U.S. health experts on Monday said the AstraZeneca vaccine is safe and effective against the novel coronavirus.
The comments by American experts came after a large study majorly conducted in the United States showed that the vaccine developed by AstraZeneca in partnership with Oxford University was 79 percent effective against the deadly virus.
The data from the study showed that the vaccine was 80 percent effective in participants aged 65 and older. It was also found to be 100 percent effective in preventing serious illness and hospitalization across all ages and ethnicities.
AstraZeneca said it would continue to analyze the data and prepare to request emergency use authorization in the United States in the coming weeks.
That would make it the fourth vaccine to be approved in the United States, following approvals for vaccines developed by Pfizer-BioNtech, Moderna and Johnson and Johnson.
AstraZeneca is widely used outside the United States and in Africa under the COVAX facility, but the vaccine has been tested in recent weeks with many countries suspending its use following deaths and complications, and studies that showed it was not very effective against new variants of the disease, especially the South African and U.K. variants.
At a Press Briefing by White House COVID-19 Response Team and Public Health Officials, Dr. Anthony Fauci, an infectious disease expert, said he was encouraged by the results of the AstraZeneca phase 3 clinical trials. His optimism was echoed by others.
“We have some good news today in the field of vaccine, and that has to do with the results that were announced yesterday from the AstraZeneca trial,” Dr. Fauci said at the briefing.
He added: “As shown on this slide, there are three platforms that have six companies involved. For the discussion over the next couple of minutes, we’re going to be looking at the chimp adeno vector that is used by AstraZeneca, which yesterday revealed the results of their phase three trial.
“Just to refresh your memory, the vector that is used in this platform is a chimp adenovirus in which the SAR-CoV spike protein DNA was inserted. That non-replication-competent harmless adenovirus is injected into the muscle of an individual. The DNA then codes for RNA, which then essentially codes for the spike protein which the body makes the immune response against. That is the fundamental mechanism of this platform.
“And so, the data: We’re talking about a phase three trial involving more than 32,000 participants who are 18 years of age or older, and it was at 88 sites — mostly in the United States but also a small amount in Chile and Peru — with a 2-to-1 randomization of vaccine to placebo.
“The demographic distribution is shown here. Around 79 percent White, 22 percent Hispanics, 8 percent Black/African American, and 4 percent Native Americans, including American Indians and Native Alaskans residing in the United States, and 4 percent Asian. Twenty percent was 65 years of age or older, and 60 percent had comorbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity, or cardiac disease. This is important to get that many people who have comorbidities.
“So right at the efficacy data, good results: 78.9 percent vaccine efficacy of preventing symptomatic disease; importantly, with regard to severe or critical disease requiring hospitalization, there was zero in the vaccine arm and five in the placebo arm.
“The good news is also that there was comparable efficacy across ethnicity and age; namely, a very good efficacy — 79.9 percent — in participants who are 65 years of age or older.
“The reactogenicity and overall safety profile were good. The vaccine was well-tolerated, and the Data and Safety Monitoring Board identified no specific safety concerns related to the vaccines. Importantly, and this is a quote from the DSMB, “No evidence of disproportionate risk of thrombosis or events characterized by thrombosis among the 21,583 participants who received at least one dose. An in-depth search of the database for venous thrombosis revealed no events in this study.
“The United States government has played a significant role in the conduct of this trial. It was funded by BARDA and by NIAID in a trial led by the company AstraZeneca; the NIAID supported by its clinical trial network, the CoVPN. The Data and Safety Monitoring Board was formed by NIAID, which monitored the trial to ensure safety and validity of the data. And NIAID intramural investigators co-authored key preclinical studies.
“And finally, on the last slide: Importantly, this vaccine can be stored, transported, and handled at refrigerator temperatures for at least six months. And also, importantly, conditional marketing authorization or emergency use is already in play in more than 70 countries across six continents, and it has been given emergency use listing by the WHO.”
Below are full transcript of their remarks at the briefing
ACTING ADMINISTRATOR SLAVITT: Good morning. Thank you for joining us. We’re now two months into our national strategy to defeat COVID-19. At the heart of our plan are a number of critical activities.
Vaccinations: We’ve had to significantly ramp up vaccine production to a level more than double when we arrived, acquired enough vaccines to vaccinate the population, and have set up a deadline — May 1st — by which all Americans should be eligible to get a vaccine.
We’ve done this not only by increasing vaccine production, but also adding thousands more vaccinators and thousands of additional locations to get vaccinated.
