Dr. Scott Bland - Health Education from a Family Physician

So we finally have COVID vaccines rolling out to the general public. Do they even work? We’re going to talk about that right now.

I’m Dr. Scott Bland, a family physician. My goal is to help you understand all the information that’s coming out about the COVID vaccine, so that you can make the choice that is the right one for you. So let’s go ahead and run through the data. There may be more vaccines later, but right now we have the Moderna and the Pfizer. Let’s get to it.

Does the Moderna Covid vaccine work?

We’ll start alphabetically with the Moderna vaccine. You’ll see, they put over 15,000 people in each group. 15,000 people got the actual vaccine (two doses worth) and 15,000 people got a placebo, which was essentially a fake injection of saline. As for results with the Moderna, you can absolutely see, there was a huge difference here. We had 11 people who, after they got their second dose happened to have symptoms consistent with COVID over a two week period. They were checked and found out that they actually had a COVID infection. This was only 11 people. But when you look at the placebo group, the people who did not get the vaccine… 185. 185 compared to 11 in terms of who had symptomatic COVID. Now, let’s look at severe symptoms, because some people have very minor symptoms. There are zero in the vaccinated group and 30 in the non-vaccinated group. Again, a pretty big difference for the two weeks after they get their second dose.

Does the Pfizer Covid vaccine work?

Now that we’ve talked about the Moderna, let’s go ahead and talk about the Pfizer vaccine. This was a slightly larger one. Over 21,000 people in each group. 21,000 got the vaccine, 21,000 got the placebo. Let’s look at the numbers of people who had symptomatic COVID. They tracked it for one week after vaccination. There was eight… just eight people with symptomatic COVID in the vaccination group and 162 in the placebo group. Eight compared to 162, in terms of who had symptomatic COVID. They also tracked a separate number for severe COVID and again that’s people who are very sick. One in the vaccinated group with severe COVID and 10 in the placebo group had severe COVID. So again, just like the Moderna, really big difference in terms of number of people with some symptoms of COVID and severe symptoms of COVID for the first week after the trial.

What we don’t know about the Moderna and Pfizer Vaccines

We don’t think the vaccine promises complete immunity to Covid.

I also think that it’s important to talk about the things that this study does not say. You don’t want to over promise. You don’t want to be dishonest in the way you represent the results of something. So let’s talk about some things that this does not actually say. This study does not mean that you can’t get COVID. We talked about the numbers. There were clearly some people with symptoms, a lot less, but some. There were some people who had severe COVID afterwards, lot less, but still some. So far, this vaccine data does not mean that no one can get COVID. And anyone who tells you that it does is not really being accurate about the data.

We don’t yet have proof the vaccine means you can’t give Covid to someone

Another thing that we need to talk about is that this does not necessarily promise that you can’t give COVID to someone else. This study was designed to look at symptoms, to look at health risks, but it was not designed to check transmissibility. I have lot of people ask me, “Hey, can I stop wearing the masks?” Do I need to keep social distancing once the vaccines are out? Do we just go back to life as normal? And I don’t know that because we haven’t been able to track if you can still transmit the virus to somebody else in a really effective way. Hopefully we’ll have that data soon, but we just don’t have it right now.

We don’t know how long the Covid vaccine lasts

The last thing that we need to be really particular about admitting is that we do not know how long these benefits will last. They clearly last for a few weeks. There’s a pretty massive benefit in terms of reduction of minor symptoms and reduction of severe symptoms. It’s pretty good data so far, but we do not know how long that will last. I can’t promise you that it’s going to last for two years. I can’t promise you that it’s going to last for 20 years. And at this point, no one can promise you that. We’re certainly hopeful and we’re going to be tracking that. As more information comes out, we can let people know, but we just don’t know yet how long this lasts.

I’m going to link below the actual studies from the New England Journal of Medicine about the Pfizer and the Moderna vaccine. You can read through them if you want. If you’ve got some follow-up questions, stuff I didn’t address that you’d like to hear about, please post them in the comments below. I’ll make sure that I get some answers out to you and try and give you some more information that I might not have gotten this video/post. Also, if you want to get updates about coronavirus issues or other medical things, as they come up, feel free to subscribe and you’ll be able to keep up with the conversation as we all learn more about this topic.

Thanks,

Dr. Scott Bland

Moderna Covid19 Study https://www.nejm.org/doi/full/10.1056/NEJMoa2035389

Pfizer Covid 19 Study https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

FDA Briefing Document about the Pfizer Vaccine: https://www.fda.gov/media/144245/download

My video discussing, “What is an FDA Emergency Use Authorization?” https://youtu.be/0oa-dLccJvQ

So just what is an emergency use authorization? The FDA has been granting a bunch of them. You probably hadn’t heard of them two years ago. You probably don’t know what they mean right now. We’re going to talk about it.

