FDA grants emergency approval for second COVID-19 vaccine

Photo: cdc.gov

Dec. 18 (UPI) — The Food and Drug Administration on Friday issued an emergency use authorization for Moderna’s COVID-19 vaccine — the second vaccine to get such approval in the United States.

The FDA announced the EUA for the Moderna vaccine on Twitter Friday evening, adding another tool in the government’s fight to lower the spread of the novel coronavirus.

“With the availability of two vaccines now for the prevention of #COVID19, 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,” FDA Commissioner Stephen Hahn said.

The agency said trials for Moderna’s two-dose mRNA-1273 vaccine have shown it may be effective in preventing COVID-19 and meets the requirements for an EUA for people 18 years old and older.

Trial results show the vaccine has 95% efficacy, Moderna said last month.

Last weeks’ EUA for the vaccine developed by Pfizer and BioNTech allowed recipients to be as young as 16 years old. The Pfizer vaccine began to be administered this week to healthcare workers, and those who live or work in nursing homes.

The Centers for Disease Control and Prevention must also give its approval for the Moderna vaccine before it can be shipped and administered to recipients.

The U.S. government has agreed to purchase 200 million doses of the Moderna vaccine and retained the option to purchase an additional 300 million doses. Nearly 6 million doses of the vaccine will be shipped out to the states next week.

Moderna said it plans to deliver about 20 million doses by the end of the month.

Moderna CEO Stéphane Bancel thanked the biotech company’s partners and trial participants for the speedy development of the vaccine.

“I am proud of what the Moderna team has achieved in collaboration with our partners,” he 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.”

As of Friday evening, the coronavirus has sickened more than 17.4 million people and killed at least 313,000 in the United States, according to Johns Hopkins University.

To read the FDA news release announcing the EUA for the Moderna vaccine, click here.


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