I volunteered to participate in a phase 3 COVID-19 vaccine trial, here’s why:
COVID-19 is not going anywhere. As everyone by now knows, you can protect yourself by staying 6 ft away from others and washing your hands frequently. If infected people (with or without symptoms) wear masks, the spread of the virus will slow. These 3 things together are currently all we have to stop more infections from happening.
A vaccine is what is needed to halt COVID-19
Once enough people are inoculated with an effective vaccine, the virus will die out as it will not find many new hosts to infect. The idea of all people wearing masks in public works via a similar mechanism – a physical (much less effective) vaccine of sorts.
We need volunteers to develop an effective vaccine as quickly as possible. We all know vaccines work: smallpox no longer exists in the wild, it is exceedingly rare to see people with lingering effects from polio, families do not lose 3 or more children in 1 year due to diphtheria. I believe in the efficacy and safety of vaccines and I want to actively participate in the solution to combat COVID-19.
While there are currently 140 vaccines being explored it is important to remember that the process to develop a safe and effective new vaccine is typically a lengthy one lasting 10-15 years or longer. Currently, there are 23 vaccine candidates in human clinical trials around the World (US, China, UK, Germany, S Korea, Australia, India, Canada, Japan, and Russia).
The Vaccine Development Process
The process for developing a vaccine begins with the Exploratory stage where potential candidates are worked on that might work. Then the Preclinical stage where safety and efficacy are tested on animals.
This stage is followed by the Clinical Research stage with 3 phases of clinical trials:
1) Phase 1 – Tested on 20 to 100 healthy adults to see how it works.
2) Phase 2 – Tested on up to several hundred people to evaluate the vaccine’s safety, immune response, proper dose, dose schedule, and method of delivery.
3) Phase 3 – The vaccine is tested on 300 to 30,000 people or more to determine how safe the vaccine is among a large group of people.
If a candidate passes Phase 3 clinical trials, it is submitted for approval and licensing by the FDA. It continues to be studied in Post-licensure monitoring after implementation in the public.
COVID-19 Vaccine Candidates
Right now there are several types of vaccines being tested in human clinical trials.
- RNA/DNA – Vaccines use genetic material copied from the virus to mimic the natural infection of the coronavirus and cause a person’s immune system to mount a response.
- Protein subunit – Vaccines contain proteins taken from the coronavirus that are directly injected into the body to produce an immune response. Current vaccines that work this way include: human papillomavirus infection (HPV), hepatitis B, and shingles vaccines.
- Viral vector – Vaccines contain a different virus that is dead or weakened, but includes genetic material from COVID-19. The immune system responds and builds a defense against the genetic material, which then prevents an actual infection.
- Weak or inactivated – These types are commonly used for the flu. They contain a weak or inactivated form of COVID-19 to stimulate a person’s immune system to build antibodies. These antibodies can later recognize the virus if an infection happens and trigger a quick, targeted response to fight it off.
- Virus-like particle vaccine – These vaccines mimic the structure of the virus, but they don’t include any genetic material. Similar vaccines are hepatitis B and human papillomavirus (HPV) vaccines.
Current Phase 3 Vaccine Candidates
- An RNA vaccine made by Moderna and the National Institute of Allergy and Infectious Diseases in the US. Their results from phase 1 that showed an immune response in all participants! Phase 3 begins in July.
- A viral vector vaccine made by the University of Oxford/ AstraZeneca/ Serum Institute of India in the UK.
- An inactivated vaccine made by Sinovac in China. They are approved for phase 3 but have not begun enrollment.
I am excited about the prospect of both participating in this historical period of vaccine development and selfishly, my own potential immunity from COVID-19.