The United States on Friday authorised Moderna’s Covid-19 vaccine for emergency use in the country, the US Food and Drug Administration announced. The authorisation came a day after the body’s advisory panel had recommended its use. This makes Moderna’s shot the second vaccine after that of Pfizer-BioNTech to receive such an authorisation in the US in a week’s time.
“The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks – supporting the company’s request for an EUA [emergency use authorisation] to allow for the vaccine to be distributed in the US for use in people 18 years of age and older,” the Food and Drug Administration said on Twitter.
Moderna has worked with the US government to prepare for the distribution of 59 lakh shots of the vaccine by this weekend, Reuters reported.
“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,” Food and Drug Administration Commissioner Stephen M Hahn said.
In a statement, Moderna said that it would deliver approximately 2 crore doses to the US government by the end of this year and expected to have between 10 crore and 12.5 crore doses in the first quarter of 2021, with 8.5 crore to 10 crore of those for the United States.
Last month, the drug manufacturer had said that its vaccine has shown 94.5% efficacy during its phase three trials. The vaccine can be kept at typical refrigerator temperatures and does not require the ultra-cold temperatures of the Pfizer-BioNTech shot, according to Reuters. It is administered in two shots 28 days apart.
Globally, the total number of coronavirus cases reached over 7.55 crore, with US recording the highest number of infections – more than 1.74 crore. The country also has the highest toll, reporting more than 3.13 lakh deaths, according to data from the Johns Hopkins University.