I joined the Moderna COVID-19 phase 3 study during the 4th quarter 2020. This is a 2-year double-blind study, where a participant has 50% chance of receiving a vaccine. However, both the studying doctor and the participant will not know whether a vaccine or a placebo were administered until the study ends. The full study spans a little over two years with 7 office visits, roughly 29 safety phone calls, and around 110 safety diaries. The participation was entirely voluntary, and any participant can drop off at anytime.
After profusely debating with myself for over a week, and filled out and signed over 30 pages of consent forms and other medical paperwork. I received two shots in October that are 28 days apart. The shots felt like the tetanus shots. Besides my arm hurting for a couple of days, everything else was completely normal. The sore arm gave me a good level of confidence that I received the "Real Thing", but I wasn't going to go test out my immunity. I filled out all my diaries, and participated in all the phone calls and office visits. Hoped that the vaccine was effective enough to receive Emergency Use Authorization (EUA) as soon as possible. It was a very special day when the EUA approval was announced.
The vaccine was only approved for EUA. Moderna would like to continue collecting data on the participants to learn the long-term effects of the vaccine, including how long it can protect people from the virus. To encourage volunteers to remain in the study, Moderna offered to un-blind the study by disclosing whether a participant has received the vaccine. The ones who received placebo were offered the vaccine. During my un-blinding appointment in late January, I learned that I indeed received the vaccine.
This is my first participation in a drug trial. As a "thank you" for my participation, Moderna has made a donation to the Second Harvest Food Bank. I also learned that Moderna was looking for 450 participants in the city, and I was the 449th volunteer.
With very little known about the mRNA vaccines at the time, it was a leap of faith to participate in the study. I searched and searched on the internet, read everything published by every Moderna trial site. Clearly stated in all the posts is that no one knows the potential long-term side effects of the mRNA vaccine. However, the mRNA research and drug trials have been available in various other areas of medicine, such as cancer treatment. While many mRNA drugs are in the R&D stage, not many have been approved due to the newness of the methodology and technology. The cutting-edge mRNA methodology allows cheaper and quicker production of medicine. In the context of vaccine, mRNA vaccine can also more precisely target the virus string as the methodology eliminate potential mutations in the vaccine. This is a factor that often cause flu vaccines to be less effective. If proven as safe and effective, the methodology can be a great advancement in medicine!
One thing we kept hearing and seeing everywhere from everyone is how the COVID-19 pandemic has changed our lives, for better and for worse. For me, while it is a rare opportunity to spend so much time with family members, my pre-school aged children had been out of school for so long, they started jumping for joy whenever they see someone their age in the distance. I have always wondered about the long-term developmental impact on them from the lack of interaction with peers. The only way to go back to somewhat of a normal life is to achieve herd immunity. I truly wish that enough people decide to get vaccinated. In the meantime, I will continue to fill out my safety diaries and report any health changes back to Moderna.
댓글