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The Turning Point: First Approved COVID-19 Vaccine and What Comes Next

On December 10th, 2020, the FDA approved emergency use authorization of the Pfizer BioNTech COVID-19 vaccine. This is an historical moment and a huge step in our COVID-19 journey towards rediscovering pre-COVID-19 life. We wanted to get all the details regarding this decision and what comes next in the vaccine process, so we sat down with Joseph Gastaldo, MD, OhioHealth’s system medical director of infectious diseases, during a recent Facebook Live event.

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

As you read on, keep in mind that this information shouldn’t replace the advice of your doctor. If you have additional questions, visit the Centers for Disease Control and Prevention COVID19 website.

What makes you the guy to talk about COVID-19? 01:19

You know, I feel like I was born for this moment. Growing up as a kid, I was really nerdy and into science. Because of that, I love to learn every day and be challenged in my work. And since COVID-19 is a new virus, I’ve been researching every day to make sure I can provide guidance to others. Helping others and providing that guidance is something I feel satisfied doing.

How long have you been an infectious disease doctor? 01:56

I finished my training at Ohio State and became an infectious disease doctor at Riverside Methodist Hospital in 2002. I’ve really enjoyed my time here as I have gotten the chance to meet so many individuals. I’m very social, so I make it a priority to get to know everyone I work with, both physicians and my patients. Overall, I feel very privileged and honored to be a member of the Riverside medical staff.

What happened today regarding a COVID-19 vaccine? 02:22

Today, the FDA approved emergency use authorization of the Pfizer BioNTech messenger RNA vaccine. We are the third western country to approve it; Canada approved it yesterday, and the United Kingdom approved it a few days ago. With everything the world has gone through due to COVID-19, this news is a ray of sunshine that should be celebrated. It’s our first baby step in a long journey of getting back to the pre-COVID-19 way of life. So, today truly was a historic day.

What are the next steps for the Pfizer vaccine? 03:07

Today an FDA subgroup, full of experts in the infectious disease and vaccine world, met virtually to make a decision recommendation for the Pfizer vaccine. Their recommendation goes to the leadership within the FDA for approval, and it was approved. This approval will now be sent to a subgroup within the CDC, where they will create the recommendations for the vaccine. After this step, in the very near future, we will have our very limited, first delivery of a COVID-19 vaccine.

Is there more than one vaccine right now in development? 04:05

Currently, we have two messenger RNA vaccines: the one approved today, made by Pfizer, and one made by Moderna. A week from today, next Thursday (12/17/20), Moderna’s vaccine will also be reviewed by the FDA. Hopefully, by this time next week, we’ll have two vaccines that are approved.

In addition to that, there are at least three other vaccines that are currently in, or going to be in, phase three trials. These vaccines are made by AstraZeneca, Johnson and Johnson and Novavax. This is good news, as we need more vaccines. I’m hopeful that, at least by summer of 2021, we will have enough vaccines available to immunize all Americans.

How did they discover the effectiveness of these vaccines? 05:07

The vaccine trials studied symptomatic COVID-19. Looking specifically at the Pfizer vaccine (the one that got approved today), they roughly had 43,000 people in the study. Half of the participants got the vaccine, and the other half got the placebo. What they found was that out of the 170 people who had symptomatic COVID-19, 95% of them had received the placebo. So that’s how they got the 95% efficacy.

When will we know how often we have to get the vaccine? 05:45

Sometime in 2021. One of the things that the studies did not do was determine how long the immunity lasts. Therefore, we’ll have to wait for more research to be done.

What we do know is that when you get immunity from the virus, from the natural infection, that immunity doesn’t last forever. At best, it lasts for maybe six or seven months. And that’s probably how the vaccines are going to perform. So I think when it’s all said and done, we will require some type of booster for this vaccine.

Who gets the vaccine first? 06:27

Priority guidelines were released by the National Academy of Science. The first priority is nursing home patients, because they been most affected by COVID-19. The second priority is our healthcare workers who are involved in taking care of COVID-19 patients, or healthcare workers involved in the front lines, such as emergency department or urgent care staff.