We are now vaccinating about 2.5 million people per day, up from 900,000 when we arrived. This weekend was the first time that the U.S. reported vaccinating more than 3 million people on consecutive days.
There are now a total of 81 million people — or nearly 1 in 3 adults — with at least one vaccine dose in the U.S., and 44 million who are fully vaccinated. Nearly 69 percent of seniors have now received their first vaccination, and 42 percent are fully vaccinated.
A second core element of our plan is to get schools open and open safely. This has meant following the science, dramatically increasing testing, and making it a priority to vaccinate teachers. With $10 billion committed to testing so far, schools have enough resources to properly test their students and staff.
Today, we’re taking another step in building an equitable and efficient response. The state of Washington will receive its first federally — federal community vaccination site. The Yakima County CVC will be able to offer up to 1,200 shots per day. Local residents will be able to drive through the Central Washington State Fair Park and get a shot.
Now, this is the 22nd federally run vaccination site we’ve opened. And as you can see from some of the tweets on the screen here, these sites get great reviews as a place to get vaccinated. Combined, they deliver nearly 100,000 shots per day.
All of the sites are in areas defined by the CDC as having a high social vulnerability rating. In fact, against the backdrop of inequity in vaccine distribution generally, and the severe toll taken by the virus on people of color, in federal vaccination centers, over 60 percent of the shots have gone to people of color.
For example, Yakima County has been particularly hard hit throughout the COVID-19 pandemic with disproportionately high infection and hospitalization rates as compared to the rest of the state.
The President has set a goal of doubling the number of community vaccination centers run by FEMA and the U.S. military to ensure that we reach the hardest-hit communities in this historic effort.
We have much more work to do, but further progress was made this weekend.
With that, I’m going to turn this over to Dr. Walensky and then to Dr. Fauci for some important updates.
DR. WALENSKY: Thank you, Andy. I’m delighted to be back with you all today. Let’s start with an overview on the state of the pandemic. The most recent seven-day average is about 53,800 cases per day, which is a slight increase from the previous seven-day period. And over the past two weeks, cases have continued to fluctuate somewhere between 50,000 and 60,000 daily cases.
The most recent seven-day average for new hospital admissions is just over 4,500 per day. Like COVID-19 cases, hospital admissions have been relatively stable over the last two weeks, hovering around 4,500 to 5,000 admissions per day.
Deaths continue to decline — a lagging indicator — with the most recent seven-day average of deaths slightly over [sic] 1,000 per day. Slightly under — sorry — 1,000 per day.
The apparent leveling off of cases and hospital admissions after the consistent declines we saw in these outcomes in early January through the end of February I consider to be very concerning.
In addition, while deaths continue to drop, they remain at elevated levels. And in the past week, the rate of decline of deaths has slowed.
We also know that the trajectory of the pandemic varies across the United States, with some states and regions of the country, such as the Northeast and the Upper Midwest, are beginning to again see a significant rise in cases.
Taken together, these statistics should serve as a warning sign for the American people. As I’ve stated before, the continued relaxation of prevention measures while cases are still high, and while concerning variants are spreading rapidly throughout the United States, is a serious threat to the progress we have made as a nation.
Increasingly, states are seeing a growing proportion of their COVID-19 cases attributed to variants. The newly identified variant, B1427/B1429, is estimated to account for 52 percent of cases in California, 41 percent in Nevada, and 25 percent in Arizona. And the B117 variant is estimated to be responsible for 9 percent of cases in New Jersey and 8 percent in Florida.
Believe me, I get it — 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 and just as we are so aggressively scaling up vaccination.
Nearly 25 percent of the American population have received at least one dose, and over 44 million people — about 13 percent of the population — is fully vaccinated. And we have more vaccine supply on the way.
Until then, we must do everything we can to stop the spread of COVID-19 and the proliferation of variants while we get more people vaccinated.
We now have 69 percent of adults over the age of 65 who have received at least one vaccine dose and 42 percent who are fully vaccinated. And we have seen that the vaccines are working. With increasing numbers of those over 65 now fully vaccinated, we’re seeing the benefit. For the first time since last summer, the percent of those over 65 presenting to our emergency departments because of COVID-19 is lower than those age 26 to 45 in the United States.
These vaccines work. We’re seeing it in the data. There are positive kinks in our curves. And we need to remain vigilant as we quickly get the rest of the American people fully vaccinated.
