FDA discusses planned nationwide pause of J&J vaccine
The Food and Drug Administration held an audio news conference on April 13, 2021, to discuss a planned nationwide pause of the single-dose Johnson & Johnson vaccine after rare reports of blood clotting disorders.
opening remarks by Dr Peter Marks, director of the FDA Center for Biologics Evaluation and Research and Dr anne shook it. The C. D. C. S. Principal deputy director. After the 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 of this audio call is being recorded and live streamed on the 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, Thank you and thank you all for joining us this morning. The F. D. A. And C. D. C. Announced that out of an abundance of caution were 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 thank you. Dr Woodcock Together the C. D. C. And the FDA. A reviewing data involving six reports of a rare type of blood clot called cerebral venous sinus thrombosis or C. B. S. T in combination with low levels of platelets in the blood called promises to pina In women ages 18 to 48 who presented with symptoms between six and 13 days after receiving the Johnson and Johnson or yeah Johnson'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 involves an anticoagulant called heparin. With cerebral venous sinus thrombosis. Pepper 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 CDCR recommending a pause in the use of this vaccine. In the United States, the FDA will revise the fact sheet for health care providers administering vaccine and the fact sheet for recipient and caregivers for the ants and 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 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 anne, shook it, the CDCs principal deputy director to speak to further explain our decision and next steps and thanks so much dr Marx. Um 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 johnson 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 Marx mentioned, there have been six reports of a severe stroke like illness linked to low platelet counts. Um and more than six million doses of the J. M. J. vaccine have been administered so far. Well, these events are very rare. We're recommending a pause in the use of the J. and J. COVID-19 vaccines in order to prepare the health care system to recognize and treat patients appropriately and to report severe events. They may be seen in people who have received the J and J vaccine. This pause will also allow the CDCs expert committee to review the situation. The safety of vaccines and the safety of the american people is of the utmost importance to us. The A. C. I. P. Or R. Advisory committee on immunization practices is the CDCs 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, a secret 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 who 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 weeks, they should be aware to look for any symptoms. If you perceive the vaccine and develop severe headache, abdominal pain, leg pain or shortness of breath, you should contact your health care provider and seek medical treatment. Now these symptoms are different from the mild flu, like symptoms, fever and so forth, that many people experience in a couple 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 vaccine. People who have vaccine appointments with the other two vaccines to continue with their appointments. Our partners are will be working to reschedule people who have the J and 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 vaccination will be able to get that when vaccines available. We're committed to following the science and ensuring transparency and to providing regular updates. You'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 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. Uh huh. Thank you. Doctor shook it. 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 will take the first question. Thank you. And once again that a star one. If you would like to ask a question. Our first question comes from Karen Stacey. You may go ahead and please state your outlet. Thanks very much. This is Karen Stacy from the Financial Times. This obviously looks like the same thing that was happening with the Astrazeneca vaccine. And I was wondering if you could tell us a little bit about the contacts that you've had with regulators in europe, about that. And also whether there's any evidence of similar events happening with Madonna and fight. Certainly this is Janet Woodcock. We are in constant contact with the regulators worldwide and looking at adverse events experience in different regions. They'll turn this over to DR Marx to answer in detail. Thanks very much. So. Um, you asked about whether there were 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, uh, cerebral vein sinus thrombosis combined with prom beside a pina operator will take the next question. Thank you. That comes from Michael erman. You may go ahead and please state your outlet. Hi, this is uh, this is my kerman from, from Reuters. I'm wondering uh just quickly how how long the pause is expected to be? What's the minimum time? And also whether you're considering limiting vaccination for J. And J to certain groups like uh People over 50 or all men and women over 50. Well the time frame 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 shook it to answer further. Yes. Thank you. Dr Woodcock. We 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. Um one of the things that the A. C. I. P. Deliberation will do is review the data on the cases and the context of risks, benefits and possible subsets of the population that maybe um in a different category. So I think the our intent is in the days ahead to provide an update regularly and that the pause provides us time for deliberation and assuring appropriate diagnosis and treatment. Mhm. Operator will take the next question. Thank you. Our next question comes from Elizabeth ways. You may go ahead and play state your outlet high. Uh usa today I did question and 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? Yeah. Well we have hypotheses Janet Woodcock dr Marx maybe want to enlarge upon that. Yeah. So thanks very much. We don't have a definitive cause but the probable cause that we believe may be uh involved here. That we can speculate is a similar mechanism that may be going on with other uh the other admiral viral vector vaccine. That is that this is an immune response that occurs very, very rarely. Um after some people receive the vaccine and that immune response leads to activation of the platelets and these extremely rare blood clots. Yes, so to be specific, this is Janet Woodcock, the person being vaccinated makes an immune response potentially that actually involves their own uh platelets or other parts of coagulation system and can cause this problem. And that's the sort of leading theory or hypothesis about what's going on here. Operator will take the next question. Thank you. And that comes from matt Perrin. You may go ahead and please state your outlet. Hi, thanks 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 seven million injections constitute a signal. Um I mean what what would have been the background rate for a type of event like this? Uh If there is um if there is another explanation possible. Certainly this is Janet Woodcock. This was a extensive work between the C. D. C. And the FDA. On on this uh set of events and analysis uh to see you know exactly what you're um asking about. So dr Marx would you like to respond? Yeah thanks very much so. Um the the issue of cerebral venus being supreme venus, Sinus thrombosis. Those 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 that the real thing that is so notable here is not just the cerebral venus, sinus thrombosis or the throne beside a pina. 