hello my name is ann aiken i'm the acting designated federal officer for nvac and i'm going to call this meeting to order it's a pleasure to be here today and i'd like to thank all the mvac members for joining us so soon after our last meeting i'd like to say a special thanks to dr hopkins the inbound chair for all of his hard work thoughtful contributions and his steadfast support even end times or i am stressed i i do appreciate it i also want to thank the nvac team elka emily downs viola jacobs carolyn shell erica knowles chris strom dr deborah de souza for zarani and david kim and hannah and the purpose of today's meeting is to provide broad perspectives from a variety of stakeholders and through this body key issues bringing up key issues that are relevant to vaccines and immune immunization so they can be examined and debated this meeting centers on responding to a charge from admiral brett jarrar the assistant secretary for health and the director of the national vaccine program invac has provided a number of thoughtful recommendations in response to this charge and will later vote on whether or not to approve a report on their work i believe this work can contribute to improve the overall vaccine system as well as help to prepare us for a dynamic and complex entertain taking of code 19 vaccination we have a full agenda today and i look forward to hearing all the presentations from our distinguished speakers the public comments and the discussion from the committee before we move on i need to go over several items first this is a public meeting it is being recorded all statements made today are on the record second this advisory council is governed by the federal advisory committee act or faka for short saka provides rules about their circumstances by which agencies or officers of the federal government can't establish or control committees or groups like this one to obtain advice or recommendations the voting members of the council are considered special government employees and are subject to conflict of interest laws and regulations the ex-official members represent different federal agencies and departments and have also been vetted for any conflicts of interest federal f ex official members are regular government employees and are therefore subject to ethics regulations issued by the office of government ethics including annual confidential financial disclosure and ethics training i've received and reviewed information about their professional personal and financial iss interests to assess real potential or apparent conflicts of interest that would comprise a member's ability to be objective in giving advice during mvac meetings i also reviewed financial disclosure and other information for all of the voting members not working for the vaccine industry to ensure that the committee members comply with federal ethics law i shared this information for an independent review by a committee specialist to further ensure accuracy this meeting contains presentations and discussions from both federal employees and people who work outside of the federal government the information provided today does not necessarily reflect the view of the national vaccine advisory committee the department of health and human services or the u.s government information about this meeting is provided in advance in the federal register and on the in back part of the hhs website after the meeting we will also post the presentation files the meeting minutes and the links to the video from the meeting on the website after we hear from admiral gerard dr bob hawkins the invac chair we'll give the chairs welcome let's proceed with roll call for today's meeting um i'm going to take the official attendance dr bob hopkins i am present i can't hear you i am present cannot here dr hopkins um so maybe someone can help him with that but i do see him so we're going to mark him as president deborah blog yes i'm here and i heard duck and my friends i also can see that deborah blog is speaking but i do not hear her this is david fleming i think they're right i can hear folks tim cook i'm present can you hear me and can you hear me chris erisman lynn friedland president i don't know if you can hear me i can now i've had to turn my volume on i'm here and good afternoon hi daniel hoff yes i'm here can you hear me yep i'm clear molly howell she mentioned a few minutes late marianne jackson i am here hello melissa martinez good morning i'm here good morning cody meisner cody was on earlier uh rob schachter here thanks hi we can hear you fine swami hi again hello and this is cody i i took my minute to unmute so i'm here great i see you now uh bob swanson um are you on i know you might be a little bit late i am on right now yes thanks great mary rubin ayan i'm here hello chris regal claire hannon um i'm here hello hello rebecca coyle rebecca coyle's present hello kelly good and i'm here thank you hello jim bloom and stock on douglas i think i see you there yes here hello gina charos nathalie elimari arnold motto justin mills oh justin i'm here i'm here oh hi justin i'll try to be on as long as i can thank you great thank you linda lambert uh yes i'm here thank you hello nancy messinger and mary beth hans said she would be running in just a few minutes late but mary beth if you're on tanya ranz valerie marshall present hello hi ann hi mary reuben hi present hello barbara mullick good afternoon i'm here hello keith jonivast hi i'm here hello and last but not least troy knighton hi anne i'm here hello thank you all i'm gonna turn the podium over um next to admiral jarrar the assistant secretary froelth and the director of the national vaccine program he taped his welcome remarks in advance of our meeting so we're going to go ahead and share them with you this will be his last nvac meeting as to ash he's been a steadfast supporter of this committee and for vaccinations and has provided nvac with a number of very rewarding charges so carolyn can you please play his video i am admiral brett johar the assistant secretary for health and a pediatric critical care physician it is an honor to welcome the members of the committee the impressive lineup of speakers and all of you watching this meeting online this is the fifth nvac meeting of the year a year during which we've experienced unprecedented strains on the health care system and indeed all of human society and the tragic loss of so many lives due to the covet 19 pandemic this has been a year like no other at least since 1918 and a sober reminder that infectious diseases will always be a threat to our species and indeed a growing one as our world becomes more interconnected but as americans have always done the pandemic has brought out the best