On the heels of the preliminary success of one COVID-19 vaccine in the United States, another leading vaccine candidate is showing promise. Biotechnology firm Moderna announced Monday that a preliminary analysis shows its experimental coronavirus vaccine is nearly 95 percent effective at preventing illness, including severe cases — a striking initial result that raises the prospect that the United States could have two coronavirus vaccines available on a limited basis by the end of the year.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna CEO Stéphane Bancel said in a news release. The results are the “first clinical validation that our vaccine can prevent COVID-19 disease.”
Only last week, global pharmaceutical company Pfizer and German biotech company BioNTech announced that their coronavirus vaccine is more than 90 percent effective in preventing people from getting sick from the virus. If both vaccines continue to do well in clinical trials, the United States could soon have two coronavirus vaccines available for those most at risk.
Both Moderna and Pfizer plan to submit applications to the U.S. Food and Drug Administration in the coming weeks to allow emergency use of their vaccines.
The new Moderna results are based on an analysis of 95 coronavirus cases that have occurred so far during the company’s Phase III clinical trial of the vaccine. Researchers began counting who fell ill at least two weeks after participants received a second vaccine dose. Of the cases, 90 were in people who received a placebo and five were in the vaccinated group, making the vaccine 94.5 percent effective. The data are preliminary and have yet to be peer reviewed by other scientists.
The FDA recommends that COVID-19 vaccines have at least 50 percent efficacy, meaning a vaccine should reduce COVID-19 cases in vaccinated people compared with a placebo by half. Both Moderna and Pfizer’s clinical trials are ongoing so the final efficacy of the vaccines could change.
It’s unclear how well Moderna’s vaccine performs in different age or racial groups, though the results do include some older participants as well as people of different racial backgrounds. Of those who got sick, 15 of the 95 cases were in people older than 65. Another 20 cases were in Hispanic, Black, Asian or multiracial participants — groups that have been disproportionately hard-hit during the pandemic.
Importantly, the new results hint that the vaccine may prevent people from developing severe disease if they do get infected with the virus. In the clinical trial so far, 11 people have fallen severely ill, all of whom had received the placebo.
It’s encouraging to see early results that suggest that the vaccine can decrease disease severity, says Nina Luning Prak, an immunologist at the University of Pennsylvania. “That’s still a small number, but it’s 11 out of 11 versus zero on the other side.”
Moderna, based in Cambridge, Mass., and the U.S. National Institute of Allergy and Infectious Diseases in Bethesda, Md., worked together to develop the vaccine. Previous work showed that the vaccine sparks an immune response in people who receive it.
By October 22, 30,000 participants had been enrolled in the company’s late-stage clinical trial, though thousands of people still needed to receive both shots, which are given one month apart.
Previous studies have shown that the vaccine is safe. People in the trial have reported mild to moderate side effects after the second injection, including fatigue, joint pain and headache. There have not been any severe reactions. Moderna plans to follow participants for two years to more completely monitor the vaccine’s safety.
Both Moderna and Pfizer’s vaccines rely on messenger RNA, or mRNA, a genetic molecule that cellular machinery “reads” to build proteins inside cells. For these vaccines, the mRNA contains instructions for building the coronavirus’ spike protein, which helps the virus enter human cells.
The vaccines induce human cells to make the spike protein, and the immune system then makes antibodies to latch onto the spike proteins. Those vaccine-stimulated antibodies may prevent the real virus from infecting healthy cells in the future.
No vaccine using such mRNA technology has ever been used in people. If such vaccines prove successful, that could expedite the vaccine-making process. “That’s one of the strengths of the platform,” Luning Prak says. “Within a matter of essentially minutes, you could basically design a vaccine.” That’s because these vaccines don’t rely on laboratory-grown cells to produce millions of doses like other types of vaccines do. All researchers need is the genetic code for a particular viral protein, such as the spike protein. Although choosing the right protein out of many possibilities to generate the best immune response may still prove tricky, mRNA vaccines “clearly have promise,” she says.
Pfizer and BioNTech’s vaccine must be kept frozen at an ultracold –70° Celsius (–94° Fahrenheit), making its distribution potentially difficult. Moderna’s vaccine, however, can remain stable at refrigerated temperatures — between 2° to 8° C or 36° to 46° F — for 30 days, the company said in the Nov. 16 news release. That could help allocate COVID-19 vaccines in areas without easy access to dry ice or specialized freezers needed for Pfizer’s vaccine.