Townhall | Kaweah Health

KAWEAH HEALTH ONLINE TOWN HALL

Please watch our COVID-19 Vaccine Townhall, filmed on Sept. 2 with Special Guest Presenters

Dr. Monica Manga
Chief of Staff
and
Dr. Ryan Gates
Vice President of Population Health Management, Kaweah Health

We’re more than a year into the pandemic and Tulare County has one of the lowest COVID-19 vaccination rates in the state. Vaccines are now available and approved by the FDA. During this Townhall event, Dr. Monica Manga and Ryan Gates answered questions from the audience about vaccinations so we can keep our community safe and informed.

Questions & Answers

Are there any differences in the effectiveness among the different available vaccines and how well are the vaccines working?
The data on the efficacy of the vaccine come from very various studies. They are designed differently, so I want to exert caution when we try to confirm one study to the other. Having said that it is true that the current available vaccines in the United States are showing a decreased neutralization power it’s variance. However, they all remain very good at preventing severe disease. I want to mention several studies that recently have been published. One of them was in England, and this was a specific towards the Pfizer vaccine.

And what this study shows is that after you get the first shot of the Pfizer vaccine, you are protected. It shows an effectiveness of 10% against the Delta variant compared to 48% against the Alpha variant. After the second shot, the effectiveness is about 88% compared to 93% against the Alpha variant. A different study in Canada analyzed the Moderna vaccine and what this study showed is that the vaccine is 72% effective about against the Delta variant, but 96% effective against severe disease. And the data released from the Johnson and Johnson shows an effectiveness against the Delta variant of about 85%.

So in conclusion, vaccinations or vaccines continue to be effective in preventing you to getting sick in the first place. They're excellent in preventing the disease and hospitalizations. Although, I think it's important also to mention that receiving the vaccine decrease your infectiousness. Should you get a breakthrough infection and also decreases your chances of developing long term symptoms from back from COVID.
For our current our current hospitalized patients who have COVID-19 who have been vaccinated, is there any data available on which vaccine they obtained?

When the patient is admitted to the hospital, we do ask the question about the vaccination status. If the patient answered 'yes' to the question, then that answer is validated through the vaccine registry. That is a very time-consuming and difficult process, so we don't follow exactly which type of vaccine the patient received.
Are there any differences, in terms of the side effects of the different available vaccines?

Well, all of the vaccine cause something called reactive genicity. Basically, what this is is your body's response to the vaccine. Kind of like your immune system gets turned on. So if you encounter the disease or the virus, then you're ready to defend yourself. And because of that, you develop certain effects. They usually occur very rapidly. The most common ones are pain at the site of the injection, swelling and fever. Some people may have muscle aches, and they rapidly subside. They do occur more frequently after the second shot of the mRNA and in young people. And if for whatever reason, you do not develop these effects, that doesn't mean that you have not turned on immunity against the disease.
We received this comment. "Vaccines don't stop the spread. So it's only a therapeutic. Vaccines also, don't stop a person from contracting the virus. Again, a therapeutic. There are many other effective Therapeutics. Maybe if those were being discussed as often as the vaccines, we wouldn't be seeing hospitalizations." What are your comments on that statement?

Well, in the sense of the author of that question, I would emphatically agree that vaccines as a therapeutic in terms of the prevention of severe disease, it's not a therapeutic in the fact that you would administer to somebody who is actively infected. So when you look at the weight of the evidence and what we're trying to do to prevent or treat severe COVID-19 disease, vaccines are absolutely the most effective, powerful therapeutic, if you want to put it in that context, when we look at the overwhelming amount of evidence of the vaccine versus, let's say, Ivermectin or hydroxychloroquine or other medications that are used as true therapeutics for people who have active disease. When you look at the evidence of the vaccine, and you would say that it doesn't stop the spread, that's simply not true.

