COVID-19 Update 9/22: J&J Boosters, CDC ACIP Meeting, Adverse Reactions, and More

On this week's COVID-19 update, Dr. Bishop discussed Johnson & Johnson's data for its booster doses, what the CDC's ACIP meeting is all about, adverse effects, and more. Among the questions he answered:

• What does J&J's booster data say?
• What are they discussing in the CDC ACIP meeting?
• What should you know about adverse reactions to the vaccines?
• How are the side effects from booster doses? 
• Are the at-home COVID tests good tests? 

Watch the video below or read on for the full recap.

Johnson & Johnson Booster Data

Here is a link to the J&J data press release. They released some data finally about what they're calling their ENSEMBLE 2 study, which was where they gave a second dose of the J&J vaccine to people about 56 days after the first dose was given.

It's a little unclear to me if they're calling this a second dose, a booster, what this is going to kind of pan out to be.

I'm calling it kind of a booster, because for most people when they get it, it's going to be six or more months since they got their first dose. It's more like a booster than a second dose in the series, in my mind. But you know, it's a little bit of semantics there. I don't think it matters too much.

What they did find was that giving the second dose did enhance and extend the protection of the J&J vaccine after the first dose. They did not release the whole dataset like we've had for some of the Pfizer boosters and those things just yet, but this was just sort of a press release of top-level results.

And they said the second dose results in 100% protection against severe or critical COVID illness, which is great. And then 75% protection against symptomatic infection against COVID-19 globally, so that includes all countries. But 94% protection against symptomatic illness in the United States. Because they did this I think a few months ago, that might not reflect the Delta variant really coming in force into the United States.

That 75% number is probably closer to the true number at preventing symptomatic infection now that we have the Delta variant, because most of the other countries that they were testing this in were probably already experiencing the Delta variant, and we got on our way up a little late on that.

So I suspect that 94% number reflects its protection against symptomatic illness from Alpha variant or one of the others, and the 75% is probably closer to the real number for the Delta variant. That would be my guess, since they did it 56 days after the first dose, and I think this was done some months back.

They also reported significant increases in antibody levels after the second dose, which is great. They said in their press release here, "We didn't find any serious side effects or problems," which, you know, that's fine. We need to see the full data set that gets released and see how that goes.

They did tease a little extra piece of data. They did one other study, but they didn't provide a lot of details giving what they called, frankly, a booster, of the J&J six months after the first shot, and just said, "We saw antibody levels increase nine times the original number one week after the booster and went up to 12 times increased four weeks after the booster."

But they didn't present any outcomes or data in terms of severe illness, symptomatic illness, anything like that. So it's kind of like a teaser, a teaser piece of data for more on the J&J.

Probably more to come on this. I would suspect the bottom line is we'll have to see the full data set come out so we can, again, like we always do, look at the adverse effect profile. It's likely going to be similar to the first dose. The other vaccines have all been kind of the same thing.

The second and third doses all have roughly similar adverse event profiles, which is to say mostly it's local reactions or minor systemic reactions, like fever, myalgias, headaches, that sort of stuff.

We'll see more data on that, but that's good news. Finally, a little bit more information for everybody who got J&J. I know everybody who got J&J has been feeling a little bit, kind of out to dry waiting for more information about what to do next.

Just as a reminder, the ACIP data we looked at two weeks ago now, even the one-shot of J&J continued to provide very good protection against severe illness, hospitalization, and death from COVID, even with the one dose.

We may see something similar happen with what we're seeing with Pfizer right now, where certain categories of people get recommended to take the second dose of J&J, but maybe not necessarily everybody because it might not be strictly necessary.

ACIP Meeting on Pfizer Boosters

(Editor's Note: The FDA and CDC have officially authorized Pfizer boosters for certain populations.)

And that bleeds into what's going on today. Next week we'll have lots to talk about thanks to the ACIP meeting. That's the Advisory Committee on Immunization Practices. That's part of the CDC.

They're talking today (Wednesday) and tomorrow (Thursday) about whether they are going to officially recommend that boosters for Pfizer be given, and if so, who should get those. So we'll have an answer to that probably at the end of the day tomorrow.

