12/18/2020

Moderna’s COVID-19 Vaccine May Soon Be Approved In The U.S.

11:47 minutes

a hand holding up a syringe with the word 'moderna' in the background
Credit: Shutterstock

This story is part of Science Friday’s coverage on the novel coronavirus, the agent of the disease COVID-19. Listen to experts discuss the spread, outbreak response, and treatment.


As the national rollout of the Pfizer/BioNTec vaccine began this week, Moderna’s own formula looks ready to add to the options for the nation’s healthcare workers and high-priority patients, at least according to a panel tasked with deciding whether the benefits outweigh the risks. On Thursday, the FDA’s independent advisory committee voted 20-0, with one abstention, to recommend the vaccine for emergency use. Now, the FDA itself must decide whether to follow through, a decision that is expected to come in the next few days.

Vox staff writer Umair Irfan talks about the similarities and differences between Moderna and Pfizer’s vaccine, what we’re learning about side effects for both injections, and the concerns about COVID-19 transmission to animals. Plus, why researchers say President-elect Biden’s goal for net-zero carbon emissions will require drastic, but feasible changes to how the nation operates. And how to view Monday’s conjunction of Saturn and Jupiter—a phenomenon theorized to be the explanation for the biblical Star of Bethlehem. 

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Segment Guests

Umair Irfan

Umair Irfan is a staff writer for Vox, based in Washington, DC.

Segment Transcript

IRA FLATOW: This is Science Friday. I’m Ira Flatow. A bit later in the hour, we’ll talk about how looking back millions of years into the Earth’s climate history can help us better predict climate change. This week the first people in the US received Pfizer’s COVID-19 vaccine just days after the FDA cleared the vaccine for an emergency use authorization, as we discussed on our show last week.

The CDC has advised the first available vaccines. That’s a stock of 6 and 1/2 million doses. It should go to health care workers and residents of long-term care homes first. And we’ve seen that happen this week.

But for millions of people in those groups who would not be covered by the initial vaccine stock from Pfizer, reinforcements may soon be on the way. An independent advisory committee just yesterday voted to recommend Moderna’s mRNA vaccine for a similar emergency use authorization, which usually is the green light for FDA approval. Here to explain more on the story plus other news from the week is Umair Irfan, staff writer at Vox. Welcome Umair.

UMAIR IRFAN: Hi, Ira. Thanks for having me.

IRA FLATOW: Let’s get into this. In an independent advisory committee for the FDA says Moderna’s vaccine is ready for emergency use. We already went through this with Pfizer’s vaccine last week. Does this mean, we’ll see Moderna’s doses shipping out pretty soon?

UMAIR IRFAN: I think that’s pretty likely. I mean, if we use the Pfizer vaccine as an example, the FDA issued its final emergency use authorization about a day after the committee voted in favor. And then a couple days later, the vaccine began rolling out. And so I expect we’ll see something quite similar here.

IRA FLATOW: And so there’s not much likelihood that the FDA would not go forward on this?

UMAIR IRFAN: It’s unlikely. I mean, the vote here was actually even more in favor of this. It was 20 to 0 with the committee. Whereas last week’s vote was 17 to 1. So that’s a pretty solid green light. But there are a few distinctions here between this and the Pfizer vaccine.

The Moderna vaccine for instances has been authorized for people over the age of 18. Whereas the Pfizer vaccine was over the age of 16. And this vaccine also has some less stringent cold storage requirements. The Pfizer-BioNTech vaccine requires storage on dry ice at temperatures of roughly minus 70 degrees Celsius. While the Moderna vaccine can be stored at ordinary freezer temperatures. And so that should ease some of the supply chain restrictions that the other vaccines were facing.

IRA FLATOW: You know, there was some talk this week about Moderna’s vaccine being effective after just one dose. Does that mean we have more vaccine available?

UMAIR IRFAN: Well, yes, the data did show that the vaccine started to kick in quite effectively in it’s protection after the first dose. But the Food and Drug Administration is very careful in its protocol. And that one-dose protocol was not assessed. And right now it’s very unlikely that they will approve this on a one-dose regimen. They’re probably going to stick to the two doses for now. Because that was what was tested and that was what was researched.