Again, one of the largest studies coming out of Israel, honestly, when you have large, large countries that have that kind of centralized medicine, you have access to incredible amounts of data. And so they published a trial that 596,618 people - that is a huge study. Normal studies have a couple thousand. But when the larger study you have on people we have involved in this study, the more confident you can be in the results. And so here we have the study over half a million people, a 92% reduction and documented infection. A 94% reduction in symptomatic COVID infection. A 87% reduction in hospitalization. So there's your therapeutic piece.

A 90% reduction in severe disease. Another study came out just August 27, so less than a week ago and again, the data just keep pouring in. But this comes from LA County, had a population study with 43,127 participants. So again, huge study. They show that unvaccinated people are 4.9 times more likely to become infected. And so, therefore stopping the spread, right back into people have less of a five fold less chance of becoming infected and therefore stopping the spread of the disease, and 29.2 times more likely to be hospitalized. So almost 30 times more likely to be hospitalized if you are unvaccinated.

So, again, from a therapeutic standpoint, absolutely. Vaccine most effective. But in terms of prevention and stopping the spread, of course, most effective as well.
Is there any truth to the rumor that the vaccine can give you COVID-19? We're hearing stories of people who are getting the vaccine, and then a few days later, they're being diagnosed with the virus. Is there any truth to that?

No. So there are live virus vaccines and more of the old school type, but that could have a chance of causing active disease because you're using a live virus. You're actually injecting people with live virus, but no, COVID vaccines are not live virus vaccines and cannot cause a COVID infection. I do know of several people who in between their vaccines did get COVID. It's just simply the contagiousness of the disease and that they contracted the disease, the virus, just coincidentally to their vaccine pattern.
So say you unknowingly have COVID. There are assymptomatic people. So say you unknowingly have COVID and you get the vaccine. Can it worsen the virus symptoms?

RYAN: So Dr. Manga mentioned and one of our answers, reactive genicity. So when you become vaccinated, if you're ramping up your immune system to build up a defense of response to the act of infection. So if you already you were annoying. There are what we call a symptomatic carriers, right? People who have the virus or shedding the virus, but maybe they feel like maybe allergies or something a very subclinical response, but they have antibodies, right? And so if you get the vaccination, you could have a more robust response to it, to build your immunity and therefore have a little more aches and fevers. But typically those aren't severe. They wouldn't be mistaken for actual COVID infection, and they tend to go away pretty quickly.

DR. MANGA: One thing that I want to mention regarding the prior question is that there's something called the incubation period. So if I get in contact with the virus and in fact, that it takes a while to actually develop the symptoms, that's why it's called incubation period. So let's say I get in contact with the virus today. We know that the Delta variant has a short incubation period than other variants. So in about three or five days is slightly that I will develop some sort of symptom. But if I got my vaccine tomorrow and then I get the symptoms, not necessarily, or I get COVID-19 not necessarily. That was just coincidental. I already have the virus and the virus was incubating before I actually develop symptoms. And it is also important to remember that the protection takes a while. So we mentioned before about the two shots of the Pfizer vaccination and how the first shot have reduced effectiveness, and you need that second shot. And it takes two weeks after that second shot to develop immunity. And it also takes two weeks after days or Johnson & Johnson to develop immunity.
Why should the approval by the FDA for the Pfizer vaccine mitigate the community's concerns when other medications previously approved have also been subsequently recalled. Do you feel this decision was rushed?

That's a great question. And I would like to start by answering that the decisions made regarding the approval of all the available vaccines in the US against COVID-19 have not been rushed. In fact, all of these vaccines have gone through rigorous studies and trials to obtain approval through the Emergency Utilization Act. All of them have to go through the needed steps of research and we have different types of trials. The most rigorous trials available are those goals, RCTs, or randomized control trials. These trials involved somewhere between 10,000 to 20,000 individuals. And the objective of this trial says to prove efficacy and safety.

