Moderna Inc became the second U.S company to release data from a large study of its experimental vaccine, saying it was 94.5% effective against COVID-19.
It will seek emergency use authorization from the U.S. Food and Drug Administration once ithas more safety data, expected later this month.
Its first analysis was based on 95 cases of COVID-19, 90 of which received a placebo with 5 receiving the vaccine. There were 11 severe cases in the placebo group and none among those that got the vaccine.
The 95 cases included 15 adults aged 65 or over, and 20 participants from diverse communities including 12 people who identified as Hispanic, 4 Black Americans, 3 Asian Americans and 1 person who was multiracial.
The results come one week after Pfizer Inc and German partner BioNTech SE said their experimental vaccine was more than 90% effective based on initial data.
Moderna, which went public in 2018, has received nearly $1 billion in research and development funding from the U.S. government and has a deal worth $1.5 billion to supply 100 million doses. The U.S. government has an option for another 400 million doses and Moderna also has supply deals with other countries.
Below are more details on Moderna’s vaccine:
– The experimental vaccine, called mRNA-1273, is based on messenger RNA (mRNA) technology,which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. Pfizer’s vaccine also uses mRNA technology.
– Other firms developing COVID-19 vaccines that use mRNA technology include Germany’s Curevac and U.S. biotech firm Arcturus Therapeutics Holdings Inc.
– An authorized, safe and effective mRNA vaccine for COVID-19 would be a first for the technology, which has previously not been used for an approved vaccine or drug.
REGULATORY AND PRODUCTION TIMELINE
– The United Kingdom’s health regulator started a real-time review of its experimental COVID-19 vaccine in October. The European Medicines Agency, Canada and Switzerland have also begun rolling reviews.
– Moderna expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021.
– The company was among the first to conduct COVID-19 vaccine human trials, starting in March and its late-stage 30,000 participant testing began on July 27 in the United States. It finished enrolling participants in October.
– The company slowed enrollment in September to increase the diversity of the trial population. It ultimately enrolled 3,000 Black American participants and more than 6,000 participants who are Hispanic.
– The vaccine candidate is being tested at about 89 clinical research sites in the United States.
– Moderna’s U.S. trial was the first under the government’s Operation Warp Speed program andis funded by Biomedical Advanced Research and Development Authority and National Institute ofAllergy and Infectious Diseases, part of the National Institutes of Health.
Here are details of how it could be distributed.
HOW COLD IS COLD STORAGE?
Moderna’s vaccine is stable for up to six months at a temperature of minus 20 degrees Celsius (-4 F), about home freezer levels, when shipped and stored.
The company said it expects the vaccine to be stable when kept at standard refrigerator temperatures of 2 to 8 degrees Celsius for 30 days, up from an initial projection of 7 days. The vaccine will be distributed in 10-dose vials and can be kept at room temperature for up to 12 hours after thawing.
By comparison, Pfizer’s vaccine can be transported and stored for up to 6 months at minus 70 degrees Celsius (-94 F). It can be stored at standard refrigerator temperatures for up to five days.
WHEN WILL IT BE SHIPPED, TO WHOM?
Moderna’s vaccine will be distributed by the U.S. government’s Operation Warp Speed program. U.S. health officials have said that at first they are most likely to distribute vaccines to healthcare workers, people who are in nursing homes, first responders and those with health conditions who are high-risk.
Most Americans will be inoculated in May or June, according to Dr. Anthony Fauci, the nation’s top infectious disease expert.
Under Operation Warp Speed’s distribution plan, the first group of shots will likely be distributed to and administered in closed settings, like hospitals and nursing homes.
After January, as supply increases, those shots will start to be available in pharmacies, doctors offices and clinics as well as mobile clinics, the plan shows.
Health officials have said it will be easier to use Moderna’s vaccine in these settings than Pfizer’s.
HOW WELL DOES THE MODERNA VACCINE WORK?
Moderna on Monday said its vaccine was 94.5% effective at preventing COVID-19 based on early results from large studies. That is similar to Pfizer’s which the U.S. drugmaker has said is more than 90% effective.
Moderna data also showed the vaccine was capable of helping prevent severe cases of COVID-19, and it represented volunteers from diverse communities.