Should pregnant people, or those trying to conceive, get the vaccine? 07:02

Pregnant people and children under the age of 18 were not in the vaccine studies. Therefore, the FDA’s approval does not include these groups. So in regards to the next step for these individuals…the science continues. I feel confident in saying that as 2021 comes along, they’ll do what’s called “bridge studies.” Through these studies, we will hopefully have an answer on the safety of COVID-19 vaccines for these groups.

If I get the vaccine, do I still need to wear a mask? 08:18

For the time being, yes. The mitigation strategies are going to be around for a while. Now, knowing that the vaccines prevent people from getting sick, going to the hospital and dying, I think as more and more Americans get vaccinated, we will see deaths, hospitalizations and ICU admissions go down.

What are the side effects of the vaccine? 09:03

First off, I’d like to clarify that there’s a difference between side effects and adverse drug reactions. That being said, the most common side effects reported from the Pfizer study were pain at the injection site, a low grade temperature, fatigue and headache. So, more or less what I describe as being off kilter for 24 hours. These side effects make sense, because when you get the vaccine, you’re going to experience an immune response. That’s your body’s way of recognizing the vaccine and starting to build immunity.

If I get the vaccine, or if nursing home patients get the vaccine, how soon can I feel safe to visit a nursing home? 10:05

Again, the mitigation strategies are going to be around for a while; they’re not going anywhere anytime soon. So once nursing home staff and residents are vaccinated and you are allowed to visit again, you still need to make sure you are wearing a mask, keeping distance and washing your hands frequently for the safety of everyone.

What happened in the UK regarding vaccine reactions? Is the vaccine safe for those with severe allergies? 10:32

In the United Kingdom, two individuals who carried epi pens went into anaphylaxis after receiving the vaccine. Their reaction responded well to their epi pens, which is great news. As we begin to vaccinate millions and millions of people throughout 2021, we’re going to monitor and study people who are very sensitive and have severe allergies, so we can learn more about how to safely vaccinate everyone.

Does the CDC monitor possible side effects? 11:28

Past what you see on the news, there is a lot of safety surveillance communications with vaccines. One thing the CDC did, that I think is really cool, is when you get the vaccine, you’re going to be asked voluntarily to download a smartphone app called V-Safe. If you choose to download V-Safe after you get vaccinated, you’ll get questions like, “Hey, how are you feeling?” from the CDC. V-Safe also allows you to report any side effects that you may be experiencing. 

Can you explain Operation Warp Speed? 12:03

The world is at war against COVID-19. People are becoming very sick, people are dying and we are hurting. So we recognized that we needed to figure out how to get a vaccine created and approved in a much more efficient way, without compromising any of the integrity of the science or safety. This is how Operation Warp Speed came to be. It is a mechanism that allowed this process to be done more efficiently, while also financially supporting companies to make the vaccines. This financial support was really important, because there’s not a lot of money to be made in vaccines. Companies tend to be very conservative with investing money into vaccines, so Operation Warp Speed provided this support instead.

Another thing that Operation Warp Speed did is they went to the vaccine companies and asked them to make vaccine doses ahead of time, so if their study is successful, there is product already created. Overall, Operation Warp Speed really helped us get where we are today in this COVID-19 journey. But I want to emphasize that Operation Warp Speed followed the exact same safety protocols and review as a traditional vaccine study. I know people have concerns about how fast this process was, but it was just as safe as previous vaccine studies. We are in the 21st century now; we have new technologies when it comes to medicines and vaccines. These new technologies were ready to handle the COVID-19 vaccine studies.

How big were the vaccine testing groups? 14:21

The Pfizer study had a total of 43,000 people in it. Half of the participants got the vaccine, half of the participants got the placebo. The studies were committed to having a very diverse background in the vaccine trials as well. Roughly 70% of the trial participants were from the United States, the rest from around the world, and both of these groups were very diverse as well.

