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Seeking Normalcy: Vaccine Updates and the Future of Ohio’s Distribution Plan

COVID-19 Scheduling Update (1/28/21): Currently, OhioHealth is scheduling vaccinations for those 75 and above. You can schedule your appointment through OhioHealth MyChart, or by calling the OhioHealth COVID-19 vaccine hotline at 614-533-6999 weekdays from 8 a.m. to 4 p.m. For the latest information regarding scheduling, visit the OhioHealth COVID-19 Vaccination Page.

Ohio’s vaccination process has been active for over a month now, and anticipation to receive the first dose runs high. Currently, we’re in phase 1B, with those 65 and older taking priority through a tiered system. With future eligibility requirements not yet announced, but word of new vaccines heading our way, we felt another Facebook live was in order to get answers to your pressing questions. Once again, we met with Joseph Gastaldo, MD, OhioHealth’s system medical director of infectious diseases, to separate fact from fiction.

Note: If you want to hear Dr. Gastaldo’s answers to the questions, we’ve provided time stamps in our story, to help you get right to the answer in the video above.

As you read on, keep in mind that this information shouldn’t replace the advice of your doctor and was recorded 1/21/21. If you have additional questions, visit the Centers for Disease Control and Prevention COVID-19 website.

Can you tell us about your role at OhioHealth, and how you became the go-to person for COVID-19? 01:21

I’ve lived in Columbus my whole life. I completed my training at Ohio State and began working as an Infectious Disease doctor at OhioHealth in 2002. About a year ago, I received a call to go to the BAC (OhioHealth David P. Blom Administrative Campus) incident command center. As you may have guessed, this request was due to COVID-19. Ever since that day, I have been evolving into the COVID-19 guidance person for OhioHealth when it comes to the clinical aspects. I’m incredibly honored and very privileged to be in this position and look forward to continuing research in 2021 on this new virus.

Do you have a typical work day, and if so, what does it look like? 02:26

Each day is a little bit different. Often, I have a lot of WebEx meetings and clinical calls regarding COVID-19. I am involved in a lot of vaccine outreach with OhioHealth and other businesses and communities within central Ohio. I also do a lot of media things, like being with all of you virtually on this Facebook live tonight.

I’m very honored and humbled to be in the media talking to the public about the vaccine and COVID-19. The vaccination is a ray of sunshine that, paired with all our mitigation strategies, will help us get through and regain a sense of normalcy.

Besides Pfizer and Moderna, will there be more vaccines? 03:50

Yes! We currently have two messenger RNA vaccines that are authorized by the FDA and recommended by the CDC. One made by Pfizer and BioNTech, the other by Moderna. They’re both two doses, separated either by 21 or 28 days, and are safe and effective. Their Achilles heel, however, is their storage requirements. Once these vaccines are made, they have to be kept frozen. Recently, there’s been news stories popping up where the vaccines were not stored properly, and unfortunately, had to be discarded.

Now in February, and later on in the spring, we’re going to have a new group of vaccines called replication-defective adenovirus vaccines. These vaccines are made by Johnson & Johnson and AstraZeneca. What’s different about these vaccines is they’re only kept in the refrigerator; they don’t require that deep storage mechanism. And tentatively, the Johnson & Johnson vaccine will likely only require one dose.

So those are the vaccines coming in the spring. But guess what? There are more vaccines in the pipeline. Novavax has a different platform type vaccine that we’ll likely have access to by late spring/ early summertime. The arrival of all of these vaccines is great news, because we need more vaccines.

There are 330 million people who live in this country- having more vaccines means we have a higher chance at offering a vaccine to those who wish to be vaccinated.

Where is Ohio right now in our vaccine process? 06:13

For the last month in Ohio, healthcare workers and those living in long-term care facilities have been the priority to receive vaccinations. Now, only a few days ago, we started vaccinating those in the public that are 80 and older. As each week comes along, that tier is going to change. Next week, for example, those 75 and older and those born with severe congenital abnormalities become eligible. The following week, it’s 70 and older…the week after that, it’s 65 and older.

I feel good about where we are in our vaccine process. But we’re just starting to scratch the surface of vaccinating Americans…but we’ll get there. You know, the fact that we’re able to offer vaccines is a reflection of science, a reflection of hard work and a reflection of our country getting the resources together to do something miraculous. This is really the equivalent of putting somebody on the moon.

I’ve heard a lot about vaccine supplies fluctuating. What do you anticipate as we go forward? 09:11

The supply has been very fluid, but now we have a new administration. It is the stated goal of the Biden administration to get 100 million Americans vaccinated within the first 100 days of his administration. That’s wonderful…but of course, show me the money. I want to see the plan…I want to see the vaccines…I want to see what that looks like.