I’m calling the American people to action, whether vaccinated or not, to recommit to doing the right thing. Take the steps we know work to stop COVID-19: Wear a well-fitted mask, socially distant, avoid crowds and travel, and be ready to roll up your sleeve to get vaccinated when the vaccine is available to you.
Thank you. I’ll now turn things over to Dr. Fauci.
DR. FAUCI: Thank you very much, Dr. Walensky. We have some good news today in the field of vaccine, and that has to do with the results that were announced yesterday from the AstraZeneca trial.
As shown on this slide, there are three platforms that have six companies involved. For the discussion over the next couple of minutes, we’re going to be looking at the chimp adeno vector that is used by AstraZeneca, which yesterday revealed the results of their phase three trial.
Just to refresh your memory, the vector that is used in this platform is a chimp adenovirus in which the SAR-CoV spike protein DNA was inserted. That non-replication-competent harmless adenovirus is injected into the muscle of an individual. The DNA then codes for RNA, which then essentially codes for the spike protein which the body makes the immune response against. That is the fundamental mechanism of this platform.
And so, the data: We’re talking about a phase three trial involving more than 32,000 participants who are 18 years of age or older, and it was at 88 sites — mostly in the United States but also a small amount in Chile and Peru — with a 2-to-1 randomization of vaccine to placebo.
The demographic distribution is shown here. Around 79 percent White, 22 percent Hispanics, 8 percent Black/African American, and 4 percent Native Americans, including American Indians and Native Alaskans residing in the United States, and 4 percent Asian. Twenty percent was 65 years of age or older, and 60 percent had comorbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity, or cardiac disease. This is important to get that many people who have comorbidities.
So right at the efficacy data, good results: 78.9 percent vaccine efficacy of preventing symptomatic disease; importantly, with regard to severe or critical disease requiring hospitalization, there was zero in the vaccine arm and five in the placebo arm. The good news is also that there was comparable efficacy across ethnicity and age; namely, a very good efficacy — 79.9 percent — in participants who are 65 years of age or older.
The reactogenicity and overall safety profile were good. The vaccine was well-tolerated, and the Data and Safety Monitoring Board identified no specific safety concerns related to the vaccines. Importantly, and this is a quote from the DSMB, “No evidence of disproportionate risk of thrombosis or events characterized by thrombosis among the 21,583 participants who received at least one dose. An in-depth search of the database for venous thrombosis revealed no events in this study.”
The United States government has played a significant role in the conduct of this trial. It was funded by BARDA and by NIAID in a trial led by the company AstraZeneca; the NIAID supported by its clinical trial network, the CoVPN. The Data and Safety Monitoring Board was formed by NIAID, which monitored the trial to ensure safety and validity of the data. And NIAID intramural investigators co-authored key preclinical studies.
And finally, on the last slide: Importantly, this vaccine can be stored, transported, and handled at refrigerator temperatures for at least six months. And also, importantly, conditional marketing authorization or emergency use is already in play in more than 70 countries across six continents, and it has been given emergency use listing by the WHO.
I’ll stop there. And back to you, Andy.
ACTING ADMINISTRATOR SLAVITT: Thank you, Dr. Fauci, Dr. Walensky.
Let’s go to questions, please.
MODERATOR: First question will go to Dan Vergano at BuzzFeed News.
Q Thanks very much. I’m wondering if you could comment on what you see going forward, if we continue vaccinating the most high risk and elderly, with regard to the death rates versus the case rates. Are we going to see much lower death rate overall with continuing, you know, relatively high case numbers? And does that communicate your message about vaccination if the death rates decline? Assuming that’s a great thing, of course, but I wonder what kind of world we’re going to see going forward with more — as more people get the vaccine. Thanks.
ACTING ADMINISTRATOR SLAVITT: Why don’t we start with Dr. Walensky and then Dr. Fauci?
DR. WALENSKY: Yeah. It’s an important question for us to consider. I think one thing we have to realize is that there’s still a death rate among people who are under the age of 65. And that death rate is certainly going to be consistent with the number of cases we have overall.
So while I consider it extraordinarily good news that our death rate is declining in those who have been vaccinated, there is still a death rate among those who are over, you know, 25 — over 20. And, you know, as those cases continue to increase in that demographic, we will see death rates in that demographic as well. So I think the messaging is very consistent. We still need to be vaccinating everyone who is eligible.
ACTING ADMINISTRATOR SLAVITT: Dr. Fauci, anything you’d add?
