The biotech company Moderna released new data Monday morning that strengthens the case for its COVID-19 vaccine. It concludes the vaccine is 94% effective — and strongly protects against serious illness. Based on these latest findings, the company plans to submit an application for emergency use authorization to the Food and Drug Administration today.
They build on Moderna's previously reported findings, based on a smaller number of cases detected in its study of about 30,000 volunteers.
Overall, the study identified 185 cases in the people who received a placebo shot, compared with 11 cases in people who got the active vaccine. These latest findings are similar to results from Pfizer, which has developed a similar vaccine. And, like the Pfizer vaccine, this one seems to prevent severe cases.
"There were 30 cases on placebo and zero cases that were on the vaccine," says Dr. Stephen Hoge, the president of Moderna. "So, it looks like in the trial we've been 100% effective at preventing severe COVID-19, which is really what's driving the burden of disease in hospitals and ultimately straining our public health systems."
Based on those findings — and an analysis of the vaccine's safety and side effects — Moderna has decided it has enough information to submit an application to the FDA. The agency will consider granting emergency use authorization for the product in the coming weeks.
"They will receive a good stack of paper," Hoge says, "but they've been receiving paper almost continuously from when we started."
Pfizer applied for emergency use authorization on Nov. 9 for its COVID-19 vaccine. The FDA will hold its advisory committee to discuss that application on Dec. 10. That meeting is open to the public.
The FDA's charge is to assure that drugs are both safe and effective, and the agency says it is not cutting corners when it comes to COVID-19 vaccines, which will potentially be given to many millions of healthy people.
"They still have an important and solemn responsibility to review that data and develop an independent perspective on it," Hoge says, "and that's not an easy thing to do on a short time horizon."
Moderna expects that on Dec. 17, the FDA will be ready for a public meeting to discuss this data. A vaccine could get the thumbs-up shortly thereafter. Either or both the Pfizer and Moderna vaccines may start to become available in mid to late December, though supplies will be limited.
Both use the same novel technology. Instead of injecting a weakened or dead virus, which is a common strategy for vaccines, these products are essentially small pieces of genetic material. When that's injected into a person's arm, it's picked up by cells in the immune system. The cells read the genetic code and use that to produce a protein that is actually a key fragment of the coronavirus. The body then builds antibodies that latch onto that fragment, so if and when someone encounters the actual coronavirus, the body is primed to fight it off with antibodies.
Though the key action is happening at a cellular level, inoculation can trigger noticeable symptoms, ranging from a sore arm to achiness, or even fever and flu-like symptoms.
Dr. Carlos del Rio, a vaccine scientist at Emory University in Atlanta, was involved in testing the Moderna vaccine. The symptoms he saw were quite similar to symptoms people get when they get the shingles vaccine. For many, the shingles vaccine creates a strong reaction.
"You feel terrible for a day or two but then you're fine," del Rio says.
That's the price of getting a vaccine that protects you, in the case of COVID-19, from a potentially deadly disease. But del Rio says it is a complication in administering the vaccine, because people who get these symptoms after a shot might think the vaccine actually gave them COVID-19.
"We're going to have to do very good messaging to explain to people this is not COVID, it's a side effect of the vaccine and it's OK to have it," del Rio says. "It actually means the vaccine is working."
The vaccine studies have been designed to show whether a shot prevents someone from falling ill. But scientists don't yet know whether people who are vaccinated can still get infected but remain without symptoms. That's important because if a vaccine can prevent even silent infections, it can further reduce the spread of the pandemic.
Hoge said the company is collecting data to look for those silent infections among vaccinated volunteers, but that information won't be in hand until early next year. So, it's possible that some people who are vaccinated can still spread the virus.
"That's why I tell people when you get vaccinated, continue wearing your mask," del Rio says. "We're going to know later if the vaccine actually prevents infection."
He says it's remarkable how quickly all this has come together — less than a year from the time the novel coronavirus was first identified, to now, apparently on the verge of having tens of millions of doses of vaccine ready to go.