Also, we really need to continue to come up with opportunities for people to be vaccinated. Are we going to vaccinate people seven days a week? How are we going to reach people who can’t come to be vaccinated? How are we going to reach people who don’t have telephones, people who can’t read, people who don’t speak English as their first language? How do we reach all Americans to have access to be vaccinated? Those are the details I want to see.

After I receive my first dose, how will I know that my second dose will be available when I need it? 10:16

This is what we’ve learned from OhioHealth: when we received our first vaccine shipment for healthcare workers, we were told to give out all of our vaccines. So when OhioHealth received our first 1,950 doses of Pfizer…we gave them all out. And guess what? By the time the three weeks rolled around, we got our second supply. That’s been the case so far at OhioHealth, and that’s also the same thing that’s happening in nursing homes. So I trust that the same mechanism is going to be in place for all vaccinations. I feel confident knowing from ODH (Ohio Department of Health), and at the federal level, that whether you get Pfizer or Moderna, at the right time you’ll get your other vaccine dose.

Currently, can I call my doctor and get on a list for a vaccine? 11:30

No, you cannot call your doctor. Currently, you have to wait until you’re eligible by the state to receive the vaccine. Once eligible, you must make an appointment. OhioHealth is accepting appointments through MyChart and by phone at 614-533-6999, but you must wait for your eligibility group. We can’t have a mob showing up for vaccines that we may or may not have. So you must have an appointment.

Should pregnant people get the vaccine? 12:08

Being pregnant or lactating is not an automatic “you cannot be vaccinated.” It basically boils down to this: pregnant people were not put in the studies. We think, speaking as an Infectious Disease doctor, that the messenger RNA vaccines are likely safe in pregnancy, although it has not been studied. Since we now know that pregnancy is a risk factor for having a bad outcome with COVID-19, we believe the benefit outweighs any potential risk. But it’s really a decision to be made by you and your healthcare provider.

If I get my first and second dose, am I safe to travel? 13:52

Yes and no. It’s going to take us many, many months to see the impact of vaccinations for the public. Two weeks after you receive your second dose, you do have another layer of protection. But, for at least the rest of 2021, the mitigation strategies (physical distancing, mask wearing, hand hygiene) are going to stay unchanged. What I’m looking at is the positivity rate, then the lagging indicators, hospitalizations and deaths. When we see improvements in those to a certain level, then we can begin to talk about what are the next steps into getting back to some form of normalcy. We’re not there yet.

How did your first and second dose go? 15:29

With my vaccination, I did pretty good. For the first vaccine, I had no side effects at all. After the second dose, I felt off-kilter for about 24 hours. I had diffuse muscle pain, a little bit of a headache, and a low grade temperature elevation in the 100 degree Fahrenheit range. I went home, I had some chicken noodle soup, I took some Tylenol, I had a good night’s sleep… and then the following morning, I felt fine. It’s completely normal to feel symptoms after getting vaccinated… it’s just a reflection of your immune system doing its thing.

What is the role of the spike protein in the development of COVID-19? 16:59

Important to note: It’s impossible for you get COVID-19 from the vaccination, as it doesn’t have the infection.

The spike protein is the actual part of the virus that enters the cell to cause infection. If we can negate or neutralize the spike protein, infection is not going to happen. When you receive the vaccine, you’re tricking your immune system to recognize the spike protein. Therefore, if you were to get COVID-19, your immune system will attack the virus and prevent you from getting sick.

If I have had COVID-19, do I need the vaccine? 17:57

Absolutely. When someone gets COVID-19, we don’t know with certainty how long their immunity lasts. And really, depending on your age and your health, you may not have a good immune response. So, officially speaking, the recommendation is if you have had COVID-19, as long as you are out of isolation and are feeling better, you can choose to be vaccinated.

Does getting the vaccine affect quarantine time when you’ve been exposed? 18:28

The CDC recommends that if someone has previously had COVID-19, for 90 days, as long as you remain asymptomatic, if you have another high risk exposure, you do not need to quarantine. The same thought process should apply to vaccinations, but we’re not there yet officially.

What do you know about adverse reactions to the vaccine? 19:34

About 12 million Americans have received the vaccine so far. We’ve learned that roughly one in a 100,000 people will have a severe allergic reaction or anaphylaxis to the vaccine. That’s why when you go to get vaccinated, you don’t just get your shot and walk away. You have to register, answer questions, and then be observed for 15-30 minutes. Part of that observation is to look for anaphylaxis. In medicine, we’re quite comfortable recognizing and treating anaphylaxis with an EpiPen and other supportive measures.

