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CDC and FDA Call for Pause of J&J Vaccine over Blood Clot Concerns; CDC Says, Vaccine Safety Top Priority for Federal Government. Aired 10-10:30a ET

Aired April 13, 2021 - 10:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

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[10:00:00]

JIM SCIUTTO, CNN NEWSROOM: A very good Tuesday morning to you. I'm Jim Sciutto.

We begin this hour with the breaking news. The White House has just announced that all federal health channels, that means mass vaccination sites, community health centers and others are immediately pausing use of the Johnson & Johnson COVID-19 vaccine. Why? This comes after this morning's recommendation by both the CDC and FDA to temporarily pause the use after six reported cases here in the U.S. of a rare and severe type of blood clot. We should note that six cases after more than 6 million doses of J&J vaccines have been administered.

The FDA is set to hold a press conference to answer further questions on this at any moment. We are following that and we'll bring it as it comes.

Also minutes from now, the prosecution in the Derek Chauvin murder trial is expected to rest its case today and the defense could begin calling its own witnesses in just hours. This comes after a second night of protests and violent clashes with police fueled by the death of yet another unarmed black man just ten miles away from where the Chauvin trial is taking place. This time, police shot 20-year-old Daunte Wright. There he is.

Also this morning, right now on Capitol Hill, a ceremony is under way for fallen U.S. police officer, Capitol Police officer Billy Evans. He was killed, you may remember, earlier this month when an attacker rammed his car into him and another officer who was injured at the north barricade of the Capitol complex.

Lots of news happening this morning. We will bring that you ceremony as well.

We do begin though with the breaking news on Johnson & Johnson's vaccine. Joining me now, CNN Senior Medical Correspondent Elizabeth Cohen. Elizabeth, describe the data here that led to this decision.

ELIZABETH COHEN, CNN SENIOR MEDICAL CORRESPONDENT: Jim, this is really an example of the system working the way that it's supposed to. As you mentioned, millions of people have gotten this vaccine and they monitored it to see if any odd things were happening and they found, well, that something very odd and very serious and very rare was happening.

So let's go over these numbers. So in the United States, nearly 7 million people have received the Johnson & Johnson vaccine and what's been documented as six cases of rare and serious brain blood clots all in women ages 18 to 48. And the symptoms appear 6 to 13 days after vaccination.

So I'm sure that people, especially young women, who have been vaccinated with Johnson & Johnson recently might be asking themselves, yikes, what should I look for? So again, I will say, this is very rare. But there are certain symptoms that you should watch out for and if you have them, you should call your health care provider.

So this is right from the CDC. You should contact your health care provider. If within three weeks of getting this vaccine, the Johnson & Johnson vaccine, you have a severe headache, abdominal pain, leg pain or shortness of breath.

Now, not all of those, you would say, what does that have to do with a brain blood clot. Well, sometimes these blood clots theoretically could appear in other parts of your body as well.

So, Jim, obviously this is not great news. No one wanted this to happen. But I want to temper this with one thing. We have been told by the federal government that achieving the vaccination goals is not dependent on J&J. It was a very small percentage of all the vaccines that were being done. Moderna and Pfizer, those are being used in much higher numbers. Moderna and Pfizer do not have this blood clot concern. So the thinking is that we can reach the goals that we need to reach in the United States without using Johnson & Johnson. Jim?

SCIUTTO: J&J doses just about 3 percent of the total number of vaccines administered so far in this country. Elizabeth Cohen, thank you so much.

Let's go to one of the sites though where Johnson & Johnson vaccines were expected to be administered. CNN's Brynn Gingras, she is at the Javits Center in New York, a major vaccination site. I got mine on that vaccination there. It was Pfizer though.

Brynn, what is the latest there? Is J&J a big part of New York's plan?

BRYNN GINGRAS, CNN NATIONAL CORRESPONDENT: Yes. Well, if you remember, Jim, J&J helped actually make the Javits Center and other mass vaccination sites around the state into a 24/7 operation. So it wasn't, as Elizabeth, a huge part of the distribution process but it certainly added to it.

And there were disappointment from people we actually spoke to this morning who were arriving --

SCIUTTO: Brynn, hold that thought if I can. Hold your thought if you can. We're going to go right to this live press conference on this decision. This is the FDA speaking about the J&J vaccine. Let's listen in.

UNIDENTIFIED FEMALE: -- help moderate a question and answer portion following brief opening remarks by Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, the CDC's principle director.

