Johnson & Johnson COVID-19 vaccine deemed "safe and effective" by the FDA

The FDA confirms the Johnson & Johnson coronavirus vaccine is safe and effective. The single-dose vaccine could receive emergency approval as early as Friday. If authorized, the Biden administration could ship up to 4 million doses by next week. CBS News' Nikki Battiste reports on the latest information, then infectious disease specialist Dr. Uzma Syed joins CBSN with analysis.

Video Transcript

LANA ZAK: The US is one step closer to adding a third coronavirus vaccine to its supply. The FDA has declared Johnson & Johnson's vaccine effective. It's only one shot, and it could be granted emergency approval as soon as Friday.

In the meantime, the Biden administration announced they will be shipping out millions of masks across the US as the Biden administration ramps up efforts to protect underserved communities. Here in the US, the infection rate continues to fall, but experts warn that it's too soon to let our guards down. The variants first found in the UK and South Africa are spreading, and health officials are warning of another homegrown variant. Nikki Battiste has the latest.

NIKKI BATTISTE: Safe and effective is how the FDA described Johnson & Johnson's one-dose vaccine.

- If an EUA is issued, we anticipate allocating 3 to 4 million doses of Johnson & Johnson vaccine next week.

NIKKI BATTISTE: The FDA confirms that J&J's vaccine is slightly less effective than the Moderna and Pfizer shots overall, but showed 85% efficacy against severe illness and complete protection against COVID-19 deaths 28 days after getting the shot. It also works better in the US than in South Africa, where a more contagious variant is dominant. Johnson & Johnson's vaccine only needs to be kept at normal refrigeration temperatures and stored for three months.

MICHAEL OSTERHOLM: I think the Johnson & Johnson vaccine is a very important new development. It does show very, very good protection against serious illness, hospitalization, and deaths.

NIKKI BATTISTE: To keep down infections, the Biden administration is planning to ship 25 million masks to community health centers and food banks. Also tonight, Moderna announcing it is preparing clinical trials for a South African variant booster shot. Researchers in California say there's a homegrown variant there, too, which not only spreads quickly, but may show resistance to COVID antibodies.

MICHAEL OSTERHOLM: We are in a race against time.

NIKKI BATTISTE: Dr. Michael Osterholm says the US should rethink how it delivers vaccines to get needles in the arms as quickly as possible.

MICHAEL OSTERHOLM: We have now compelling data showing that there is no need to provide two doses of vaccine to anyone who has already had COVID.

NIKKI BATTISTE: But there is good news. Lucia DeClerck was diagnosed with COVID last month on her 105th birthday, the same day she received her second dose of the Pfizer vaccine. Now a survivor of both the Spanish flu and COVID, she credits a regimen of nine gin-soaked raisins and faith.

LUCIA DECLERCK: Pray. Pray. Pray. And don't eat junk food.

NIKKI BATTISTE: The FDA's vaccine panel is scheduled to publicly review J&J's data Friday, which means authorization could come as early as this weekend. If that happens, millions of doses could be headed to states next week. Lana.

LANA ZAK: Nikki, very exciting. And what a wonderful woman. Thank you. Infectious disease specialist Dr. Uzma Syed joins me now. Doctor, thank you for all that you do, and thank you for joining us tonight.

So emergency approval for the one-shot Johnson & Johnson vaccine could come as soon as Friday. It is about 66% effective, which is less than Pfizer and Moderna's vaccines. Can you put this into context for us? I have heard from other experts that 66% is still a good number. Explain that.

UZMA SYED: Absolutely. I think it's really important for us to remember that things are constantly in flux with COVID-19. When the Pfizer and Moderna trials were underway, we didn't have these variants that we do now when some of these other trials are taking way. And especially if you look at the regions where the J&J vaccine trial was undergoing and AstraZeneca, you have to look at the prominence of the B1351 variant in South Africa.

So a lot of these things lead to the decrease in numbers that you're seeing. But the thing that we need to focus on that's most important is that this vaccine is 85% effective in preventing severe illness and 100% effective in preventing death. So when you're talking about a pandemic of this global scale, we really have to focus on saving more lives. And every single day, every single vaccine that can prevent a life is really our goal at this point.

LANA ZAK: Yeah, that-- that 100% prevention of deaths is powerful, especially given the death toll here in the United States. So speaking of variants, Moderna says it has sent a candidate for a variant-specific booster shot to the National Institutes of Health for a clinical study. Can you explain what a booster shot actually does?

UZMA SYED: Absolutely. So this is a really amazing thing with these new technologies and these new platforms that are being used that they can be tweaked very easily and rather quickly. So we've heard that Moderna has already submitted this new vaccine, which, you know, we're looking at these variants of concern as they're emerging, and basically they're looking at different ways that they can build these boosters into-- into the population.

So what they want to do is study it in clinical trial to see whether a booster, in addition to this two-series vaccine, is something that would be plausible, or combining the original vaccine and this new vaccine that they've developed against these variants, or giving it as a-- as a third shot. So there's many different things that are up that they're looking at right now. And it's really important to remember that we do have solutions for these new variants that are emerging, so it's really promising.

LANA ZAK: And global coronavirus cases have fallen for a sixth consecutive week, according to the World Health Organization, which is really positive news. And as we heard in Nikki's piece, the CDC says the US could see up to 12,000 fewer deaths over the next five weeks. How much are these cases being driven down now by people actually getting the vaccine?

UZMA SYED: It's really amazing to see the steady decline in cases, both globally and nationally. And I think there's many different reasons for this. There are many variables that are potentially playing into effect right now causing this, whether it be more stricter public health measures, you know, these fear of variants. As more and more variants are emerging, people are more fearful, and so they are taking more precautions.

Some of it has to do with the seasonality of coronaviruses, and we normally see these ebbs and flows. So all of these things are likely playing into this, the decline in cases. But we do want to keep on top of it because, obviously, the vaccinations are going up.

But I don't think the vaccinations alone are really the explanation for why the cases are declining, because we really haven't reached that high threshold just yet. So it's most likely a combination of things. But what we want to do is continue to increase and ramp up those vaccinations so we can really get ahead of all these variants and continue to save more lives and continue to drive those cases down.

LANA ZAK: That is the hope that we all have. Dr. Uzma Syed, thank you.

UZMA SYED: Thank you.