RNA enters the cell. That fat molecule fuses with the cell and then releases the RNA into the cell so we can get responses to it, but that seems unlikely. Maybe it’s a preservative in the vaccine that people respond to. This is worrying, but it’s going to be a small number of people. We need to find out what it is. We tested 20, 40, 50,000 people in the clinical trials, so that’s a small number, even if it is.
The other problem is that humans are going to have immune responses, and so it does not respond to the components of the vaccine, but to the coronavirus protein produced by the mRNA in the patients’ cells. This is definitely less worrying in my opinion because it means the vaccines work if you respond to the protein. This is more likely to happen with the second dose than for the first dose, because you are set on responding to it. But you can respond to it with the first dose, especially if you have already developed antibodies against the specific protein sequence, because you may be exposed to another coronavirus that contains that sequence. It’s not a big deal, but if people overreact, it’s obviously a problem, and maybe they’ll get drugs to help their immune system tolerate the vaccine.
Cardina: Yes. There is actually only news this morning that the National Institutes of Health is conducting a study to determine which part of the Pfizer vaccine is likely to be responsible for this anaphylactic reaction. So they are trying to get an answer to what we are seeing here. Hopefully they can get their arms around it. Although it will be a complicated study, because they are going to look for people who have a history of allergic reactions. They are on top of it. They certainly do not ignore this problem. Again, this should definitely not be a reason not to get the vaccine unless you have a history. They outlined some guidelines about if you have a history of allergic reactions related to vaccines, you probably should not get them. But other than that, it should not be a reason to avoid it.
A few other interesting things that went on with the Pfizer vaccine development is that Pfizer and the federal government were going back and forth last week because the rollout was slower than expected in terms of dose doses. We are only now seeing the beginning of distribution and communication challenges with the attempt to get the US vaccinated. Whats going on here?
Orelli: Yes, I mean the states are not getting awards as expected, but we do not really know if the problem was that they were expecting. The federal government told them they were expecting too much, or if there was a problem with Pfizer or whatever, the federal government accepted responsibility, I heard. There seemed to be a problem with the federal government, after you manufactured a vaccine, it was tested to make sure that was really what they were thinking. Then they thought they could send immediately afterwards. But it apparently takes two days to process paperwork. Then Pfizer can send it out. That seems to be part of the case.
But there were some other problems. There are a few other reports that Pfizer had the vaccine ready to be distributed without instructions. This is clearly not the two-day problem. Then it’s not a big surprise. They did not have much time to plan it and try to roll it out as quickly as possible. I’m sure these things happen all the time with launches, and we just do not care about them because they are not important news events.
Cardina: Yes, there is a lot of attention paid to every little step of this rollout. Another headline was that there are more doses in each vial of the Pfizer vaccine than originally thought. Can you explain what’s going on?
Orelli: Yes. The vaccine comes as a concentrated solution that is frozen, and then thawed. Then the doctor and the nurse add additional solutions to get it in the right concentration. Eventually it is supposed to be five doses in each vial. Obviously you want a little extra. While they take it out there as maybe a loss or if you have to get an air bubble out of the needle, you have to lose there. But even with the factors, each vial seemed to be enough for six plus doses. The doctors wondered if they should use the sixth dose, because whoever you vaccinate, now you have to have another vaccine within 21 or 28 days to give the second dose. The FDA says it’s okay to use the second – any extra dose, but do not combine between the vials.