[10:05:11]

After their remarks, we will then move to the question and answer portion of the call. Reporters on the call will be in a listen-only mode until we open the call up for questions. As a reminder, this audio call is being recorded and livestreamed on the FDA's YouTube channel. When asking a question, state your name and affiliation. You will be given the opportunity for one question.

With that, I will now turn the call over to acting FDA Commissioner Dr. Janet Woodcock.

DR. JANET WOODCOCK, ACTING FDA COMMISSIONER: Thank you, and thank you all for joining us.

This morning, the FDA and CDC announced that out of an abundance of caution, we're recommending a pause in the use of the Johnson & Johnson COVID-19 vaccine due to reports of six cases of a rare and severe type of blood clot following vaccine administration. We're recommending this pause while we work together to fully understand these events and also so we can get information out to health care providers and vaccine recipients.

Right now, I would like to stress these events appear to be extremely rare. However, COVID-19 vaccine safety is a top priority for the federal government. And we take all reports of adverse events following vaccination very seriously. I'd like to turn it over to Dr. Peter Marks, Director of FDA's Center for Biologics Evaluation and Research, for more information about these reports. Peter?

DR. PETER MARKS, DIRECTOR, FDA CENTER FOR BIOLOGICS EVALUATION AND RESEARCH: Thank you, Dr. Woodcock.

Together, the CDC and the FDA are reviewing data involving six reports of a rare type of blood clot called cerebral venous sinus thrombosis, or CVST, in combination with low levels of platelets in the blood, called thrombocytopenia, in women ages 18 to 48 who presented with symptoms between 6 and 13 days after receiving the Johnson & Johnson, or Janssen's COVID-19 vaccine.

Treatment of this specific type of blood clot is different from typical treatments for other types of blood clots, which usually involve anti-coagulant called heparin. With cerebral venous sinus thrombosis, heparin may be dangerous and alternative treatments need to be given preferably under the guidance of physicians experienced in the treatment of blood clots.

Of the clots seen in the United States, one case was fatal and one patient is in critical condition. While we review the available data out of an abundance of caution, the FDA and CDC are recommending a pause in the use of this vaccine in the United States.

The FDA will revise the fact sheets for the health care providers administering vaccine and the fact sheet for recipient and caregivers for the Janssen COVID-19 vaccine to include this adverse event information to ensure that health care providers are able to make appropriate benefit/risk determinations for their patients.

I want to reiterate what Dr. Woodcock said. Right now, these events appear to be extremely rare. That said, COVID-19 vaccine safety is a top priority for federal government and we take all reports of adverse events following vaccination very seriously. Health care providers who see people presenting to them with either low blood platelet count or blood clots should establish whether or not the individual has recently been vaccinated in order to inform the appropriate diagnostic evaluation and management.

Now I'd like to turn to Dr. Anne Schuchat, the CDC's principal deputy director, to speak to further explain our decision and next steps. Anne?

DR. ANNE SCHUCHAT, PRINCIPAL DEPUTY DIRECTOR, CDC: Thank you so much, Dr. Marks.

I know that the information we're providing today is going to be very concerning to Americans who have already received the Johnson & Johnson vaccine or Janssen vaccine. And I want to let you know what we're doing to learn more and to protect people in the meantime and what can you do to be on the alert.

As Dr. Marks mentioned, there have been six reports of a severe stroke-like illness linked to low platelet counts, and more than 6 million doses of the J&J vaccine have been administered so far. While these events are very rare, we're recommending a pause in the use of the J&J COVID-19 vaccine in order to prepare the health care system to recognize and treat patients appropriately and to report severe events they may be seeing in people who received the J&J vaccine.

[10:10:02]

This pause will also allow the CDC's expert committee to review the situation.

The safety of vaccine and the safety American people is the utmost importance to us. The ACIP, or our Advisory Committee on Immunization Practices, is the CDC's independent scientific expert committee on immunization matters. We are scheduling for them to convene tomorrow to review the data we have on these initial cases. This will allow careful deliberation about what we know so far about these events and consider next steps given the current context of the COVID-19 pandemic in the United States and our broader immunization efforts. As a reminder, ACIP meetings are open to public viewing.

Today, we're also alerting state health officials and other leaders in the states and cities, pharmacies and other health care providers who are administering the vaccine to make sure that they know about the pause and so clinicians know how to evaluate and report severe events after vaccination.

