COVID-19 Update 9/8: Monoclonal Antibodies, Pfizer Vaccine, Israel, Delta, and More

On this week's COVID-19 update, Dr. Steven Bishop discussed several topics, including: 

• What are monoclonal antibodies? Do they work? 
• Is there a difference between the fully approved Pfizer vaccine and the EUA-approved Pfizer vaccine? 
• What's happening with vaccines in Israel? 
• What's the status of this Delta wave? 
• And more. 

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

Treating COVID with Monoclonal Antibodies

The first thing I want to talk about, that's really not getting enough discussion, is the treatment of COVID with monoclonal antibodies. Here are two articles I'll discuss:

• Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19
• What Is Monoclonal Antibody Therapy & Who Is Eligible to Receive It?

Regeneron is the big common one that's being used in our area, and this is the one we're using most commonly here at PartnerMD. It's an FDA-authorized treatment for COVID.

It's a monoclonal antibody, and what that means is that they have taken and artificially created antibodies that specifically target the protein on the COVID virus. These are neutralizing antibodies, and that's the antibody that we want to elicit when we create a vaccine.

We want to elicit antibodies that neutralize the virus and make it unable to replicate and do the things that it wants to do and binds it up. That's what these drugs are designed to do as well.

Regeneron is probably the most commonly used one, especially around here. That's the one we're using. It's the most widely available.

These are excellent treatments for COVID. The data that has come out in the last few months, and actually since January, has shown that not only does Regeneron and the other antibody set work extremely well to treat symptomatic COVID, especially in those who are mild to moderately ill — so people who aren't needing to be in the hospital yet — these are very effective treatments for people.

And they are actually very effective for prophylaxis. If you are a high-risk person who has been exposed to COVID and there's a risk that you would do very badly with COVID, you can get this treatment as prophylaxis, and it will prevent you from getting COVID at a substantial rate.

The first article I posted there is on the prophylaxis trial. It was a significant decrease and the relative reduction risk was a 92% reduction in people getting the drug and preventing them from getting COVID after an exposure. So the drug works very well.

We can't use it on everybody. A) There are supply limitations, but B) Not everyone needs it. For those who are using it as prophylaxis, the best thing is to use it for people who have a very high risk after exposure. People who are above 65. If they have obesity. If they're pregnant. If they have diabetes or some other immune system problems.

Generally, that is for either people who are not vaccinated, or even if you are vaccinated and you want post-exposure prophylaxis, we can use these antibody treatments for that.

For those who are fully vaccinated, you can also, again, use this both prophylactically if you've got an immune system problem, but also for treatment, whether you've been vaccinated or not, and it still will reduce your risk of needing to go to the hospital and of dying from COVID.

For those folks, again, if you're using it as a treatment, it's going to be in those high-risk people for the most part, but these are excellent treatments.

They should be used a lot more widely than they are being used currently. So that's why I want to talk about them a lot today and mention them. Our physicians are prescribing those treatments at PartnerMD, but we're not giving them here because they are an infusion.

How Do Monoclonal Antibodies Work

This is how they work. There are a couple of different ways to get them. They can either be given as a subcutaneous injection or as an IV infusion. It takes about an hour and you have to be monitored, get your vital signs checked, those sorts of things.

It's free because of the way the government has set up the contracts, et cetera. There may be some charges for the nursing labor to do the administration and that sort of thing, but the drug itself is no cost.

So again, it really is something that we should be using a lot more widely, but we're not yet. In addition to encouraging people to get vaccinated, I think we need to also be using this as a treatment:

• For people who are choosing not to or who can't get vaccinated for whatever reason
• For people who have a significant breakthrough case in which they are getting a little bit more ill than we would like on a breakthrough case.

So excellent drugs, as I said. Definitely need to be using those a lot more frequently. So they're excellent and again, FDA authorized for use. 

Monoclonal Antibody Protocols

"Do you have a protocol for treatments? Can you prescribe treatment once a person is admitted to the hospital?"

No, we do not do that. Now, in the hospitals in this area, generally, if you're admitted, most people are getting not only the monoclonal antibody treatments but also Remdesivir and steroids and some other things as well. That's all being commonly used in the area here.

Boosters

"Do you have the booster available yet?"

