Moderna Inc has received authorisation from the US Food and Drug Administration (FDA) for the emergency use of its vaccine mRNA-1273 against COVID-19 in individuals 18 years of age or older, the US biotechnology company announced today. "The Moderna COVID-19 Vaccine is now authorised for distribution and use under an Emergency Use Authorisation (EUA)," Moderna said in a statement.
The company said total 200 million doses have been ordered by the US government to date, and that it retains the option to purchase up to an additional 300 million doses. "Approximately 20 million doses will be delivered by the end of December 2020," Moderna said.
We just announced that the FDA has authorized the Moderna COVID-19 Vaccine in the U.S. for emergency use to prevent COVID-19 in individuals 18 and over. The Moderna COVID-19 Vaccine has not been approved or licensed by the FDA. https://t.co/zyd6dfJr53pic.twitter.com/oNeB3DXazu— Moderna (@moderna_tx) December 19, 2020
The US FDA aprroval comes a day after a panel of outside advisers to the US drug regulators fully endorsed the vaccine candidate. Of the total 21 VRBPAC (Vaccines and Related Biological Products Advisory Committee) members, 20 voted in favour of authorising Moderna vaccine, while one abstained.
US President Donald Trump congratulated the nation on the approval of second vaccine, saying "the Moderna vaccine is now available!".
Congratulations, the Moderna vaccine is now available!— Donald J. Trump (@realDonaldTrump) December 19, 2020
Stephane Bancel, Chief Executive Officer of Moderna, said he was proud of Moderna's achievements. "We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorisation, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants," he said.
Under Operation Warp Speed, the Department of Defence, in partnership with the Department of Health and Human Services and the US Centers for Disease Control and Prevention, will manage allocation and distribution of the vaccine in the US. The company expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the US alone.
The FDA recommendation is on Phase 3 clinical trial data and primary efficacy analysis conducted on 196 cases, which indicated the efficacy rate of 94.1 per cent for Moderna vaccine. "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 hospitalisations and deaths in the United States each day," said FDA Commissioner Stephen M Hahn.
Today, FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. https://t.co/w4BQVg0n2Gpic.twitter.com/cw5JwYqxsh— U.S. FDA (@US_FDA) December 19, 2020
He said with Moderna, the FDA has now authorised two COVID-19 vaccines in an expedited timeframe, while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality.
The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus's mRNA that instructs cells in the body to make the virus's distinctive "spike" protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against coronavirus.
On December 12, Pfizer Inc and BioNTech SE became the first pharma duo to get the US FDA approval of their mRNA-based vaccine, BNT162b2, for emergency use.