People sometimes forget the decades of research behind the development of mRNA vaccines, and act as if the idea for them developed overnight, and that the attitude must have been “let’s try this, what could go wrong?”. I say thank god the decades of research helped paved the way for developing vaccines in the face of a true emergency situation. Millions of lives have been saved thanks to these new vaccines.
Despite the global threat of COVID-19, mRNA vaccines, which are highly effective at preventing COVID-19 illness and have passed rigorous safety
www.oligotherapeutics.org
How do we know that it is really safe if the development and approval processes were so rushed?
As discussed in the last point, the development process has been underway for decades. Moderna and Pfizer-BioNTech did not start from the beginning and produce vaccines in less than a year. They used the platforms they had spent years developing and perfecting, then inserted the necessary piece of genetic code and completed the design for an effective mRNA vaccine.
You can think about it this way. Once computers, operating platforms, and software were created, it was a much simpler matter to provide software updates to make small changes. However, we didn’t go from the first computers to today’s smartphones and easily installed apps and updates in just a year or two. The decades of development have brought us to the place where software is easily created and incorporated into existing platforms.
mRNA vaccines operate under a somewhat similar process. Since producing mRNA vaccines uses a process of biochemical synthesis, once the genetic code of a virus is known, the piece of mRNA needed to create an immune response can quickly be synthesized and incorporated into the existing platform to create an effective vaccine.
Approval processes were not changed for these vaccines. You can view details about the FDA’s process
here and the European Union’s process
here. All new vaccinations and medications go through rigorous testing, and the final steps include 3 phases of human trials. The final phase requires testing thousands of people.
Moderna’s phase 3 trial included 30,420 participants, of which half received the vaccine (8), and
Pfizer-BioNTech’s phase 3 trial included 43,548 participants, with just under half receiving the vaccine (9). The other half in both groups received a placebo in order to accurately compare results between the participants who received a vaccine or a placebo. Both vaccines met the requirements of safety and efficacy, with an astonishing 94.1% and 95% rate of being effective in preventing COVID-19 illness (8, 9).