The development comes weeks after rival Pfizer Inc and its German partner BioNTech SE sought full approval for their COVID-19 vaccine in the United States.
Moderna said it will continue to submit data to the US Food and Drug Administration on a rolling basis over the coming weeks with a request for a priority review.
The company informed that its shipment has been cleared by the US Food and Drug Administration (FDA), which can result in the opening of a new export market for pet food raw material supply.
U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson's COVID-19 vaccine after six women under 50 given the shot developed rare blood clots.
The healthcare conglomerate has only shipped around 4.25 million doses in total, according to federal data, far less than the 20 million it promised to deliver by the end of March.
The Philippines, which has the second-highest number of COVID-19 cases and deaths in Southeast Asia, is facing a renewed wave of infections, with nearly 20,000 new cases reported in the past four days.
The mRNA molecules are encased in particles of fat to protect them, but they still degrade more quickly than traditional vaccines and so require stricter storage measures.
J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections.
J&J's vaccine was 66% effective in preventing COVID-19 against multiple variants in a global trial involving nearly 44,000 people, the company said last month.
The Sheba Medical Center’s findings compare with overall efficacy of around 95% in a two dose regimen 21 days apart for the shot developed with Germany’s BioNTech.
The drugmaker’s application to the U.S. Food and Drug Administration (FDA) follows its Jan. 29 report in which it said the vaccine had a 66% rate of preventing infections in its large global trial.
Our key takeaway is that if the FDA would have wanted to reject the drug, we would have heard the decision by now.
The road to getting a regulatory nod for the drug has been rocky, with the companies scrapping two studies of the therapy in March 2019, and reversing that decision a few months later.
The Food and Drug Administration is expected to issue formal approval Friday. This would make Moderna's vaccine the second to be approved in a Western country following the one developed by Pfizer-BioNTech.