“These are very exciting results.” – Dr. Anthony Fauci |
- In Moderna’s trial, 15,000 study participants were given a placebo shot. Over several months, 90 of them developed Covid-19 – 11 of them severe.
- Another 15,000 participants were given the vaccine, and only five of them developed Covid-19. None of the five became severely ill. – CNN
Nov 16, 2020
Stat News – Moderna’s vaccine against Covid-19 is strongly effective, the company said Monday, building excitement about the potential of controlling the global pandemic.
The news comes exactly a week after similar results from Pfizer and BioNTech, which announced broadly similar results.
The Moderna vaccine reduced the risk of Covid-19 infection by 94.5%:
- There were 95 cases of infection among patients who received placebo in the company’s 30,000-patient study.
- There were only five infections in patients who developed Covid-19 after receiving Moderna’s vaccine, mRNA-1273.
- There were 11 total cases of severe disease, all of them in the placebo group.
At the time of its data release, Pfizer and BioNTech had no severe cases in their study. The companies said they will file for an emergency use authorization with the Food and Drug Administration in the coming weeks, and will file with other global regulators.
The European Medicines Agency announced Monday that it has begun a rolling review of the Moderna vaccine.
Moderna said in its press release that there were no significant safety concerns.
Severe events that occurred in greater than 2% of patients included fatigue and muscle pain, which happened in nearly one patient in 10, and headache and achiness. These events were “generally short-lived,” the company said.
The vaccine was designed with assistance from the National Institute of Allergy and Infectious Diseases’ vaccine research center; development of the vaccine has been supported by nearly $1 billion in grants from the Biomedical Advanced Research and Development Authority.
Moderna has a $1.525 billion contract to provide the United States with 100 million doses of the vaccine through Operation Warp Speed, the government’s fast-track program for Covid-19 vaccines, therapeutics, and diagnostics. The contract gives the U.S. government an option to purchase an additional 400 million doses.
The Moderna results come one week after the Pfizer-BioNTech collaboration reported that a preliminary analysis of their mRNA vaccine suggested it was strongly protective … Read more.
CNN – The Moderna vaccine is 94.5% effective against coronavirus, according to early data released Monday by the company, making it the second vaccine in the United States to have a stunningly high success rate.
Dr. Anthony Fauci, the nation’s top infectious disease doctor. “It’s just as good as it gets — 94.5% is truly outstanding.”
Moderna heard its results on a call Sunday afternoon with members of the Data Safety and Monitoring Board, an independent panel analyzing Moderna’s clinical trial data.
Dr. Tal Zacks, Moderna’s chief medical officer, said:
“It was one of the greatest moments in my life and my career. It is absolutely amazing to be able to develop this vaccine and see the ability to prevent symptomatic disease with such high efficacy.”
Vaccinations could begin in the second half of December, Fauci said. Vaccinations are expected to begin with high-risk groups and to be available for the rest of the population next spring.
The company says its vaccine did not have any serious side effects. A small percentage of those who received it experienced symptoms such as body aches and headaches.
Moderna plans to apply to the US Food and Drug Administration for authorization of its vaccine soon after it accumulates more safety data later this month.
Fauci says he expects the first Covid-19 vaccinations to begin “towards the latter part of December, rather than the early part of December.”
Initially, there won’t be enough vaccine for everyone. The highest priority groups, which include health care workers, the elderly, and people with underlying medical conditions, will get the vaccine first … Read more.
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