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Moderna to seek U.S. and EU authorization for its vaccine on Monday

Stock Markets Nov 30, 2020 10:40AM ET
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2/2 © Reuters. FILE PHOTO: FILE PHOTO: Vials and medical syringe are seen in front of Moderna logo in this illustration 2/2
 
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By Julie Steenhuysen and Michael Erman

(Reuters) - Moderna (NASDAQ:MRNA) Inc will apply for U.S. and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said.

Moderna also reported that its vaccine's efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The filing sets Moderna's product up to be the second vaccine likely to receive U.S. emergency use authorization this year following a shot developed by Pfizer (NYSE:PFE) and BioNTech which had a 95% efficacy rate.

"We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna Chief Medical Officer Tal Zaks said. "We expect to be playing a major part in turning around this pandemic."

Of the 196 people who contracted COVID-19 out of over 30,000 volunteers, 185 had received a placebo and 11 got the vaccine. Moderna reported 30 severe cases, all in the placebo group, which means the vaccine was 100% effective against severe cases.

Moderna shares opened 13% higher at a record $144 following the results and then went on to hit a peak of $150.14, or a gain of 668% so far this year.

"As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public," said Alexander Edwards, associate professor in biomedical technology at Britain's University of Reading.

In addition to filing its U.S. application, Moderna said it would seek conditional approval from the European Medicines Agency, which is already reviewing its data, and would continue to talk with other regulators doing similar rolling reviews.

"Although we await the 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 at Britain's Faculty of Pharmaceutical Medicine.

He expected Britain's Medicines and Healthcare products Regulatory Agency to approve the vaccine within two weeks.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

'JUST OVERWHELMING'

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in 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 both Moderna and Pfizer/BioNTech use a new technology called synthetic messenger RNA (mRNA) whereas others, such as Britain's AstraZeneca (NASDAQ:AZN), are using more traditional methods.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got 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 released on Nov. 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 of what it means for the pandemic that's raging around 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 proved more effective than anticipated and were far superior to the 50% benchmark set by the U.S. Food and Drug Administration (FDA).

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and come as new infections and COVID-19 hospitalizations are at record levels across 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 U.S. regulator. They will review Moderna's data a week later.

Soon after getting the green light, Moderna expects its vaccine to be shipped to distribution points across the United States by the government's Operation Warp Speed program and drug distributor McKesson Corp (NYSE:MCK).

The distribution is expected to be easier than Pfizer's because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer's vaccine.

CONSISTENT ACROSS AGE AND ETHNICITY

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one death related to COVID-19 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 being sick if you've been vaccinated are decreased 20-fold," said Moderna's Zaks.

Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday's details confirmed the vaccine was highly effective, including against severe cases.

"Whilst 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," she said.

Moderna reported no new side effects since its interim analysis, which showed the most common side effects were fatigue, injection site redness and pain, headache and body aches, which rose after the second dose and were short-lived.

Zaks said the vaccine caused significant flu-like symptoms in some participants which, "goes hand-in-hand with having such a potent vaccine." But it has not caused any significant safety concerns 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 early in 2021. It hopes to have the vaccine available for adolescents by September, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

Moderna to seek U.S. and EU authorization for its vaccine on Monday
 

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Comments (6)
Keval Gala
Keval Gala Nov 30, 2020 9:03AM ET
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what about russian vaccine ?? they supposed to claim it first and with best results right ?? just check the number of Corona cases per day in Russia it's above 25K per day.. Vaccine may or may not help to get rid of this Chinese Virus.. it's 50-50 chances.
me ish
me ish Nov 30, 2020 7:44AM ET
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by the time the vaccine is rolled out to the mainstream population in large quantities, most people will have already have been infected by the virus and therefore will have already developed a natural immunity to the virus. but I guess this vaccine will be great for those people who have been isolating as they have been concerned about getting very sick due to either very old age and/or other underlying comorbidity health conditions. I'm not really sure why anyone would want to take the vaccine if they've already had the virus  - I'd be very surprised if the body's natural immunity was less effective than what the vaccine can do for it.
Mike Dough
Mike Dough Nov 30, 2020 7:44AM ET
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Like an annual flu shot for later
Chester Are
Chester Are Nov 30, 2020 7:38AM ET
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wow, adolescents won't get it until September of next year.  Forget about going  back to school before summer!  This is disappointing for parents. Post
Joseph Smeir
Joseph Smeir Nov 30, 2020 7:35AM ET
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Every Monday we hear about the vaccine. Stop pumping the market
Matius Marvn
Matius Marvn Nov 30, 2020 7:31AM ET
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tanks all manipulate , RALLY continue 2021
Pratt Man
Pratt Man Nov 30, 2020 7:31AM ET
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What will it be in the real world without masks? The flu season is down 56% due to pep and social distancing, once that stops, how effective will the vaccine really be? My calculations have it about 65%
Yuge Profits
Yuge Profits Nov 30, 2020 7:31AM ET
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Amazing
 
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