No, we do not have new doses of vaccines available to patients here at PartnerMD. And remember, CDC is only recommending booster doses at this time for people who have one of those specific immune system or immune system-related conditions.

There is no recommendation in general for boosters for most people. Only people who have specific immune system disorders. So no other recommendations on boosters just yet.

Pfizer Vaccine: Full FDA Approval vs. EUA Approval

The next thing I wanted to talk about some was this question —someone asked on the blog if, there's this core sort of ongoing, I don't even know if the word is controversy, just discussion about this whole issue around the way that the FDA approved the Pfizer vaccine as Comirnaty, which is the strangest, most poorly chosen name, it's very difficult to pronounce.

Someone was asking if they had released the material data safety sheets and they have. Here is the data safety sheet.

So people are worried, "Oh, is this a different vaccine than the one we've been using under the EUA?"

And the answer is no. They are the same thing. They are legally distinct, meaning that one is a brand name version and one is sort of, almost think of it as a generic version. But it's the same vaccine, same drug.

The reason that they did it this way — approving the new brand name while they kept the EUA active — was so that we can keep using the doses of Pfizer under the EUA that we already have, while they start production of the brand name version.

Otherwise, they are the exact same thing. There's no issue one way or the other. The safety data is all the same, and it's the same drug. And just think of it as a name-brand drug versus a generic drug.

IV Vitamin C? 

"Can we get IV vitamin C at home?"

I'm not aware of anyone that's doing that in the area. There may be some wellness centers in the area, not at PartnerMD, that are doing IV vitamin C infusions and such, but it's not something we specifically recommend or prescribe here.

What's happening with vaccines in Israel? 

The next topic I wanted to talk about is — there's this concern that people have, people who are still a little bit hesitant about taking the vaccines, one of their questions is, well, if the vaccines work, why are we seeing all of these cases in Israel?

This Israel is the one that keeps coming up because they've had a big increase in cases lately and some increase in hospitalizations and deaths. I want to break this down a little bit for you guys.

I understand the question. We absolutely should be curious every time we see something that doesn't quite make sense to us. It's always good to take a closer look and figure out what's going on there, but I think there are some easy-to-explain issues as to why this might be happening. 

A couple of things to think of. First off, even though Israel is a very highly vaccinated country, it's still only got about 60% of its population vaccinated. It's nowhere near a 90-100% vaccination rate that would really create significant herd immunity in any way.

I think that's sort of the first thing to keep in mind. They still have 40% of the population essentially that's unvaccinated. That's partly what's driving the ongoing cases from Delta variant — cases, hospitalizations, and fatalities are being driven partly by the fact that 40% of the population is unvaccinated.

The second thing that's going on — Israel has mostly used the Pfizer vaccine. And if you recall, what we talked about the last couple of weeks, the Pfizer vaccine does show a fairly precipitous drop-off in terms of protecting against transmission or infection.

Mostly what's been going on in Israel is an increase in new cases, even up to higher than they were back in December, January. They have lots of new cases, and that does not surprise me significantly given that the Pfizer protection from transmission, and Moderna too, but particularly Pfizer for the Delta variant, degrades pretty significantly.

So you're going to see lots of cases. Between the protection from transmission degrading from Pfizer, plus the fact that still 40% of people are unvaccinated, I'm not surprised that we're seeing big upticks in cases.

Now, if you go and look at the data, what you're actually seeing is, even though the cases are way up and hospitalizations are up a lot, the hospitalizations and the fatalities, in particular, are nowhere near where they were back in December, January, and February.

Even though their case numbers are way up, the hospitalizations and fatalities are, while increased, still low — about half or less compared to what they were over the winter.

That, to me, is showing that the vaccines are doing what they do best, which is keeping people as much as possible out of the hospital and from dying.

Always remember, you're always going to have some breakthrough cases of people going to the hospital and some people, unfortunately, still dying from breakthrough cases, particularly people who are older, people who have immune system problems and maybe didn't respond as well to the vaccine.

It doesn't surprise me that with the spread of Delta, we've seen an uptick, just like we've seen here in Virginia — we've seen an uptick even though roughly the same percentage of our population is vaccinated, about 60% — we've seen an uptick in hospitalizations, an uptick in cases, and an uptick in deaths. 

