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Moderna to seek approval for its COVID-19 vaccine in Europe and US

November 30, 2020
Biotech company Moderna said it will on Monday ask for approval of its COVID-19 vaccine in both Europe and the US.
Biotech company Moderna said it will on Monday ask for approval of its COVID-19 vaccine in both Europe and the US.

WASHINGTON — Biotech company Moderna said it will on Monday ask for approval of its COVID-19 vaccine in both Europe and the US.

The firm made the announcement as it revealed that final trial results showed its vaccine was 94.1% effective. Moderna said the vaccine was 100% effective against severe COVID-19.

The company will file for conditional approval from the European Medicines Agency and for an emergency use authorization from the US Food and Drug Administration.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease," said Stéphane Bancel, chief executive officer of Moderna.

"We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” he continued.

It came after results showed that 196 of the 30,000 participants in the Moderna trials contracted COVID-19. Just 11 of those cases were among people who received the Moderna candidate vaccine.

They build on Moderna's previously reported findings, based on a smaller number of cases detected in its study of some 30,000 volunteers.

"There were 30 cases on placebo and zero cases that were on the vaccine," said Dr. Stephen Hoge, the president of Moderna. "So, it looks like in the trial we've been 100 percent effective at preventing severe COVID-19, which is really what's driving the burden of disease in hospitals and ultimately straining our public health systems."

Pfizer applied for emergency use authorization on Nov. 9 for its COVID-19 vaccine. The FDA will hold its advisory committee to discuss that application on Dec. 10. That meeting is open to the public.

The FDA's charge is to assure that drugs are both safe and effective and the agency says it is not cutting corners when it comes to COVID-19 vaccines, which after all, will potentially be given to many millions of healthy people.

Moderna expects that on Dec. 17, the FDA will be ready for a public meeting to discuss this data. A vaccine could get the thumbs-up shortly thereafter. Either or both the Pfizer and Moderna vaccines may start to become available in mid to late December, though supplies will be limited.

Both use the same novel technology. Instead of injecting a weakened or dead virus, which is a common strategy for vaccines, these products are essentially small pieces of genetic material. When that's injected into a person's arm, it's picked up by cells in the immune system.

The cells read the genetic code and use that to produce a protein that is actually a key fragment of the coronavirus. The body then builds antibodies that latch onto that fragment, so if and when someone encounters the actual coronavirus, the body is primed to fight it off with antibodies.

Though the key action is happening at a cellular level, inoculation can trigger noticeable symptoms, ranging from a sore arm to achiness, or even fever and flu-like symptoms. — Agencies


November 30, 2020
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