The first phase 3 vaccine trial is underway! Moderna is the biotech company partnering with the National Institutes of Health that is first off the blocks. Phase 1 trials test safety. Phase 2 trials test efficacy and safety in a slightly larger number of people. Then phase 3 trials are done in even larger numbers to get a lock-in on safety and efficacy. This trial by Moderna will include 30,000 people, half with active vaccine and half with a placebo. While the entire trial will last 2 years, we may have preliminary results in as little as 3 months, especially if it works well.
Other phase 3 trials are hoping to get underway as well which is good as we will need alternatives and choices in our vaccine selection.
But the selling of the vaccine begins now. About 20% of Americans according to a CNN poll would not take the vaccine even if it were available. I have seen right here on Facebook some Friends declare publicly they wouldn’t take the vaccine and these are not the old school anti-vaxer crowd of yore. These are a brand new breed of vaccine unenthusiasts who are afraid of being experimented upon. So the work begins to educate.
The technology to make this vaccine is new and exciting. Normally, we have to get portions of the virus and deactivate it and inject it to get an immune response. That takes time…. a long time. With this new mRNA technology, we can get the piece of genetic code that the virus uses to make its spike proteins that allows it to infect humans. One can enclose this piece of mRNA in a bubble of lipid using nanotechnology then inject it into humans. The mRNA is taken up by our immune system cells as it is recognized as foreign. The mRNA then uses the cell to make the spike proteins. The spike proteins get to the cell membrane where our human host defense mechanism rings the bells and makes antibodies to it, elicits an immune response, destroys it, and most importantly REMEMBERS it. So if another spike protein from SARS-CoV-2 were to enter the body, the immune system would know it and destroy it before it caused illness.
While the process of vaccine manufacturing is inventive and new, it does not reduce the safety of the vaccine. All vaccines have to be studied for its safety and efficacy. Wouldn’t matter if we mixed dirt in a ditch and stuck it on a lollipop and called it a vaccine. You still have to TEST it. These studies are rigorous. Randomized placebo-controlled trials. The Diamond Standard for trials. Sure, we’ve had drugs release in the past that were safe during phase 3 trials and when they were mass-marketed, side effects were more clearly known and they were taken off the market. It happens. However, we have mechanisms to understand and discover that as well.
So with anything and everything we have to weigh the risks and benefits. With vaccines, we all have to be involved. Vaccines are not effective in everyone so everyone has to get it to supply the population with “herd immunity”. Enough people in a population are immune so the infecting agent cannot gain a hold. When and if we prove a vaccine safe and effective, the choice will be to take the vaccine and endure a risk that there is yet an unknown side effect. Or not take the vaccine and let the pandemic endure.