Lastly, I know there are people who have gotten the vaccine who are probably very concerned. For people that got vaccine more than a month ago, the risk to them is very low at this time. For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms. If you've received the vaccine and developed severe headache, abdominal pain, leg pain or shortness of breath, you should contact your health care provider and seek medical treatment.

These symptoms are different from mild flu-like symptoms, fever and so forth, that many people experience in a couple days after receiving the vaccine.

Importantly, there are three vaccines available and we are not seeing these clotting events with lower platelet counts with the other two vaccines. People who have vaccine appointments with the other two vaccines should continue with their appointment. Our partners will be working to reschedule people who have the J&J vaccine appointments in the days ahead.

This may be a bit bumpy. We want to make sure that we're getting the word out to the public and to our providers, but we do want to make sure that people who are scheduled to have vaccination will be able to get that when vaccine is available.

We're committed to following the science, ensuring transparency and to provide you regular updates. We're going to tell what you we know when we know it and what you can do to protect yourself. And our intention is to update you in the days ahead.

I know this has been a long and difficult pandemic and a very long year-and-a-half and that people are tired of the steps that they need to take and are keen to be able to be vaccinated. The steps we're taking today are meant to make sure that the health care system is ready to diagnose, treat and report and that you, the American public, has the information you need to stay safe. Thank you.

UNIDENTIFIED FEMALE: Thank you, Dr. Schuchat. At this time, we will begin the question and answer portion of the briefing. When asking a question, please state your name and affiliation. Operator, we'll take the first question.

UNIDENTIFIED FEMALE: Thank you. And once again, that is star one if you would like to ask a question.

Our first question comes from Kiran Stacey. You may go ahead, and please state your outlet.

KIRAN STACEY, WASHINGTON CORRESPONDENT, FINANCIAL TIMES: Thanks very much. This is Kiran Stacey from the Financial Times.

This obviously looks like the same thing that is happening with the AstraZeneca vaccine. And I was wondering if you can tell us a little bit about the context that you had with regulators in Europe about that, and also whether there is any evidence of similar events happening with Moderna and Pfizer.

WOODCOCK: Certainly. This is Janet Woodcock. We are in constant contact with the regulators worldwide and looking at adverse events experienced in different regions. I'll turn this over to Dr. Marks to answer in detail.

MARKS: Yes, thank you very much. So you asked about whether there was similar cases with the Moderna or Pfizer vaccines, and there have been over 180 million doses of these vaccines administered. And at this time, we have not found any reports of cerebral venous sinus thrombosis combined with thrombocytopenia.

[10:15:02]

UNIDENTIFIED FEMALE: Operator, we'll take the next question.

Thank you. That comes from Michael Erman, you may go ahead and please state your outlet.

MICHAEL ERMAN, CORRESPONDENT, REUTERS: Hi. This is Mike Erman from Reuters. I'm wondering just quickly how long the pause is expected to be, what is the minimum time, and also whether you're considering limiting vaccination for J&J to certain groups, like people over 50 or all men and women over 50?

WOODCOCK: Well, timeframe will depend, obviously, in what we learn in the next few days. However, we expect it to be a matter of days for this pause. And I will maybe turn it over to Dr. Schuchat to answer further.

SCHUCHAT: Yes, thank you, Dr. Woodcock.

We are committed to an expeditious review of the available information and to an aggressive outreach to clinicians so that they know how to diagnose, treat and report. One of the things that the ACIP deliberation will do is review the data on the cases and the context of risks, benefits and possible subsets of the population that may be in a different category. So I think our intent is in the days ahead to provide an update with you regularly and that that pause provides us time for deliberations and assuring appropriate diagnosis and treatment.

UNIDENTIFIED FEMALE: Operator, we'll take the next question.

UNIDENTIFIED FEMALE: Thank you. Our next question comes from Elizabeth Weise. You may go ahead and please state your outlet.

ELIZABETH WEISE, NATIONAL CORRESPONDET, USA TODAY: Hi. USA Today.

I have a question, and maybe this is for Dr. Marks. Do you have any sense of what the mechanism behind this might be, what could potentially be causing this?

WOODCOCK: Yes. Well, we have hypothesis. It's Janet Woodcock. Dr. Marks may be want to enlarge upon that.

