Moderna's COVID-19 Vaccine Shines In Clinical Trial

Nov 16, 2020
Originally published on November 16, 2020 7:21 am

A second COVID-19 vaccine now also appears highly effective in preventing illness following exposure to the virus that causes the disease.

The biotech company Moderna Inc. said Monday that its experimental vaccine was 94.5% effective in preventing disease, according to an analysis of its clinical trial.

The news comes a week after Pfizer and BioNTech said their vaccine was more than 90% effective.

The results for both vaccines come from interim analyses of large clinical studies. In the Moderna study there were 30,000 volunteers. Half got two doses of the vaccine 28 days apart; half got two shots of a placebo on the same schedule.

There were 95 instances of COVID-19 illness among the study participants; only five of those cases were in the vaccinated group. Ninety were in the group receiving the placebo. Of these, there were 11 cases of severe disease. The results indicate the vaccine was inducing the kind of immune response that protects people if they were exposed to the coronavirus.

"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," St├ęphane Bancel, chief executive officer of Moderna, said in a statement.

Both the Moderna and Pfizer vaccines use the same technology to make their vaccines. It's based on a molecule known as mRNA, or messenger RNA. That molecule contains genetic instructions for making proteins inside cells.

For the vaccine, researchers created an mRNA with the code for making the coronavirus spike protein. The protein is the key to the virus infecting cells. It's also what can trigger someone's immune system to make antibodies against the virus, but without causing infection since the rest of the virus is missing.

That two mRNA vaccines appear to be working is remarkable, since the technology is new and there hasn't been an mRNA vaccine approved by the Food and Drug Administration made to date.

The Moderna and Pfizer studies were conducted using slightly different protocols. To be counted as a COVID-19 case, participants in the Moderna study had to have at least two symptoms of disease in addition to a positive test for the virus. The Pfizer study required only one symptom. Also, Moderna waited 14 days following the second injection to begin counting cases; Pfizer's study started counting at seven days.

The vaccines also differ in their storage requirements. Moderna says its vaccine can be safely stored in freezers at about 25 degrees Fahrenheit (minus 4 degrees Celsius), a temperature easily reached by a home refrigerator freezer. Pfizer's vaccine required storage in specialized ultracold freezers capable of cooling below minus 94 degrees Fahrenheit (minus 70 degrees Celsius). Moderna also says its vaccine will remain potent for up to 30 days at normal refrigerated temperatures, which should ease distribution.

Both companies' vaccine studies managed to recruit a reasonably diverse group of people. Moderna reports 6,000 enrollees who identified as Hispanic or Latinx and more than 3,000 participants who identified as Black or African American, as well as 7,000 people older than 65, and 5,000 with high-risk chronic diseases.

Pfizer and Moderna are still gathering safety data the Food and Drug Administration has said is necessary for consideration of an emergency use authorization that would allow the companies to distribute the vaccine during the pandemic.

Side effects seen for the Moderna vaccine at the interim analysis included pain at the injection site, fatigue and aching muscles and joints. The data safety and monitoring board didn't identify "any significant safety concerns."

Moderna said it intends to file "in the coming weeks" with the FDA for authorization of the company's vaccine for emergency use.

The federal Operation Warp Speed project to hasten development of COVID-19 vaccines awarded Moderna a $1.5 billion contract in August to ramp up manufacturing and deliver 100 million vaccine doses, enough for 50 million people. The government has an option to buy up to 400 million more doses.

Moderna said Monday that it expects to be able to ship about 20 million vaccine doses in the U.S. by the end of 2020. Next year, the company said it expects to be able to make 500 million to 1 billion doses worldwide.

The research and development of the Moderna vaccine was aided by $955 million in federal funding from the Biomedical Advanced Research and Development Authority. Moderna has also been developing this vaccine alongside the National Institute for Allergy and Infectious Diseases, which in July told NPR it expects to spend about $410 million on the effort.

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I'm Steve Inskeep with news of a second coronavirus vaccine. We started last week with Pfizer's assertion that early testing showed its vaccine is 90% effective. A new week, new vaccine - today the biotech company Moderna says its experimental vaccine is nearly 95% effective. NPR's Joe Palca is with us to evaluate this. Hi there, Joe.

JOE PALCA, BYLINE: Morning, Steve.

INSKEEP: Is that as good as it sounds?

PALCA: Yeah, I think so. It's very good, especially considering the Food and Drug Administration was prepared to consider greenlighting a vaccine with only 50% efficacy. So scientists who've seen these results so far are impressed.

INSKEEP: How did Moderna determine that it worked so well?

PALCA: Well, it was a big study of 30,000 volunteers. They came from a variety of ethnic backgrounds - 6,000 self-identified as Latinx or Hispanic, 3,000 self-identified as Black or African American. Half got two injections of the vaccine. Half got two injections of an inert placebo. And in order to see if the vaccine works, you have to wait until people get exposed to the virus. Moderna chief medical officer Tal Zaks says that wasn't a problem.

TAL ZAKS: Unfortunately, cases are occurring at high rates in this country. And the paradox of that is that it enables rapid vaccine development because you're able to quickly demonstrate whether the vaccine works or not. And as we've shown today, ours certainly seems to work very well.

PALCA: So there were a total of 95 people who got sick. Ninety were in the placebo group, compared with only five in the vaccinated group. So the vaccine appeared to be working, and it didn't seem to cause any serious side effects.

INSKEEP: Disturbing at the same time that it's hopeful, that we have the right environment for testing a vaccine for that reason.

PALCA: Yeah, exactly.

INSKEEP: Now, Pfizer, we mentioned, had this vaccine that needs to be stored in ultracold freezers, which raised questions about how you practically get that across the country. Is Moderna's vaccine any better in that respect?

PALCA: Yes, it seems to be. I mean, they've done some testing. And they also put out a release today saying that their vaccine was stable for 30 days at what you would consider a normal refrigerator-freezer temperature, about - well, it's about minus-20 centigrade or minus-4 Fahrenheit. And it also stayed stable - I'm sorry. It stayed stable for six months at that temperature and 30 days at normal refrigerator temperatures. So that makes life a lot easier.

INSKEEP: Well, what comes next, then?

PALCA: Well, what comes next is in the next few weeks, the company will consider applying for what's called an EUA, an emergency use authorization. And that means that, under the circumstances, because we're in a pandemic emergency, they can go ahead and give the vaccine out more widely. They have to wait a little longer to get safety data. They're waiting to see if the vaccine actually causes any problems itself. And they want to wait at least two months, until half the volunteers have completed their full vaccine dosage. So it's still a couple days for that to happen and then a couple days for this - or couple weeks, maybe, to get this application together to the Food and Drug Administration. And then the FDA has to go ahead and make its decision about whether to give some sort of authorization, this emergency use authorization.

INSKEEP: Yeah, this process that can take years is being crunched down to weeks, months, even days. But I guess the FDA still has the basic questions - is it safe? Is it effective?

PALCA: Right. And the thing is - people have said, well, are we cutting corners or rushing this to the market? And the answer seems to be no because it's just the process, which is normally, I'll get back to you some time, has been shortened to be, let's do this right away and as fast as we can.

INSKEEP: NPR's Joe Palca, thanks.

PALCA: You're welcome. Transcript provided by NPR, Copyright NPR.