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Answering your vaccine questions before authorization

We took your questions to Dr. Bill Smith, who is heading up the human clinical trials at Volunteer Research Group at UT Medical Center.

KNOXVILLE, Tenn. — Many of you have reached out with questions about the COVID-19 vaccines as they get closer to approval and being sent across the country.

We took your questions to Dr. Bill Smith, who is leading the human clinical trials at Volunteer Research Group at UT Medical Center.

Some of these answers are edited for conciseness and clarity.

When the vaccine is ready to be given to people other than healthcare workers, how long will it be before people who are immunocompromised can get a shot?

"That will be determined by the criteria the CDC and other government agencies establish for distribution. Based on the criteria that have been circulated from the U.K., it looks like you would be somebody that would be in the second or third tier, which means very early in the process. 

Your age would be another determining factor. That is also one of the criteria as well as underlying illnesses that help to determine priority."

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When do you foresee the vaccines arriving in East Tennessee?

"The best guess right now, if everything went the way that everyone is hoping, the FDA will rule on the 10th, and we would have the vaccine on the 11th."

Three years ago, after receiving the flu vaccine for 25 years, I had a severe reaction and was told to never get it again for the rest of my life. How will this affect me for receiving the COVID-19 vaccine when it becomes available to the general public?

"The Moderna and Pfizer vaccines are totally different technology, totally different ingredients, and there should be no crossreactivity. The Janssen vaccine that will probably be approved early next year is also new technology that would not have cross-contamination from prior technologies. So for many of these vaccines, you are going to be fine. 

This is really a question though that ultimately you should discuss with your family physician and make that decision jointly."

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Will people get to choose which vaccine they get if there are multiple ones approved and how do those recommendations work with a physician?

"Initially, at least, there are going to be limited supplies of the vaccines, so people will be advised to take whatever is available when their group priority will allow them to get a vaccine. 

Any of the vaccines that are going to be approved are going to be effective and waiting on one or the others for a slight difference in percentage really is not realistic.

The key message that needs to be emphasized in this is there have been no serious cases of COVID-19 infections in people that have received the injections, and there have been no deaths. 

Even if you were to get COVID-19, there is every reason to believe you're going to have a much milder case, and that you're going to be much better off than if you weren't vaccinated at all."

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Will the vaccine be a one-time thing or will we need a vaccine every year as we do with the flu shot?

"All of the vaccines that are currently being tested in the U.S. that are close to approval are all two injections except for the Janssen J&J vaccine, which they're going to try the single injection. Two injections are going to be the norm.

How long those two vaccines are going to last? We don't know. From SARs and some of the other coronavirus infections, the antibody and recognition cells have lasted for some time, so there's hope that this may last longer than just an annual vaccine.

The studies that are being used for approval run two years so that we're going to continue to follow antibody levels. We're going to continue to see if there are infections that develop a year, 18 months, after vaccination. That would tell us how long these really last, so we're hopeful that particularly with some of these new technologies that they're going to last longer, but we do not have that information.

That's why it's important to continue to enroll and participate in these studies, so that we can answer some of these remaining questions about duration, effectiveness long-term, etc."

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If you have had COVID-19, do you still need to take the vaccine when it becomes available? Would it be safe for a person in that situation to take the vaccine?

"Yes. The most current recommendations from the CDC and public health authorities is for people to go ahead and be vaccinated when it's available to their group.

There seem to be no negative consequences of vaccinating someone who has had COVID-19 previously from looking at the data of the vaccine studies that are being evaluated. So for now, the answer is yes. 

As with many things around COVID-19, this could change, but it won't change because of safety. It would change because of a better understanding of the immunity you would get from an infection."

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When will a healthy, younger adult be able to get the vaccine?

"We don't know. This is being controlled by the government, primarily through CDC, state and local health departments. There will be guidelines that will be published soon.

The younger and healthier you are, the later in the process you are going to get vaccinated. So if you are young and healthy, the quickest way to get a vaccine is to do one of the vaccine trials."

Earlier in the pandemic, there was a theory about certain blood types possibly being immune or resistant to COVID-19, has that proven to be true and how does that apply to who should have the vaccine?

"That does not influence at all who should have the vaccine. Everyone should have the vaccine when the vaccine is available for their risk group.

It does appear that blood type O may have a lower infection rate and less severe infections. It may appear that types A and AB have a higher risk of infection and severe infections. This was early data, but it really hasn't changed. However, it doesn't mean that you're safe or doomed."

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Are they going to put a tracker chip in the vaccines to keep up with us?

"No. There are many of these internet stories that are being published by the anti-vaxxers, but no, there are no chips in the vaccines. We don't have transmitters that are that good to where they could do it even if they wanted to, but absolutely not."

What assurance is there that there aren't any long-term side effects or dangers since it was rushed in development?

"Safety in every possible way has not been compromised. The shortcuts that have been taken have been on the regulatory side in terms of the way that the data is requested and the parts of the data that are being looked at. All the safety data is being reviewed.

Some of the secondary data that answers other questions about the vaccine is still being collected but is a long way from being reviewed or published. 

The other part of the process that has been dramatically shortened is related to financial risk. That risk was mitigated or totally eliminated by Operation Warpspeed, where the government covered certain costs in developing the vaccines, so companies did not have to wait in assessing both the safety and financial risk to get to the large studies."

How significant is the FDA giving the Pfizer vaccine emergency use authorization?

"This is extremely significant because it will allow Pfizer to begin shipping vaccine and it to be given to large numbers of people on an expedited basis. Tennessee is part of their early rollout, so we will be as early as anyone beginning to get these injections."

The UK is a little bit ahead of us and has started administering the Pfizer vaccine. As a result, there have been several cases...a couple of cases of severe allergic reaction. Was this expected, or just how rare is it for this to happen in a case like this?

"This is not something that happens very commonly. And the information that is now being made available indicates that both of these people who had these allergic reactions had significant history of severe allergic reactions. They both carried Epipens, which are self-administered to treat severe allergic reactions. So in these individuals, it may not have been expected, but by the same token, it isn't unexpected, and it's not generalizable to the general public. People that have typical allergies should not be worried about taking these vaccines at all."

We do know that there can be side effects shortly after the doses are administered, but what about months, years down the road?

"Well, we don't have any data for months or years down the road, but the information we have from other vaccines and from the limited data that we've got with these vaccines would suggest that most if not all of the side effects occur early on after the injections and that long term risks are minimal. And when you compare those risks with the risk of having a COVID infection, the risk/benefit ratio is overwhelming.