MARKS: Yes. So, thanks very much. We don't have a definitive cause. But the probable cause that we believe may be involved here that we can speculate is a similar mechanism that may be going on with other -- the other adenoviral vector vaccine, that is that this is an immune response that occurs very, very rarely after some people receive the vaccine. And that immune response leads to activation of the platelets and these extremely rare blood clots.

WOODCOCK: Yes. So to be specific, this is Janet Woodcock, the person being vaccinated makes an immune response potentially that actually involves their own platelets or other parts of the coagulation system and can cause this problem. And that is the sort of leading theory or hypothesis about what is going on here.

UNIDENTIFIED FEMALE: Operator, we'll take the next question.

Thank you. And that comes from Matt Perrone. You may go ahead and please state your outlet.

MATT PERRONE, HEALTH REPORTER, ASSOCIATED PRESS: Hi, thank, with the Associated Press. Thanks for taking questions.

Can you talk a little bit more about just how the FDA determined that these six events out of, you know, almost 7 million injections constitute a signal? I mean, what would have been the background rate for the type of event like this, if there is another explanation possible?

WOODCOCK: Certainly. This is Janet Woodcock. This is an extensive work between the CDC and the FDA on this set of events and analysis to see exactly what you're asking about. So, Dr. Marks, you would like to respond?

MARKS: Yes, thanks very much.

So, the issue of the cerebral venous sinus thrombosis, the background rate of that is probably somewhere between 2 and 14 per million people. But that's in the setting of a normal platelet count. The combination here, the real thing that is so notable here is not just the cerebral venous sinus thrombosis or the thrombocytopenia. Those two things can occur. It's their occurrence together that makes a pattern and that pattern is very, very similar to what was seen in Europe with another vaccine. So I think have to take the time to make sure we understand this complication and we address it properly.

[10:20:06]

PERRONE: Thank you.

UNIDENTIFIED FEMALE: Operator, we'll take the next question.

UNIDENTIFIED FEMALE: Ann Flaherty, you may go ahead, and please state your outlet.

ANNE FLAHERTY, ABC NEWS CONTRIBUTOR: Hi, this is Anne Flaherty with ABC News.

So what would you say to people who are concerned and frustrated that they think this might be an overreaction considering it's six people out of 7 million?

WOODCOCK: If I would, Dr. Schuchat, to go on to that -- okay.

SCHUCHAT: Sure. We are committed to safety and transparency and to expeditiously learning as much as we can so that further steps can be taken. When we saw this pattern and we're aware of that treatment needed to be individualized for this condition, it was at the utmost importance for us to get the word out.

That said, the pandemic is quite severe and cases are increasing in a lot of places vaccination is critical. So we want to make sure that we make some recommendations quickly.

UNIDENTIFIED FEMALE: Thank you. Operator, we'll take the next question.

UNIDENTIFIED FEMALE: Thank you. Jacqueline Howard, you may go ahead, please state your outlet.

JACQUELINE HOWARD, CNN HEALTH REPORTER: Thanks for taking my question. I'm with CNN.

And I would like to know more about the decision-making process for the pause. It seems like just yesterday, we were told that this was something that was being looked into. And then this morning, the decision was made. We also understand that some states may be upset that they were not given a heads-up. So can someone explain how did this decision happen quickly and why was the decision made and were states involved or given awareness or heads-up that the pause would happen? Thank you.

WOODCOCK: Dr. Marks? Go ahead.

SCHUCHAT: Yes. Maybe I can just start and then let Dr. Marks expand.

I wish that we had more time to get everyone prepared and that this could go even more smoothly, we -- as we learned about the issue with appropriate treatment, and it was clear that we needed to alert the public. We want to -- we included the pause in addition to the alert so that there was time for the health care community to learn what they needed to learn about how to diagnose, treat and report. But the decision was based on the events that might occur between when we made that realization and then we got the word out.

So it was a question of wanting to make sure we could be open with our concerns and prepare the health care community to diagnose, treat and report while the more detailed deliberation occurs tomorrow.

WOODCOCK: I don't know if you have anything to ask, Dr. Marks.

MARKS: Now, if I could just echo that the issue here with these types of blood clots is that if one administers the standard treatments that we as doctors have learned to give for blood clots, one can actually cause tremendous harm or the outcome can be fatal.

So one needs to make sure that providers are aware that if they see people who have low blood platelets or if they see people who have blood clots, they need to inquire about history of recent vaccination and then act accordingly in the diagnosis and management of those individuals.

