Were the COVID shots rushed?

Mar 24, 2021

By Trevor Shewfelt, Pharmacist at the Dauphin Clinic Pharmacy

Spring has sprung. Time for a fresh start. The days are over 12 hours long. The snow is leaving. Easter is just around the corner, and Easter is all about miracles. Dying for humanity's sins and rising from the dead is a big one on the miracle scale. But there are lots of little miracles all around us if we care to look. Your heart has been beating every day without a break since before you were born. A tiny maple key grows into a huge tree. That tree took water, sunshine and carbon dioxide out of the air and changed that carbon dioxide gas into thousands of pounds of wood. It is hard to believe that is even possible.

All the questions we get in the pharmacy seem to have miraculously changed as well. They used to be things like "Which one of my pills is for my heart?" or "If my vomit looks like coffee grounds is that bad?" or "What do I do if I haven't pooped in a week?" Questions in the pharmacy are usually very interesting and very, well, variable. Now they all seem to be COVID vaccine questions. Let's look at a couple of them.

The first question is still, "How do I get a COVID shot." We went over this last time, but here is a quick recap. Go to manitoba.ca/vaccine and click on Eligibility Criteria. If you are in the right age range, call 1-844-626-8222 or book your vaccination online. This will get you the Brandon Super Site for a shot. At the time of writing, if you want to get a COVID shot at a pharmacy in Manitoba, you must be between 50 and 64, or First Nations and aged 30 to 64. Plus, you must meet certain health criteria. We are waiting to see when we get our next shipment of AstraZeneca vaccine. To get onto our vaccine waiting list, go to www.dcp.ca and follow the links.

One of the other most common questions is about the speed of vaccine development. If a normal vaccine takes years to decades to develop, how did we get so many vaccines approved so fast? We didn't even know the virus SARS-Cov-2 existed until about 16 months ago. Doesn't that mean the vaccines were rushed and therefore unsafe? Aren't we just guinea pigs?

Back in 2003, there was an outbreak of SARS 1. Many people died, including some in Toronto. But the outbreak went away on its own. Then in 2012 there was an outbreak of MERS in the Middle East. Again, many people died, but it didn't spread far outside the Middle East. Both SARS 1 and MERS were corona viruses similar to SARS-Cov-2. Researchers looked into making vaccines for both of them. However, since both SARS 1 and MERS went away on their own, funding for virus development went away too. But researchers now had about 20 years of ideas about corona virus vaccines to work with. When they started working on a vaccine against SARS-Cov-2, they weren't starting from scratch. SARS 1 and MERS meant researchers had some idea how to make a vaccine against a corona virus when COVID-19 started. That helped speed vaccine development. The other thing that helped was buckets and buckets of money.

Operation Warp Speed was put in place under the Trump Administration in the US. Money from Operation Warp Speed let drug companies do trials in parallel instead of one after another. Normally a drug company has a vaccine candidate that they are pretty sure will work after doing a bunch of experiments in the lab and on animals like mice, ferrets and chimps. These are called pre-clinical trials. Then they start clinical trials on people. Phase 1 trials are only done on a few healthy young people. All Phase 1 trials are really looking for is to see if the vaccine candidate is safe. If the vaccine candidate passes Phase 1, then Phase 2 trials look at the vaccine candidate is a larger number of people and look to see if it is safe and effective. If it passes Phase 2, then Phase 3 is the really big trial. Phase 3 trials look at 30-40,000 people. Half get the vaccine candidate and half get placebo. These big Phase 3 trials are where we get the numbers like what percent effective a certain vaccine is. If the vaccine candidate passes its Phase 3 trial, then the company applies to get licensed in a certain country. If it is licensed, the company starts building factories to start making large quantities of the vaccine for sale. Operation Warp Speed changed that.

This is an oversimplification, but Operation Warp Speed let companies do Phase 1, Phase 2, Phase 3 trials, and vaccine manufacturing at the same time. A drug company would never build a vaccine manufacturing plant before its vaccine candidate passed its Phase 1 trial in normal times. If the vaccine candidate proved unsafe in Phase 1, the drug company would lose a bunch of money on a vaccine plant it would never use. But Operation Warp Speed meant that even if a company's vaccine candidate failed one of the trials, the company wouldn't lose money. A company could afford to run Phase 1, 2 and 3 trials at the same time as it scaled up manufacturing.

It is amazing that approved vaccines against the virus SARS-Cov-2 which causes COVID-19 started going into arms within a year of the virus's discovery. The vaccine development was fast, but not rushed and not done poorly. All the normal safety protocols were followed. In fact, these vaccines continue to be some of the most scrutinized medical interventions the world has ever seen. They are an example of what humans can do when we all work together. And they are an example of what can be done if a government throws billions of dollars at a problem.

The atoms in your right hand were originally created in a star that exploded billions of years ago. The atoms in your left hand could have come from a completely different exploding star. You really are made of star dust. Spring is a time for rebirth and renewal. Easter is a time to celebrate miracles. The speed at which COVID vaccines came to market can be called miraculous. The speed of development was due to many, many smart people working together. The real miracle might be that Trump's administration agreed to throw buckets and buckets of money at the problem.

As always if you have any questions or concerns about these or other products, ask your pharmacist.

The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.

 


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