DR. FAUCI: No. Just to underscore what Dr. Walensky said: Every time we look at data, it looks at when you’re dealing with severe outcomes, hospitalizations, and deaths — the vaccines, all of them, have a very good track record. So, as Dr. Walensky said, that just underscores the importance of getting everybody vaccinated as quickly as we possibly can.
ACTING ADMINISTRATOR SLAVITT: Great. Thank you. Next question.
MODERATOR: Next we’ll go to Tom Howell at the Washington Times.
Q Hey, thanks for doing the call. With the AstraZeneca news and also robust data from Novavax, it looks like both of those might get emergency approval by May. I’m just wondering how you’re thinking about that in terms of supplies — the challenge shifting now to what to do with any surplus; how to maintain interest in the shots here at home. How are you, kind of, working through, you know, whether we’re going to have more supply than we need and what the challenges are now? Thanks.
ACTING ADMINISTRATOR SLAVITT: Thank you, Tom. So, first of all, I’ll start and then see if, Dr. Fauci, you want to add something.
So I think it’s too early for us to declare that we’re in a surplus position. We have been carefully planning. We have — obviously, the highest priority is to, as Dr. Fauci just said, to vaccine the U.S. public as quickly as possible.
So — but obviously, the more we get confidence in our increased supply, the more flexibility that gives us for different events down the road, whether it’s vaccinating adolescents, whether it is sharing that supply with other countries, as we announced at the end of last week — four more million doses were just shared with Mexico and Canada — or whether it’s other events.
So we are, obviously, monitoring the scenarios very closely and tracking these closely. Obviously, it is great news for both the U.S. and the world the more vaccines and the more supply that exist.
Dr. Fauci, anything you’d add?
DR. FAUCI: No, actually, Andy, you said it very well. I just want to underscore one aspect of it, which was on one of the slides that I mentioned: that there are very many countries in Europe and throughout the world who have already authorized this. So the fact that a United States-run study has confirmed the efficacy and the safety of this vaccine I think is an important contribution to global health in general.
I’ll stop there.
ACTING ADMINISTRATOR SLAVITT: Yeah, and something that, Dr. Fauci, you may want to — both of us would say is: It’s important to just remind everyone we cannot and will not get ahead of the FDA. The FDA has incredibly rigorous scientific process. And so while we would certainly call today’s news “encouraging” — it’s the kind of thing we like to see — we have a rigorous process that will come once an EUA is submitted, and that will give us all more information and reason to be comfortable.
MODERATOR: Let’s go to Jeremy Diamond at CNN.
Q Hey, thanks for doing the briefing, as always. First of all, I’m wondering, you know, we’ve been between 54- and 58,000 new daily cases over the last two weeks. You guys are warning about the potential risks in that. What more are you doing to encourage states to maintain or re-impose coronavirus restrictions rather than relaxing them, as so many are?
And then, secondly, do you still expect Johnson & Johnson to deliver 20 million doses by the end of the month, which is just a week away now? Thanks.
ACTING ADMINISTRATOR SLAVITT: So, Dr. Walensky — Dr. Walensky, would you like to take the first question about the kind of flattening of case rates and things that we can be doing as a country?
DR. WALENSKY: Yeah, I’d be happy to. You know, we are looking at these data. We’re reaching out to individual states, trying to encourage them. We are having weekly governors’ calls. We’re doing outreach with states, territories to encourage them to look at their case data, to look at what’s happening with the variants, and to do as much outreach as we can to try and — to slow down the relaxation.
ACTING ADMINISTRATOR SLAVITT: Yeah. And obviously you’ve heard the President say, and you’ve heard our — both Dr. Fauci and Dr. Walensky say that we believe it’s a mistake to get rid of mask mandates.
Obviously, governors have certain authority there, but so do corporations, so do employers, so do individuals. And we’re making concerted efforts to make sure that people know that whether or not there’s a mandate in place, people that — it’s in the people’s strong interest — strong interest — to continue to wear a mask until such time that people have had a chance to be vaccinated.
On the Johnson & Johnson question: We are obviously working very closely with the company. We are going to see a nice increase in Johnson & Johnson this week. And we should have more information, you know, around the first week in April to report on how they’ve done. Obviously, they’ve got a lot of increases that they need to be committed to doing. So we’ll continue to keep everyone posted.
MODERATOR: We’ll go to Rachel Roubein at Politico.
