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Dr. Patricia Edwards: I will trust the vaccine, and here’s why

For the Monitor
Published: 9/29/2020 3:43:44 PM

My inspiration for writing this column is some disturbing chatter I’ve heard about the upcoming COVID-19 vaccine. No, it’s not about the vaccine itself, but about fears of whether it will be safe. I’m going to explain why I feel it will ultimately be a safe vaccine.

In the spring, President Donald Trump stated that a vaccine for COVID-19 would be a priority and he named the project Operation Warp Speed. While I’m sure the idea was to tell the American public that we would have a vaccine as soon as possible and quicker than any other vaccine ever developed, this designation has had the effect of making Americans afraid that usual procedures would not be followed and a vaccine would be rushed and thereby not safe. I do not believe this is an issue for the following reasons.

First, most vaccines are created in labs that are working 9 to 5 like most businesses. This time the labs have been working overtime and in many cases 24/7 to create this vaccine. That is because this is a pandemic and therefore a crisis so the labs have stepped up to the plate and are indeed working overtime. I have seen this in my own family as my son who works in a lab has had some unusual hours such as working until 3 a.m. and sometimes going in as early as 5 a.m. His job is usually 8 to 5. This is occurring in many labs that are associated in any way with vaccine production, from making reagents and other items used in production of vaccines to the labs that actually create the vaccines. We must also remember that the virus itself had already been identified in China before it got to the United States so we didn’t have to do the step of identifying the virus, which also allowed the labs to start right away on finding a vaccine.

Also, after the vaccine is created there needs to be rigorous testing that cannot be done quickly, and so this is where the process actually slows down and goes according to the usual time course for creating a vaccine. There is no “warp speed” here.

The first part is Phase 1 testing. This consists of giving the vaccine to small numbers of willing volunteers to check for any serious or common side effects. This usually takes 20 to 80 volunteers who will be monitored for side effects and will determine what dose of the vaccine is safe.

Phase 2 testing is next and it involves several hundred subjects and usually takes months to again evaluate safety and start to evaluate if the vaccine is effective. Two vaccines in development have now passed out of this phase.

Phase 3 testing has thousands of volunteers, and I have heard that one of the current vaccines is hoping to get 60,000 to 70,000 volunteers from various countries to participate in the trial. This phase can take months to years, and it will look for side effects in large numbers of people as well as hopefully determine if the vaccine actually works to prevent COVID-19. At this point the process may go a bit faster than usual due to the need for a treatment. The time course may be shortened due to the high risk of severe illness and fatality from this virus, but scientists have already said that there must be adequate time to determine safety and efficacy.

Also, one vaccine is given in two doses that must be administered one month apart and no shortcuts there. In addition, many vaccines have been created for viruses before, such as measles and chickenpox, giving scientists a better idea of side effects they are looking for.

Phase 4 testing follows. As the vaccine is given to the general public, the testing still goes on as reports come in of any adverse effects. This goes on for years. In my career I have seen several “new at the time” vaccines come into use and usually find that there are fewer side effects than predicted from the earlier trials when it gets out into the populace.

One vaccine I remember not continuing was the Lyme vaccine, but the issue there was not about side effects and more about low demand for the vaccine and hesitancy on the part of the public to get it. I also remember it wasn’t very effective and required yearly vaccination and so was removed until a better vaccine could be developed. Also, there was not a big push to find a vaccine as there is effective medical treatment for Lyme disease. At present, there is no effective treatment for COVID-19.

There has been a lot of talk about getting the vaccine out sooner to the public, but the scientists working on the vaccine have assured us that they will not rush this process, as it’s a matter of public safety.

In fact, a safety monitoring board has to watch over the vaccine production. This vaccine is not a political tool – it is in the interest of the public health. So, I am sure that it will be considered safe before it is released, and not released on a campaign deadline.

I don’t expect the vaccine to be approved before December or January for public use. We also have to realize that the first doses will go to high-risk populations, such as medical workers, essential workers, and nursing home residents.

I feel that we will not see enough doses of the vaccine manufactured for the general public until late winter or early spring.

It seems like the pandemic will affect the United States for at least one year, maybe more. So, I will be lining up to receive the vaccine myself as soon as it is available – with confidence and hope that it will help us get back to a more normal way of life.

(Dr. Patricia Edwards of Bow is a pediatrician and president of Concord Pediatrics in Concord.)


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