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Moderna's headquarters in Cambridge, Mass.

Moderna on Monday submitted its Covid-19 vaccine to the US Food and Drug Administration for emergency use approval after the latest data showed it is 94% effective at preventing the disease, and 100% effective at preventing severe forms of the disease. The company reported that there were zero such COVID-19 cases among volunteers who were vaccinated, compared with 30 cases in the placebo group.

The Cambridge, Massachusetts-based biotechnology company is almost certain to have one of the first coronavirus vaccines cleared for use in the US, alongside similar vaccines from Pfizer and BioNTech, which were submitted earlier in November.


The FDA is expected to review the Moderna data at a public meeting on December 17, one week after it reviews Pfizer’s vaccine, according to Moderna’s CEO Stephane Bancel, who said in an interview, “We have been working nonstop in the last few weeks” to get the vaccine data ready for the FDA review.

According to Moderna, its latest data from the Phase 3 clinical trial, involving more than 30,000 volunteers, showed the vaccine is 100% effective at preventing severe Covid-19 cases, and 94% effective at preventing every case of the disease. The company claims that these results are consistent across several demographics, including age, sex, and ethnicity. It also said no serious safety issues are emanating from the new data, suggesting the side effects of the vaccine were pain as a result of the injection, headaches, and fatigue.

Moderna’s vaccine, like Pfizer’s and BioNTech’s, utilizes a new technology that shoots the recipient with messenger RNA to code for a protein called spike that studs the surface of the coronavirus. But Moderna may have the edge over its competitors because of its reported advantage in the storage it requires.

Moderna’s vaccine remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days, and at room temperature for up to 12 hours. In comparison, Pfizer’s coronavirus vaccine must be stored at the super-cold temperature of -70°C, which means that buyers of the Pfizer vaccines, such as the State of Israel (which also plans to procure Moderna’s product) will have to construct specialized freezers that may cost as much as $20,000 each, and are not commonly found outside research facilities.

To support the distribution of its vaccine, once its production is approved, Pfizer was forced to develop a shipping container that maintains the -70° C temperature for up to 10 days unopened but must be regularly refilled with dry ice to maintain the same temperature for 30 days. And there, experts say, lies a heap of trouble, because once you opened the container to put in new dry ice, a whole lot of unpredicted things can happen.


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David writes news at