IRA FLATOW: Also talk about this vaccine protecting against asymptomatic spread.

UMAIR IRFAN: Yeah, that’s right, I mean, we know, for instance, that this vaccine and the other vaccines are very effective against preventing disease where people actually start to get sick and start to have symptoms. But here you know we know with COVID-19 that a lot of people who don’t show symptoms at all can still spread the disease.

And the Moderna trial actually did some screening and testing to find out how those asymptomatic spreaders were being affected. And they saw that there was, in fact, a decline. And so this is a really good sign for ending the pandemic. And for reducing transmission with this vaccine.

IRA FLATOW: There was also some puzzling news that Pfizer announced in a press release that they have millions of doses just sitting in their warehouses with no instructions from the White House where to ship them.

UMAIR IRFAN: Yeah, that’s right. It’s showing some of the hiccups in the supply chain here. You know, several state officials have reported that their allocations for this vaccine were cut. And yet at the same time, the manufacturers were saying that they have a bunch of doses that are still unclaimed. And so, it’s showing that there’s a little bit of a miscommunication here that hopefully will get resolved pretty soon.

On the other hand, you may have also seen the news that some pharmacists reported that the vials for the Pfizer-BioNTech vaccine actually had more doses than they realized. And the FDA has approved those extra doses to be used if pharmacies can actually scrounge them up.

IRA FLATOW: Interesting. Also speaking of Pfizer, we also need to mention that a few people have had some extremely adverse reactions in the process. I’m talking about two health care workers in Alaska, two people in the UK. Is that something we should be worried about?

UMAIR IRFAN: That is something to be concerned about because people with severe allergies were actually excluded from the phase III clinical trial pools. And they have their own discretion. If they’re eligible to get the vaccine or whether or not to get them. And right now regulators in both the UK and the US are basically saying that if you have a history of anaphylaxis or very severe allergic reactions, you probably shouldn’t be getting these vaccines right now.

But there are also other side effects to be concerned about as well. You know, the Moderna data that was released this week showed that about 16% of trial participants experienced a severe adverse reaction, which was defined as something that requires medical attention or prevents people from going about their lives. These are things like pain, swelling, headache and fever. But they tend to be a little bit more intense with these vaccines than with other vaccines. One doctor suggested that if you are going to get one of these shots, you may want to schedule the day off of work.

IRA FLATOW: So it’s not like the anaphylactic reaction you were talking about before.

UMAIR IRFAN: Right, these are not super severe reactions. But health officials want people to be aware of this. Part of how we build trust with vaccines is to make sure people are not surprised by what happens here. And since these are two-dose vaccines, we want people to come back for the second dose. So if people do experience some mild to moderate side effects, we want to ensure them that these are normal. They’re within the normal parameters and that you should still come back and finish your course of this vaccine.

IRA FLATOW: Let’s move on to the news on the animal front. I’m speaking about a mink in Utah testing positive this week.

UMAIR IRFAN: Yeah, that’s right. That follows the news that in Denmark they called about 17 million minks due to COVID infection risk. And now there’s one mink, a wild one in Utah that tested positive for this virus. And we’ve seen already several instances of other animals being infected with this virus, cats, dogs, lions, tigers. You may remember earlier in the pandemic, there were Tigers at the Bronx Zoo that got sick. And they had a cough with this virus.

And this is more than just a novelty. I mean, it’s kind of concerning because one, you don’t want another reservoir for this disease. If another animal can start transmitting this virus to other animals, then that increases the likelihood of a mutation that could potentially bounce back to us.

But the other concern is also for animals like endangered species, like mountain gorillas in these wildlife preserves in Africa. Workers there are actually taking COVID precautions to ensure that those animals don’t get infected because their respiratory systems are very similar to ours. And there’s only a few hundred of these gorillas left in many of these reserves. And so they’re taking extra care to make sure that they don’t get sick with these diseases.

IRA FLATOW: Is there anything we can learn about the virus when it shows up in these animals.

UMAIR IRFAN: It could shed some light on how the virus made the jump from animals to humans in the first place. And so we’re trying to see, what are the modes of transmission? What kinds of animals are most vulnerable? And what happens when they start transmitting it to each other? And that could potentially help us get ahead of the next pandemic as well.