Remember FDA approves what they think would be reasonable and legal in terms of, from a safety standpoint. They make a safety recommendation and an efficacy recommendation based on the data that Pfizer submits, so that's whether the product can go on the market or not, right? Under a EUA or otherwise. FDA is really making sort of a market decision.

And then CDC/ACIP makes a medical recommendation and that's their role. And that's why there are two different groups of people here and there's kind of a multi-step to this process.

So there's a, "Is this safe and effective enough to be given out to the U.S. public?" And if so, and ACIP says, "Okay, it's safe and effective. Who do we actually recommend take this?"

And that becomes sort of a medical recommendation from that group of physicians that sit on that committee. We'll have probably that decision by the end of the day tomorrow (Thursday), and then we'll know kind of where we're going to head with at least with Pfizer, for booster doses, third doses, whatever you want to call it.

And then hopefully soon, we'll repeat this process with Moderna and then probably with J&J as well. So again, a little bit of good news there for our J&J people, but again, continue to have good faith that your vaccine, the first one you got, is a good one. There's not a pressing need for a booster for most people based on the ACIP data from a couple of weeks ago, so it's okay to sort of sit back and wait a little bit while we sort out the follow-up study data and make some decisions on this.

Adverse Reactions & Misinformation

There's an article making the rounds. It's from something called the World Tribune. I'm not going to post the link to the article because I don't think it's responsible to share it, quite honestly. Because I think that it's full of a lot of misinformation.

And I'm not really someone who likes to necessarily label everything that doesn't agree with what I think as misinformation.

But I read through it. There's a lot of comments, a lot of discussion in there, with things that just aren't factually accurate, both about the vaccines and the process related to the vaccine. So I'm not going to share that article, but I do want to address it because many people are probably seeing it.

What happened was there was a local ABC affiliate that posted on Facebook asking people to share stories of their friends and loved ones who had passed away from COVID. And then they got flooded with comments of people claiming that their loved one, spouse, friend, whoever had some horrible side effect from the vaccine and that this happened, or that happened. There sort of became like a whole thing where the Facebook post was flooded with this information.

I just want to address it in a general way, and the reason I want to address it is:

• A) It's making the rounds.
• B) There's a lot of not-great info on there.
• C) A few of our patients have sent it to us and asked us to comment and discuss it.

So I want to talk about it. The problem with any medical intervention, vaccines included, or anything else is that you're always going to have a couple of things.

You're always going to have a certain percentage of people that truly do have a side effect or an adverse effect from that intervention, no matter what it is. Whether we're talking about taking an aspirin, using an antibiotic, having surgery done, or a vaccine, it doesn't matter what it is. You're always going to have a certain number of people that have a real, true negative adverse impact from that intervention.

That is just the way medicine works in general, unfortunately. There's always going to be a certain percentage of people that have a bad outcome. Because not everybody's the same and things don't always go perfectly. Same thing with vaccines, right? There's always going to be some people that — whether it's genetics, environment, whatever it is — they're going to react poorly to a vaccine.

So that's absolutely true. And I think what's driving a lot of what's going on here on social media is people not being honest, and just saying, "Look, we know some people are going to have negative impacts with the vaccine. Let's talk about that. Let's figure out what the negative impacts are and discuss those openly."

Instead, I think what you're seeing is a lot of, "Don't talk about that." And so people are feeling suppressed in that way when they are having real problems.

And that's, that's something we do have to discuss, right? Like the myocarditis risk for young men with the mRNA vaccines. It is a real thing. It is now in the FDA labeling. It's been a real thing since the vaccine was being given, but a lot of people felt like they couldn't talk about it, because, for whatever reason, they felt like that information was going to be suppressed, taken down, whatever.

And so it leads to this sort of conspiratorial thinking about the adverse effects of vaccines. There's not a grand conspiracy here with this. We've got to be honest and let people talk about adverse effects openly. So I think that's what's led to some of this.

So you've got some people that have real negative effects from vaccines, right? But that's a small number, a few percent here or there that are really having a real issue.

