AstraZeneca under scrutiny after accusations of cherry-picking vaccine data in U.S. trial

AstraZeneca is facing questions after an independent review board said the company included outdated information from its U.S. COVID vaccine trial. It comes as the head of the CDC warns the U.S. could face another avoidable surge in cases. CBS News reporter Alex Tin joins CBSN's "Red & Blue" anchor Elaine Quijano with more on the controversy and the latest vaccintion numbers.

Video Transcript

ELAINE QUIJANO: President Biden spent Tuesday in Ohio, promoting the American Rescue Plan. His administration is working to meet its goal of reopening a majority of schools for in-person classes this spring. But the nation's largest teacher's union is questioning an update to school safety guidelines. Natalie Brandt has the latest on the White House's pandemic response.

NATALIE BRANDT: President Biden toured a Columbus, Ohio, cancer and research institute as part of his Help Is Here tour to tout the American Rescue Plan.

PRESIDENT BIDEN: I don't want to see anybody go through what my son went through.

NATALIE BRANDT: The trip also comes on the 11th anniversary of the Affordable Care Act becoming law. The White House is currently encouraging Americans who need health insurance to sign up on The special enrollment period runs through May 15.

The recently passed COVID relief package includes $122 billion for schools. But the nation's second-largest teacher's union worries school districts still lack the resources and planning to implement the CDC's latest guidance.

- How much more change can we do in one year?

NATALIE BRANDT: The American Federation of Teachers wrote the Biden administration to express concern about the CDC's new social distancing guidance for schools. It's reduced to three feet between most students when they're wearing masks.

There are also new questions about the data AstraZeneca released from its COVID-19 vaccine trial in the US. The National Institute of Allergy and Infectious Diseases says the company may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.

- This is really what you call an unforced error. Because the fact is this is very likely a very good vaccine.

NATALIE BRANDT: AstraZeneca says it will work to provide the most up-to-date information to regulators. The pharmaceutical company is expected to apply for emergency use authorization in the US in coming weeks. Natalie Brandt, CBS News, the White House.

ELAINE QUIJANO: For more, let's bring in CBS News reporter Alex Tin, who has been covering the pandemic response of states nationwide. Hi, there, Alex. So what more can you tell us about the accusations that independent review board launched against AstraZeneca on Tuesday? And how will that impact the US vaccine rollout?

ALEX TIN: Well, to be clear, this is a data safety monitoring board that exists during the trial period. It's the same board and the same group of top experts and bioethicists and statisticians that were monitoring the data around clinical trials for other vaccines we've seen earlier, like the Moderna COVID-19 vaccine.

And it was this board that yesterday, according to what we've heard now from NIAID, which was running this clinical trial for AstraZeneca, that they were told by the data safety monitoring board that the release that AstraZeneca had put out, the release detailing these great results that looked better than the Johnson & Johnson COVID-19 vaccine, which is run on a comparable platform using a similar technology. That it seems to be misleading. That it was using data that did not seem to be as up-to-date as it could have been, showing the most accurate efficacy numbers that they could have been showing.

Now to be clear, we haven't independently confirmed this. But the contents of that letter have since been reported by two outlets, as far that I've seen. The Washington Post and the New York Times. And what they detail in their reports is very similar to what we heard from Dr. Anthony Fauci in that clip you played earlier, just a few minutes ago.

Which is very harsh words from these independent experts saying that AstraZeneca appeared to at least, again reportedly, overemphasize and mislead the people regarding their efficacy numbers. The company says that they were simply doing an analysis based on an earlier endpoint, and they plan to release more data, more full data, within 48 hours.

We'll see what that data shows once it comes out. And of course, all of this is going to become, in some ways moot, once the FDA weighs in. Because they will be doing a very thorough search of all of the data and all of the trial information to make sure that everything is up to snuff.

ELAINE QUIJANO: OK. I feel like I have such a better understanding now. Alex, with that explanation. Let's turn to the Johnson & Johnson vaccine. Despite the rapid pace of vaccinations, the Biden administration is now concerned that Johnson & Johnson will not be able to deliver millions of vaccines on time. So, Alex, what are we learning about that?

