Moderna’s Experimental COVID-19 Vaccine Receives ‘Fast-track’ Review Approval By FDA

The U.S. Food and Drug Administration (FDA) is said to have fast-tracked the regulatory process for the experimental COVID-19 vaccine by Moderna, the biopharmaceutical company announced in a press statement.

The company said that the FDA has granted a granted “fast track” designation to its experimental coronavirus mRNA vaccine, mRNA-1273. The FDA’s move is expected to step-up the regulatory review process to check the safety and efficacy of the vaccine.

But what does receiving fast-track designation means?

“ Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” explained Tal Zaks, Chief Medical Officer at Moderna. “As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”

Vaccine candidates with “fast-tag” designation are prioritized concerning the clinical review and it means that the FDA intends to decide on the COVID-19 vaccine within six months.

Like other pharmaceutical companies, Moderna has been racing to find a vaccine against the novel coronavirus, which has affected almost 4.5 million people across the globe so far.

More than 100 such COVID-19 vaccine candidates are being developed or are already in the clinical trial phase. However, the World Health Organization (WHO) believes that it may take anywhere from 12 to 18 months to find the right COVID-19 vaccine that is effective against the novel virus.

The FDA reviewed Moderna’s Investigational New Drug (IND) application for mRNA-1273. This allowed the company to move to Phase 2 of the clinical trial, which is expected to begin soon. Now the company plans to finalize the guidelines for Phase 3, which is expected to start in the summer of 2020.

mRNA-1273 is an mRNA vaccine against SARS-CoV-2. The first phase of the study completed in February 2020. Moderna received a funding of $483 million from a U.S. government agency to support the development and testing of the experimental coronavirus vaccine.

The mRNA-1273 vaccine works by triggering the cells of the body to produce coronavirus proteins that automatically trigger an immune response against the virus.