National Post (National Edition)
Moderna to seek U.S., EU clearance for COVID-19 vaccine
Moderna Inc. plans to submit its COVID-19 shot for regulatory approval in the U.S. and the EU on Monday, making it the second western vaccine maker on track to start distribution in December.
The Boston-based biotech's new trial data showed its vaccine's efficacy rate was 94.1 per cent and there were no serious safety concerns.
Stéphane Bancel, Moderna chief executive, said the firm was “most excited” about the vaccine's ability to prevent severe disease. In the trial of 30,000, none of the participants who were vaccinated developed severe COVID-19.
“So 94 per cent of people we have no disease, no symptoms ... Those who get it will be very, very mild and so you will almost stop, if not entirely stop, hospitalization, and death,” he said.
Among participants who received a placebo, there were 30 cases of severe disease and one death. Moderna's trial included high proportions of ethnic minorities, the elderly, and those with underlying conditions, so the number of participants on the placebo who developed severe disease was three times higher than in the placebo arm of the Pfizer-BioNTech trial.
In addition to filing for approval in the U.S. and the EU, Moderna will send the same trial data to regulators where it is already under rolling review, including in the U.K., the company said.
The U.S. Food and Drug Administration's advisory group is likely to discuss the Moderna vaccine on Dec. 17, a week after the advisers analyze the vaccine from Pfizer and its German partner BioNTech.
In the U.K vaccines are regulated by the EU's European Medicines Agency until the end of the Brexit transition on Dec. 31. However, the U.K.'s Medicines and Healthcare products Regulatory Agency also has the power to authorize products temporarily in cases of urgent public need.
The U.K. is set to become the first western country to roll out a COVID-19 vaccine, with the first Pfizer-BioNTech shots expected to be given as early as Dec. 7.
Bancel said it was “highly possible” that another developed country would approve the Moderna vaccine before the U.S., suggesting the U.K. or Canada may be the first to issue an emergency approval.
But he said the U.S. was ahead in its ability to distribute an approved vaccine within 24 hours. In Europe, Moderna vaccines are being made in Switzerland and put into vials in Spain. The U.K. regulator would need to approve the vaccine before it leaves the Spanish factory.
“The U.S. has done extremely well. This has been months and months of preparation and planning,” he said. He added that others would still be able to move fast, just not as quickly. “I don't think the other countries are as ready.”
Following FDA guidelines, Moderna has tracked the average trial participant for at least two months to check for safety. There were no serious safety concerns, with side effects including joint and muscle pain, headaches and fatigue.
AstraZeneca and the University of Oxford's vaccine data confused experts last week with a large gap between the efficacy rates. In the largest group of participants, which took two doses, the efficacy rate was 62 per cent, but in the subset of people under 55 who were given one and a half doses, rather than two, the efficacy rate was 90 per cent.
Bancel said one advantage of the messengerRNA technique used by Moderna, as well as rivals Pfizer and BioNTech, was that there was “strong efficacy across the board,” compared with the adenovirus-based technology used by AstraZeneca and Oxford. “You don't have the same patient to patient variability,” he said.
Moderna rose 20 per cent in New York Monday to a record US$152.74. The shares are up more than sevenfold since the year began.