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Moderna Inc. said Monday that it applied for emergency U.S. clearance for its COVID-19 vaccine after full results from a late-stage study showed it was 94.1% effective without serious safety concerns. .
The U.S. Food and Drug Administration (FDA) said an advisory committee would meet to discuss the application on Dec. 17, making Moderna’s candidate the second highly effective vaccine likely to receive regulatory backing from USA and a possible launch this year.
An injection developed by Pfizer Inc. and BioNTech SE that was 95% effective in its pivotal test will be reviewed by a panel of outside experts a week earlier. The FDA will decide on emergency use authorizations (EUA) after the assessors make their recommendations.
Moderna, which also plans to seek European approval, reported that its vaccine’s efficacy was consistent based on age, race, ethnicity, and gender demographics, as well as being 100% successful in preventing severe cases of the disease. It has killed nearly 1.5 million people around the world.
“We think we have a vaccine that is very effective. We now have the data to prove it, ”said Tal Zaks, Moderna’s chief medical officer. “We hope to play an important role in reversing this pandemic.”
Of the 196 people who contracted COVID-19 out of more than 30,000 volunteers in the trial, 185 had received a placebo and 11 the vaccine. Moderna reported 30 severe cases, all in the placebo group.
Moderna’s shares rose 3% in extended trading after closing 20%. They have gained about 700% this year.
“As the number of reported cases grows, confidence grows that this amazing protection will be maintained in a product that can be deployed to protect the public,” said Alexander Edwards, associate professor of biomedical technology at the University of Reading in Greater Brittany.
In addition to applying in the US, Moderna said it will seek conditional approval from the European Medicines Agency and continue to speak with other regulators conducting similar ongoing reviews.
“While we await full details of these results in published form, we can now assume that this vaccine will be approved for use in December,” said Gillies O’Bryan-Tear, chair of policy and communications, Britain’s College of Pharmaceutical Medicine. .
He expected Britain’s Medicines and Health Products Regulatory Agency to approve the vaccine in two weeks.
‘SIMPLY HATCHABLE’
Moderna said it was on track to have about 20 million doses of its vaccine ready to ship to the United States by the end of 2020, enough to inoculate 10 million people.
The Lonza Group of Switzerland, which has a contract with Moderna to supply ingredients for the vaccine, rose 4.4%.
The vaccines developed by Moderna and Pfizer / BioNTech use a new technology called synthetic messenger RNA (mRNA), while others, such as AstraZeneca’s, use more traditional methods.
AstraZeneca has announced an average efficacy rate of 70% for its vaccine and up to 90% for a subset of trial participants who received a half dose, followed by a full dose. Some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.
Moderna’s final efficacy result was slightly lower than an interim analysis published on November 16 of 94.5% effectiveness, a difference that Zaks said was not statistically significant.
“At this level of effectiveness, when you just do the math on what it means for the pandemic hitting us, it’s just overwhelming,” said Zaks, who said he cried when he saw the final results over the weekend.
Both Moderna and Pfizer vaccines were shown to be more effective than anticipated and well above the FDA-approved 50% baseline.
Recent weeks of positive vaccine results have fueled hopes that a pandemic that has hit economies will end as new COVID-19 infections and hospitalizations are at record levels across the United States. .
Almost immediately after receiving an EUA, Moderna expects its vaccine to be shipped to distribution points in the United States by the government’s Operation Warp Speed program and drug distributor McKesson Corp.
Distribution is expected to be less complicated than that of the Pfizer vaccine. While it should be stored in a freezer, it does not require the ultra-cold temperature or specialized equipment needed for Pfizer’s vaccine.
CONSISTENT ACROSS AGE AND ETHNICITY
Moderna said the 196 COVID-19 cases in his trial included 33 adults over the age of 65 and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one COVID-19-related death in the placebo group during the trial.
“This is as black and white as an effect on a population will be. Your chances of actually getting sick if you have been vaccinated are reduced 20 times, ”said Mr. Zaks of Moderna.
Moderna reported no new side effects since their interim analysis, the most common of which were fatigue, injection site redness and pain, headache, and body aches, which increased after the second dose and were of short duration.
Zaks said the vaccine caused flu-like symptoms in some participants, which “goes hand in hand with having such a powerful vaccine.” But it hasn’t caused any significant security problems so far, he said.
Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers in early 2021. It hopes to have the vaccine available to adolescents in September, Zaks said.
Other vaccine manufacturers have said they are studying their vaccines in younger people as well. – Julie Steenhuysen Y Michael Erman / Reuters
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