Moderna Says Preliminary Trial Data Shows Its Coronavirus Vaccine Is More Than 94% Effective

Moderna said preliminary phase three trial data shows its coronavirus vaccine is more than 94% effective in preventing Covid-19 — a result CEO Stephane Bancel called a “game changer.” CNBC informed.

The analysis evaluated 95 confirmed Covid-19 infections among the trial’s 30,000 participants. Moderna, which developed its vaccine in collaboration with the National Institute of Allergy and Infectious Diseases, said 90 cases of Covid-19 were observed in the placebo group versus five cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 94.5%, it said.

Shares of the company jumped more than 12% in premarket trading.

The announcement comes on the heels of similar news last week from Pfizer’s late-stage Covid-19 vaccine trial as pharmaceutical companies across the world race against the clock to find ways to prevent the virus, which has spread to more than 54.4 million people, killing more than 1.3 million, according to data compiled by Johns Hopkins University.

Health and Human Services Secretary Alex Azar told CNBC on Monday that U.S. Food and Drug Administration will move “as quickly as possible” to clear Pfizer and Moderna’s coronavirus vaccines for emergency use.

Bancel called it a “pivotal moment.”

“Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters,” he said in a statement. “This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”

The Cambridge, Massachusetts-based company also said there were no “significant” safety concerns, adding the vaccine was generally safe and well tolerated with the majority of adverse events in participants being labeled as mild or moderate. Side effects included pain at the injection site and, after the second dose, fatigue, muscle pain and headaches.

“Knowing that we have a vaccine that would help more people who would take it is just a wonderful feeling,” Bancel said in an interview with CNBC. “As you know a lot of people have been reluctant in surveys to take a vaccine because I think we’re worried about the politicization of a vaccine, they’re worried about what you get with a flu shot you know 50% to 60% efficacy.”

With an efficacy rate of 95%, “that’s a game changer, I believe,” he said.

Bancel said the company plans to test the vaccine in teens “very soon,” followed by children under the age of 12. “We have to be very, very careful because safety is priority No. 1,” he said in a separate interview on CNBC’s “Squawk Box,” adding most trials test vaccines on healthy adults first to assess safety.

Investors were expecting Moderna’s vaccine to be highly effective after Pfizer, another front-runner in the Covid-19 vaccine race, said last week that its product was more than 90% effective. Moderna’s candidate, like that of the Pfizer-BioNTech partnership, is using messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response.

Medical experts note it remains unclear how long the vaccine provides immunity and whether or how often people may need periodic booster shots.

“These vaccines are going to be approved and then rolled out with basically a few months worth of data. You’re not going to do a two-year study to see whether it’s effective for two years with more than 200,000 people dying this year” in the U.S., said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Dr. Soumya Swaminathan, the World Health Organization’s chief scientist, said other questions remain about the vaccine, including whether it decreases the infectiousness of the virus and whether it is highly effective in subgroups like the elderly. She said the WHO-backed COVAX initiative is also thinking about the equitable distribution of the vaccine, which will initially be in short supply.

“We’re looking at at least the first half of next year as being a period with very, very limited doses,” she said. “Supplies are going to be limited. There are bilateral deals that many of the companies have done. So many of the doses have already been booked by some countries.”

Moderna said Monday its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at negative 4 degrees Fahrenheit. By comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

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