US: FDA grants emergency use approval for Moderna's COVID-19 vaccine
What's the story
The US Food and Drug Administration (FDA) has authorized the COVID-19 Vaccine developed by Moderna and the National Institutes of Health for emergency use to ramp up immunization efforts across the world's worst-affected country by the coronavirus pandemic. On Friday, Moderna's vaccine became the second candidate to receive emergency use authorization (EUA) from the US drug regulator after Pfizer earlier this month. Here's more.
Details
Moderna shot 94% effective at preventing the deadly disease
Moderna's vaccine was found to be 94% effective at preventing COVID-19 in clinical trials. With the EUA, it can now be administered to people aged 18 years or older in the US. The US ordered 200 million doses of Moderna's vaccine and the rollout is expected to happen soon. The first vaccine doses will be given to healthcare workers and long-term nursing home residents.
Vaccine
It can protect against severe cases, prevent asymptomatic infections
Moderna's vaccine has been developed using gene-based mRNA technology. It was also found to be effective at protecting against severe cases of COVID-19 as well as preventing asymptomatic infections. On December 11, the FDA granted EUA to Pfizer-BioNTech's COVID-19 vaccine, which is 95% effective against the disease. The Pfizer vaccine is also based on similar gene-based technology.
Storage, distribution
Moderna's less stringent storage requirements compared to Pfizer
Interestingly, Moderna's vaccine is easier to store as compared to the Pfizer-BioNTech vaccine, which is required to be stored at ultra-low temperatures (-70°C to -80°C) until it's ready to be administered. However, Moderna's vaccine can be stored for up to 30 days in a refrigerator between 2°C and 8°C, making it easier to store, which could ease some of the logistical challenges of distribution.
Statement
Delivery of doses to US Government to begin immediately
"The Moderna COVID-19 Vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA)...Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021," said Moderna in a press release. It also said that delivery of the vaccine doses to the US government will commence immediately.
On approval
'Another crucial step in the fight against this global pandemic'
"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," stated FDA Commissioner Stephen Hahn. The EUA for Moderna's vaccine came after it was recommended by the FDA's advisory committee of independent experts.
Statement
'We remain focused on scaling up manufacturing: Moderna CEO
"I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites...I am proud of what the Moderna team has achieved in collaboration with our partners," stated Moderna CEO, Stephane Bancel. "We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease," he added.