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COVID-19 Update 6/23: Numbers, Myocarditis, Full FDA Approval, and More

June 23rd, 2021 | 5 min. read

By Steve E. Bishop, M.D.

COVID-19 Update 6/23: Numbers, Myocarditis, Full FDA Approval, and More

On this COVID-19 update, Dr. Steven Bishop provided an update on declining numbers across the country, discussed the rate of myocarditis and pericarditis after vaccinations, and answered questions on full FDA approval timelines and masks for schools. 

A couple of things in general. Across most of the U.S., hospitalizations and fatalities continue to decline slowly, which is excellent news. We're still running nationally about 300-400 fatalities a day. So obviously too many but we are making good progress.

Lots of people have been vaccinated at this point, which is excellent. I know in Virginia, I think we've approached over the 50% mark on people who have been vaccinated with both doses, which is really good. And so hopefully that will just continue to decline over time. I saw an update from one of the local health systems every evening and there were only a few patients in ICU in the local Richmond area. And I believe across Virginia there were only about 30ish patients who are in an ICU or on ventilators across the state currently, which is great.

We haven't had numbers like that since close to the beginning of the pandemic. So that is all good news. And I think that's probably going to stay stable even as some of these variants continue to be an issue and come in, even though everyone's talking about the Delta variant right now and that's the one that was first identified in India and it's kind of spread around.

It's probably going to come here to Virginia soon if it hasn't hit already, again that's the natural history of these things. Once they develop, if they're more infectious than the prior strain, they're going to become dominant. There's almost nothing you can do to prevent that. So that one will become dominant over time and will transmit. The good news is that from what I can tell it doesn't seem that it's any worse in terms of disease severity than the other variants or the original strains that we have.

And the good news, too, is that the vaccines continue to provide excellent protection against pretty much all of the new variants that have shown up, especially the Pfizer and the Moderna vaccines. They still have 80 to 90% or more protection from severe disease and death. Not quite as good at preventing all infections, but still very good results for the vaccine. So I will take it.

Myocarditis and Pericarditis

Other updates on vaccines that you guys have probably been following in the news. Today, the CDC's advisory group on immunizations is meeting to review data on particularly Pfizer and Moderna, but I think they're looking across the board including J&J as well, at the reports of myocarditis and pericarditis that have occurred, especially in young people after both doses of the COVID vaccine.

There have been about 1,200 reported cases of myocarditis or pericarditis since the start of the vaccination campaign and that's nationwide. For those who aren't familiar, myocarditis is inflammation of the heart muscle itself, and pericarditis is inflammation of the sac of tissue that is covering the heart and that the heart sits in. The heart sits in this very small sort of bag of water called the pericardium. And that helps it move around and do what it needs to do as it pumps and beats.

So that outer tissue can get inflamed or the heart itself can get inflamed and that can happen for a lot of reasons. Viral infections are by far and away the most common cause of those two syndromes, including COVID and other things, too. Influenza can do it. Cold viruses can do it. Pretty much any respiratory virus has the potential to also cause these problems.

However, we are seeing a pretty significantly increased number compared to the expected number of cases you would see this seasonally and for COVID in general after people get the vaccination. So it's about double, especially in young men. So men 16 to 24, the rate of myocarditis and pericarditis post-vaccination is about twice of what you would expect to see just sort of that randomly happen out in the community. So expect to hear results from that meeting.

They were supposed to meet last week to discuss the data but it got postponed due to the Juneteenth holiday and that being a federal holiday so things got moved to this week. So hopefully by end of business Friday we'll have some updated recommendations and reports about that information and see what they have come up with based on looking at all of the data.

Treatments and Therapeutics

I know on treatments and therapeutics, the only things that have come out are some additional sort of positive studies on ivermectin in particular. But again, these are smaller studies in smaller journals but we'll see how the data continues to bear out over time.

We certainly have used ivermectin here and we'll probably keep using it if we need to but we haven't needed to prescribe it lately, because frankly, so few people are sick with COVID, which is great because of vaccines are working. But we'll keep following that. And Pfizer is working on an oral drug as well. So I'm sure we'll see more data about that also in the coming months.

Full FDA Approval for Vaccines

"Do you know when the vaccines will get full approval from the FDA? I've heard some won't get the vaccine until full approval."

Yeah, so I don't know right now. My guess is that full approval will come for adults by the end of the summer for Moderna and probably Pfizer. For the under 18s, I think it may be a little longer, especially since we've had this issue now with the myocarditis and the pericarditis. I think that's going to set back full approval. I think people are going to want to see, and the FDA is going to want to see, more larger-scale studies on, at least I would hope, on the under 18 population or under 16 for Pfizer population for full approval for that.

That's going to take a little bit longer maybe my guess. I'm just guessing end of the year you might see that, but probably end of the summer for full approval for adults, for 18+ for Moderna and Pfizer so, great question.

Vaccines for Children Under 12

"Any idea for access to vaccines for those under 12?"

Yeah, I think it's going to be a little longer. A lot of that I think is going to hinge on what comes out of this meeting this week with the Advisory Committee on Immunization. We will see. I don't think there is going to be a strong data release on the under-twelves for another month or two.

Masks in Schools

"Masks or no masks for schools in the fall?"

Are you asking my thoughts or whether I think that most schools are going to use them? I guess I can answer both. So my thoughts are that the data continue to show that schools are not a major source of transmission for COVID. And with all of the adults having the chance or hopefully choosing to be vaccinated, all the teachers and the staff, I think the risk to having maskless kids in school is negligible.

And I think the school boards should not be using masks in the fall. I think most counties in Virginia probably will follow that and they will not have masks. Some may and we'll just have to see that'll be up to each school district to decide. But I think most school districts are not going to have masks in the fall. And I think that that's the right choice, especially given how higher vaccination rates have gotten so far.

Steve E. Bishop, M.D.

As a board-certified internist and concierge doctor in Richmond, VA, Dr. Steven Bishop is passionate about helping his patients improve their lives through better health. He helps healthy adults adjust their lifestyles as they age and helps patients with complex medical diseases manage and improve their health.