Via Teleconference 

11:12 A.M. EDT

MR. ZIENTS:  Good morning.  Thank you for joining us.  Today I will discuss the implications of the FDA and CDC’s decision to pause the Johnson & Johnson vaccine administration, and also provide an update on our accelerating vaccination program.  Then I’ll turn it to Dr. Walensky for an update on the state of the pandemic and on the Johnson & Johnson pause, followed by Dr. Fauci who will also provide his perspective on J&J. 

As you know, yesterday, the FDA and CDC announced that out of an abundance of caution they have recommended a pause in the use of the Johnson & Johnson vaccine as they review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.

I want to be clear that this announcement will not have a significant impact on our vaccination program.  The J&J vaccine makes up less than 5 percent of the more than 190 million recorded shots in the arms in the U.S. to date. 

The President has always said that we are at war with the virus. And as such, we have mobilized a wartime effort so that we’re prepared for a range of scenarios and contingencies.  This is why the President took aggressive action earlier this year to move up manufacturing, production, and delivery schedules for both the Pfizer and Moderna vaccines and to secure enough Pfizer and Moderna doses for 300 million Americans by the end of July.

Over the last few weeks, we’ve made more than 25 million doses of Pfizer and Moderna available to states, Tribes, and territories and through federal channels each week. In fact, yesterday, we announced that this week we will make 28 million doses of Pfizer and Moderna available.  And as we’ve done from the beginning of this administration, we will continue to get supply out the door as soon as it’s available.

Importantly, this means we have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of vaccinations, meet the President’s goal of 200 million shots by his 100th day in office, and continue to reach every adult who wants to be vaccinated by the end of May.

We are working now with our state and federal partners to get anyone currently scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine.   We’re seeing this take place across the country.

The President has committed to the American people that his administration will always lead with science, tell the truth, and give Americans the facts as we know them.  Over the past 24 hours, we’ve been working to provide clear information to the public related to the J&J pause, engaging state and local health officials, governors, community leaders, clinicians, and medical experts.

And our public health officials will continue to appear on television, radio, and social media to communicate directly to the American people so Americans have the latest information and answers to their questions and the opportunity to learn more about the safety and the efficacy of the vaccines and the importance of getting vaccinated.

Stepping back, building vaccine confidence and increasing access to vaccination is central to our efforts to put this pandemic behind us.  That’s why we’ve invested $3 billion to help states and community-based organizations build vaccine confidence, particularly in the hardest-hit and highest-risk communities.

We are getting fact-based messaging and resources into the hands of trusted local messengers.  And it’s why we are making data on the state of the pandemic publicly available, holding these regular press briefings, and are committed to sharing the facts at every turn.

Yesterday’s actions should give the American people confidence in the FDA and CDC, the thoroughness of their review process, and their commitment to transparency and protection of public health.

We believe that by empowering Americans with data and facts, we will strengthen the public’s trust in government and increase their confidence in the vaccines.

In terms of an update on our vaccination program, our vaccination efforts continue to accelerate.  In total, more than 122 million Americans have already received at least one shot, and more than 75 million Americans are already fully vaccinated.  And as you can see from our weekly progress report, our vaccination program is accelerating.  Our current seven-day average is 3.3 million vaccinations per day.  When I last spoke at this briefing last Friday, the seven-day average was 3 million.  So, once again, strong progress.

In the very short term, we do expect some impact on daily averages as sites and appointments transition from Johnson & Johnson to Moderna and Pfizer vaccines.  However, I want to be clear that we have more than enough Pfizer and Moderna vaccine supply to continue or even accelerate the current pace of vaccinations and meet the President’s goal of 200 million shots by his 100th day in office.

In closing, we still have a lot of work to do.  As the President has said, the war against COVID-19 is far from won and we need everyone to do their part.  So, please, please wear a mask, socially distance, and get vaccinated when it’s your turn. 

With that, I’ll turn it over to Dr. Walensky.  Dr Walensky.

DR. WALENSKY:  Thank you so much.  Today, I would like to discuss what’s on everyone’s mind: our recent announcement to recommend a pause on administering the Johnson & Johnson vaccine at this time.  But, first, I do want to share with you where we are in the context of the pandemic. 

Yesterday, the CDC reported 61,000 new cases of COVID.  As such, CDC’s most recent data show the seven-day average of new cases has continued to increase, now 6 percent over the seven-day period with a seven-day average of 67,530. 

