FDA clears Moderna vaccine for emergency use



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The vaccine was found to be almost 95% effective in clinical trials that enrolled 30,000 patients, of which around 40% were over 65 or had chronic health conditions such as heart problems and diabetes that made them older. vulnerable to the virus.

FDA clearance now allows its use for people 18 years of age and older. The first coronavirus vaccine licensed in the United States, from Pfizer, is licensed for people as young as 16. But the FDA warned in both cases that people with severe allergies should not take the vaccines at this time. “About five” allergic reactions to Pfizer’s shooting have been reported since its launch on Monday, including one in Alaska, Peter Marks told reporters.

Although the agency has not yet isolated the cause, Marks speculated that a component shared in the two vaccines, polyethylene glycol, could be a culprit. The ingredient is commonly used in pharmaceutical preparations and drugs like laxatives, he said.

Nearly 6 million doses of the Moderna vaccine will be shipped to 3,285 sites across the country in the first week, General Gustave Perna, Operation Warp Speed ​​chief operating officer, said on Monday.

Like Pfizer’s vaccine, the Moderna vaccine uses messenger RNA technology that instructs cells to recognize and fight the virus. The Trump administration last week doubled its vaccine order from Moderna to 200 million doses after Pfizer said it would not be able to deliver more vaccines until the third quarter of 2021.

Moderna, a ten-year-old Massachusetts biotech company, has never brought a product to market before. But the company developed its potential vaccine days after learning about the virus’s genetic sequence and began working with the National Institutes of Health to test doses. Moderna was the first of dozens of vaccine manufacturers to begin late stage trials with tens of thousands of volunteers.

He received nearly $ 1 billion from the US government to develop and study the vaccine.

“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines in the fight against the virus. I want to thank the NIH and [the National Institute of Allergy and Infectious Diseases] for their scientific leadership, ”said Moderna CEO Stéphane Bancel, who added that government funding for Operation Warp Speed ​​and other agencies has“ helped accelerate our progress to this point ”.

Moderna signed a manufacturing contract with Swiss company Lonza AG in May to produce up to one billion doses of the vaccine next year. In the meantime, it’s likely to be a cornerstone of America’s goal of immunizing millions of Americans.

The administration has spent billions to obtain up to 900 million potential vaccine doses from six manufacturers. But several have encountered obstacles that could delay authorization and more options against the pandemic.

“It has been less than a year since the world was first informed about SARS-CoV-2 and the terrible disease it can cause,” Anthony Fauci, director of NIAID, said in a statement. “To have not one but two safe and highly effective COVID-19 vaccines ready for deployment to the American public is truly a remarkable scientific achievement, and an important step towards ending the pandemic that has caused so much suffering.”

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