in us we have fought together courageously we have together solved problems heretofore thought unsurmountable like developing a vaccine and potentially starting to distribute it within 12 months we have come together to support our medical and public health professionals as never before and i think the nation has finally realized and is committed to addressing and fixing the historic health disparities that have plagued our nation for decades if not centuries your work today is not easy it has never been our nation is asking you to make recommendations so that we can save the lives and avert suffering and prepare for a brighter future in which all americans have a fair and realistic opportunity to maximize their health and of course never before has the importance of vaccines been so evident across the globe childhood vaccines adult vaccines influenza vaccines and god willing one or more covet 19 vaccines within the next few weeks since your last meeting in october there have also been a number of groundbreaking announcements about the safety and high efficacy of candidate vaccines across all age groups evaluated as you know the fda will also be considering emergency use authorization of the pfizer vaccine after the vaccines and related biological products advisory committee meeting on december 10th and we anticipate the moderna vaccine will be considered by the committee the following week we all expect these to be the first and second of a number of vaccines to be considered for an eua and we have the expectation that at least 20 million americans will be able to receive covid vaccines by the end of this year with these vaccines there is a light at the end of the tunnel the end of the pandemic is in sight likewise we are all actively assessing the recommendations for vaccine allocation to be offered by asip because there will be a relatively limited supply of vaccines in 2020 it is critical that we immunize for impact to save the most lives and to avert any potential for overwhelming our hospitals and icu's that clearly means that those at the highest risk like those in our long-term care facilities and other elderly individuals and those with significant comorbidities need to be prioritized along with healthcare workers you have an important role in this overall process to finalize and potentially approve your recommendations in regard to the following charge to support communications to enhance informed vaccine decision making what should hhs do before during and after the covid19 vaccination campaign to improve the confidence in these vaccines and our nation's immunization system especially within underserved communities including racial and ethnic minorities to enhance vaccination of our diverse populations the fda standards for approval and licensure of vaccines for covet 19 addresses safety and effectiveness and encourages inclusion of minorities the elderly pregnant women and people with medical comorbidities in clinical trials in particular for the covet 19 vaccine i am interested in the approach the nation should take in regard to vaccination of children given that there will be relatively little data on children from some of the early clinical trials as context the case fatality rate for children under age 18 is 0.02 what is the appropriate approach and timing of generating the needed data and proceeding to potential childhood vaccination as we move forward to develop new and improved vaccines what lessons can we learn from covet 19 vaccine development more broadly to promote innovation and shorten timelines to increase availability of new vaccines to the american public nvac is an established and respected committee with unequaled expertise and also tremendous dedication and i have the utmost faith that this committee's recommendations about covet 19 vaccination will provide us with important guidance for moving forward your recommendations will of course receive my full attention and have a meaningful impact on future efforts at hhs and throughout the immunization system now and in years to come let me speak for a moment about influenza vaccines at the nvac meeting in september i spoke about ensuring that every american age six months and older get the annual flu vaccine particularly this year because we were concerned that both the flu virus and the virus causing covet 19 would potentially circulate simultaneously this fall and winter we worked with the private sector to ensure ample supply of flu vaccines this year and ensure every american especially communities of color and those at highest risk for the consequences of flu and covet 19 are aware of how important flu vaccination is and can easily get vaccinated as of november 6th 179.6 million doses of the flu vaccine have been distributed in the united states which is the highest number of doses distributed in a single flu season the good news great news actually is that seasonal influenza activity in the united states remains lower than usual for this time of the year as of november 14th approximately 44.5 percent of children had received the flu vaccine which is comparable to last year we do need to improve that please double down on your communications we need everyone not just experts but moms and dads grandparents and friends to encourage the people in their lives to get the flu vaccine of particular concern flu vaccination rates for african-american children and for children whose income is below the federal poverty line are lower this year than last year indicating worsening disparities 28.3 percent of african american children received the flu vaccine this year comparatively lower than the 32.1 percent of african-american children who were vaccinated last year while a higher percentage of white children have received the vaccine this year when compared to last year similarly children living below the federal poverty level had lower estimates of receiving the flu vaccine 32.4 percent when compared to last year's estimate of 36.9 percent we need to fix this now and the surgeon general and i and all the leadership are addressing this every single day we cannot lose ground in the fight against serious diseases that we can already prevent this includes flu but also all other vaccine preventable diseases such as hpv shingles whooping cough chickenpox and measles we know that children and adults often have not received routine vaccinations due to the pandemic and the risk of potential outbreaks of traditional diseases like measles is deeply concerning however working with state and local health officials professional associations and many others i am pleased to say we've made progress in reversing this trend particularly for children but there is much more work to do for