Hospital admissions also continue to increase.  The most recent seven-day average — a little over 5,400 admissions per day — is also up 6.8 percent from the previous seven-day period.

And unfortunately, there were also 569 deaths again yesterday. 

Now I want to switch topics to the decision we made yesterday to pause administration on the Johnson & Johnson vaccine.  I have always told you I’m going to tell you the truth and I’m going to lead with science.  And today is, once again, one of those moments.

CDC and FDA were alerted to six cases of rare types of blood clots, called cerebral venous sinus thrombosis, that occurred in combination with low levels of platelets — or a condition known as thrombocytopenia.  Two individuals with these blood clots also had clots in their abdominal cavity or the veins of their gastrointestinal tract. 

The cases were reported to the Vaccine Adverse Events Reporting Systems, known as VAERS, which is a system that CDC and FDA co-manage to serve as an early warning system to monitor the safety of vaccines.  All six individuals with these clots were women between the ages of 18 and 48, and their symptoms presented 6 to 13 days after they were vaccinated with the Johnson & Johnson vaccine. 

These reports of cerebral venous sinus thrombosis and thrombocytopenia are similar to reports of thrombotic events with thrombocytopenia seen in Europe after vaccination with the AstraZeneca vaccine.

In the European cases, both men and women presented with the blood clots, though they were more frequent in women.  The AstraZeneca and Johnson & Johnson vaccines both use an adenovirus vector.  These vaccines are different from the Pfizer and Moderna vaccines, which are mRNA-based vaccines.

And to be very clear, these types of reactions — blood clots in combination with low platelets — are not being seen with the authorized vaccines from Pfizer and Moderna. 

I want to take a step back and explain how these events fit into what we know about the Johnson & Johnson vaccine.  Our latest data shows that we have administered more than 7.2 million doses of Johnson & Johnson vaccine and have yet observed only six of these cases. 

Right now, we believe these events to be extremely rare, but we are also not yet certain we have heard about all possible cases, as this syndrome may not be easily recognized as one associated with the vaccine.  CDC and FDA are working rapidly to investigate each case and understand whether there is a causal relationship between these blood clots and vaccine administration. 

The decision to pause administration of Johnson & Johnson vaccine was made specifically for three reasons: 

First, we want to alert the healthcare providers to be on the lookout for these rare events post-vaccination and to make sure that they are treating patients appropriately.  It is imperative for healthcare workers to know that the treatment of these clots is different than our current standard of care.  While we would typically treat blood clots with a medication called heparin, heparin and its derivatives should definitively be avoided in the treatment of these clots while an investigation of the cause is ongoing. 

Second, there may be additional cases to report.  We want people who have received a vaccine and their healthcare providers to be aware of these events and report them to the CDC and FDA through the VAERS system. 

And third, the pause will allow our independent committee of scientific experts to review the safety information on this vaccine and these events to determine their significance.

Today, at 1:30, CDC will convene the Advisory Committee on Immunization Practices — or ACIP — to discuss the safety data around the Johnson & Johnson vaccine.  Convening the ACIP during a deliberation such as this is part of our standard process to ensure we are gathering the best expert advice. 

During the meeting, ACIP will review the safety profile of the Johnson & Johnson vaccine based on all of the available evidence.  They will analyze the clinical information around these six events post-vaccination and others that are reported, and once able to review the best available evidence, deliberate on potential updates to the vaccine recommendations and uses of the vaccine. 

I know the information we have presented may be very concerning to Americans, especially those who have already received the Johnson & Johnson vaccine.  For people who have received the vaccine more than a month ago, the risk of a blood clot is exceptionally low. 

For people who received the vaccine — meaning recently, meaning within the last few weeks — they should be aware of their symptoms and immediately seek medical assistance with any symptoms of concern.  But also, I want to reiterate to this group: Even in this group, these events are extremely rare. 

Symptoms of a cerebral venous sinus thrombosis or other associated severe blood clot might include a severe headache, abdominal pain, leg pain, or shortness of breath, all leading to an emergency department visit. 

Importantly, we have two other vaccines that are authorized for use in this country.  Again, we are not seeing these events with the other two vaccines — with Pfizer and Moderna. 

People who have vaccine appointments to receive mRNA vaccines should keep their appointments, and we will work with our partners across the country to reschedule those who are intending to get the Johnson & Johnson vaccine.

I want to share with you my confidence in the system that we have in place.  Jointly, CDC and FDA were able to identify these rare events and act quickly to alert healthcare providers and the public.  This demonstrates that the safety systems we have in place are working. 

