Moderna Inc will apply for US and European emergency authorization for its Covid-19 vaccine 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 US emergency use authorization this year following a shot developed by Pfizer 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.
“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 authorization in the United States and Europe, putting it about a week ahead of Moderna.