I think we're almost to the back end of this Delta wave. And that's what Israel's seen too and if you look at their data, they are peaking as well and coming back down.

The big thing to remember, again, just a couple of big takeaways:

• 40% of people are still unvaccinated in Israel.
• They used Pfizer. The efficacy drops to around 40-ish percent for preventing transmission after a few months. They mostly used that, so Delta is going to spread amongst vaccinated people
• But their hospitalizations and fatalities, while they have increased, have stayed far, far, far lower than they were over the winter

The vaccines are still doing their job. This data makes sense to me. I see why it can be confusing and why people may question it, but I think there are some logical explanations there and actually, it's kind of what I would expect to see because of the way that the vaccines have turned out to work.

And I know people are disappointed. I am too. I was hopeful initially that the vaccines would prevent transmission. I think we were all hoping that, but it just doesn't seem the case and the vaccines' main effects are to keep you out of the hospital. Keep you from dying. And honestly, I'm happy with that and I will take it. I'll take it.

The goal is to make this infection as much of a non-event for people as we possibly can. So I think this is still good and I don't think the Israel data or the data from any country that I've seen at this point really supports a view of not taking the vaccine.

I don't think that's supported by the data that we're seeing. The vaccines work, but I continue to encourage people to take the vaccinations to prevent hospitalization and death.

Status of the Delta Wave

I'm looking at our local data here in Virginia and the United States. I think based on what we're seeing in the numbers, it seems like we've plateaued on cases and hospitalizations, and we're probably starting the back half of the wave from the Delta variant spread most likely.

It'll probably continue to decline over the next 40 to 60 days, and that's pretty consistent with what was seen in India and in the UK. They had about a 120-day cycle for their wave of Delta in those two countries and our Delta wave started in early July, so we're about 60 days in now and we've got probably another 60 days to go.

60 days to the peak and 60 days to the end. So probably in the next two months, we'll see that tick down.

Another COVID Wave? 

We will probably see another wave of COVID uptick as we get into December, January, and deep into the respiratory virus season. Don't be surprised when we see that most likely again, whether it's more Delta, a smaller Delta wave, or if it's a new variant that comes along. Who knows at this point, but that's kind of where we're at on all those things.

Regeneron Shortages

"Is there any shortage of Regeneron?"

There are some intermittent supply issues with that in different places. I've heard of it a bit in Texas, in particular, some places are having some supply shortages there. But in general, it's fairly available in our area.

Regeneron Infusion Centers

"Are there any plans to set up Regeneron infusion center like Florida?"

I'm not aware of Virginia doing that, but it is fairly available in the area. We've been using a couple of local infusion centers here ourselves, and we haven't had any trouble yet getting anybody in. It's usually not the same day. It's usually sort of the next day or within 48 hours.

So there's a little bit of planning that has to be done to get that done, but I'm not aware of any of our patients or anybody locally wanting to get Regeneron who hasn't been able to get Regeneron. They may have had to wait a day or two, but they've all been able to get it.

There was a shortage months ago. Earlier this year, January, February, there were shortages and there was not a lot of dose supply, but I believe that that's been significantly improved at this point, so.

Regeneron Treatment Window

"What is the window to get Regeneron?"

If you are using it for prophylaxis after exposure, you want to get it as soon as you can after the exposure.

Same thing with treatment. If you're using it as treatment, you just want to use it as soon as you can. Basically, you can take it any time prior to admission to the hospital. They may give it to you in there as an inpatient, but there's really no specific window that says, "Okay, well you're day five so you can't have it."

There's no window like that, but the earlier the better is the general rule of thumb there.

Booster Timeline & Flu Shots

"Is six months about right for a booster? Should I still get a flu shot?" 

The CDC hasn't recommended boosters for anybody yet except those who are immunocompromised and have a specific or have a specific immune condition or taking certain types of immune system suppressing drugs.

I would hold off on that, but I would definitely get a flu shot. Pretty much everybody should get a flu shot this year. I usually recommend people wait until mid to late September to do that. That kind of optimizes the protection window a little bit more than getting it earlier. And you can get a COVID shot at the same time as the flu shot if you want to do them at the same time. 

When is the next update?

Our next update will be Wednesday, September 15, 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.