Virus World

Moderna said Monday that its coronavirus vaccine candidate is 94.5% effective in fighting the virus, per an initial analysis released by the company.

Why it matters: The Moderna vaccine — alongside Pfizer's similarly effective candidate — provides another dash of hope that the pandemic currently raging across the world could be tamed by next year.

The state of play: Moderna's study, done in collaboration with the National Institute of Health, looked at 30,000 participants — with half receiving a placebo.

• In 95 cases of COVID-19 that developed among participants, 90 were taking the placebo.
• Of the 11 people who contracted "severe" COVID-19 infections, all were taking a placebo.
• Moderna reports there are no significant safety concerns so far.
• The company also said that the vaccine could be stored at refrigerator temperatures for up to a month — compared to Pfizer's vaccine candidate, which requires ultra-cold conditions.

What they're saying: "It’s extremely good news. If you look at the data, the numbers speak for themselves," said Dr. Anthony Fauci, per the Washington Post.

• "I describe myself as a realist, but I’m fundamentally a cautious optimist. I felt we’d likely get something less than this. … I said certainly a 90-plus-percent effective vaccine is possible, but I wasn’t counting on it."

The big picture: The Moderna vaccine was part of the federal government's Operation Warp Speed acceleration project, and the company received about $2.5 billion to back its research and development.

• Pfizer, on the other hand, funded its own vaccine research but did commit to an Operation Warp Speed deal to speed potential distribution.

Worth noting: Like Pfizer's announcement last week, Moderna's details on its vaccine candidate came in the form of a press release.

• The data has not been peer-reviewed and its effectiveness could change as the study progresses, but Moderna says they plan to submit to a peer-reviewed publication when the study is complete.
• Pfizer CEO Albert Bourla said that his company had avoided such specificity about effectiveness given that the numbers could continue changing as its trial continues.

Moderna's press release (Nov. 16, 2020):

https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

The investigational vaccine was developed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The trial is to be conducted at nearly 100 US research sites, according to Moderna. The first Phase 3 clinical trial of a coronavirus vaccine in the United States began Monday. The investigational vaccine was developed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The trial is to be conducted at nearly 100 US research sites, according to Moderna. The first patient was dosed at a site in Savannah, Georgia. The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the Moderna/NIH vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes. Volunteers will receive either two 100 microgram injections of the vaccine or a placebo about 28 days apart. Investigators and participants will not know who has received the vaccine.

Results from a Phase 1 trial of the vaccine published earlier this month in the New England Journal of Medicine found it induced immune responses in all of the volunteers and was generally safe. It had mild side effects, including fatigue, chills, headache, muscle pain, pain at the injection site. A Phase 1 study typically studies a small number of people and focuses on whether a vaccine is safe and elicits an immune response. In Phase 2, the clinical study is expanded and the vaccine is given to people who have characteristics -- such as age and physical health -- similar to those for whom the new vaccine is intended, according to the US Centers for Disease Control and Prevention. In Phase 3, the vaccine is given to thousands of people and tested for efficacy and again for safety. The Moderna/NIH vaccine is one of 25 in clinical trials around the world, according to the World Health Organization. Moderna is one of several companies that received support from Operation Warp Speed, the federal government's Covid-19 vaccine program. On Sunday, Moderna announced it had received an additional $472 million from the Biomedical Advanced Research and Development Authority for Phase 3 study and development of its Covid-19 vaccine, bringing the total to $955 million.

See also NIH Press Release (July 27, 2020):

https://www.nih.gov/news-events/news-releases/phase-3-clinical-trial-investigational-vaccine-covid-19-begins