I heard you vaccinated your parents this past week. How was that? 20:38

It was very emotional, and I’m incredibly honored and privileged to not only be vaccinated myself, but also to vaccinate my parents. My parents are in their 80s, and fortunately very healthy. They have been volunteers at OhioHealth for years, and were very excited about getting vaccinated. My mom and dad helped support me through pharmacy and medical school. And, when I vaccinated them, my mom made a funny comment saying, “That’s what I get for getting you through medical school.”

Will the COVID-19 vaccine be a yearly vaccine? 21:32

One of the things that we don’t know yet is, when you get vaccinated, how long the duration of the immunity is. That’s one thing that we still need to learn in 2021. My clinical hunch is we are going to require some type of booster, potentially every year or every other year. Novavax, one of the vaccine companies, is actually studying a combined flu-COVID-19 vaccine. So we’ll see what that looks like moving forward, but some type of booster is very likely.

Can I get other vaccines, such as the shingles vaccine, at the same time as the COVID-19 vaccine? 22:24

This hasn’t been studied yet. Again, we want to lead with recommendations based on science. So officially, the recommendation is to not receive any other vaccine within 14 days of receiving the COVID-19 vaccine. However, we have been trying to not put up barriers when it comes to vaccination. For example, I recently got a call about a woman in her 90s arriving to her vaccine appointment, and she received a flu shot 13 days prior. They were worried so they called me and I told them to give her the vaccine, and it all ended up okay. But again, the recommendation is to separate vaccines by 14 days so we should try to stick to that.

Should I take Tylenol before or after my vaccination? 23:19

The CDC recommends taking Tylenol or Ibuprofen if you have symptoms. So I would say, take it as needed.

Does the vaccine prevent you from passing COVID-19 on to others? 24:09

The study endpoint was symptomatic COVID-19. So, when it comes to asymptomatic infection or transmission, we do not know yet as it still needs to be studied. It is my hunch that the vaccine will decrease the impact of asymptomatic infection, but it still needs to be studied in a randomized, controlled trial.

What are your thoughts on the new mutations, or variants, of COVID-19? 24:52

Just to play devil’s advocate, it is a mutation. I don’t like to use the word mutation, however, as it sounds like something from an X-Men movie. But, RNA viruses mutate all the time. Flu is an RNA virus. Coronavirus is an RNA virus. This virus changed all throughout 2020, and it will continue to change. Why we’re just hearing about variants now is because the variants or the mutations that we are seeing are in the spike protein. The worst case scenario, and this has not happened, is that there is a mutation that will change the spike protein enough to induce what we call immune escape, where the vaccines are rendered ineffective. However, that is not the case with the current variants. We need to study it and allow scientists to continue testing the variants against the immune response from the vaccines.

Both Pfizer and Moderna have stated that it’s anticipated that their vaccines will induce immunity to these variants. So far, the variants have not transformed into something that causes higher severity of illness. But, it’s looking like the variants, specifically, the variant in the United Kingdom, is much more contagious; it spreads more efficiently. So that’s the concern: if we see more variants out there, as a result of spreading more efficiently, we could see more COVID-19. So again, we need more people vaccinated and we need to continue with the mitigation strategies. I know we’re all tired, but we need to stay focused on what we’re doing.

Does monoclonal antibody infusion provide future immunity as well, or should you still get a vaccine if you’ve had that treatment? 27:19

When you get the monoclonal antibody infusion, you’re actually getting immune protection, what we call passive immunity, that’s going to stay in your system for about 90 days. The recommendation, and I do agree with this, is that if you’ve been given a monoclonal antibody, you should wait to get the vaccine for about 90 days because the monoclonal antibody could likely interfere with an immune response.

Will getting the vaccine stop you from getting COVID-19? 28:09

The vaccine endpoint was symptomatic COVID-19. So, the D in COVID is disease, meaning you have symptoms. The vaccines are roughly 94% to 95% effective in the study of preventing symptomatic COVID-19. Now, we don’t know yet about asymptomatic infection, but the vaccines are very effective in preventing symptomatic COVID-19.

If you do get COVID-19 after being vaccinated, is it less extreme? 29:19

We haven’t vaccinated enough people yet in the public to know that. Now, healthcare workers that received their first dose and then later had COVID-19 symptoms were swabbed and were PCR detectable. What we know is to achieve the 94% to 95% efficacy rate, you must have both doses.