Do experts have any idea about possible long term effects of the vaccine? 15:03

We’re going to keep watching and researching. The science still continues. But what we do know is that the vaccines are safe; there have been no serious adverse drug reactions noted from the messenger RNA vaccine trials. The vaccines were well tolerated, there were no safety concerns in the studies and we have data now from at least two months of people who have received the vaccines.

What is the vaccine composed of? I’m worried it may contain something I’m allergic to. 15:41

You can actually look up the components of the messenger RNA vaccine on the FDA’s website. Right now, what I think people are having allergic reactions to is what the messenger RNA is surrounded by: a little piece of fat or lipid, called a lipid nanoparticle. However, none of the 43,000 people in the Pfizer’s study had a reaction to this.

Do experts know anything about asymptomatic virus transmission from vaccinated people? 16:31

That’s a great question that was not studied in the vaccine trials. The only thing that they measured was symptomatic COVID-19. Now, the AstraZeneca study’s primary endpoint was also symptomatic COVID-19, but a lot of participants had weekly PCR tests done. So once we get more clarity on those results, that’s one thing I’ll specifically be looking at now. They talked about that today at the FDA meeting. And you know, we could still study that moving forward as people get vaccinated. So I have a hunch that there’s going to be more information known throughout 2021 on that topic.

Are all the vaccines in development the same or different? 17:23

They all follow the same pattern. The messenger RNA vaccines first came to fruition because those started first. Now, the ones that started later, like the AstraZeneca, Johnson and Johnson and Novavax vaccines, are not messenger RNA vaccines. Luckily, we’ve had a lot of volunteers in our country sign up for the trials. Because of this, I expect AstraZeneca will be reviewed sometime in January or February by the FDA, followed closely by Johnson and Johnson and then Novavax.

Are you planning to get the vaccine? 18:09

Yes, absolutely. When there is a vaccine that is FDA approved and CDC recommended, and I get a call that it’s my turn, I will happily roll up my sleeve and receive the vaccine. I will recommend it for my parents, my friends, my loved ones, and most importantly, for my patients.

When will I have to get the booster shot? 18:36

My understanding, from my discussions and being on some CDC calls, is you get the second dose after 21 days. However, I think the recommendations are going to allow a little grace; maybe one or two days. When it comes to getting a booster sometime in the future, we don’t know yet when that booster is going to be given. So we just have to allow the science to continue in order to answer that.

Can I call my doctor today and get on a list for the vaccine? 19:18

Unfortunately, not yet. When Ohio gets the first batch of vaccines, they are going to be designated for people who live in nursing homes and for healthcare workers. But I’m very optimistic that there will be a time, maybe in the spring or summer of 2021, when people can go to their local retail pharmacy and get vaccinated. We’ll get there. We just have to be patient.

If my friend gets the vaccine, is it safe to hang around them? 20:12

You should still practice the mitigation strategies until we have an idea of what’s going on in the community. For us to get any kind of herd immunity, it really involves getting vaccinations out for a lot of people, and we’re just not there yet. So the recommendations…wearing masks, physical distancing…they’re going to be here for a while; at least through most of 2021.

My friend had COVID-19. Do we have less of a risk of sharing COVID-19 between us, or can they get sick again? 20:49

We are seeing people, more and more, getting reinfected again with the same virus, indicating that they do lose some immunity over time. So, when you get infected with the virus, we don’t know how long your immunity lasts for. That’s why if you’ve had COVID-19, if you had COVID-19 four or five months ago, you should continue to be cautious and practice mitigation strategies as it’s possible you could get infected again.

Is the Pfizer vaccine a live vaccine? 21:40

It is not a live vaccine; none of the vaccines that are in phase three trials right now in North America are live viruses. The messenger RNA vaccine does not change your genetic material, does not become part of your cellular DNA. The RNA that you’re injected with overtime does degrade.