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 uh europe uh, with another vaccine. So I think we have to uh take the time to make sure we understand this uh complication. Uh, and we address it properly. Thank you. Operator will take the next question and florida. You may go ahead and please state your outlet. Hi, Suzanne clarity with abc news. Um, 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 seven million, I would just ask dr uh, to go on to that. Sure, you know, we are committed to safety and transparency and to expeditiously loading as much as we can so that further steps can be taken when we saw this pattern. And we're aware of that treatment um needed to be individualized for this condition. Um 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 vaccinations credible. So we want to make sure that we make some recommendations quickly. Mhm. Thank you. Operator will take the next question. Thank you. Jacqueline Howard. You may go ahead. Please state your outlet. Thanks for taking my question. Um 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 uh maybe upset that they were not given a heads up. So can someone explain how did this decision happen quickly and why? Um was the decision made in Worth States involved or given uh awareness or heads up that the pause would happen? Thank you. Sure. The doctor mark go ahead. Yeah, maybe I can just start and and then let DR Marx uh extend. Um I wish that we had more time to get everyone prepared and that this could go uh even more smoothly. We um as we learned about the issue with appropriate treatment and uh it was clear to us that we needed to alert the public. Um We wanted 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 um the decision was based on the events that might occur between when we made that realization and when 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 uh to diagnose treat and report while the more detailed deliberation occurs tomorrow. Mhm. I don't know if you have anything to add dR Marx. No, I 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, um one can actually cause tremendous harm um 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. 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. Operator will take the next question. Thank you. Caroline Chen, you may go ahead and please state your outlet. Hi, I'm Caroline Kennedy republika. Um, 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. Mhm. This is Janet Woodcock. I believe there are few too few cases for us to make that determination for this particular vaccine. We may uh be hearing about more cases. We will look further into these will have deliberations as we just described tomorrow about the details, but we aren't prepared at this time to a signal, you know, out single out. Any particular subgroup operator will take the next question. Thank you, Jackie lee. You may go ahead and please state your outlet. Hi, Good morning. Thanks so much for having this call. I'm with Bloomberg Law. Um, I was hoping that someone could address kind of the anything that you would suggest going forward regarding messaging for this. Um, I would anticipate that anything that you would suggest going forward regarding messaging for this. Um, 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 help providers to avoid that situation? Mm Well, this is Janet Woodcock. Again, number one, you know, we we've 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 uh our messages that in doing this, we feel we're taking the route that will provide the most safety for the patient by um by enabling healthcare professionals to recognize to properly treat and properly report any of the events that might happen. So 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 uh the risk 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. Maybe I could expand. This is dr shook it. 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 vaccine and we have real world evidence now of the vaccine's effectiveness in the U. S. So we're taking this um pause and uh precautions around the J. And J. Product in the context of a large robust and highly safe and effective vaccination effort. Thank you, operator will take the next question. Thank you. Evan Brown. You may go ahead and please take your outlet. Hi, good morning. This is Evan Brown from Fox News. Uh, I'm curious about the choice of words in your announcements. You are recommending a pause uh 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? Uh, and um what would happen or what should happen? Or what are your words to a state or a county or a nonprofit outfit that does not heed your recommendation. Thank you. DR Marx. Would you like to answer that one? Thanks very much for that question. This is a recommendation and it's not a mandate. It's out of an abundance of caution or recommending that the vaccine d 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 uh, the vaccine because it could be right in many cases, that benefit risk will be beneficial overall to that uh individual in the large majority of cases. So, um 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, operator will take the next question. Thank you Sarah Overman. You may go ahead and please state your outlet. Hi, thank you. This is Sarah over mall from politico. Um going back to Caroline question on subgroups. You know that there's a few cases now, but is there any sort of risk from link to birth control? Because all of the women are of childbearing age. Um, and then also obviously there are six confirmed cases now, but probably more going to come out as people recognize this. So, is there a number how many probable cases you guys have on your horizon right now? Mhm. Mhm. Um Dr Marcia, I'm happy to take this one. Yeah, thanks very much. Um so um at this time, uh it's not clear that there's any association with the oral contraceptive pill birth control in uh the individuals who have 