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“It’s working”: Dr. Rai says real world study shows COVID vaccine is safe and effective

Published: Feb. 25, 2021 at 7:30 AM CST
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GREEN BAY, Wis. (WBAY) - A real world study of the COVID-19 vaccine shows it is effective for a wide range of outcomes.

“We’ve shown it’s really safe. We’ve shown it’s working, it’s efficacious. That type of data is really important to see in the real world versus a study world. The real world is showing the studies were true,” says Prevea President and CEO Dr. Ashok Rai.

CLICK HERE to read the study published in the New England Journal of Medicine.

Dr. Rai joins us Tuesdays and Thursdays on Action 2 News This Morning. Have a question? Email news@wbay.com

Previous Dr. Rai segments: https://www.wbay.com/health/drrai/

INCREASE IN SUPPLY COMING IN MARCH?

We’re looking ahead to the expected approval of the Johnson & Johnson vaccine and promises from Moderna and Pfizer for increased production.

“It really depends. It’s coming off the production line, now how quickly is it going to get to the state of Wisconsin, distributed to us and into arms? So when they say March, I’m maybe a little cynical, is it March 31 or is it Monday? Right now, we’ve gotten our allocations for the next two weeks. I don’t think we’re going to see significant increases until mid-March now, unless the state starts to layer on more doses to what they’ve already told us we’re going to get, which is a possibility and a hopeful one. But obviously with J&J coming out and saying 20 million doses in the month of March, say two-to-three percent come to the state of Wisconsin, that’s 600,000 doses in a month. That’s more than we normally get from the other two combined. A lot easier to give and transport. You look at Moderna and Pfizer with their news, they’ve got to get paid. They’ve got to deliver a certain amount of doses by March 31. They’ve got a lot to make up in March. You add up those numbers, it could be a really good March, and at the very least, it will be a very good April.”

HERD IMMUNITY

“We’ll know it after we’re there. It isn’t one of these things--and I think there’s been people writing articles and predicting April or May or June--I think that’s actually really dangerous. Remember, you know you get there when we see our case rate get down to nothing, and we know it’s not being transmitted from person to person, when there’s no more of a host for this virus, then you can look back and say, maybe it was August 2 that this happened on. Yeah, you can use predictive modeling, you can use artificial intelligence to say we’re going to get there. But there’s a lot of variables in there that we don’t have true factual knowledge of. And this virus has shown to basically disprove a lot of the modeling that we’ve seen in the past, how it replicates so rapidly, how it can mutate. So I think it’s really important that until we’re there, we continue to make sure that we get everybody vaccinated and we continue to wear a mask until that’s done. Then hopefully sometime this late summer or fall, we’ll look back and like, wow, this date was probably the date that we really got to that point in this area where there was no more spread.”

ISRAEL’S SUCCESS AND VACCINE EFFICACY STUDY

What can we learn from Israel on their vaccine success?

“Like we’ve mentioned, it’s been published this week, there’s been some vaccine hesitancy in the United States around ‘Is it safe, does it work?’ Now we’re starting to see both in Israel in their publications and what we’re seeing in the United States is it’s not 30,000 people in one group and 30,000 people in another group in a Phase 3 study that we’re talking about any more. We’re talking about 600,000 people that were vaccinated versus 600,000 people that were not. We’ve shown it’s really safe. We’ve shown it’s working, it’s efficacious. That type of data is really important to see in the real world versus a study world. The real world is showing the studies were true.

“We’ve given tens of millions across the world and the United States as well, and over a million in the state of Wisconsin, and not having any significant effects, anything that’s happening days or months after, now that we’ve seen it and everybody’s been watching for it, which is another thing, it’s not like it’s being ignored. They’re watching for it like a hawk. We’ve found out, once again, that this vaccine is very safe and it’s working very well. That’s why we need to get it into everybody’s arms.

“It’s interesting because we don’t talk much about the vehicle of how they’re delivered. These delivery vehicles both with Moderna, Pfizer, and now with J&J, they’re not the type that are going to sit there and be in your body for awhile. They’re going to create an antibody response to a single protein that’s going to go away. You’ll keep the immunity, but you won’t have the remnants of anything from the vaccine.”