"A vaccine that prevents people from getting, sick, especially from getting critically ill? It's a great vaccine right now," del Rio says. With nearly 2,000 deaths per day, "My God, we really need this vaccine."
You can contact NPR Science Correspondent Richard Harris at firstname.lastname@example.org.
RACHEL MARTIN, HOST:
Mondays seem to be the day we end up getting good news on vaccines. A couple weeks ago, the biotechnology company Moderna announced early results from the study of its experimental vaccine. And today, they're announcing fuller results, which concludes that their vaccine is 94% effective. We've got NPR's science correspondent Richard Harris with us this morning. Hi, Richard.
RICHARD HARRIS, BYLINE: Good morning.
MARTIN: Good morning. So some good news. What makes today's news, though, different from what we already heard?
HARRIS: Yeah. Well, it's a little hard to keep track, but Moderna had previously released analysis of some early results from its study. Now it has a lot more data from a study of 30,000 people, half of whom got the vaccine and half of whom got a placebo. They announced this morning that the vaccine was 94% percent effective in protecting people from COVID-19. Dr. Stephen Hoge, who's the president of Moderna, says the news is even better when it comes to severe cases.
STEPHEN HOGE: There were 30 cases on placebo and zero cases that were on the vaccine. So it looks like in the trial, we've been 100% effective at preventing severe COVID-19, which is really what's driving the burden of disease in hospitals and ultimately straining our public health systems.
MARTIN: OK, so a fuller picture of the effectiveness of this vaccine. So what happens now?
HARRIS: Well, Moderna has also collected a lot of data about safety and side effects. And the company says that information is encouraging as well. So they say today, they will submit an application for emergency use authorization to the FDA. Here's Dr. Hoge again.
HOGE: They will get a good stack of paper, but they've been receiving paper almost continuously from when we started. They still have an important, solemn responsibility to review that data and develop an independent perspective on it. And that's not an easy piece of work to do on a short time horizon.
HARRIS: But Moderna expects that in a little more than two weeks, the FDA will be ready for a public meeting to discuss this data. And a vaccine could get the thumbs up shortly thereafter, presuming it passes, of course. Now, either this vaccine or the Pfizer vaccine, which is very similar, could become available in mid to late December.
MARTIN: Wow. So assuming the FDA does its review of this Moderna vaccine, decides that these vaccines are safe and effective, what's it going to be like to get one of these shots, whether it's the Moderna one or the Pfizer one or any other clinical trial that makes it through?
HARRIS: Yeah. Well, both have side effects like soreness and achy arm, some fever and even some flu-like symptoms. I talked to Dr. Carlos del Rio at Emory University, which is one of the many sites that tested out the Moderna vaccine. And he said the side effects were - that he saw, they were very similar to those that come with the shingles vaccine, which is to say not much fun.
CARLOS DEL RIO: The side effects are not very dissimilar. You feel terrible for a day or two, but then you're fine, right?
HARRIS: But that's the price of getting a vaccine that protects you in the case of COVID from a potentially deadly disease. But, you know, del Rio says it's a complication in administering the vaccine because people who get these symptoms might think the vaccine has actually given them COVID-19.
DEL RIO: We're going to have to do very good messaging to explain to people that this is not COVID. This is a side effect of the vaccine and it's OK to have it. It actually means that the vaccine is working.
MARTIN: So judging by the reports from the Moderna and the Pfizer studies, it looks like someone who is vaccinated is unlikely to get COVID. Does that mean that they won't spread the infection, Richard?
HARRIS: Yeah, well, that's an important question, and there is no answer as yet. Moderna says so far it's been focusing on people who have symptoms of COVID-19, and it will take some months to figure out whether people who got the vaccine may also have gotten infected, but they just don't have symptoms. So Carlos del Rio at Emory says it's possible that - that's something that needs to be straightened out.
MARTIN: All right. NPR science correspondent Richard Harris, thank you.
HARRIS: Anytime. Transcript provided by NPR, Copyright NPR.