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 and 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 will learn of. Hopefully it's just going to be a few operator will take the next question. Thank you, Leanne Winnick. You may go ahead and please state your outlet. I am from CBS News and I have actually two questions. Um, as you mentioned that some people may have a conversation with their health care 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? And 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 doses goals since his inauguration? Thanks. Either. Anyone would like to respond to this. Uh, so, uh, let me start with the second question first. I think the, the vaccine supply um, has become, uh, more abundant over time. And I, you know, I think that this, uh, this temporary pause um is uh is hopefully not going to have a large adverse effect on making those goals uh in a timely manner, if at all, if any at all. Um uh in terms of uh risk factors, I think those are at this point, um they are specific enough that, you know, um to an individual, that that's going to have to be a determination that an individual has with their health care provider. And I'll turn that over to dR shook it. Since this is she may have more to say about that. Yes. And thank you DR Marx. Um, we're working right now from a small number from the six events that have been reported here in the US. And so while um We're seeing them in 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. Um I as my understanding is that there weren't um predisposing conditions for these uh these events in at least some of those uh individuals. Um And then the issue of supply, just to say that currently um the change a product had been providing um the minority the great minority of doses um every dose is precious and we're keen to get as many doses as possible administered as frequently, I'm sorry, as 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. I couldn't hear what you said, dr shook it. You said there were or were not pre existing conditions in the six cases. Um 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 you know I think it's I think my main point Is that um review of six is um difficult to make generalizations from. Um We're going to have our expert committee take a careful look and we're of course trying to assure that providers will report um 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 operator will take our next question. Thank you. Helen Braswell. You may go ahead and please state your outlet high. Yes it's Helen brian's welcome staff. Thank you for taking my question. Um I think that's a question for dr Marx. Um your remarks earlier suggests you think this is a class effect. Are you looking back through data of the various um experimental um adenovirus vector vaccines that have been produced over the years? The one Gs K. Was making within a I. D. Or the J. And J. Ebola vaccine for that matter. To see if there's a data there that can help you with this problem? The simple answer is yes. We're going to look at the totality of the evidence available to us that informs this so yes. But do you think it is a class effect? Well we I hesitate to call it a class effect but I think what it is it um it's plainly obvious to us already that what we're seeing with the Yance and vaccines looks very similar to what was being seen with the Astrazeneca vaccine. One is uh the astrazeneca is a chimpanzee adenovirus vectored vaccine. The uh johnson is a human adenovirus vector vaccine. So um I think we can't make some broad statement yet. But obviously they are from uh, the same general class of uh, viral vectors. Change a is doing a two dose trial. Have you asked them to pause that? I think you can look at uh, statements that will come out of J and J today um, about their voluntary actions about in response to this request for a pause. Thank you operator. We will take our last question. Thank you. DR Jon lapook. You may go ahead. Please state your outlet. Hi. Dr Donald for the CBS News. I'm wondering if you could help put this in perspective a little bit more. The cBS t you stand with about 2 to 14 per million. I assume that's per year in paint. Since with normal platelets and these six people in order to annualized them. That's over. What about the six weeks since authorization? That's probably correct. Right. So do we know what the what the rate is in people with normal with low platelets? Because it's the 2 to 14 to 17 sounds like one in a million if it's six for six or seven million. That's very very about what the background rate would be in. People with normal platelets. But we're saying this is what makes this unusual is that they have the combination of the low platelets and clotting. So do we know what the background rate is in people who have C. V. S. T. And low platelets? This is peter marks. We don't, but we what we do know is that this type of a uh combination of low platelets and uh and blood clots has been very rarely seen in the past in other situations as an autoimmune phenomenon. But it's very very rare. Such that I don't I don't have an annualized rate that I can provide you because I can imagine as a clinician, I mean headache, we're going to now see a lot of people with headache. Uh management specifics I guess you didn't want to really go into, but I guess it's not anti coagulation standard, It's maybe some kind of thrown back to me or something. But I can imagine in the next couple of days, which is probably why you're rushing to get this success quickly. There's going to be a lot of phone calls to doctors like me, so maybe I can pass it over to dr shook it in a moment. But I think that the key, 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. Um with a median 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 um internists 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 vaccination, that is likely just what has been seen in uh the common adverse events that are not serious. Um With these vaccines, it would be more important that if somebody presented to an emergency room with a very severe headache or um with blood clots that uh 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 um that if someone ends up with a very severe headache um or uh any type of shortness of breath. Pain in their legs, um, uh pain in their abdomen that's uh severe that they would want to seek medical attention. And uh, if there are low platelets at that time, um, uh, one needs to consider this entity. Thanks. Thanks a lot because thank you. Okay. This concludes today's media briefing. A replay will be available on the Fds Youtube page. Um And just to note the FDA and CBC press releases have been posted on our agency's website. Um So, thank you very much for joining today and goodbye and thank you. This concludes today's conference call. You may go ahead and disconnect at this time.