FDA confirms Johnson & Johnson's COVID-19 vaccine works well

An FDA review released today confirmes the single-dose Johnson & Johnson vaccine is both safe and effective against COVID-19, likely setting the stage for a third vaccine to be authorized for use in the U.S. Dr. Neeta Ogden joined CBSN with more.

Video Transcript

ANNE-MARIE GREEN: The Biden administration is further increasing vaccine shipments. Across the country, states will soon start receiving 14.5 million doses as early as next week. And that is up from 13.5 million, the White House announced just last week. And this all comes as the FDA review out today found a single shot of Johnson & Johnson's COVID-19 vaccine is both safe and effective, potentially setting the stage for a third coronavirus vaccine to be authorized as soon as this weekend.

So Dr. Neeta Ogden is an Internal Medicine Specialist and an Immunologist, and joining us to talk a little bit more about this breaking news and some more information. So this is a multiple-step process. But it looks like the FDA is in favor of moving the Johnson & Johnson vaccine forward. What can you tell us about the clinical trial that the FDA reviewed?

NEETA OGDEN: Good morning. So I think it's a really exciting day. The Advisory Committee on Vaccines to the FDA will convene shortly this week. And then it's very likely that this Johnson & Johnson vaccine will get approved for emergency use authorization.

So what do we know about this study? It was approximately 44,000 people. And they conducted the study with two months of safety data, which is required by the FDA. And what they found was that overall in the United States, it was 76% effective in preventing moderate disease.

Overall globally, it was around 66%. So now we're seeing numbers well above what's required by the FDA of that 50% efficacy. And the best thing is that we saw that it was 85% effective in preventing severe disease and hospitalizations, which is what we obviously really, really care about here.

So the other things that are wonderful about the Johnson & Johnson vaccine is that it requires easy storage. It can just be kept in a fridge for months. It's just one shot. So this is really going to change the sort of vaccine landscape globally, these types of vaccines that are more easily stored, just more accessible in general.

And the other thing that we really want to think about is how it's going to be now distributed. We keep hearing about vaccine delays. And unfortunately, that exists with this vaccine as well. So immediately, they say roughly 2 to 4 million doses will be available. By March we're looking at 20 million doses, and by June they're promising 100 million doses. We're really hoping that that does come to fruition.

VLADIMIR DRUTHIERS: So Dr. Ogden, understanding that you are a doctor and not somebody who is responsible for logistics, I do have a question that has been sort of on my mind, which is when we talk about the bottlenecks with regards to distribution, is it because the pharmaceutical companies have not yet produced enough of those vaccines? Or is there a bottleneck somewhere else with delivery, with shipping? I'm just trying to understand why there are these delays that suggest, as the president has, that for all of us who want the vaccine, we'll be able to get 'em by July.

But when you talk to some people-- this is just anecdotal. But like I had mentioned to Anne-Marie a couple of days ago, I know for example that my nephew's teachers in Rochester, New York have all been vaccinated. I know that friends of mine who are doctors here in New York and in other places have already received vaccinations. So I'm just trying to understand how some people are able to get it and how some people are still sort of waiting.

NEETA OGDEN: Yeah, you know, I think this is a multifactorial thing. And a lot of people are scratching their heads about why there's this wait. There's so much demand, it's obviously outpacing supply.

So a few things. Number one, Operation Warp Speed did a pretty good job in getting a vaccine here. But then they basically left the allocation to local governments and states that were, frankly, overwhelmed by these surges that we saw around December and January.

There was also a lack of communication. There were far too many doses allocated to nursing homes than were needed, and they were sort of sitting around without sort of thought put to moving on to the next group of people who would need them.

There's also a bit of a production delay happening here in what we call the finish and fill steps, where we're actually finishing that vaccine bottle and filling it with the actual product. And that has led to production delays that are slowly being overcome as well. For the Pfizer vaccine, for example, they believe that if they're able to increase the amount of doses in the vial, that can help get over that delay.

So I think that it's just been such a slow rollout, because of a number of logistical steps. But I feel like we're on pace, as they say, for the spring for these hurdles to be overcome as they sort of figure out the system and for the vaccine to truly be available to more people.

ANNE-MARIE GREEN: So there are two studies suggesting that a new COVID-19 variant that was discovered in California is even more contagious than the earlier forms of the virus. And you know, this comes as we've seen sort of the highly contagious strain that emerged in Brazil now pop up in Alaska.

I know we kind of-- I feel like we keep asking this question over and over again. But I think every time someone hears about another variant, they sort of freak out a little. So what threat do these new variants pose?

NEETA OGDEN: You know, it's always remarkable when we hear about a variant, just because of the way that this vaccine-- this virus, sorry-- has played out in the world, actually. And so it's always concerning. But really, this is the nature of viruses. They do mutate. Variants do emerge, especially when there's such a high level of virus replication ongoing all around the country. So I'm not surprised.

I think, though, California-- again, they saw a huge surge this fall and into the winter. And that was likely due to variants. We simply weren't keeping track of them. And you know, like the B117 variant in the UK, this California variant that's been identified recently has been shown to double roughly every 10 to 18 days. So you can see how quickly these things can spread.

Of course, all of the variants are now showing-- at least, the California and the B117 variant-- are showing that they're likely more contagious. It's the P1 variant and the B135 that we are talking about Brazil and South Africa that we are a little bit more concerned about immune escape. Will they still-- will they wreak havoc for people in terms of reinfection or if people have been vaccinated? I mean, these are just answers we don't have. And frankly, we probably won't know until the country gets vaccinated and we see if people start getting sick.

I really hesitate to get overwhelmed by these types of stories and these studies about antibodies, and did they work or not, because as we've talked about before, the immune system has a lot more going on than just neutralizing antibodies. And I think that those different levels will play out. In the future, we will see that people will be protected from these variants if they've been vaccinated.

VLADIMIR DRUTHIERS: Looking forward to that. Dr. Neeta Ogden, always great to have you. Thank you very much as always

NEETA OGDEN: Thanks for having me.