IRA FLATOW: All right, let’s look at some other news this week that did not get so much attention. President-elect Biden had his electoral college win certified. And there’s a new report out of Princeton University on his ambitious goal of getting us to net zero carbon emissions by the year 2050. And that report says it’s pretty feasible if we set our minds to it.

UMAIR IRFAN: Yeah, it does. I mean this is a report by researchers at Princeton University. As you noted, they examined the pathways to get to net zero greenhouse gas emissions in the US economy by 2050. And they said that there are multiple strategies that you could use, anything from going to 100% renewable energy to keeping fossil fuels with carbon and capture and storage, and also the infrastructure that would be needed.

Now, they said that a lot of the technology is already there. And that many of these changes are already underway. But we would need a lot of drastic changes in the near future as well, things like shutting down all coal power plants by roughly 2030. And by 2030 half of all new cars would have to be electric. We would need new high voltage transmission systems and even pipelines to move captured carbon dioxide around the country.

But one of the things they also found was that this would cost about $2.3 trillion over the next 10 years, which is roughly in the same ballpark as what we would be spending anyway in terms of our energy infrastructure. And so they’re saying that we’re going to be spending this money anyway, let’s do so thoughtfully in a way that actually helps us meet our climate change ambitions.

IRA FLATOW: And as far as Biden’s chances of making good on his pledge, his team also announced several new key appointments this week who might be influential in getting us there. I’m speaking about yesterday, New Mexico representative Deb Haaland was picked for interior. She’s both the first Native American tapped for the job. And a big opponent of oil drilling in the Arctic Wildlife Refuge. Good news for the climate goals.

UMAIR IRFAN: Right, yeah, you know, as they say in DC, the personnel is policy. And yes, representative Deb Haaland, a member of the Laguna Pueblo has a track record of opposing mining and drilling on public lands. The Interior Department is kind of overlooked as an environmental agency.

But it has jurisdiction over 20% of land in the US. And those lands produce about 1/5 of the country’s greenhouse gas emissions. There’s a lot of mining and drilling. But she has a track record of opposing a lot of that and supporting Native American rights. And so it’s very likely that that will be something that will shake out in the future if she takes over this department.

IRA FLATOW: Plus we have the other picks this week of Michael Regan for EPA and Gina McCarthy.

UMAIR IRFAN: Yeah, that’s right. Michael Regan is the head of North Carolina’s department of Environmental Quality and Gina McCarthy herself was the former head of the EPA and she was brought on board to be a climate advisor. And former Michigan Governor Jennifer Granholm was also selected to lead the Department of Energy.

IRA FLATOW: That’s really interesting picks. One last story close to my heart urging us to get outside and take a look at the skies, the great conjunction of Jupiter and Saturn. If you’ve been watching all week, they’ve been moving closer and closer together in the sky. And they have their finale, the big night is Monday night.

UMAIR IRFAN: Yeah, that’s right. These are the two largest planets in our solar system. And from our vantage point they will be the closest they’ve been in 400 years. And for the first time in 800 years, this will actually happen at night where we can easily see them. You don’t need a telescope or even binoculars to see them in the sky.

Both planets are moving eastward with respect to the stars. And Saturn will initially be in the lead. And you can actually start seeing those planets moving closer together this weekend if you want to start warming up and figuring out where to stake out your cameras to take photos of this. The planets will be easy to see with the unaided eye if you looked in the southwestern sky.

This is happening also on the same night as the winter solstice. This is sort of a coincidence. But it’s an auspicious day for astronomical phenomena.

IRA FLATOW: Speaking of coincidences, this is sort of a theorized phenomenon that may have resulted in the Christmas star in the biblical reference.

UMAIR IRFAN: Yeah, that’s right. You know, there are multiple explanations that are out there. But the timing roughly works here that this may have been this alignment that might have led to the star of Bethlehem or the Christmas star that appeared about 2000 years ago.

IRA FLATOW: Great news, Umair. Thanks for taking time to be with us today.

UMAIR IRFAN: Glad to be here, Ira. Umair Irfan is staff writer for Vox. He joined us from Washington.

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