• September 28, 2020

CATES: Developing a vaccine - Odessa American: People

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CATES: Developing a vaccine

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Posted: Monday, May 25, 2020 4:00 am

I have a picture that I keep on my cell phone, use as my background on my PC in my home office, and have framed in my family picture “gallery” at my house.

The picture is of my Dad as a toddler in the early 1940’s and his sister Gertrude Ann — 18 months younger. I never met Gertrude Ann, because she died a few days after that picture was taken. She died of croup.

When she died, the antibiotics that treat croup didn’t exist. Because of those antibiotics, croup now is rarely serious. We rarely see polio and other horrible viral illnesses like measles, whooping cough, diphtheria, and tetanus in 2020 because of vaccines.

I have met people who had polio as children, one who was on a ventilator her entire life. The others have had many physical challenges to contend with because of that disease. The polio vaccine didn’t exist for them as kids either.

I keep the picture of my Dad and Gertrude Ann close because I never want to forget that antibiotics and vaccines are little miracles, medications that save lives every single day. I don’t want to forget the cost of becoming lax when we don’t vaccinate as we should or abuse antibiotics so they don’t work as well.

Those behaviors costs us lives, like Gertrude Ann, when we take things like antibiotics and vaccines for granted. If there is any good that will come from the COVID pandemic, I think that may be it, a reminder that vaccines are miracles and we should never take them for granted.

Unfortunately, developing a vaccine is not like the movies. The experts cannot just take the blood of someone who survived and pull out a vaccine, mass produce the vaccine in an old factory in town and distribute it to the at-risk population in a matter of hours.

It took Dr. Jonas Salk, the scientist who developed the polio vaccine, nearly three years to come up with the right formula for his vaccine. We are much better at that now because of Dr. Salk’s research, but it still can take months to years.

That is actually one of the reasons why the flu vaccine is not always as effective as we wish it was. The experts at the Centers for Disease Control (CDC), the National Institutes of Health (NIH), private “think tanks” and drug manufacturers have to make educated guesses on what the flu will look like in two years — because it takes that long to develop, manufacture, and distribute the vaccine.

And sometimes, the flu varieties the experts think will be the strains that will appear as flu that year are not the right ones, and the flu vaccine is not very helpful. Fortunately, the virus that causes COVID-19 is not like the flu. There are not millions of different possibilities. So, once a vaccine is developed, it will be more like polio and we will be able to turn this disease from something that has now killed nearly 100,000 people in this country to something that is rare.

The process for vaccine development is complicated. First drug manufacturers, usually in conjunction with the CDC and NIH, have to find a vaccine that works in animal trials. Then they have to go to the Food and Drug Administration (FDA) and show that evidence, along with how it’s manufactured, and how they maintained quality during animal testing.

The FDA then clears the vaccine for human trials. Human trials are usually done in three phases. Phase 1 trials are done on a very small number of patients who are very closely monitored for any signs of problems, things like the vaccine not working, or people having horrible/fatal side effects or allergic reactions.

You may have seen in the news that Moderna has successfully completed Phase 1 trials on their coronavirus vaccine — that is a very big deal, but they still have a long way to go to get that vaccine out to the public.

Phase 2 trials work on figuring out the right dosages to get the best results. These also involve a much larger number of people.

Phase 3 trials are the biggest trials in numbers of people, and they look for less severe side effects versus effectiveness. Phase 2 and 3 take longer than Phase 1 trials because of the numbers of people needed.

They have to look at the vaccine in men and women, different ages from kids to the elderly, different races, and different health conditions. Finding those people and then looking at results can take quite a bit of time. Once all three phases are completed, then the drug has to be produced, which involves licensing and quality control — it’s important that every vaccine does what it is supposed to do and that the packaging is sterile and safe for healthcare workers to administer, and then gotten out to the public.

Because it is so important, everyone involved from the CDC and NIH to the FDA and drug companies are putting every resource they can towards getting a COVID-19 vaccine out to the public as quickly as possible. But that does not mean they can take shortcuts.

Short-cutting the process could result in millions of people getting a vaccine that is worse than the disease. Because there are no shortcuts — that means time, probably a year or so. And unfortunately that means, even though we are opening back up, we still have to be smart and try to limit transmission of the COVID-19 virus until that vaccine is available.

For that reason, please wear a mask when you are out in public, wash your hands frequently, and social distance as much as possible. Those all buy us the time we need for the miracle of a COVID-19 vaccine to happen.

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