Based on interim data from a late-stage clinical trial, US drugmaker Moderna said its experimental vaccine was 94.5 percent successful in preventing COVID-19, becoming the country’s second company in a week to announce results far beyond expectations.
Together with Pfizer’s vaccine, also shown to be more than 90 percent efficient, and pending more safety data and regulatory review, the United States could have two vaccines authorized for emergency use in December with as many as 60 million doses of vaccine available by the year’s end.
The US government could have access to more than 1 billion doses next year, from the two vaccine developers alone which is more than what the country’s 330 million residents will need.
The vaccines, both developed using modern technologies known as messenger RNA or mRNA, are effective new tools for battling a pandemic that has infected and killed 1.3 million people worldwide. The news also comes at a time when cases of COVID-19 are soaring, hitting new peaks in the US and forcing back lockdowns in some European countries.
The interim review of Moderna was based on 95 infections among participants in the trial who received either a placebo (a substance or treatment which is designed to have no therapeutic value) or the vaccine. Out of these, only five infections occurred in those who received the vaccine, which is given 28 days apart as two shots.
Moderna’s advantage over Pfizer-BioNTech vaccine
The main benefit of Moderna’s vaccine is that unlike Pfizer’s, it does not require ultra-cold storage, making it easier to administer. Moderna expects the vaccine to be stable for 30 days at normal refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48°F) and can be stored at -20 degrees Celsius for up to 6 months.
The Pfizer vaccine must be shipped and stored at a temperature of minus 70 degrees Celsius which is similar to an Antarctic winter. It can be stored for up to five days at normal refrigerator temperatures.
Effective against severe COVID-19 cases
The results from Moderna’s 30,000 participant-strong study also indicated that the vaccine prevented severe cases of COVID-19, a problem that remains with the Pfizer vaccine. Out of the 95 infected cases in Moderna’s trial, 11 were severe and all 11 occurred among volunteers who got the placebo.
Moderna, part of the Operation Warp Speed program of the US government, expects to produce about 20 million doses of the vaccine for the United States this year, millions of which the company has already produced and is ready to ship if it receives authorization from the FDA (Food and Drug Administration).
The 95 infected cases of COVID-19 involved many key populations at increased risk of severe disease, including 15 cases in adults 65 years of age and older, and 20 cases in racially diverse groups.
The majority of side effects have been mild to moderate. However, after taking the second dose, a large number of volunteers reported more intense aches and pains, including about 10 percent who had fatigue severe enough to interfere with everyday activities, while another 9 percent had severe body aches. The company said most of these complaints were usually short-lived.
The data from Moderna further validate the promising but previously untested mRNA platform, which transforms the human body into a vaccine factory by coaxing cells to generate certain virus proteins that the immune system sees as a threat and mounts a response to.
What happens next?
In the next week or so, Moderna expects to have adequate safety data needed for US authorization and the company plans to apply for authorization for emergency use in the coming weeks.
Moderna has secured almost $1 billion from the US government in research and development grants and has a $1.5 billion deal for 100 million doses.
By 2021, the company plans to have between 500 million and 1 billion doses, divided between its US and international production sites. Production will be partially dependent on demand, the company said.
The US government has said COVID-19 vaccines will be provided free to Americans, whether they have health insurance, are uninsured or are covered by government health programs such as Medicare.
Moderna has also stated that it would use its data in order to obtain approval in Europe and other regions.
Other countries such as China and Russia have already begun vaccinations. Russia licensed its “Sputnik-V” COVID-19 vaccine for domestic use in August before it released data from large-scale trials. It said on November 11 that its vaccine was 92 percent effective based on 20 infections in its large trial.