FDA, CDC Press Conference on Pause of Johnson & Johnson Vaccine Transcript April 13

Operator: (01:50) Good morning. And thank you for standing by. As a reminder, today's conference is being recorded. If you have any objections to please disconnect at this time. Your lines are in listen only mode until the question and answer session of today's conference. At that time, you may press star followed by the number one to ask a question. Please unmute your phones and state your name when prompted. It is now my pleasure to turn the conference over to Stephanie Tacomo. Thank you. You may begin. Stephanie Tacomo: (02:17) Good morning and welcome to this joint media briefing by the FDA and CDC on the Johnson and Johnson COVID 19 vaccine. I'm Stephanie Tacomo with FDA's office media affairs. In a moment, I will turn it over to Dr. Janet Woodcock acting commissioner of the Food and Drug Administration who will 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. Ann Schuchat, the CDC's principal deputy director. 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 live streamed on the FDA's YouTube channel. When asking a question, please 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: (03:19) 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 and 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 healthcare providers and vaccine recipients. Right now, I'd 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 Center for Biologics Evaluation and Research for more information about these reports. Peter. Peter Marks: (04:22) 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 CBST in combination with low levels of platelets in the blood called thrombocytopenia in women ages 18 to 48 who presented with symptoms between six and 13 days after receiving the Johnson and Johnson or Janssen 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 an anticoagulant 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. Peter Marks: (05:33) The FDA will revise the fact sheet for the healthcare 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 healthcare providers are able to make appropriate benefit, risk determinations for their patients. I want to reiterate what Dr. Woodcock said. Right now, these events that 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. Healthcare providers who see people presenting to them with either a 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. Ann Schuchat, the CDC's principal deputy director to speak to further explain our decision and next steps. Ann. Ann Schuchat: (06:40) Thanks 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 and Johnson 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 you can 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 healthcare system to recognize and treat patients appropriately and to report severe events they may be seeing in people who've received the J&J vaccine. This pause will also allow the CDC's expert committee to review the situation. The safety of vaccines and the safety of the American people is of the utmost importance to us. Ann Schuchat: (07:55) 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 healthcare 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. Ann Schuchat: (08:57) Lastly, I know there are people who have gotten the vaccine who are probably very concerned. For people who've got the vaccine more than a month ago, the risk of them is very low at this time. For people who recently got the vaccine within the last couple of weeks, they should be aware to look for any symptoms. If you've received the vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath, you should contact your healthcare provider and seek medical treatment. Now, these symptoms are different from mild flu like symptoms, fever and so forth that many people experience in the couple of days after receipt of the vaccine. Importantly, there are three vaccines available and we are not seeing these clotting events with low platelet counts with the other two vaccines. People who have vaccine appointments with the other two vaccines should continue with their appointment. Ann Schuchat: (10:02) The other two vaccines to continue with their payments, our partners are, we'll be working to reschedule people who have the J&J vaccine appointment, 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 vaccinations will be able to get that one that seems available. We're committed to following the science and ensuring transparency, and to providing regular updates. We're going to tell you what 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 healthcare system is ready to diagnose, treat, and report, and that you, the American public has the information you need to stay safe. Thank you. Stephanie Tacomo: (11:18) Thank you, Dr. [Shookett 00:11:20] 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. Operator: (11:31) Thank you. And once again, that is star one if you would like to ask a question. Our first question comes from [Kiren Stacy 00:11:37]. You may go ahead and please state your outlet. Kiran Stacy: (11:41) Thanks very much. This is Karin Stacey from the Financial Times. This obviously looks like the same thing that was happening with the AstraZeneca vaccine, and I was wondering if you had a little bit about the context that you've had with regulators in Europe about that, and also whether there's any evidence of similar events happening with Moderna and Pfizer [inaudible 00:12:00]? Dr. Janet Woodcock: (12:03) Certainly, this is Janet Woodcock. We are in constant contact with the regulators worldwide and looking at adverse events experienced in different regions. They'll turn this over to Dr. [Marx 00:12:15] to answer in detail. Peter Marks: (12:18) Thanks very much. So you asked about whether there were similar cases with the Moderna or Pfizer vaccines, and