Moderna vaccine shows 94.5% effectiveness against COVID
Moderna Inc. is the second pharmaceutical in a week to announce that an independent monitoring board has found its vaccine highly effective against COVID-19.
Moderna’s Phase 3 showed 94.5% efficacy. Last Monday, Pfizer’s Phase 3 vaccine showed a 90% success rate in fighting the virus. The FDA has said it would accept vaccines that showed greater than 50% efficacy.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible,” said Stéphane Bancel, CEO. “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.”
It will still be months before the vaccine is widely available.
Moderna is based in Cambridge, Massachusetts.
This study, known as the COVE study, enrolled more than 30,000 participants in the U.S.
The flu vaccine, given every year, has an efficacy rate of 40%-50%.
Moderna’s vaccine, like Pfizer’s, requires two doses. In both cases, half of the clinical trial participants received a placebo. Like, Pfizer, Moderna’s test showed the majority of cases were among those receiving the placebo.
This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group; 5 cases observed in the group that received the active vaccine.
A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group.
The 95 COVID-19 cases included 15 adults over 65, and 20 people identifying as being from diverse communities, including 12 Hispanic or Latino, four Black, three Asian American and one multiracial.
“The scientists were right on it,” said Dr. Manoj Jain, the infectious disease physician who is advising the City of Memphis on its COVID response. “The vaccine is absolutely quite effective and very promising. The challenge is going to be getting people to accept the vaccine.”
Both the Pfizer and Moderna vaccines use genetics to provoke an immune response in the coronavirus genes. Ten other companies have large-scale trials in Phase 3 around the world. More than 50 others are in earlier stages of work.
The results come as the nation struggles to tamp down the virus. It surpassed 11 million cases Sunday, after reaching 10 million last Monday. Ten days earlier, it hit 9 million.
On Sunday, the governor of Washington state announced a ban on indoor dining in restaurants, which will go into effect today until Dec. 14. In-store retail occupancy is limited to 25%. Indoor fitness facilities and gyms are to close. Similar orders were issued earlier for Illinois.
Both Pfizer and Moderna released their data by press releases and not peer-reviewed journals. Neither have released the details that allow other researchers to validate the results, which means they cannot be considered conclusive and could change.
“You must make sure there are no nuances in the data that aren’t really captured in a press release,” said Dr. Scott Strome, executive dean of the College of Medicine at University of Tennessee Health Science Center here.
“The good news about the Moderna vaccine is that it does not require the same degree of cold storage of the Pfizer vaccine, and that is a huge deal.”
Moderna’s must be stored at minus 4 degrees Fahrenheit; Pfizer’s must be kept much colder, at minus 94 degrees Fahrenheit, which will complicate distribution.
“The real challenge for any drug is that you have to track its provenance - from when it was made and what temperature it was stored at,” Strome said. “You want to make sure they are compliant from the moment they are manufactured to the moment they enter a patient.
“I don’t believe the U.S. or anywhere in the world, for that matter, has experience with transporting vaccines to massive numbers of people at these temperatures.”
Both of vaccines use synthetic versions of the virus’s genetic material to tell the person’s cells to begin making copies of a fragment of the virus. It alerts the immune system to mount an attack if it encounters the real virus.
The news means that the first two vaccines out of the chute have both shown remarkable signs of success, Jain said.
It’s too early to tell how availability will work or if people will be able to choose which vaccine they receive, he said.
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Moderna Inc. Dr. Manoj Jain coronavirus vaccine COVID vaccine COVID-19 vaccineJane Roberts
Longtime journalist Jane Roberts is a Minnesotan by birth and a Memphian by choice. She's lived and reported in the city more than two decades. She covers business news and features for The Daily Memphian.
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