The other thing that happens when you do any medical intervention and you follow patients over time, random things are going to happen to people that were going to probably happen to them anyway. It just happens to be close in time with the medical intervention.

Again, whether this is a medication, a surgery, a vaccine, doesn't matter what it is. If you take a certain population of people, random stuff is going to happen. Strokes, heart attacks, sudden deaths, cancer diagnosis, some neurological illness, seizures, whatever.

You're going to have a certain percentage of people have these things that were going to happen to them most likely, anyway. It's just that they also happen to get a vaccine around the same time.

Adverse Reactions: How VAERS Works

So what happens is, when you've got these adverse event reporting systems, they collect all data about any bad thing that happened to somebody after getting a vaccine.

It doesn't mean just because it makes it into the VAERS system that it was caused by the vaccine. Most likely, and in the vast majority of cases, it just means something random happened to them, and after it's investigated, it's found to have no relation to the vaccine or the drug or the surgery or whatever it is we're monitoring. It's a coincidence.

And unfortunately, our lives are full of coincidences. But our brain has trouble struggling with that when we see our Aunt Sally, or our Uncle Bob, or our cousin Jim, they got the vaccine yesterday and today they had a stroke. It's easy to make that association in your mind.

And I understand that from a realistic perspective, but when you actually look at the information you have to compare the rate of these random things happening to people who didn't get the vaccine and the rate of these things happening to people who did.

And when you compare them, you find most of the time there's no difference, except for a few things here or there. Again, think about the myocarditis, the heart inflammation. That showed up as a real signal in the data.

That was happening more frequently in adolescent males than you would expect to happen randomly in the population of adolescent males, right? So some of those things do shake out over time, but by and large, most of these associations that people are coming up with are not true.

They feel true to them. And I understand that, but when you actually look at the aggregate information, most of them don't pan out.

When we kind of present those anecdotes and those one-off stories as, "Well, see, this is what can happen when you take the vaccine," I think that that's very disingenuous and I think it scares people unnecessarily, and I think it leads them down a road that may actually be harmful to them, especially if there's someone who really could benefit from the vaccine.

I think we do need to be very careful about that, tread lightly, unless the data really is on our side with these things. That's why, again, I wanted to address this, and most of what's being posted in that article, and in that Facebook post, is sort of these one-off weird stories about, "Well, so-and-so, you know, they got the vaccine and then this happened to them."

Well, most of the time that's going to turn out to not be related to the vaccine. I'm sure that that terrible thing did happen to that person, but it doesn't mean it's from the vaccine.

Schools & Quarantining

"I'm in Chesterfield County and am struggling to understand the science behind the exposure/quarantining guidance at schools (if vaccinated, no quarantine but if not, quarantine). It seems like the vaccines prevent serious complications but do not prevent infection and that COVID will be with us possibly forever. From a medical perspective does contract tracking and quarantine even make sense given that it looks like we really can't prevent infection?

Yeah, it's a little messy out there right now in terms of the quarantine and contact tracing rules. I think that there's a couple of things playing in here.

First, I think, as most people probably know because I've talked about it before, I live in Chesterfield County. My kids go to Chesterfield public schools. I think that the quarantine and contact tracing guidance that they have set up for the public schools is confusing and it's being implemented inconsistently.

I think that that's causing even more confusion because it's being implemented inconsistently at the school level. That being said, it's correct that if you are vaccinated, no quarantine is needed based on the Virginia Department of Health and those other things. And that's generally true.

If you're vaccinated and exposed, you don't need to isolate. You should wear a mask. You should get tested five days after your exposure, but you don't need to isolate. And if you are unvaccinated, then you still do need to isolate.

I agree with you. I think we are transitioning to a model where this infection is going to be endemic, which means we're probably not going to get rid of it. But I think that honestly, that is a very emotional topic for a lot of people. And a lot of people are not there yet. And so they're having a hard time making that transition.

I think that ACIP and these FDA committees are trying to move the population in the direction of that realization because they keep talking about, "Okay, the vaccines are great. They're going to keep you alive. They're going to keep you out of the hospital. Probably not going to keep you from getting infected."