Then after those and after medication or a drug gets approved, then there's ongoing surveillance. And this can happen in many ways, too. We have the VAERS, which is our Vaccine Adverse Reporting System, which is a self reporting system and under numerous types of trials from observation through complex ones, like the ones that Israel that enrolled more than 1.7 million individuals. In order for any medication or vaccine to be approved by the FDA, they expect that they go at least through two well-done clinical trials.

And on top of that, but the FDA reviewers do, is that they assess the benefits and the risks and uncertainties, and the benefits must outweigh those risk and uncertainties. There is something called the accelerated approval, which is an expedited process, and this was a pathway that was established in 1992 and this was used for certain drugs or medications for life-threatening conditions. So these passed many drugs have entered the market mostly for HIV and cancer treatment. It is also important to say that one time medication or vaccine gets FDA approval, the drug maker is required to perform for post-marketing trials. It's an ongoing surveillance and they must demonstrate benefit and assess other side effects. And if further trials for fail to prove benefit or major side effects occur, FDA may withdraw is approval currently in the US. We only have one vaccine that has approval by the FDA for 16 and older, and that's the Pfizer vaccine.
We have been experiencing really high hospitalization rates for other causes different than COVID. So the question was, are these a consequence of the vaccinations?

No, they're not. One of the most important strategies that we have trying to prevent the spread of COVID-19 is social distancing. That's the accepted term. I don't like it. I personally use physical distancing because a consequence of this, many things have occurred. Number one, is social isolation, and we have seen through the pandemic and increase of behavior and mental disorders, including depression, increasing the rates of childhood obesity, and suicide rate. The other thing that it's an unintended consequence is medical distancing and in fact, throughout the pandemic, we have seen a dramatic decrease in visits to primary care, decrease overall immunization rates and performance of preventive cast.

And we live in a county which have a very high prevalence of chronic conditions, specifically diabetes, hypertension and obesity. And if this current conditions gone and check and become uncontrolled, then many consequences can happen, and those can range for strokes, heart attacks to kidney failure. And I believe that we are starting to see the consequences of medical distances in our Emergency Department.
COVID vaccines have been linked to increased blood clots, inflammation of the heart. And in theory, could those be a contributing factor to the increase in hospitalizations if they could?

So it is true that no vaccine is 100% safe. I want to go back about what we discussed at the beginning that we active genecity. mRNA vaccines are considered highly reactive, meaning if you get one of those vaccines, chances are you're going to have one of those effects, and most of them occur rapidly within 24 hours, usually within two days. However, the some that can be delayed, and those usually are like rashes, itchiness. These delayed effects can occur five to 14 days after you got your vaccine.

And more common with the modern vaccine. I want to make an emphasis is that if you do have those effects, that's not a contradiction for you getting your second shot. But in general, for any medication or vaccine to prove safety, it's a very difficult task. We need to take into on many things. How often the event happen, how close it is to the administration of the drug or the vaccine. So effects like the ones that we just mentioned are very easy to spot. They frequently and they occur right after you get the induction.

But for those that occur less frequent, less frequent than it's challenging. And we talk about randomized control trials or RCTs. And the objective of those trials is benefit or efficacy and safety. They enrolled somewhere between ten to 20,000 individuals, which this means is that with this, studies were able to detect events that occur in about one in every 10,000 individuals. But if you have something that is more rare that occur less often than you need bigger surveillance, we talk about surveyors, so that is very important. True it relies on self-reporting, but it's especially good when those rare events that occur or clinical significance and they don't occur in the general population. So it's easy to spot those used in the system. But for others, when they don't occur as often or it's difficult to establish their relationship, then other types of studies are needed. In Israel, an interesting study was just recently published. This study enrolled more than 1.7 million individuals, and they use electronic medical records. And for each of these vaccinated individuals, they match it with an individuals that have similar characteristics, but that he or she was not vaccinated.

