US FDA authorizes Moderna Covid-19 vaccine mRNA-1273
Moderna Covid-19 vaccine : The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for mRNA-1273, the messenger RNA (mRNA) Covid-19 vaccine candidate of Moderna.
The FDA authorization is for the use of mRNA-1273 in individuals aged 18 years and more for the prevention of Covid-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Following the EUA, Moderna will begin delivery of the Covid-19 vaccine to the US government as per a deal signed worth up to $1.52 billion in August for the manufacturing and supply of 100 million doses of the mRNA-1273 vaccine.
Moderna said that it will continue to compile further data and will look to file a biologics license application (BLA) with the FDA for seeking full licensure in 2021.
Stéphane Bancel – Moderna CEO, commenting on the FDA EUA for Moderna Covid-19 vaccine, said: “We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants.
“It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”
The FDA said that the Moderna Covid-19 vaccine has met the statutory criteria for getting its EUA. The regulator said that the totality of the available data provided by the US biotech company has shown clear evidence that mRNA-1273 can be effective in the prevention of Covid-19.
According to the FDA, the Moderna Covid-19 vaccine contains mRNA, which is genetic material. The vaccine has a small piece of the mRNA of SARS-CoV-2 virus which instructs cells in the body to make the virus’ distinctive “spike” protein, explained the FDA.
The regulator further said that after a person is injected with the vaccine, their body produces copies of the spike protein, which does not result in Covid-19, but stimulates the immune system to learn to react defensively by producing an immune response against the SARS-CoV-2 virus.
Commenting on the FDA EUA for Moderna Covid-19 vaccine, Stephen M. Hahn – FDA Commissioner Stephen M. Hahn said: “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day.
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.”
Last week, the FDA issued emergency use authorization to Pfizer and BioNTech for their mRNA vaccine BNT162b2 for protection against Covid-19.