GRANDPARENT VISITS

Is it safe for fully vaccinated grandparents to visit their grandchildren?

“It’s important to understand there’s two risk factors here: Number one is the vaccine’s not 100 percent, but it’s significantly less risky for you. Now remember, it’s also risky for the children or say the children’s parents that have not been vaccinated because you could still be transmitting. So there’s still some risk associated there. Whatever you can do to minimize that risk is best. Obviously, I think that people are wanting to move on with life with their vaccines. We fully understand that. I think people just need to understand that yes, you’ve mitigated your risk significantly by having the vaccine, but you have not mitigated to zero for yourself, and you’re still putting other people at risk. So I think the larger population that can be vaccinated, or they stay masked, that would be a better situation.”

SCHEDULING STRUGGLES

A couple in their 70s has been trying to get into a vaccine clinic, but they’re unable to secure an appointment. What option do they have?

“Within an hour or two things fill up pretty quickly. We’re going to get a little bit better on predicting when those schedules are opening up. We’ve kind of determined our vaccine week starts on a Wednesday, ends on a Tuesday. Shipments normally arrive on a Monday, Tuesday. We never want to open up a schedule unless there’s a vaccine on a shelf. Never want to cancel anybody. Really looking at Monday nights opening up schedules, so that’s going to be at least Prevea’s cadence moving forward. The state of Wisconsin’s got a map coming up that will show everybody that’s vaccinating, because we’re not the only people that’s doing it. That’s a good thing. There are other health systems vaccinating, there’s pharmacies vaccinating. They’ll be able to show you different ways you can get an appointment with all of them. For some, you can actually even register with the state to get on their list and get a call back for a vaccine. But really, the rate-limiting step right now is supply. It’s getting better, it’s just not at the level we want. We’re still getting about half of what we need to be at full capacity to even think about expanding more.”

VACCINE CHOICE

Can a patient ask for the vaccine they want? Can they choose Moderna or Pfizer?

“The way it works right now, especially between Moderna and Pfizer, and we get this question a lot because people are trying to predict their lives 21 and 28 days out, we really don’t know. Like I said, we want to be able to have those appointments and have the vaccine on the shelf. So usually it’s a day before that we’ll confirm what we’re going to give, if not the morning of, depending on what’s going on. The state has given us both Pfizer and Moderna to give us as much vaccine to get into arms. And that’s our priority. Because the second dose scheduling is so complicated, we can’t move that date at all. It’s hard to know and you can’t pick and we can’t tell you on the schedule if you’re a Pfizer day or a Moderna day.

“I think most of the issue is not about any kind of efficacy or safety. It’s the seven days of scheduling that affects people’s personal plans.”

EFFICACY AND THE ELDERLY

Are the vaccines less effective in the elderly population?

“It’s a great question. In the studies, it did not show a huge difference between the ages. Actually, even this week we’ve received more data, because now that the vaccine has been put into hundreds of thousands if not millions of people in certain countries--like in Israel they published their data--they had 600,000 people that had the vaccine and compared them over time and looked at it over different age ranges and found it to be very similar over the age ranges, as well.”

POSITIVE BETWEEN SHOTS

What happens when you test positive between COVID-19 vaccine doses?

“Nothing to worry about, other than you have COVID now and you have to definitely isolate for 10 days, and then if your 21 days or 28 days fall within that 10 days, you need to work with us to move that. That’s the very rare exception where we can move that 21 or 28 days, is if somebody actually has documented COVID. We still need that second shot in you. We will get it to you. It’s just a small scheduling issue that needs to happen.”

IBUPROFEN AND VACCINE

Should you avoid ibuprofen before you get the vaccine?

“In some of the literature they’ve been debating this. Will it mute your immune response or not? The CDC has not come out and said don’t do X, Y, or Z. They’ve even recommended it post-vaccination if you’re having that reactogenicity and it’s pretty significant and you’re not getting over it, that may be ibuprofen or Tylenol or whatever brand you prefer would be OK. There’s no solid data saying that you shouldn’t. There’s this theoretical or hypothetical ‘don’t take it before.’ We’ve always said you’ll get over those symptoms, so no reason to really need it.”

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