Only a week after Pfizer did, the American company Moderna has announced that, in the first data of its clinical trials, its vaccine against the coronavirus allows an efficiency of 94.5% against disease. In addition, through a statement, he has ensured that his vaccine can be stored in a normal freezer.
The phase 3 studies have had more than 30,000 participants and the result is based on the analysis of confirmed COVID-19 cases as of two weeks after the second dose of vaccine. This first analysis was based on 95 cases divided into two groups: 90 cases of coronavirus were observed from the first placebo group, while only 5 cases were observed in the other group treated with the vaccine. So the efficiency is 94.5%.
A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases in this first interim analysis. All 11 cases occurred in the placebo group and none in the vaccinated group.
The 95 cases of COVID-19 included 15 older adults (over 65 years of age) and 20 participants who identified as belonging to diverse communities (including 12 Latino, 4 African American, 3 Asian American, and 1 multiracial).
Preliminary analysis suggests a safety profile and broadly consistent efficacy across all subgroups evaluated.
Moderna’s Executive Director, Stéphane Bancel, explained that “since the beginning of January” they have “pursued this virus with the intention of protect as many as possible of people all over the world. “This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” he adds.
“This milestone is only possible thanks to the hard work and sacrifices of many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. We remain committed and focused on doing our part to help end the COVID-19 pandemic, “he defended.
Based on these interim safety and efficacy data, Moderna intends to apply for an Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates that the EUA will be informed of the final safety and efficacy data. Moderna also plans to submit requests for authorizations to global regulatory agencies.
By the end of 2020, the company expects to have approximately 20 million doses your vaccine lists. Moderna will remain on track to manufacture 500 million to 1 billion doses globally in 2021.
Along with Pfizer’s vaccine, which has also been shown to be over 90% effective, and pending further safety data and regulatory review, the United States could have two vaccines licensed for emergency use in December with up to 60 million doses of vaccine available by the end of the year.
Stored in a freezer
Moderna’s vaccine stable at 2 ° to 8 ° C, the temperature of a standard household or medical refrigerator, for 30 days. According to the company, it also remains stable at -20 ° C for up to six months, in refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.
This data is completely different from that of Pfizer. Their vaccine, which was 90% effective, has a major obstacle to its worldwide distribution: it has to be kept at a temperature below -70º C. For this, they are used some special refrigerators with ice dry with capacity for up to 975 vials. But it is an expensive method. In the case of Moderna, a normal refrigerator is enough. These are its characteristics:
Long-term shipping and storage: For shipping and long-term storage Moderna expects the vaccine to be kept at -20 ° C, equal to most household or medical freezer temperatures, for up to 6 months. It is an easy storage and distribution method as most pharmaceutical distribution companies have the capacity to store and ship products at -20 ° C all over the world.
Refrigerated storage: After thawing, to facilitate storage at administration sites, Moderna expects the vaccine to remain stable under standard refrigerated conditions of 2 ° to 8 ° C for up to 30 days within the 6-month shelf life.
Room temperature for vaccination: Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature for up to 12 hours.
No dilution required at the vaccination site– The vaccine will not require on-site dilution or special handling, facilitating vaccination in a variety of settings, including pharmacies and doctor’s offices.