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Moderna Inc to apply for US and European emergency authorisation

Vaccine 94.1% effective based on full trial results and with no serious safety concerns
The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorisation this year following a shot developed by Pfizer and BioNTech which had a 95 per cent efficacy rate.
The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorisation this year following a shot developed by Pfizer and BioNTech which had a 95 per cent efficacy rate.
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Reuters   |   New York   |   Published 01.12.20, 02:05 AM

Moderna Inc will apply for US and European emergency authorisation for its Covid-19 vaccine on Monday after full results from a late-stage study showed it was 94.1 per cent 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 per cent 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 US emergency use authorisation this year following a shot developed by Pfizer and BioNTech which had a 95 per cent 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 per cent effective against severe cases.

Moderna shares opened 13 per cent higher at a record $144 following the results and then went on to hit a peak of $150.14, or a gain of 668 per cent 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 US 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 authorisation in the US and Europe, putting it about a week ahead of Moderna.

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.



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