Biotech firm Moderna Inc. (NASDAQ: MRNA) Monday reported initial results from a Phase 3 trial of its COVID-19 vaccine (mRNA-1273) that proved 94.5% effective in preventing the infection. This first interim analysis was based on 95 cases of the disease, of which 90 were observed in subjects who received the placebo and five were observed in the group receiving the mRNA-1273 vaccine.
The company also announced Monday that its vaccine remains stable for 30 days at refrigerated temperatures of 36° to 46°F (2° to 8°C), the temperature of a standard home or medical refrigerator. The vaccine remains stable at −4°F for up to six months and at room temperature for up to 12 hours. The Pfizer/BioNTech vaccine requires a refrigerated temperature of −94°F (−70°C) to maintain viability for six months.
The Moderna trial enrolled more than 30,000 participants and was overseen by a data safety monitoring board appointed by the National Institutes of Health. In addition to meeting its primary endpoint, the trial also analyzed 11 severe cases of COVID-19 and found that all had occurred in the placebo group and none in the vaccinated group.
The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or Latinx, four African Americans, three Asian Americans and one multiracial subject).
No significant safety concerns were reported and adverse events, according to Moderna, including injection site pain, fatigue and muscle pain, were generally short-lived. The company plans to request an emergency use authorization (EUA) from the U.S. Food and Drug Administration in the coming weeks, along with final safety and efficacy data with a median duration of at least two months. Applications for authorizations in other regions of the world also are planned.
Moderna expects to have at least 20 million doses of the vaccine prepared for distribution in the United States by the end of this year and said it remains on schedule to manufacture 500 million to 1 billion doses globally next year.
Moderna’s stock price jumped more than 13% in Monday’s premarket session to $101.10, above the 52-week range of $17.68 to $95.21. Shares were up more than 9% to $98.08 shortly after the open. The consensus price target on the stock is $94.79.
Dow Futures were up about 1.7% in the premarket, although Pfizer was down nearly 2%. The index was up about 1.3% after the open.