Moderna Says Preliminary Trial Data Shows COVID Vaccine Is 94.5 Percent Effective
"This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna CEO Stéphane Bancel said
Moderna Inc. says that preliminary phase three trial data shows its coronavirus vaccine is 94.5 percent effective.
In a statement on Monday, Moderna said that the trial, known as the COVE study, involved 30,000 participants, 15,000 of whom were given a placebo, or a shot that has no effect. After several months, 90 of them developed COVID-19, 11 of which were severe cases.
Meanwhile, the other 15,000 participants were given the COVID-19 vaccine, and only five of them contracted the virus. None of them fell severely ill.
Overall, the study's results showed an estimated 94.5 percent vaccine efficiency, the company said.
"This is a pivotal moment in the development of our COVID-19 vaccine candidate,” CEO Stéphane Bancel said in the statement. “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. 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.”
Moderna, part of the U.S. government's Operation Warp Speed program, also said the COVE study did not show any "significant safety concerns" and that the vaccine was generally well-tolerated.
"We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study," said Bancel. "We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
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Moderna's announcement comes exactly one week after Pfizer Inc. said the early efficacy tests of its coronavirus vaccine showed 90 percent efficiency.
"This is a first but critical step as we continue our work to deliver a safe and effective vaccine," CEO Albert Bourla said in a statement.
Bourla went on to say that more data is needed before the company can apply for FDA Emergency Use Authorization, and clinical studies are still ongoing.
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Last month, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told CBS Evening News that a COVID-19 vaccine is likely on its way, and people will know by November or December if there's a "safe and effective candidate."
"[A vaccine] will likely be [available] within the first quarter of 2021, by let’s say April of 2021," he said at the time. "But that would be predicated on the fact that all of the vaccines that are in clinical trials have proven to be safe and effective."
"We've made an estimate to have about 700 million doses by the end of April," added Fauci. "But that means from all six companies that we're making investments in. That means that all six of those candidates have to have a vaccine that is proven to be safe and effective."
As information about the coronavirus pandemic rapidly changes, PEOPLE is committed to providing the most recent data in our coverage. Some of the information in this story may have changed after publication. For the latest on COVID-19, readers are encouraged to use online resources from CDC, WHO, and local public health departments. To help provide doctors and nurses on the front lines with life-saving medical resources, donate to Direct Relief here.