Are the vaccines in development right now interchangeable? 22:08

No, they’re not interchangeable because they’re all different. Mechanistically, the messenger RNA vaccines work the same, but they’re not interchangeable. Think of the vaccines like race cars. I have a Mustang and you have a Camaro. They’re both sports cars and they kind of do the same thing, but they’re different.

Will the first wave of those vaccinated still be protected when others get their vaccine later? 22:44

So again, the science continues. When you get vaccinated, you will have immunity for at least, if I had to say, six to 12 months. As 2021 comes along, that particular question is going to be evaluated and is currently being studied in the trials that are still going on.

Do you anticipate, in the future, that we’ll get the COVID-19 vaccine when we get the flu shot? 23:56

The simple answer that is yes. In fact, Novavax is working on a stand-alone COVID-19 vaccine as well as studying a combined influenza and COVID-19 vaccine. So I think someday, we could have a combined influenza and COVID-19 vaccination.

Why do some of the vaccines need to be stored in subzero temperatures? 24:52

The messenger RNA vaccines are very fragile, meaning that they can be damaged. Once they’re damaged, they will not work that well. This is why we must freeze these vaccines. The Pfizer vaccine has to be frozen at minus 75 degrees Celsius. The Moderna vaccine is frozen in a normal, pharmacy-grade freezer. So once the vaccines are taken out and put in the refrigerator, you have to use them within a specific amount of time.

If I’m allergic to the flu vaccine, should I try the COVID-19 vaccine? 25:41

They’re different vaccines. If somebody has an allergy to the flu vaccine, I’d want to know a little bit more information. What exactly is that allergy? And, if you do have a serious type of allergy, like anaphylaxis, do you know exactly what is causing anaphylaxis? If yes, we could then see if that ingredient is in the COVID-19 vaccine.

Will children be vaccinated? 26:10

At this point in time, no. The approval that happened today did not include children. However, I think we will have more clarity on that and hopefully we will have the FDA approval for children to get vaccinated sometime in 2021.

Same thing goes for pregnant people. Between both studies there were close to 75,000 participants. Therefore, I can promise you there were people who received the vaccine and later became pregnant. If this happened, they’re going to do what’s called a “bridge analysis” for both pregnant and pediatric patients. I’m optimistic this will occur sometime in 2021, but we want to do it knowing that it’s safe. We don’t want to cut any corners at all. I want everyone to be vaccinated, but I want to make sure that it’s done in a safe way. As more vaccines are FDA approved, we may realize that some vaccines work better in different populations. For example, we know some flu vaccines work better in people above the age of 65. We didn’t know that many years ago…that’s relatively new. So as we continue to research the different types of COVID-19 vaccines, these are the types of things we’re going to look for.

Why do you want a diverse group of participants in vaccine trials? 27:34

Having a diverse group of participants in vaccine trials helps researchers know if a vaccine works better or worse in certain populations.

Why would a vaccine trial be paused? 28:16

If the data monitoring board finds there may be an adverse reaction to the vaccine, they could legally pause the vaccine study. There were no pauses at all for the Pfizer and Moderna studies, but there were pauses for the AstraZeneca and Johnson and Johnson studies. If a pause exists, only the FDA can lift that pause so the proper time can be taken to investigate.

There was a pause recently due to an instance in the United Kingdom. They thought a patient developed transverse myelitis, a hyperimmune response, from the vaccine. After further investigation, the FDA determined that the outcome was not related to the vaccine. A similar scenario occurred with the Johnson and Johnson vaccine. However, pauses shouldn’t scare anyone. They happen all the time. We do the same types of studies for things like antibiotics, birth control pills and high blood pressure medications, and there’s always a data safety monitoring board there in case a pause is needed. We want pauses to happen, so we can investigate things to make sure that they’re not related to the medication or vaccine that person received.

I’m tested for COVID-19 twice a week at work. Will I test positive after I get the vaccine? 30:01

The simple answer to that is no. Getting a COVID-19 vaccine will not have anything to do with you having a positive or detectable test. Someone who gets tested on a regular basis at work…my hunch is that type of test is an antigen test. An antigen test or a PCR test will not be positive or detectable due to receiving a COVID-19 vaccine.