And then they also studied people that actually had COVID 19. And this particular study did show that faster or mRNA vaccine do have an increased frequency like myocarditis when they compare the frequency of this event in people that received the vaccine with people that actually had COVID. The same outcomes were far more frequent in people that had COVID in people that have the vaccine. I do want to explain a little bit more about this because it is important to understand then we need to look at to see who gets the side effect.

And what they saw is that this actually occurs more frequently in young men. So between the ages of 12 to 29 and most of these cases were mild and they were treated simply with an inflammatory. But there were cases that require ICU here. At this point in time, we don't know if you develop myocarditis, which is inflammation of the heart or pericarditis inflammation around the heart with the first shot, if that predisposes you of another episode with the second shot. But the recommendation from expert is that you defer the second shot. We have not seen any cases of myocarditis associated with the vaccine at Kaweah Health.

The other part that I want to talk about is the Johnson and Johnson vaccine. So in terms of the reactive genecity, Johnson and Johnson is far less reactogenetic the mRNA vaccines. But interesting, there has been an association with something called thrombosis with thrombocytopenia syndrome. So in the US we have administered over 7 million doses of the J&J vaccine, and as of August 11, 42 cases have been confirmed of this syndrome, which is basically in a very simplistic way, is a syndrome where you have class in usual and your platelets are low. And when they dig into the information, try to see here who is getting this, they saw that it's more common in women that are young, 50 or younger, and also in people that have history of an immune mediated syndrome with thrombosis and low platelets. So our recommendation or the recommendation of the expert is that the Johnson & Johnson vaccine should not be provided to younger women or people that have a history of this type of syndrome.

We have not seen any cases either at Kaweah Health.
So what is the hospital's response to the data coming out of the nation of Israel in regards to the soar in COVID positive individuals, even though Israel is one of the most vaccinated nations? Have we heard a report that there has been a surge in COVID positive cases in Israel?

So yes. So Israel did report that there has been an increase in cases. And that's what prompted the decision of offering for dose of the mRNA vaccine for those individuals that are immunosuppressed. This also prompted the idea of the individuals that have been vaccinated with mRNA vaccines will require boosters that has not yet been approved in the United States.
For the individuals who have had COVID-19 and then they get reinspected, does the vaccination make an impact?

Most definitely. It still prevent serious complications. It still prevent hospitalizations.
Is it safe to get the vaccine if a person currently has COVID, or should they wait until the virus is completely out of their system?

No, you wouldn't want to receive the vaccine while you are actively infected with the COVID virus. You would wait until you're fully recovered to use that ten to 14 day window that you've been without a fever of 100.4 for at least 24 hours before you would start receiving a vaccine. But you want to make sure that you fully recover from the infection before you start your vaccine series. But you should as soon as you recover, start the vaccine process.
How long does the natural immunity last? If a person has had COVID, and why are natural antibodies not taken into account for deciding if a vaccination is needed?

That's an interesting question. And we might not have a true answer to that question. We know that there has been just a recent study published that I'm sure the audience is aware of in health care workers who have COVID, and they analyze them. And it was seeing that natural immunity last up to eight months, eight months after they had the disease. So it is true that after recovering from COVID-19, infection is rare in the months after infection. So you may choose if you have COVID to delay your vaccination.

However, you can also choose to get vaccinated. And in terms of why antibodies are not taking into account for deciding whether you should vaccinate it or not, it's because antibodies does just part of the story. So immunity is not only antibodies, we have humoral and cellar immune responses, and all those together are responsible to make us safe against the BIOS. Yes, we can measure all those things, but those things are very complex. They're difficult, they're time consuming and costly.
Is it true that people who have had COVID-19 can get really sick, more sick from the COVID vaccine than, say, somebody who hasn't had COVID?

No, I think receiving the vaccine won't make you really sick. If you've had the infection before, you have some natural immunity floating around, you have some antibodies in there. So when you receive the vaccine, you'll likely have a more robust response to it. So you have more aches. We have a little subgrade fever, more fatigued than a person who has never been exposed to the virus and receive their vaccine.