We will continue to monitor vaccinations and adverse events across this country.  This pause will allow us to accelerate reporting of possible adverse events from healthcare providers across the country and to all of you.

As we obtain more data and can carefully review each case, we will be able to provide the best recommendations and appropriate next steps given the current context of the COVID-19 pandemic and our broader immunization efforts.

We are committed to following the science and ensuring complete transparency as we pursue this investigation.  As our promise, we are going to tell you what we know when we know it.

And with that, I will turn things to Dr. Fauci.

DR. FAUCI:   Thank you very much, Dr. Walensky.  What I’d like to do is just spend a minute or so just adding one aspect of this discussion that we have been questioned on fairly intensively over the last 24 hours, and that is the issue of whether or not this action on the part of the CDC and the FDA will actually make the issue of vaccine hesitancy even a more difficult problem as people see what’s going on here and then they then, essentially, extrapolate that to the issue of hesitancy not only for this vaccine, but for all the vaccines that are available.

To underscore what Dr. Walensky said, this was done in an abundance of caution to be able to take a look at the issues that Dr. Walensky delineated.  Importantly, when I go out and try to counter the issues of hesitancy, a substantial proportion of the hesitancy is centered around concern that the vaccines might not be safe. 

I’ve addressed this many times on this briefing.  For example, the question: “You did this so quickly — in 11 months; it usually takes years.  Is there are a real problem here?  Did you cut corners?  And did you not pay enough attention to safety?”

The fact that, following the EUA, we have continued to follow very carefully any possibility of adverse events, I believe, is the other side of the coin of hesitancy.  It should reinforce, in those individuals, how we take safety so seriously. 

So as opposed to looking this as a negative safety issue, it could be looked at as a positive issue, where they know that when we let a vaccine be available and give it a go-ahead to be put into the arms of the American people, we do it with a considerable degree of confidence as to its safety. 

So when I get asked questions about whether or not this has set us back from a hesitancy standpoint, I give the opposite of it, mainly what I’ve just explained. 

So, with that, let’s get back to Jeff.

MR. ZIENTS:  Thank you, Dr. Fauci.  Thank you, Dr. Walensky.  Why don’t we open it up for a few questions.

MODERATOR:  Thank you.  And a reminder, guys, we don’t have a ton of time today, so please keep your question to one question.  First, we will go to Cheyenne Haslett at ABC.

Q    Hi, thanks for taking this question.  I wonder: Are you prepared to increase Pfizer or Moderna to states in the case that people are too concerned to go with J&J even if the pause is lifted?

MR: ZIENTS:  So we are going to continue to allocate doses the way we’ve described in the past, which is based on states’ population — adult population. 

There is plenty of supply in the system.  For the last three weeks, we’ve distributed or made available more than 25 million doses of Pfizer and Moderna.  This week we shipped out 28 million doses through our state and federal channels.

So there is plenty of supply in the system of Moderna and Pfizer, including to replace J&J appointments with Pfizer and Moderna vaccine.  And that’s happening, as we speak, throughout the country.

Next question.

MODERATOR:  Victoria Knight, Kaiser Health News.

Q    Hi, thanks for taking my question.  My question is about vaccine passports.  I know the federal government — you guys have repeatedly said you’re not going to maintain a federal database, but does that mean you’re just going to leave it up to every state to track it?  What is your plan if people lose their vaccination cards?  It just seems like it could become kind of a hot mess if someone is not overseeing everyone’s vaccinations. 

MR. ZIENTS:  So — so, you’re right.  You know, let me be clear that the government is not now, nor will we be supporting a system that requires Americans to carry a credential.  There’ll be no federal vaccination database, no federal mandate requiring everyone to obtain a single vaccination credential.

As these tools are being considered by the private and not-for-profit sectors, our interest is simple, and that’s about protecting Americans’ privacy and their rights so the systems aren’t used unfairly. 

So we will make sure that, you know, consumers’ protections are first and foremost in the private and not-for-profit sector efforts.  But there will be no government — federal government system in place. 

Next question. 

MODERATOR:  Erin Billups, Spectrum News. 

Q    Hi.  Thank you for taking my question.  In light of new variants circulating and the need to vaccinate as many people as possible, what is the plan to combat growing vaccine hesitancy on the ground in the wake of the J&J pause?  Does the CDC have plans to work with, say, community health centers and local governments and help them with this?