The Pfizer vaccine seems temperamental with how cold it needs to be. What would happen if I received it when the temperature was slightly off? 30:37

So, we call that the “cold chain.” There is so much infrastructure in place to make sure that the vaccine is at the right temperature. You’re required to take the temperature many times throughout the day to ensure that it’s at critical storage temperature. Also, once it’s put in the refrigerator, they’re required to take the temperature of the refrigerator on a regular basis. Now, if a situation arises where the temperature of the vaccine is too warm, the vaccine potency can be compromised, meaning that you may not have the same immune response to it. Instead of getting a full dose, you would maybe get a half or a third of a dose. That’s why ensuring that the vaccine is stored properly is very, very important.

What is the waiting period for vaccines? 31:39

Hyperimmune conditions, such as Guillain-Barré and transverse myelitis, appear (if they appear at all) within a six week period. So the FDA Commissioner required an automatic eight week pause to see if there were any hyperimmune responses in the vaccine trial participants. No hyperimmune responses occurred with any of the messenger RNA vaccines. Because hyperimmune responses are seen more often with live viruses or things that are grown in viral cultures, my hunch is that we won’t see them much with these newer generation vaccines. Nonetheless, a layer of protection is there due to the eight week pause so the FDA can investigate for hyperimmune responses.

Why do they use placebo vaccines in trials? 32:48

Some of the side effects that we measure are very subjective, like fatigue. Fatigue may mean something different to you than it does to me. So when people enroll in a trial, we have to give a placebo in order to get a true measure of what the side effects are. When you look at some of the side effects from the Pfizer trial, one of the side effects is fatigue. I think roughly about 30% of people who got the vaccine complained of fatigue. But guess what? 30% of the people who got the placebo also complained about fatigue. So placebos really allow us to investigate complaints in order to figure out if the side effect is from the vaccine or not.

What is the typical vaccine to placebo ratio? 33:50

It’s almost 50-50. Again, a randomized control trial is that half the participants get the vaccine, half the participants get the placebo and no one knows who gets what; it’s blinded, both to the recipient and the giver.

After your first dose, is your second dose set aside for you? 34:11

As of right now, this is what the federal government has told us: when we get our approximate 98,000 doses next week, we were told to use them up; give them to 98,000 people in nursing homes and healthcare. Approximately 21 days later, we will get another 98,000 doses to give to those people. Therefore, we will not be holding any doses from the first shipment.

If I have COVID-19 now, how long do I need to wait to get the vaccine? 34:54

So if you actually have COVID-19 now, we would want you to recover and get out of your isolation first, before getting the vaccine. When people are sick with a fever, they already have immune stimulation going on. We really want them to get over that first.

Are the first and second vaccine doses the same? 35:26

Yes, they are. The first and second doses are the same. But one thing it’s very important to know is: Pfizer, Moderna: they’re both messenger RNA vaccines, but they’re not identical. So, if your first shot is Pfizer, your second shot is Pfizer. You can’t switch over to the other vaccine.

Is there anything you would like to say that we haven’t touched on yet? 35:46

I feel confident in the types of trials that were set up. I feel confident in the review process at the level of the FDA that happened today, and what’s going to happen at the CDC. The science continues. As 2021 comes along, we’re still going to learn a lot about this virus COVID-19 and the vaccines. I feel confident in saying that as more people get vaccinated, fewer people will get sick, fewer people will become hospitalized and fewer people will die from this virus. When you look at the overall deaths in our country, our death numbers are going up as our positivity numbers. And that’s what makes me sad as a country, we’re at a war; people are dying, and these vaccines will save lives. This is really a turning point for where we are in this COVID-19 journey.