And I think you're going to hear more and more of that message over time. But I think people, because our vaccination rates are still a little bit low and because we still have a fair number of people who are in the hospital and dying, I think we're not ready to get rid of the quarantine rules or the isolation rules at this point, as a society to do that.

I think we're going to get there, but it's going to take a little more time. But yeah, what's going on in Chesterfield County, specifically, I think is confusing because the way the rules are being implemented

Side Effects from Third Doses

"For those that are getting the third dose, are they having any side effects?"

Side effects tend to be similar to the second dose. That's for Pfizer. I don't have all the data on the second dose for J&J. I only have what they put out in the press release. So Pfizer, third dose, the side effect profile is pretty much the same as the second dose with the exception that some people had a little bit more lymph node swelling with the third dose compared to the second, but otherwise pretty much the same.

Timing for Different Vaccinations

"With the possibility of having multiple vaccines this Fall (Covid booster, flu shot, and Shingrix) I am unclear how much time to leave between vaccines. Should there be a reaction, I would want to be able to identify which caused it. Can you advise?"

For this situation, you can get the COVID and flu vaccine together if you want to. If you want to separate them, I would space them out by two weeks, but the official recommendation is you can actually take the COVID and the flu shot together if you like.

But if you want to be pretty clear and have good margins around each one, I would separate them out by two weeks each. And I would definitely get the SHINGRIX alone. That one can make you feel a little crummy, especially the second dose.

At-Home COVID Tests

"What's your opinion on a home test for COVID?"

They are great. The home test for COVID is mostly the BinaxNOW, and there may be one or two other brands out there.

They are very similar to the test we've been using in our offices. I've used them at home for myself and my family. They work fine. They work well if you can find them. They're now out of stock everywhere, but they are good tests.

Modifying COVID Vaccines in the Future

"Over time, do we anticipate vaccines to be modified based on the variants, similar to how we handle the flu vaccine?"

Maybe. Maybe. I'm not sure. I think that's going to depend on how long and how robust this protection from severe illness and hospitalization lasts.

I don't think FDA or ACIP is going to be excited about giving boosters of any kind unless they find that that hospitalization and severe illness protection is waning. If we keep finding that that's stably high, I'm not sure we're going to need boosters for everybody at any point, but we'll have to see. It is certainly a possibility.

Second Shots for J&J Recipients

"Sorry if I missed this earlier, given the new data on J&J, do you think it's likely all J&J recipients will get a second shot to put this vaccine more on par with the mRNA vaccines?"

Maybe. I'm not sure, is the short answer on that. The long answer is, I don't know if it's going to be strictly necessary for everybody to get a second shot.

I keep going back to the ACIP data from a couple of weeks ago. They showed that just with the one dose, people were having very good sustained protection against severe illness and hospitalization, even out at that six-month mark with just the one dose of J&J.

If they use the same logic for Moderna and J&J that they use with Pfizer, I'm not sure the FDA is going to be excited about approving a second dose for J&J based on that information. But we'll see. We will see.

Downside for Getting Third Dose if Not 65+?

"What would be the downside to getting a third dose, if you weren't 65 plus?"

The downside is the potential side effects, right? And like with anything, no drug, no vaccine is perfectly safe. They never are. They never will be.

The FDA and the CDC's role in this is to advise people on the risk and benefit profile. Getting a third dose may not make sense for everybody because of potential risk, right? Either for side effects, short or long-term that we just don't know.

And if you have sustained good protection, there may not be any point in getting a third dose of something, if the protection is good and long-lasting. I think that's the issue. It's like with anything else — we don't want to do medical interventions if we don't need to. That goes for antibiotics. That goes for surgeries. And then it's the same for vaccines. Don't do stuff if you don't have to do it because there are always risks associated with that. 

When will the next update be?  

Our next update will be Wednesday, September 29, at 1:00 p.m. live on the PartnerMD Facebook page. As always, we will post the full video and complete blog recap on Thursday morning. If you'd like these delivered to your inbox in our weekly blog recap emails, you can manage your email preferences here.