If I have received both COVID-19 vaccine doses, should I keep wearing my mask? 30:05

For the time being, yes. However, I do think there could be some discussion of relaxing that if you are with someone else who has been vaccinated. We’re not there yet though, because we just started vaccinating the public this week. So for the time being, you should still be wearing a mask.

What do you tell people who feel this vaccine process was rushed? 30:56

The fact that we were able to get the vaccines out so quickly is a combination of modern day science (we could do genetic sequencing very quickly) and that we already knew a lot about this virus from the original SARS Coronavirus 1, which first came on the scene in 2003. Therefore, we already had vaccines and infrastructure in place. The third thing is that there is so much COVID-19 activity out there, which made it easy to study symptomatic COVID-19.

The way the vaccine study was done was the exact same way we do other vaccine studies. In addition to that, typically when vaccines are developed, the process is very slow because drug companies do not make a lot of money off vaccines. This makes them very conservative in doing levels of stage one, stage two and stage three, before they provide more money to make sure they’re going to get a return on their investment. Because Operation Warp Speed received so much money from the federal government, they were able to tell the drug companies, “hey, here’s your money. Don’t worry about the financial risk of making a vaccine that may not come to fruition. Here’s the money-get moving on the vaccines.” So collectively, all of those things really got us to where we are today.

Are there any groups that shouldn’t get vaccinated right now? 33:00

At this point in time, the only people who cannot get vaccinated are children and adolescents. The Pfizer vaccine is only authorized for 16 and older, and Moderna is 18 and older. The only other people who should not get the vaccine are those with a known hypersensitivity reaction to any of the four ingredients in the vaccine: messenger RNA, which nobody is allergic to because we all have that, a little bit of salt, a little bit of sugar, and a lipid nanoparticle.

The lipid nanoparticle is what we think is causing the severe allergic reactions or anaphylaxis. The lipid nanoparticle has two things in it that are recognized as the likely offending agent: polyethylene glycol, which is the active ingredient in a laxative called miraLAX, and polysorbate. So, again, when you go to get vaccinated, you disclose your allergy history to them. If you have a severe allergy to anything else, whether it be another vaccine, penicillin, peanuts, puppies or anything you have severe allergy to, tell them that. You will still be allowed to get the vaccine, they will just observe you for 30 minutes instead of 15 to look for signs of anaphylaxis.

Currently, we’re in phase 1B of Ohio’s Vaccination plan. Do we know what 1C is yet? 34:34

Well, yes and no. We kind of know from the federal level, but each state is doing it differently. We look to the Ohio Department of Health for guidance on not only what each phase looks like, but their dates as well. We’re currently doing phases in a tiered way and changing it every week, because we really want to allow the time for senior citizens to get vaccinated. As we get more vaccines, I’m hopeful that the process will become much more efficient.

What does the 1B phase look like? 35:43

Phase 1B is as follows:

  • January 19: Ohioans 80 and older
  • January 25: Ohioans 75 and older; those with a developmental or intellectual disability and one of these conditions
  • February 1: Ohioans 70 and older; K-12 employees
  • February 8: Ohioans 65 and older
  • February 15: Ohioans with severe congenital, developmental, or early onset, and inherited conditions

The future of our vaccine distribution is based on how we do with these populations and what the vaccine supply looks like. It just goes along with being flexible through this whole process of reassessing and learning. I ask for everybody’s grace, understanding and patience. When we get vaccines, we’re not getting them from the company. Remember, the federal government has all these vaccines, so they determine the number of vaccines we receive and when. And then each state’s health department and state leadership determines where the vaccines go.

Do any of the vaccines react badly with other medications? 37:21

So far, no. When you look at the Pfizer and Moderna trials, collectively, both of them had around 75,000 people in them. There were many people in those trials who had medical conditions, such as diabetes or lung disease, and therefore were taking additional medications. So no, there is no drug interaction that’s recognized with messenger RNA vaccines.

Final thoughts? 37:54

I think we touched on a lot of important information. The endpoint is basically this: the vaccines that we have are safe and effective in preventing symptomatic COVID-19. We are going to learn more about the virus and the vaccines in 2021, especially the new vaccines on the way. And finally, I want us as a community to think about getting vaccinated. Vaccines will save lives, because fewer people will get COVID-19 and thus fewer people will die. We will find a sense of normalcy again…it’s just going to take time.

This article is based off of a live interview conducted on Facebook on January 21, 2021. Due to the changing nature of COVID-19, some information might be dated. Always check with the CDC for the latest changing information concerning COVID-19.

 

Go to COVID-19 Toolkit page on OhioHealth blog

 

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