PremiumFor the second time this month, a more positive news comes from another Covid vaccine candidate. Moderna Inc today announced that the independent NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has shown that the company's experimental vaccine is 94.5% effective in preventing novel coronavirus.
"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," said Stephane Bancel, Moderna's CEO.
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Premium Premium This study, known as the COVE study, enrolled more than 30,000 participants in US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Moderna shares rose more than 9% in pre-market U.S. trading, while in Europe, the Stoxx 600 Index was up 1.5%
Dr. Stephen Hoge, Moderna’s president, welcomed the “really important milestone" but said having similar results from two different companies is what’s most reassuring.
“That should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives," Hoge told The Associated Press.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).
Moderna's first analysis was based on 95 cases of COVID-19, 90 of which received a placebo with 5 receiving the vaccine. There were 11 severe cases in the placebo group and none among those that got the vaccine. The 95 cases included 15 adults aged 65 or over, and 20 participants from diverse communities including 12 people who identified as Hispanic, 4 Black Americans, 3 Asian Americans and 1 person who was multiracial.
The results come one week after Pfizer Inc and German partner BioNTech SE said their experimental vaccine was more than 90% effective based on initial data. Moderna, which went public in 2018, has received nearly $1 billion in research and development funding from the US government and has a deal worth $1.5 billion to supply 100 million doses.
Such outcome from both the companies arrive at a moment when the pandemic’s grip is tightening. The US surpassed 11 million coronavirus cases Sunday as Florida reported the most new infections since July and new cases in California hit a three-month high. Deaths and hospitalizations are also rising. Europe has also seen cases soar as much of the world braces for what is expected to be a dire winter.
While the results are preliminary, both Moderna and Pfizer are expected to seek emergency-use authorization from the U.S. Food and Drug Administration if further study shows their vaccines are safe. In its statement, Moderna said it could seek a go-ahead from regulators in the coming weeks.
The company said it would expect an emergency authorization to be based on a final analysis containing 151 cases, along with two months of safety follow-up data that U.S. regulators want to see. That final data is expected later this month.
Moreover, both Moderna's shots and the Pfizer-BioNTech candidate are so-called mRNA vaccines, a brand-new technology. They aren’t made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
The strong results were a surprise. Scientists have warned for months that any COVID-19 shot may be only as good as flu vaccines, which are about 50% effective.
Another steep challenge: distributing doses that must be kept very cold. Both the Moderna and Pfizer shots are frozen but at different temperatures. Moderna announced Monday that once thawed, its doses can last longer in a refrigerator than initially thought, up to 30 days. Pfizer's shots require long-term storage at ultra-cold temperatures.
With inputs from agencies
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