MR. ZIENTS:  Why don’t — why don’t I go first there, and then, Drs. Fauci and Walensky, if you want to add anything.  I think you’re — you’re absolutely correct that building vaccine confidence is critical to making sure Americans get vaccinated when it’s their turn.  And we have a robust campaign to increase vaccine confidence. 

We’ve allocated $3 billion to community-based organizations, as you point out, to increase vaccine access and confidence in hard-hit and hard-to-reach places.  We built the COVID-19 Community Corps to get local leaders key information about the vaccines.

All the research shows that people look to leaders in their communities for counsel and advice on issues like whether they should get vaccinated.  And we’re ramping up our targeted paid media efforts in multiple languages to increase confidence.

You know, leading with science, as Dr. Fauci talked about, and giving Americans the facts they need is central to building that vaccine confidence.  And I think yesterday’s action should give the American people increased confidence in the FDA and CDC, the seriousness of the review process, and the steadfastness of their commitment to transparency. 

And we’re — you know, we’re already hearing from leaders — and, Dr. Fauci, you should comment on this — that, you know, experts in the communities are — appreciate how the FDA and CDC are handling this situation with J&J.  And that’s, in fact, helping them to build confidence at the local level. 

Dr.  Fauci, anything to add there?

DR. FAUCI:  Just one issue that’s just very fresh in my mind, and that had to do with the COVID-19 Community Corps.  Surgeon General Vivek Murthy and I addressed the group last night.  They were on the Zoom, literally 2,000 people — could you imagine that on Zoom? — (laughs) — in which we spoke about just what you’re talking about: explaining to them what has gone on and why they need to get out there as trusted members of the community and explain to people why this was done and why we feel that that’s an important part of the safety that we like to guarantee whenever we get products into the arms of people. 

MR. ZIENTS:  Okay, next question. 

MODERATOR:  Zeke Miller, AP. 

Q    Thank you all for doing the call.  Jeff, I was hoping you might be able to address whether the administration was looking to purchase additional Pfizer or Moderna doses now because of this J&J pause, particularly given that now more of those doses will be going to adults to make up for the J&J doses and the promise of Pfizer getting an EUA in for teenagers.  Is there a procurement process underway for that? 

And then, secondly, is there an estimate of if the Johnson & Johnson vaccine remains paused, how much slower the vaccination program will be, particularly in the May timeframe?  You know, you must be able to project out some estimate of what the impact would be in terms of when all adults would be vaccinated. 

MR. ZIENTS:  So, Zeke, on Pfizer and Moderna, you’ll recall that in February the President ordered 100 million additional doses of each Pfizer and Moderna, which brings us to 600 million doses by the end of July.  That Pfizer CEO recently announced yesterday that he’s actually accelerating that timeframe to mid-July. 

So that’s enough doses to vaccinate 300 million Americans, so there’s no further procurement under underway in the moment.  So there’s plenty of Pfizer and Moderna doses on order and being delivered. 

Furthermore, we’re doing everything we can to accelerate the delivery of those doses.  And again, Pfizer announced that they’ll deliver their first 200 of their 300 before their May 31st deadline.  And I know Moderna is on track, and we’re working with Moderna to do everything we can to accelerate those doses.

I forgot — can you repeat your second question? 

Q    It was just: Is there an estimate, if the J&J vaccine remains paused, what the impact would be on the pace of — or the timeline by which you expect —

MR. ZIENTS:  We don’t — we don’t expect any significant impact whatsoever, in that those numbers that I showed you, the accelerating weekly vaccinations, we can support that level of vaccination, and even more, with the current supply that we have of Moderna and Pfizer doses.

Next question, please.

MODERATOR:  Last question.  Let’s go to Chris Megerian at the Los Angeles Times.

Q    Hi.  Yeah, I had a question about the schedule for May.  My understanding was that the President moved up the timeline for having enough doses to the middle of May, but you mentioned the end of May.  Is that slipping a couple weeks because of the J&J situation?  How would you characterize that?

MR. ZIENTS:  There’s no change.  We’ve always talked about enough doses to vaccinate adult Americans by the end of May, and there’s been no change in that.  What has changed, as I mentioned earlier, is that Pfizer will deliver their 200 million doses before the end of May, and Moderna stays — it remains on track. 

And, you know, we are on track for the various goals that we’ve set.  The next goal that is in our sight is 200 million doses by the President’s 100th day, which is April 29th, and we’re on track to meet or beat that goal.

Well, I want to thank everybody.  Next briefing will be on Friday.  Thank you.

11:37 A.M. EDT

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