Moderna also reported that its vaccine’s efficacy rate was consistent based on age, race, ethnicity, and gender demographics, as well as having a 100% success rate in preventing severe cases of a disease that it has killed. almost 1.5 million people.
The filing states that Moderna’s product will be the second vaccine likely to receive US emergency use authorization this year, following an injection developed by Pfizer and BioNTech that had a 95% efficacy rate.
“We think we have a vaccine that is very effective. Now we have the data to prove it,” said Moderna’s chief medical officer, Tal Zaks. “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, 185 had received a placebo and 11 received the vaccine. Moderna reported 30 severe cases, all in the placebo group, meaning the vaccine was 100% effective against severe cases.
Moderna’s stock rose 6.7% to $ 138.58 in pre-market trading in the US, a record and an increase of more than 600% this year.
“As the number of reported cases increases, 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 Great Britain. Brittany.
In addition to filing its application in the US, Moderna said it would seek conditional approval from the European Medicines Agency, which is already reviewing its data, and will 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.
Pfizer has already applied for emergency use authorization in the United States and Europe, placing it about a week before Moderna.
‘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.
Switzerland’s Lonza, 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 Britain’s AstraZeneca, use more traditional methods.
AstraZeneca has announced an average efficacy rate of 70% for its injection and up to 90% for a subset of trial participants who received a half dose, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.
Moderna’s latest efficacy result is slightly lower than an interim analysis published Nov. 16 of 94.5% effectiveness, a difference 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 the Moderna and Pfizer vaccines were shown to be more effective than anticipated and were well above the 50% benchmark set by the US Food and Drug Administration (FDA).
Recent weeks of positive vaccine results have sparked hopes for an end to a pandemic that has hit economies and comes as new infections and hospitalizations from Covid-19 are at record levels in the United States.
Independent advisers to the FDA are scheduled to meet on Dec. 10 to review Pfizer’s data and make a recommendation to the US regulator. They will review Moderna’s data a week later.
Shortly after receiving the green light, 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 easier than Pfizer’s because, while it must be stored in a freezer, it does not require the ultra-cold temperature that Pfizer’s vaccine requires.
CONSISTENT ACROSS AGE AND ETHNICITY
Moderna said the 196 Covid-19 cases in her 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 the effect will be in a population. The chances that you will actually get sick if you have been vaccinated are reduced 20 times,” Moderna’s Zaks said.
Azra Ghani, chair of infectious disease epidemiology at Imperial College London, said details on Monday confirmed the vaccine was highly effective, even against severe cases.
“While this does not exclude some risk of severe disease after vaccination, given the relatively small number of severe cases, these results suggest very high efficacy,” he said.
Moderna reported no new side effects since their interim analysis, which showed that the most common side effects were fatigue, injection site redness and pain, headache, and body aches, which increased after the second dose and were short-lived. duration.
Zaks said the vaccine caused flu-like symptoms in some participants, which “goes hand in hand with having such a powerful vaccine.” But so far it hasn’t caused any significant security problems, 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 for adolescents in September, Zaks said.
Other vaccine manufacturers have said they are studying their vaccines in young people as well.
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