there've been over 180 million doses of these vaccines administered, and at this time we've not found any reports of cerebral vein sinus thrombosis combined with thrombocytopenia. Stephanie Tacomo: (12:43) Operator. We'll take the next question. Operator: (12:47) Thank you. That comes from Michael [Urman 00:12:48]. You may go ahead and please state your outlet. Mike Urman: (12:53) Hi, this is, this is Mike Urman from [Reuters 00:12:55]. I'm wondering, just quickly, how long the pause is expected to be what's 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? Dr. Janet Woodcock: (13:15) Well, the timeframe will depend obviously on 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. Shookett to answer further. Ann Schuchat: (13:31) 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 will have to diagnose, treat and record. One of the things that the [ACIP 00:03:49] 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 regularly and that the pause provide those time for deliberation, and assuring appropriate diagnosis and treatment. Stephanie Tacomo: (14:15) Operator, we'll take the next question. Operator: (14:19) Thank you. Our next question comes from Elizabeth [Wais 00:14:22], you may go ahead and please state your outlet. Elizabeth Wais: (14:24) Hi. USA Today. I think the question, and maybe this is for Dr. Marx; do you have any sense of what the mechanism behind this might be? What could potentially be causing this? Dr. Janet Woodcock: (14:37) Yeah, well, we have hypotheses, this is Janet Woodcock. Dr. Marx, maybe you want to enlarge upon that? Peter Marks: (14:44) Yeah, 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 adeno viral vectored 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. Dr. Janet Woodcock: (15:20) Yeah. 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's the sort of leading theory or hypothesis about what's going on here. Stephanie Tacomo: (15:48) Operator, we'll take the next question. Operator: (15:51) Thank you. And that comes from Matt [inaudible 00:15:54]. You may go ahead and please state your outlet. Matt: (15:57) Hi, thanks. For 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 almost 7 million injections constitute a signal? I mean, what would have been the background rate for a type of events like this? If there is another explanation possible? Dr. Janet Woodcock: (16:22) Certainly. This is Janet Woodcock. This was a 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. Marx would you like to respond? Peter Marks: (16:42) Yeah, thanks very much. So the issue of cerebral venous veins, cerebral venous sinus thrombosis, the background rate of that is probably somewhere between two 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 we have to take the time to make sure we understand this complication, and we address it properly. Stephanie Tacomo: (17:46) Operator, we'll take the next question. Operator: (17:50) [Anne Flaherty 00:17:50], you may go ahead and please state your outlet. Anne Flaherty: (17:53) Hi, this is Anne Flaherty with ABC News. So, what do you say to people who are concerned and frustrated that they think this might be an overreaction considering it's six people and out of 7 million? Stephanie Tacomo: (18:07) I would ask Dr. [inaudible 00:18:11] to respond to that. Ann Schuchat: (18:13) Okay. Sure. You know, 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 were aware of that treatment needed to be individualized for this condition, it was of the utmost important for us to get the word out. That said, the pandemic is quite severe and cases are increasing in a lot of places, and vaccination is critical, so we want to make sure that we make some recommendations quickly. Stephanie Tacomo: (18:57) Thank you, Operator, we'll take the next question. Operator: (19:00) Thank you, Jacqueline Howard, you may go ahead, please state your outlet. Jaqueline Howard: (19:05) 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. Stephanie Tacomo: (19:44) Dr. Marx? Oh, go ahead. Dr. Janet Woodcock: (19:46) Yeah, maybe I can just start and then let Dr. Marx expand. I wish that we had more time to get everyone prepared, and that this could go even more smoothly. As we learned- Ann Schuchat: (20:03) -and more smoothly. As we learned about the issue with appropriate treatment, and it was clear to us that we needed to alert the public, we included the pause in addition to the alert, so that there was time for the healthcare 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 when we got the word out. It was a question of wanting to make sure we could be open with our concerns and prepare the healthcare community to diagnose, treat and report while the more detailed deliberation occurs tomorrow. Ann Schuchat: (20:59) I don't know if you have anything to add, Dr. Marks. Peter Marks: (21:02) No, I would 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 a history of recent vaccination and then act accordingly in the diagnosis and management of those individuals, that 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. Speaker 1: (22:03) Operator. We'll take the next question. Speaker 2: (22:06) Thank you. Caroline Chen, you may go ahead and please state your outlet. Caroline Chen: (22:11) Hi, I'm Caroline Chen and ProPublica. I was wondering if the FDA has any sense of any sub-populations 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? Dr. Janet Woodcock: (22:27) This is Janet Woodcock. I believe there are too few cases for us to make that determination for this particular vaccine. We may be hearing about more cases. We will look further into these. We will have deliberations as was just described tomorrow about the details, but we aren't prepared at this time to single out any particular subgroup. Speaker 1: (22:59) Operator, we'll take the next question. Speaker 