ALEX TIN: Well, it's interesting. Because in Johnson & Johnson's case, unlike what we've heard from say Pfizer, which is basically running all of the plants, all across their supply chain, that is producing some of the critical final steps of their vaccine. Johnson & Johnson, at least in the United States, has been relying on some contractors.

Those contractors here in the United States, two of them, Catalent and Emergent, have yet to receive emergency use authorization from the Food and Drug Administration to release the doses that they've been manufacturing. emergent is a key early step of manufacturing the Johnson & Johnson vaccine. They then ship it off to so-called fill-in f finish sites, like Catalent in Indiana.

And just today, Catalent announced that they had finally received authorization from the Food and Drug Administration to begin releasing these doses that they have been producing in their plant. You know, bottling the vaccine into these vials that can then be released around the country. They say that it could be perhaps millions of additional doses, which will be a huge boost for Johnson & Johnson. Because as you said, they have that 20 million benchmark they're trying to hit by the end of the month. And so far, they are falling far short of that.

ELAINE QUIJANO: Well, Alex, at a virtual White House briefing Tuesday, CDC director Dr. Rochelle Walensky raised alarms over how quickly states are rolling back COVID restrictions. Let's play part of that.

ROCHELLE WALENSKY: We all want to return to our everyday activities and spend time with our family, friends, and loved ones. But we must find the fortitude to hang in there for just a little bit longer. We are at a critical point in this pandemic, a fork in the road, where we as a country must decide which path we are going to take.

We must act now, and I am worried that if we don't take the right actions now, we will have another avoidable surge, just as we are seeing in Europe right now.

ELAINE QUIJANO: So, Alex, how does the current pace of vaccinations compare to the spread of variants?

ALEX TIN: Well, it is important to recognize two things when we're thinking about that question. First, we are at a record pace of vaccinations. There are more vaccines being administered in this country every day than there have been, not only at any time in history, but also compared to other countries that have been rolling out their vaccine efforts.

Now at the same time, we have seen this growing trend of the variants that have been spreading in various parts of the country. Obviously the one that remains the most concerning is the so-called B117 variant, the one that was first identified in the United Kingdom, that the CDC still says they estimate will become the dominant strain here in the United States, probably by the end of this month or early next month.

But we don't have an exact figure-- at least not publicly yet-- of how much those variants are spreading. We have some of the information we've heard from the CDC's National Variant Surveillance program. We have some anecdotal data we've heard from private labs.

But we don't have a definitive number yet of how many of these variants are out there. What percentage of the cases in the country are of these variants. Because that requires sequencing of these variants, which is still in limited capacity. But what we do know is these variants are fast spreading. They're highly transmissible. And in many states, they're already impacting decisions that providers have to make.

For example, in California, Arizona, and Nevada recently, the Department of Health and Human Services, the federal agency that has been distributing a so-called monoclonal antibody cocktail to help people reduce their hospitalization potentially, when diagnosed with COVID-19, had to curb distribution of that medicine in those three states because they now fear that the spread of a California-identified variant, B1429 and 427 is so fast and so widespread that they think it could neutralize the use of that medicine.

ELAINE QUIJANO: Wow, that is really remarkable and sobering, Alex, to think of that. Because we'd heard about that particular treatment for some time as being thought of as effective, right? And now to hear that there's this threat with these very variants. Very, very sobering stuff, Alex Tin-- Alex, though-- go ahead, Alex. Yeah.

ALEX TIN: Yeah, and just to clarify that this treatment is not entirely made unusable by the variants. There are some monoclonal antibody treatments.


ALEX TIN: That can be used and appear to be effective against the variants. But some of them are not. And that's the fear for federal officials.

ELAINE QUIJANO: All right. Alex Tin. Alex, as always, we really appreciate your thoroughness helping us to understand all of these very quickly moving parts to this beat. Thank you, Alex.

ALEX TIN: Thank you.