Hi, I’m Dr. Scott Bland. I am a family physician, and we’re here to help you understand the health information that matters to you most. So, Emergency use authorizations are things that have been around for awhile. You’ve probably never even heard of them until coronavirus came around and all of a sudden it’s all over the news. I’ve gotten a lot of people texting me and calling me, asking me, “what is an FDA Emergency Use Authorization?”. And so I figured lots of people will want to know, so we’re going to go through it. The first thing to understand about an emergency use authorization is that they are granted by the FDA and they are different than an FDA approval.

You may or may not be aware, but to get FDA approval for a test or for a treatment for a disease, it can take quite some time. It takes years and years of data. A company might have to spend billions of dollars to get a medicine to market and go through all the testing that’s required. It is a very exhaustive process. However, every now and then, something happens that doesn’t really give us a lot of time. Something is so urgent we have to change the rules. We have to move a little bit faster, and that is where an emergency use authorization comes into play. It’s been used in other situations in the past, but we’re going to talk about this in relation to the two vaccines currently authorized for the coronavirus. I think it’s important for you to understand the actual source data as much as possible.

I will link down below the actual document that the FDA was using to outline the criteria they were going to use to say, “we met all the necessary requirements to get an emergency use authorization”.

We’ll start with the first one, serious risk to health and life. You know, if anything qualifies for that, I would have to say that the coronavirus does qualify. 450,000 people in the U S have had their deaths attributed to coronavirus. At the time that we’re publishing this over 2 million people around the world have died. A lot of communities have been devastated. I know that I have lost patients. A lot of people have lost family members. This has been a real pandemic, a world changing event. It certainly qualifies as meeting the first criteria, this is an emergency.

The second criteria is that based on what we know, however limited, what we’re proposing to give an emergency use authorization for actually works. Whenever something serious comes up, something scary, something that is an emergency… there’s often this impulse to just “do something”. That is risky and has a lot of problems with it because you can often end up doing more harm than good. This is true even if you have good intentions. So part of an emergency use authorization is saying, “Hey, we actually think this really works”. This isn’t just a “try everything” approach. Sure we have limited information. It’s less than a normal FDA approval process, but the information we have is pretty good. I actually have a whole video that goes through some of the data about the Moderna and the Pfizer vaccines. (click for that video) This explains to you how I really think that those two vaccines particularly qualify for the second criteria here, which is, “we think this works”.

Number three is, the benefits outweigh the risks. There are pros and cons to everything that we do in medicine. I am constantly telling my patients that there are strings attached to everything. We do not have a perfect medicine for any disease. When you’re dealing with an emergency use authorization situation that still applies. We may not have as much data, but we are really intentional about trying to make sure that what we’re doing is going to cause more good than bad. If you think you found something that could cure coronavirus (which is a wonderful thing) but it killed half of the patients with liver failure afterwards… that would not be a good idea. That would cause more harm than good. So you have to look at the data that you have available (however limited) in an emergency use authorization situation and ask yourself if this isgoing to help more people than or hurts. I really do think looking at the data we have so far for the Pfizer and Moderna trials, those vaccines do qualify for number three. I think they do more good than bad.

The last criteria for an emergency use authorization is actually one that makes a lot of sense. We don’t have better options. If there were better options, you wouldn’t need to go to this one. And so we have to decide if this is the best option we have. There might be a situation where a test with a 75% sensitivity would be good enough, but it wouldn’t be good enough if you also had a test that had a 95% sensitivity. If you had a vaccine that gave 30% coverage, and that was the best vaccine that existed. Sure, give that vaccine. That’d be great. But, I wouldn’t give it if there was another vaccine that gave 95% coverage, right? If you had better options, you wouldn’t be asking for, or getting, an emergency use authorization.

So you’ve probably started thinking some follow up questions, some comments that you’ve got, go ahead and leave them below. And we’ll start talking through those. If there’s one that make sense for further videos, I’ll add those and I’ll put them out. You can subscribe if you want some ability to follow along with that conversation.

But we’re going to go over it one more time. The four things that the FDA is considering when they’re deciding, if somebody needs an emergency use authorization criteria:

1: It’s gotta be an actual emergency. It’s got to be a big, serious situation that causes serious risk to life, serious risk to health.

2: The thing that they’re proposing actually works. It’s got to be beneficial. It’s got to do the thing that it says it’s going to do.

3: It’s got to do more good than bad. This is different than #2, but also just as important. You don’t want to do more harm than you do good. So, it’s important that you weigh the risks and the benefits of the thing.

4: It’s the best option you have.

So when you look at a situation where there’s an emergency, you have something that works, it does more good than bad, and you don’t have better options. That is the kind of thing that really qualifies for an FDA Emergency Use Authorization.

FDA Emergency Use Authorization Criteria: (page 6) https://www.fda.gov/media/142749/download

FDA Factsheet for Pfizer Covid19 Vaccine: https://www.fda.gov/media/144414/download

Fact sheet site for Moderna Covid19 Vaccine: https://www.modernatx.com/covid19vaccine-eua/

CDC Covid19 data tracker: https://covid.cdc.gov/covid-data-tracker/#datatracker-home

My video discussing the effectiveness of the Moderna and Pfizer Covid Vaccines https://youtu.be/AbP-HGwloCw