This was taken rapidly in order to honor our commitment to the American public to ensure that any safety signal that came up during this vaccine rollout was fully addressed in a transparent manner.

UNIDENTIFIED FEMALE: Operator, we'll take the next question.

UNIDENTIFIED FEMALE: Thank you. Caroline Chen, you may go ahead, and please state your outlet.

CAROLINE CHEN, INVESTIGATIVE REPORTER, PROPUBLICA: Hi, I'm Caroline Chen from ProPublica.

I was wondering if the FDA has any sense of any subpopulations or medical histories that may predispose a person to this rare side effect or even if you have a hypothesis on that at this point.

WOODCOCK: This is Janet Woodcock. I believe there are too few cases for us to make that determination for this particular vaccine.

[10:25:00]

We may be hearing about more cases. We will look further into these. We'll have deliberations, which was described, tomorrow about the detail. But we aren't prepared at this time to single out any particular subgroup.

UNIDENTIFIED FEMALE: Operator, we'll take the next question.

UNIDENTIFIED FEMALE: Thank you. Jacquie Lee, you may go ahead, and please state your outlet.

JACQUIE LEE, JOURNALIST, BLOOMBERG LAW: Hi, good morning, thank you so much for having this call. I'm with Bloomberg Law.

I was hoping that someone could address kind of the -- anything that you would suggest going forward regarding messaging for this. I would anticipate that, you know, there could be some fears about this stoking some more vaccine hesitancy. And so, you know, what would you recommend to health providers to avoid that situation?

WOODCOCK: Well, this is Janet Woodcock. Again, number one, we had several questions about -- related to this. I think we need to reiterate. We are committed to vaccination. We feel that is a really important tool to get this pandemic under control. We're also committed to patient safety. And our message is that in doing this, we feel we're taking the route that will provide the most safety for the patient by enabling health care professionals to recognize, to properly treat and properly report any of the events that might happen. But the message to patients, I think, would be to those who haven't been vaccinated would continue to be to get vaccines that are available to them because the risks from the pandemic are significant. And that the government is really looking into very carefully any safety problems so that they can be managed properly with this particularly vaccine and all vaccines.

SCHUCHAT: Maybe I could expand. This is Dr. Schuchat. Just to say, I agree with Dr. Woodcock's assessment. And just to remind clinicians in the public that 121 million people have been vaccinated with at least one dose of one of the three vaccines, and the vast majority of the doses were of the other two products, the Pfizer and Moderna products.

With our intensive safety monitoring, we have not detected this type of syndrome with the low platelets among the other vaccines. And we have real world evidence now of the vaccine's effectiveness in the U.S. So we're taking this pause and precautions around the J&J product in the context of a large, robust and highly safe and effective vaccination effort.

UNIDENTIFIED FEMALE: Thank you. Operator, we'll take the next question.

UNIDENTIFIED FEMALE: Thank you. Evan Brawn, you may go ahead, and please state your outlet.

EBEN BROWN, NATIONAL CORRESPONDENT, FOX NEWS: Hi, good morning. This is Eben Brown from Fox News.

I am curious about the choice of words in your announcements. You are recommending a pause in the use of the Johnson & Johnson vaccine but you are not ordering a stoppage. Is there a difference between the two? What would that difference be? And what would happen or what should happen or what are your words to a state or a county or a non- profit outfit that does not heed your recommendation? Thank you.

WOODCOCK: Dr. Marks, would you like to answer that one?

MARKS: Yes. Thanks very much for that question.

This is a recommendation and it's not a mandate. It's out of an abundance of caution we're recommending that the vaccine be paused in terms of its administration. However, if an individual health care provider has a conversation with an individual patient and they determine that the benefit/risk for that individual patient is appropriate, we're not going to stop that provider from administering the vaccine because it could be, right, in many cases, that benefit/risk will be beneficial overall to that individual in a large majority of cases.

So, again, we're recommending a pause out of an abundance of caution. But on an individual basis, a provider and patient can make a determination whether or not to receive the vaccine.

UNIDENTIFIED FEMALE: Operator, we'll take the next question.

[10:30:00]

UNIDENTIFIED FEMALE: Thank you. Sarah Owermohle, you may go ahead, and please state your outlet.

SARAH OWERMOHLE, HEALTH CARE REPORTER, POLITICO: Hi, thank you. This is Sarah Owermohle from Politico.