Should investors be concerned about the launch of the coronavirus vaccine from Pfizer and BioNTech?

In this video of Motley Fool Live, recorded on December 21, Corinne Cardina, head of the health and cannabis office, and Fool.com contributor Brian Orelli discuss the launch of the Pfizer (NYSE: PFE) and BioNTechin (NASDAQ: BNTX) coronavirus vaccine. The launch was slower than expected, but the biggest concern may be the allergic reactions caused by the vaccine. The duo also discusses the mystery of additional doses in each bottle.

Corrine Cardina: Let’s talk about the vaccines that have been launched. Last week, of course, the Pfizer and BioNTech vaccine had its first full week of doses being administered, which was probably to be expected, but there was no shortage of drama. By Sunday afternoon, nearly half a million people had received a dose of the vaccine in the United States yesterday, according to the CDC. On Friday night, there were about five incidents that potentially involved allergic reactions and are under investigation according to the FDA. Are these allergic reactions relative or are they part of the course of any vaccine?

Brian Orelli: There are two reactions that we could think of. One is an allergic reaction, which would be a reaction to the components of the vaccine. We definitely need to find that out. The two main components of both vaccines, Modernin (NASDAQ: MRNA) and from Pfizer, there is an RNA, which is the part of the mRNA and everyone has RNA in their bodies, so probably the patients are not reacting to the RNA and so it’s surrounded by a set of fat molecules, it’s very similar to a cell and this is how the RNA enters the cell. This fat molecule merges with the cell and then releases the RNA into the cell, so we could be getting reactions to it, but it seems unlikely. Perhaps it is a preservative of the vaccine that people are reacting to. This is worrying, but it will be a small number of people. We have to find out what it is. We have 20, 40, 50,000 people who have been tested in clinical trials, so it’s a small number, even if it is.

The other issue is that people will have immunological reactions, and that is not reacting to the components of the vaccine, but reacting to the coronavirus protein that is produced by mRNA in patients’ cells. This is definitely less worrying, in my opinion, because it means that vaccines work if you are reacting to the protein. It is more likely to happen on the second dose than on the first because you were prepared to react to it. But you could react to it at the first dose, especially if you have already developed antibodies to that specific protein sequence, because maybe you are exposed to a different coronavirus that has that sequence. It’s not a big problem, but obviously if people are overreacting, it’s a problem and maybe they can get some drugs to help their immune system tolerate the vaccine.

Cardina: Yes. In fact, there is only news this morning that the National Institutes of Health is preparing a study to identify which part of the Pfizer vaccine is probably responsible for this anaphylactic reaction. So, they’re trying to get an answer to what we’re seeing here. Fortunately, they can put their arms around it. Although it is a complicated study, because they will look for people with a history of allergic reactions. They are on top of that. They are definitely not ignoring this problem. Again, it definitely shouldn’t be a reason not to get the vaccine, unless you have a history. They have published some guidelines on whether you have a history of allergic reactions related to vaccines, you should probably not receive this. But other than that, there should be no reason to avoid it.

Some other interesting things that happened with the launch of the Pfizer vaccine are that Pfizer and the federal government, we are coming and going last week because the launch was slower than expected in terms of dose volume. Are we now seeing the start of distribution and communication challenges when trying to vaccinate the US? What’s going on here?

Orelli: Yes, I mean that the states are not receiving quotas as expected, but we are not sure if the problem was what they expected. The federal government told them that they are expecting too much or if there was a problem with Pfizer or something, the federal government took some responsibility, I heard. There seemed to be some problem with the federal government assuming that after you make a vaccine, it is tested to make sure it is really what they think it is made of. So they thought they would be able to send it immediately after that. But it apparently takes two days to process the paperwork. Then Pfizer could dispatch it. This seems to be one of the problems.

But there were a few other problems. There are some other reports that Pfizer had a vaccine ready to be distributed without instructions. This is clearly not the two-day problem. So it’s not a big surprise. They did not have much time to plan for this and are trying to implement it as soon as possible. I’m sure these things happen all the time with releases and we just don’t care about them because they are not big news.

Cardina: Yes, there is a lot of attention in each small step of this launch. Another headline was that it appears that there are more doses in each vial of the Pfizer vaccine than originally thought. Can you explain what is going on there?

Orelli: Yes. The vaccine comes as a concentrated solution that is frozen and then thawed. Then the doctor, the nurse, adds additional solutions to obtain the correct concentration. Ultimately, there should be five doses in each bottle. Obviously, you want a little more. As they are pulling out, maybe some loss or if you have to remove an air bubble from the needle, you will have to lose a little there. But even with these factors, it seems that each bottle had enough for more than six doses. The doctors were wondering if they should use the sixth dose because whoever you vaccinate with, now you also have to get another vaccine in 21 or 28 days to give the second dose. The FDA says it’s okay to use the second – any extra doses, but don’t mix between the bottles.

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