Moderna Inc. (NASDAQ:MRNA) has said that it has received FDA approval for “Fast Track” designation for its potential coronavirus vaccine. This is a move that will accelerate the regulatory evaluation process.
Fast Track approval to accelerate the development process of the vaccine
The Cambridge biotechnology company has been in the race to develop an effective and safe vaccine against COVID-19, which has killed over 285,000 people across the globe. With the Fast Track designation, Modern will now meet frequently with the FDA to deliberate on the progress of the development of the vaccine as well as data going with it. The company is currently conducting the second phase of the study on the coronavirus vaccine, following approval from the FDA.
The move means that Moderna’s vaccine will be eligible for Accelerated Approval as well as Priority Review. According to FDA, the Fast Track designation is meant to deliver vital new drugs faster to patients. With frequent communication, it is easier to address questions and any issues around the vaccine faster, thus leading to quick approval of the drug and access from patients.
Currently, there are over 100 potential coronavirus vaccines under development, with some already in clinical trials. However, in April, WHO warned that for a vaccine to be considered safe and effective, it has to take a minimum of 12 months to develop. The company is planning to commence late-stage trials of this vaccine by summer. Equally, Modern has said that there is a possibility of approval of marketing application in 2021.
Moderna is employing mRNA tech in development of a vaccine
The company’s vaccine employs mRNA technology that directs body cells to produce specific COVID-19 proteins that trigger an immune response. Although this approach is applicable in various treatment types, it is yet to be approved for any drug. In April, the company received funding of $483 million from a government agency to speed up the development of the vaccine.
Several drugmakers, including Johnson& Johnson (NYSE:JNJ) and Pfizer Inc. (NYSE:PFE) in collaboration with German pharmaceutical company BioNTech are in the process of developing the COVID-19 vaccine.