Tag: Moderna

Pfizer, Moderna vaccines are 90% effective after two doses in study of real-life conditions, CDC confirms

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Report on essential workers is one of the first to estimate protection against any infection, regardless of symptoms

The Pfizer-BioNTech and Moderna vaccines being deployed to fight the coronavirus pandemic are robustly effective in preventing infections in real-life conditions, according to a federal study released Monday that provides reassurance of protection for front-line workers in the United States.

In a study of about 4,000 health-care personnel, police, firefighters and other essential workers, the Centers for Disease Control and Prevention found that the vaccines reduced the risk of infection by 80 percent after one shot. Protection increased to 90 percent following the second dose. The findings are consistent with clinical trial results and studies showing strong effectiveness in Israel and the United Kingdom, and in initial studies of health-care workers at the UT Southwestern Medical Center and in Southern California.

The CDC report is significant, experts said, because it analyzed how well the vaccines worked among a diverse group of front-line working-age adults whose jobs make them more likely to be exposed to the virus and to spread it. Continue reading.

FDA vows to move ‘rapidly’ to authorize second coronavirus vaccine

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Agency announcement follows Thursday’s positive review of Moderna’s shot by outside advisers

The Food and Drug Administration said Thursday night that it will “rapidly work toward” emergency authorization of Moderna’s coronavirus vaccine, just hours after agency advisers endorsed the shot. The announcement appeared to pave the way for another weapon against a pandemic that has killed about 310,000 people in the United States.

The FDA statement came after the agency’s vaccine advisory panel voted almost unanimously — 20 in favor, with one abstention — that the benefits of the highly effective vaccine outweighed its risks for people 18 years of age and older. The FDA intends to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly about the schedule.

“I just want to make the point of what a remarkable scientific achievement this is, and pay thanks to all the scientists, present and past, who contributed to this,” James E.K. Hildreth, president of Meharry Medical College and a member of the advisory panel, said at the close of the committee meeting on Thursday. “To go from having a [genetic] sequence of a virus in January, to having two vaccines available in December, is a remarkable achievement.” Continue reading.

Moderna to apply for emergency use authorization for COVID-19 vaccine candidate on Monday

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Moderna announced that it will apply for emergency use authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate on Monday.

The company said in a statement that testing showed its vaccine candidate was 94.1 percent effective in preventing COVID-19 and was 100 percent effective against severe COVID-19.

It also said “no serious safety concerns” have been identified to date. Some trial participants have experienced reactions like pain at the site of the injection or fatigue. Continue reading.

Moderna says coronavirus vaccine is 94.5 percent effective

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Moderna announced Monday morning that its coronavirus vaccine candidate was 94.5 percent effective in an interim analysis, a second promising data point in the push for a successful vaccine.

The announcement comes one week after Pfizer announced its vaccine was over 90 percent effective, meaning there are now two vaccines with very high levels of efficacy in interim analyses of clinical trial data.

Moderna based its data on a large clinical study involving 30,000 volunteers, half of whom received two doses of the vaccine over a 28-day period. There were 95 cases of coronavirus recorded among participants, with only 5 of them in the group receiving the vaccine. Continue reading.

Why Are We Paying Moderna Twice For An Unproven Vaccine?

Moderna, a relatively new biotech firm, generally is seen as the U.S. frontrunner in developing a coronavirus vaccine.

It trails several Chinese companies.

Based in Cambridge, MA, Moderna should certainly get an award for milking the government.

It doesn’t matter if the vaccine works. Moderna already was paid twice over. Continue reading.