For the second time this month, more positive news comes from another Covid vaccine candidate. Moderna Inc today announced that the NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its candidate vaccine against COVID-19, has shown that the company’s experimental vaccine is 94.5 % effective in preventing the new 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, CEO of Moderna.
This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. 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, US Department of Health and Human Services.
Moderna’s shares were up more than 9% in pre-market trading in the US, while in Europe, the Stoxx 600 index was up 1.5%.
Moderna president Dr. Stephen Hoge welcomed the “really important milestone” but said that having similar results from two different companies is the most reassuring.
“That should give us all hope that actually a vaccine can stop this pandemic and hopefully bring us back to our lives,” Hoge told The Associated Press.
The primary endpoint of the COVE Phase 3 study is based on the analysis of confirmed and adjudicated COVID-19 cases beginning two weeks after 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 the efficacy of the 94.5% vaccine (p <0.0001).
Moderna’s first analysis was based on 95 COVID-19 cases, 90 of which received a placebo and 5 of which received the vaccine. There were 11 severe cases in the placebo group and none among those who received the vaccine. The 95 cases included 15 adults 65 years of age and older and 20 participants from diverse communities, including 12 individuals who identified as Hispanic, 4 African-American, 3 Asian-American, and 1 person multiracial.
The results come a 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.
This result from both companies comes at a time when control of the pandemic is tightening. The United States surpassed 11 million coronavirus cases on 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 increasing. Europe has also seen cases skyrocket as much of the world prepares for what is expected to be a terrible winter.
While the results are preliminary, both Moderna and Pfizer are expected to apply for emergency use authorization from the US Food and Drug Administration if further study shows their vaccines are safe. In its statement, Moderna said it could seek the go-ahead from regulators in the coming weeks.
The company said it would expect an emergency clearance to be based on a final analysis containing 151 cases, along with two months of safety tracking data that US regulators want to see. Final data is expected later this month.
In addition, both Moderna’s and Pfizer-BioNTech’s candidate vaccines are so-called mRNA vaccines, a completely new technology. They are not made with the coronavirus itself, which means that there is no chance that someone could get it from the injections. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the enriched protein on the surface of the virus.
The good results were a surprise. Scientists have warned for months that any COVID-19 vaccine can be as good as flu vaccines, which are about 50% effective.
Another great challenge: distributing doses that must be kept very cold. Both Moderna and Pfizer intakes 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 injections require prolonged storage at extremely cold temperatures.
With contributions from agencies
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