FDA grants emergency use authorization for Moderna Covid-19 vaccine

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Moderna‘s Covid-19 vaccine, mRNA-1273, marking a significant milestone in the global fight against the Covid-19 pandemic. This vaccine is now approved for use in individuals aged 18 years and older to prevent Covid-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The approval of Moderna’s vaccine follows a string of promising clinical data, making it the second mRNA-based vaccine to receive EUA from the FDA after Pfizer-BioNTech’s BNT162b2.

Moderna poised to begin vaccine distribution in the US

With the emergency use authorization in hand, Moderna is set to begin the delivery of mRNA-1273 to the US government, which was part of a deal worth up to $1.52 billion. This agreement, signed in August 2020, will see the biotech company supply 100 million doses of the vaccine to help combat the ongoing pandemic. As production ramps up, Moderna plans to continue compiling additional data, aiming to submit a biologics license application (BLA) to the FDA for full licensure in 2021.

The science behind Moderna’s mRNA vaccine

The Moderna Covid-19 vaccine works by utilizing messenger RNA (mRNA), a novel approach in vaccine technology. According to the FDA, the vaccine contains a small piece of mRNA that encodes the spike protein of the SARS-CoV-2 virus. When administered, the mRNA instructs cells in the body to produce copies of this spike protein. The body then recognizes the protein as foreign, prompting an immune response without causing the disease itself. This process helps the immune system prepare for future exposure to the virus.

Leadership reacts to FDA EUA

Moderna’s CEO, Stéphane Bancel, expressed his pride in the company’s achievement, stating that it took just 11 months to create and manufacture the vaccine, a remarkable feat considering the typical vaccine development timeline. Bancel credited the development to a decade-long scientific, entrepreneurial, and medical journey, thanking everyone who contributed to this success. He emphasized that the company remains focused on scaling up production to ensure that as many people as possible can be protected against Covid-19.

In a statement on the EUA, FDA Commissioner Stephen M. Hahn underscored the significance of this approval, noting that it represents another crucial step in the ongoing battle against Covid-19. Hahn highlighted the FDA’s rigorous scientific review process, which ensures that safety and efficacy standards are met, even in the face of an expedited timeline. He also pointed to the broader effort to combat the pandemic, with two vaccines now authorized for emergency use in the US.

What’s next for Moderna and the global fight against Covid-19?

The approval of Moderna’s mRNA-1273 vaccine marks a turning point in the pandemic response, offering another powerful tool to help curb the spread of Covid-19. Alongside Pfizer-BioNTech’s vaccine, which received its EUA the previous week, the US now has two mRNA-based vaccines that can offer protection against the virus. As both companies continue to scale production, millions of doses will soon be distributed worldwide.

While the approval of these vaccines offers hope, experts warn that the pandemic is far from over, and continued efforts in testing, treatment, and vaccination will be needed to ultimately overcome Covid-19.