Will I be able to choose which brand vaccine I get? 37:00

My hunch is the CDC, who gives the recommendations, is not going to recommend one vaccine over the other initially. However, as the science comes out, they may realize one vaccine works better for certain populations. Look at the flu shots. There are over five different types of flu vaccinations that are out there, but the CDC does not recommend one flu vaccine over the other.

Can you get the COVID-19 vaccine at the same time as other vaccines that you’re due for? 37:33

I honestly can’t answer that because we don’t know yet. The next step for the vaccine is to go to the CDC, and they will create their final recommendations answering questions like that. Now, my hunch is yes. However, given the fact that this is a new vaccine and we want to do everything we can to be extra cautious, the CDC is probably going to recommend not to do that. So again, let’s wait and see what the CDC says.

Will the vaccine evolve like the flu vaccine, where experts guess what strains need to be covered each year? 38:07

The fact that this Coronavirus has already changed…it’s possible. But, the immune response, the spike protein, hasn’t changed. So, at this point in time, it doesn’t look like that’s the case. Hypothetically, if the spike protein changes, we could have to change the vaccine to a different type of messenger RNA. Again, the science continues and we will all learn together.

Does the virus mutate? 38:45

I don’t want to say the word mutate because that kind of brings in the things from science fiction movies…but this virus does change. All viruses change; Influenza changes every year. Immunologically, the way we recognize the vaccine in our body hasn’t changed. The way we develop an immune response hasn’t changed, because the spike protein hasn’t changed. Now, if the spike protein changes enough in the future, we’ll change the vaccine accordingly.

Do you know if the vaccine has been tested on people with epilepsy? 39:27

I don’t know; they did not call out epilepsy in the Pfizer study. However, the ACIP might have comments on that.

Do you think the Bell’s Palsy reaction in the trial participants was related to the vaccine? 39:53

So, tentatively, the answer to that is no, it is not plausible that the Bell’s Palsy was from the vaccine. However, as we start vaccinating 98,000 people in Ohio, we will follow that and see if an association is there. For those who did develop Bell’s Palsy, some of them have had the Bell’s Palsy resolved and are getting better.

Is there a common link between people who tend to get a more severe reaction to COVID-19? 40:33

One of the things that we’ve been talking about in the scientific community is how much virus you get exposed to. So if I’m not wearing a mask around someone infected with COVID-19, and I get a huge amount of it exposed to me, I’m going to get sicker than I would if I was only exposed to a small amount of the virus.

Another thing that is being studied is the clear association of having severe COVID-19 and having lower vitamin D levels. If you suspect you’re low in vitamin D, my advice would be to talk to your doctor and discuss if a supplement is appropriate for you. Now, I’m not telling anyone to take vitamin D. If you take too much vitamin D, you can become very sick. So please discuss it with your healthcare provider about it.

Where will the vaccine be given out? Will it start at hospitals and then branch out from there? 42:06

What’s going to happen initially is the vaccine will be prioritized for those who work in hospitals, frontline responders and nursing home residents. After we feel confident that we have enough vaccine doses, then the vaccine will be rolled out to are elderly people, those with medical conditions, K-12 teachers, frontline workers, and so on. There’s a process in place and we will start going through that process. I feel quite confident that the Ohio Department of Health will provide clarity to us as we go through the distribution process.

Final thoughts? 43:15

I’m so happy to talk about the vaccine. This really is a shimmer of sunshine. You know, these next few months and weeks are going to be the most challenging time for us. It’s going to take time for things to get better, and we need people to stay on point with mitigation strategies and look forward to getting the vaccine.

We need to talk about the vaccine respectfully to everybody. Vaccine hesitancy is out there, and it has a lot to do with people not understanding the science and the rigorous review process. So we need to have conversations with everybody in every community. We need medical leaders, we need business leaders, we need church leaders. I’m not the appropriate person to go to a synagogue, nor am I the appropriate person to speak to an African American community regarding vaccine hesitancy. We need leaders from all communities to stand up and talk about the vaccine.

This article is based off of a live interview conducted on Facebook on December 10, 2020. 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.

 

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