2: (23:03) Thank you. Jacquie Lee, you may go ahead and please state your outlet. Jacquie Lee: (23:08) Hi, good morning. Thanks so much for having this call. I'm with Bloomberg Law. I was hoping that someone could address anything that you would suggest, going forward, regarding messaging for this. I would anticipate that there could be some fears about this stoking some more vaccine hesitancy. What would you recommend to help providers to avoid that situation? Dr. Janet Woodcock: (23:33) Well, this is Janet Woodcock again. Number one, we've had several questions 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. Dr. Janet Woodcock: (23:52) We're also committed to patient safety. Our messages is that in doing this, we feel we're taking the route that will provide the most safety for the patients, by enabling healthcare professionals to recognize, to properly treat, and properly report any of the events that might happen. Dr. Janet Woodcock: (24:17) But the message to the 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 could be managed properly with this particular vaccine and all vaccines. Ann Schuchat: (24:46) Maybe I could expand, this as Dr. Schuchat, just to say agree with Dr. Woodcock's assessment, and just to remind clinicians and the public that 121 million people have been vaccinated with at least one dose of one of the three vaccines. 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. We have real world evidence now of the vaccines' effectiveness in the US. 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. Speaker 1: (25:49) Thank you, operator. We'll take the next question. Speaker 2: (25:52) Thank you, Eben Brown, you may go ahead and please state your outlet. Eben Brown: (25:58) Hi, good morning. This is Eben Brown from Fox news. I'm curious about the choice of words in your announcements. You are recommending a pause in the use of the Johnson and 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. Dr. Janet Woodcock: (26:31) Dr. Marks, would you like to answer that one? Peter Marks: (26:33) Yeah. 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 healthcare provider has a conversation with an individual patient and they determined 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 the large majority of cases. 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. Speaker 1: (27:34) Operator, we'll take the next question. Speaker 2: (27:37) Thank you. Sarah Owermohle you may go ahead and please state your outlet. Sarah Owermohle: (27:42) Hi, thank you. This is Sarah Owermohle from Politico. Going back to Caroline's question on subgroups. I know that there's a few cases now, but is there any [inaudible 00:27:53] risk linked to birth control, because all of the women are of childbearing age. Then also, obviously there are six confirmed cases now, but probably more are going to come out as people recognize this. Is there a number? How many probable cases do you guys have on your horizon right now? Dr. Janet Woodcock: (28:12) Dr. Marks? Peter Marks: (28:14) I'm happy to take this one. Yeah, thanks very much. At this time, it's not clear that there's any association with the oral contraceptive pill, birth control, in the individuals who had these blood clots. Additionally, I think it's too early to make any speculation on how many cases will come out. I do agree with you that it's possible we will learn of more cases. That's part of the reason why we're taking the pause to try to ascertain that. But I cannot speculate on how many more we'll learn of. Hopefully it's just going to be a few. Speaker 1: (28:57) Thank you. Operator, we'll take the next question. Speaker 2: (29:01) Thank you, Leigh Ann Winick, you may go ahead and please state your outlet. Stephanie Tacomo: (29:06) I am from CBS News. I have actually two questions. You mentioned that some people may have a conversation with their healthcare provider and decide that this is appropriate for them, but most people are going to mass vaccination sites and don't have that relationship. Are there certain risk factors that an individual would know from their medical history? Secondly, could you estimate the number of J&J that were meant to be given out in the days ahead and how that might affect the President's 200 million dose goal since his inauguration? Thanks. Dr. Janet Woodcock: (29:42) Either, anyone would like to respond to this question? Peter Marks: (29:49) Yeah. Let me start with the second question first. I think the vaccine supply has become more abundant over time. I think that this temporary pause is- Peter Marks: (30:03) ... This temporary pause is hopefully not going to have a large adverse effect on making those goals in a timely manner, if any at all. In terms of risk factors, I think at this point they are specific enough to an individual that that's going to have to be a determination that an individual has with their healthcare provider. And I'll turn that over to Dr. Schuchat since she may have more to say about that. Ann Schuchat: (30:38) Yes. And thank you, Dr. Marks. We are working right now from a small number from the six events that had been reported here in the U.S. And so while we are seeing them in women under 50, I think we are going to need to take some time and have our advisory committee on immunization practices, take additional time to review. My understanding is that there weren't predisposing conditions for these events in at least some of those individuals. And then the issue of supply, just to say that currently the J&J product has been providing the great minority of doses. Every dose is precious, and we're keen to get as many doses as possible administered as rapidly as possible and as equitably as possible. But it's too early for us to know the impact on the supply longer term. Speaker 3: (31:47) I couldn't hear what you said, Dr. Schuchat. You said there were or were not preexisting conditions in these six cases? Ann Schuchat: (31:54) What I tried to say is there were not in all of them. So not to say that there may have been some, but I think my main point is that review of six is difficult to make generalizations from. We're going to have our expert committee take a careful look and we're, of course, trying to assure that providers will report suspect episodes so that they can be further investigated. Because the numbers are quite small, small enough that it's hard to generalize, but large enough that we wanted to take the action with the pause. Speaker 3: (32:36) Operator will take our next question. Speaker 4: (32:40) Thank you. Helen Braswell, You may go ahead and please state your outlet. Helen Braswell: (32:45) Hi, yes. It's Helen Braswell from [inaudible 00:32:47] Thanks for taking my question. I think this is a question for Dr. Marks. Your remarks earlier suggest you think this is a class effect. Are you looking back through data of the various experimental adenovirus vectored vaccines that have been produced over the years? The one GSK was making with an AID or the J&J Ebola vaccine for that matter to see if there's a data there that can help you with this problem? Peter Marks: (33:17) Yeah, the simple answer is yes. We're going to look at the totality of the evidence available to us that informs this. So yes. Helen Braswell: (33:31) But you think it is a class effect? Peter Marks: (33:32) Well, I hesitate to call it a class effect, but I think it's plainly obvious to us already that what we're seeing with the Janssen vaccines looks very similar to what was being seen with the AstraZeneca vaccine. One is the AstraZeneca is a chimpanzee adenoviral vectored vaccine. The Janssen is a human adenoviral vector vaccine. So I can't make some broad statement yet, but obviously they are from the same general class of viral vectors. Helen Braswell: (34:18) J&J is doing a two dose trial. Have you asked them to pause that? Peter Marks: (34:24) I think you can look at statements that will come out of J&J today about their voluntary actions in response to this request for a pause. Speaker 3: (34:39) Thank you. Operator, we will take our last question. Speaker 4: (34:43) Thank you. Dr. John [inaudible 00:34:46] you may go ahead. Please state your outlet. Speaker 5: (34:48) Hi, Dr. [inaudible 00:34:49] CBS News. I'm wondering if you could help put this in perspective a little bit more. The CBST you said was about two to 14 per million, I assume that's per year [inaudible 00:35:02] with normal platelets. And these six people, in order to annualize them, that's over about six weeks since authorization? Peter Marks: (35:11) That's probably correct. Ann Schuchat: (35:14) Right, right. Speaker 5: (35:16) So do we know what the rate is in people with low platelets? Because it sounds like it was one in a million, if it's six or seven million. That's about what the background rate would be in people with normal platelets. But we're saying what makes this unusual is that they have the combination of the low platelets and the clotting. So do we know what the background rate is in people who have the CBST and low platelets? Peter Marks: (35:46) This is Peter Marks. We don't, but what we do know is that this type of a combination of low platelets and blood clots has been very rarely seen in the past in other situations as an auto-immune phenomenon. But it's very, very rare, such that I don't have an annualized rate that I can provide you. Speaker 5: (36:13) Because I can imagine as a clinician, headache. We're going to now see a lot of people with headache. The management specifics, I guess you didn't want to really go into. But I guess it's not anticoagulation standard, it's maybe some kind of thrombectomy or something. But I can imagine in the next couple of days, which is probably why you're rushing to get this assessed quickly, there's going to be a lot of phone calls to doctors like me. Peter Marks: (36:38) So maybe I can pass it over to Dr. Schuchat in a moment. But I think some of the key information here is that these have usually occurred at least about a week after vaccination and not longer than three weeks after vaccination, with a median of about nine days after vaccination. We know that for these vaccines, for the first several days after vaccination, there are flu like symptoms which can include headaches. So I think for the internist out there and the primary care providers who are caring for patients, if they're seeing flu like symptoms and headache for the first few days after a vaccination, that is likely just what has been seen in the common adverse events that are not serious with these vaccines. Peter Marks: (37:38) It would be more important that if somebody presented to an emergency room with a very severe headache or with blood clots, that a history of prior vaccination be elicited and then appropriate management be instituted. So I think this is the message that we need to get out to healthcare providers, that if someone ends up with a very severe headache or any type of shortness of breath, pain in their legs, pain in their abdomen that's severe, that they would want to seek medical attention. And if there are low platelets at that time, one needs to consider this entity. Speaker 5: (38:26) Thanks a lot. Peter Marks: (38:29) Thank you. Speaker 3: (38:30) Okay, this concludes today's media briefing. A replay will be available on the FDA's YouTube page. And just to note, the FDA and CDC press releases have been posted on our agency's website. So thank you very much for joining today and goodbye. Speaker 4: (38:48) And thank you. This concludes today's conference call. You may go ahead and disconnect at this time.