Q Hi, thanks for taking my question. I just wanted to follow up on the last one from Jeremy. Since April 1st is the end of next week, do you think that J&J will have that 20 million shots? Can you give us an estimate of how many J&J shots are going out this week and how much states are seeing in their projections for next week?
ACTING ADMINISTRATOR SLAVITT: Yeah, I’m not going to give you precise numbers. Obviously, this is a ramped-up manufacturing process. We’re working with them very closely. I don’t think — yeah, I wouldn’t signal to you that they’re going to be far away from the numbers that they have projected at all, give or take a little bit. Obviously, we’re holding them accountable and working closely with them.
But with — at this point in time, I don’t want to commit to what’s going to happen over the course of the coming week. I would leave that to the company.
MODERATOR: Next we’ll go to Nancy Cordes at CBS.
Q Thank you. How do you plan to deal with hesitancy surrounding the AstraZeneca vaccine in particular? Or do you anticipate that by the time it’s in circulation, there will be so much supply of the other vaccines that it really won’t matter?
And then, given Dr. Walensky’s comments about the uptick in cases and the fork in the road that the country is facing, what’s your guidance for people who have been vaccinated when it comes to going on vacation? Because the TSA just reported that Sunday was its busiest air travel day of the year so far.
ACTING ADMINISTRATOR SLAVITT: Okay, so let me start with Dr. Fauci with the first question, just to begin with the facts. Because I think the best — the best method for talking about people’s perception is to start with the actual ground-truth facts. It’s the reason we do these briefings in the first place.
So, Dr. Fauci, do you want to reiterate the points your — you — your point of view?
DR. FAUCI: Yeah. The vaccine hesitancy surrounding AZ, related to reports from the European group that there was a greater incidence of thromboembolic events associated with the vaccine: During this trial here, there was no indication at all. Now, remember, you’re dealing with 30,000 people in a trial.
The important thing to point out is that when you give vaccine to millions and millions of people, you got to make sure that when you look at the occurrence of what could appear to be an adverse event, that you essentially compare that into what the background of that type of event would be anyway in society. And the European Medicines Agency — the EMA — indicated in their examination that they did not see an increased risk of these types of events. Of note, in the trial that I just reported on, they did also not see this, even though it was only in 30-plus thousand.
But as Andy mentioned just a moment ago, the FDA is going to very, very carefully go over all of these data. There will be an application for an EUA, and I can tell you, you can rest assured that the FDA will put a great deal of scrutiny in every aspect of these data.
ACTING ADMINISTRATOR SLAVITT: Yes. And I just very much appreciate that — those comments. And it’s one of the reasons why it’s so important people ask, “Why does the FDA take time to do their work?” People also ask, “Why do you make such a point of emphasizing the FDA’s independence?” and “Why do you make such an important point about emphasizing the transparency?” It’s because the science is going to be what the science is. The results are going to be what the results are going to be. And the American public will need to hear that directly, and it’s important that they have great confidence in what comes out of our independent scientific agencies.
So we’re going to hold on any judgment, other than what Dr. Fauci has indicated from these studies, until we hear from the FDA. And they will go through a very rigorous process, and after that, we will help interpret the results to the public.
So there was a second question, which I think is for Dr. Walensky, which is, I believe, commenting on travel and the uptick in travel. And I think there was a — part of that question was, you know, “What about the vaccinated people that are traveling?” I don’t think — what I saw, down in Miami — it didn’t look like a whole bunch of vaccinated people, but I could be wrong. But maybe you want to address that one.
DR. WALENSKY: Yeah, you know, as we’ve articulated before, CDC is working on updated guidance for what you can do if you’re vaccinated, and that will include travel.
But I want to, sort of, go back to what Andy said, and that is: Much of the travel, we know, is related to people who are going on spring break. For the most part, people who go on spring break are not the demographic that we’ve been focusing in on travel. We’re worried not just for what happens when you are on the airplane itself, but what happens when people travel. That is, they go out; they mix — they mix with people who are not vaccinated.
We currently are at a situation — if we look at our European friends — we just don’t want to be at this rapid uptick of cases again, and that is very possible that that could happen. We’ve seen that. We’re behind the eight ball when that starts to happen. And that results in uptick of cases, hospitalizations, and then death.
So we’re so close to vaccinating so many more people. So I would just encourage people and remind people: Now is not the time to travel.
ACTING ADMINISTRATOR SLAVITT: I think that’s a great way to end this briefing. Thank you very much for listening in and your questions. And we will be back again on Wednesday.
11:28 A.M. EDT