I do think that if you are previously exposed to the virus, you might have a little more robust response to the vaccine, but certainly not to the point of going to the ED or getting hospitalized.
Is it recommended to get the COVID vaccine if someone has already been "vaccine injured"?

Talk to your physician. They know your case, they know your history, they know what your reaction was, and what is their recommendation for you. It's hard to give a concrete answer when we we really don't know what the person asked a question, what kind of response they had in the past in terms of injury.

And if you have doubt, like, if you think that you might be severely allergic to any of those medicines, we do recommend speaking with an allergy specialist that can specifically evaluate for that and give you a specific recommendation.
Why there has not been a vaccine for HIV or herpes, for example, but the COVID vaccine was developed within two years. Any thoughts on that?

We needed something, right. We needed the vaccine. We need therapeutics, too. It's much more difficult to develop therapeutics for viral infections. Vaccines are easier. But in terms of the question, it's a very good question. And honestly, to the person who asked that - I'm excited about what this means for future vaccine development, what we have learned in scientific community over the last two years to development of these vaccines, to the new technologies of mRNA vaccines. I think it opens up a whole new host of opportunity to develop vaccines for other diseases and conditions.

Well, it's a different virus. It's a very different virus. The scientific community really needs to be applauded. This is a Nobel Prize worthy development. I think the earlier question was, "Was it rushed?" Well, it was certainly expeditious, but I think the term "rushed" implies that we overstepped rules, or did things and the way it wasn't safe, or controlled. So no, in that sense, it wasn't rushed, but it's absolutely expedited, right? A worldwide pandemic. And how did we respond?
Why has the state mandated healthcare workers to get the COVID-19 vaccine?

I think that health care workers, we have an ethical duty to our patients, and vaccines are part of that duty. We get vaccinated, we're protecting ourselves. We're protecting our patients. We're protecting our loved ones.
Why is Kaweah Health marking nondisclosed status patients as unvaccinated versus undisclosed?

We put the patient in vaccinated, unvaccinated, or undisclosed/unknown. There are patients who come into the hospital incapacitated, nonverbal, unable to respond to that. So we do not include the undisclosed/unknown in the unvaccinated population. There's three separate buckets, and we put those patients in the reporting.

And we just want to clarify that we are going by what the patient tells us. That's how we're tracking vaccinations. If they do say that they are vaccinated, that data is validated. They do look into the registry to confirm that they are actually vaccinated.
My granddaughter is eleven. And when will individuals under the age of twelve be eligible to receive the vaccine?

It depends on when your granddaughter's birthday is, when she'll be able to get the vaccine. So is it was first to market. Pfizer will be first to market, likely for their approval for five to twelve year olds. Again, there's no set date on this, but they did say perhaps late September or early fall, they'll be applying for their Emergency Use Approval (EUA), their nurse use approval with the FDA for ages five to twelve. And then they're already studying up to five. It is separate FDA application. Moderna, again, came in after Pfizer. They're looking at the end of the year for their submission to the FDA for five to twelve year old immunizations. There's active trials going on as we speak on the effectiveness and safety and the dosage for those.
So the vaccine was created to fight against the previous variant of COVID. So does the vaccine help fight against this Delta variant? Or does it not? And is that the reason why we're seeing so many new cases of the Delta?

So it still works. It doesn't work as good as for the other variants. So all the viruses mutate, and when they mutate, it's an evolutionary thing, right? So what they're trying to do is to survive whatever conditions they do. And we're giving them a vaccine, so the virus is trying to overcome that. They still work against severe disease, but it does not work as good. The new variant is more transmissible than the prior one, but actually has a shorter incubation period in that it's more infectious.

So the amount of virus that you can have in your nose if you get infected, it's a lot more than it used to be for the older variant. And that comes back to what we need to do. We need to get vaccinated. We need to use masks when we are indoors and we need to maintain physical distance.

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