children and especially for adults along with our partners hhs has been raising awareness of the importance of catching up on childhood immunizations and that it is safe for parents to bring their children in for recommended vaccines through using provisions of the prep act hhs also increased access to life-saving childhood vaccines by authorizing state licensed pharmacists and professionals under their supervision to administer vaccines to children ages 3 to 18 years during the covet 19 public health emergency the fact is every child and community is healthier and stronger when immunization rates are high we continue to closely monitor child and adult immunization rates and spread the catch-up message to help spread this message i encourage you to share many of the great resources and information available on vaccines.gov thank you again for your dedication and commitment and to improving the vaccination system in the united states and responding to my charge i understand that the committee has been fully engaged in this response and working hard on the report for discussion and vote today this is my last nvac meeting as the ash i came here to hhs with vaccination as one of my highest priorities and i think we have made progress together it has been the honor of my life to work with you over these past three years and i wish the committee all the best as you continue your critically important work it has been a great privilege to work with such dedicated professionals focused on improving the vaccination system broadly in our country i look forward to hearing insights from today's deliberations and the committee's response to my charge i will now turn it over to dr hopkins for the chairs welcome thank you well thank you admiral giraffe that was a important address we appreciate your support of immunization and of our committee over this last three years and we'll miss you and your input as we move forward i'd like to welcome all of you all to today's meeting and i certainly want to start off in addition to those comments with thanks to ann elka and the rest of the oidp team in uh preparing what i think is going to be a very useful and informative meeting today as we try to bring to conclusion our response to uh dr jawaz uh charge to us could go to the next slide please so uh to start off with for some housekeeping remarks uh those uh are able to attend are able to sign in by the webcast at the address you see on the slide http://www.hhs.gov live this meeting is recorded in streams so statements made are on the record and may be included in meeting minutes before speaking please ensure that you're not muted and identify yourself and please speak clearly and also mute yourself when you're not speaking encourage members and speakers to be on camera when speaking but we ask that you stop sharing video when you're not speaking to preserve bandwidth we'll go to the next slide please we will have public comment verbal comments scheduled at 4 30 pm eastern time today we ask that those all verbal comments all be limited to three minutes in length you may also submit written comments to nvac hhs.gov those written comments should be limited to three pages in length and the oidp will include all properly submitted written comments in the meeting minutes next slide please our highlights for today we're going to start off with talking about advancing novel coronavirus vaccines we're going to talk about approaches to including pregnant women in covet 19 vaccine trials talk a bit about vaccine safety systems and covet 19.
i have an important uh comment from cms about no co-pays and coverage for coveted 19 vaccines followed by review of our response to the charge public comment charge discussion and our vote go to the next slide please i hope that you all have our upcoming meetings on your calendars february 4th to 5th 2021 june 16 17 and september 1516. hopefully we will be able to at least participate in the majority of those face-to-face but if not this is at least a reasonable backup plan and our schedule is also posted on the hhs.gov website you'd go to the next slide please so our next event we're pleased to have dr stanley plotkin here with us he is an emeritus professor in the university from the university of pennsylvania and is a also done a lot of consulting work for vaccine manufacturers he's going to provide his thoughts about vaccinating children and learning from covenant 19 vaccine development dr plotkin thank you for joining us you have the floor um right do you hear me i hear you okay well i don't see the oh boy yes that's dave um there you are i see you in there yeah right okay not that not that you need to see me but anyway uh all right so i i've been asked to comment on uh why i think children should eventually receive vaccines uh against soros too now um of course there are populations that need vaccines against the coronavirus before children there's no no doubt about that but ultimately in in my view children should be included in vaccination now um i was asked to do this relatively recently and i'm i i hope that i am correctly responding to what you uh want uh but i do have a couple of slides about uh pregnancy and yes so uh pregnancy it does as far as i can tell from the literature does not seem to be primarily a problem of infection of the fetus but rather infection of the pregnant woman who obviously late in pregnancy has less respiratory reserve than been in a non-pregnant state and i'm just without dwelling on this i am simply going to show a few references uh to this subject which leads me to the view that i've uh just stated that um this is not primarily a problem like rubella or cytomegalovirus so i think you can see from the titles of the slides the point that i am just stating so i'll just move on to the next slide then um and the these uh references may be useful to you simply in terms of uh consideration of uh immunization in a pregnancy of course we tend not to vaccinate in pregnancy because of concerns relating to the fetus but so far it does not appear that we have any specific issue with a sars two vaccine in in that regard uh especially a uh an activated vaccine it's true that we don't have a lot of evidence from for messenger rna vaccines and they will have to be tested in a pregnancy and in general of course we tend to try to avoid the vaccinating in the first trimester of pregnancy out of an abundance of caution even though there is little or no evidence that any vaccine given in the first trimester aside from live vaccines could could be harmful so um let me move then to what i think is the important issue and that is the vaccination of uh children and so if i could move on to the next slide um well uh this slide also is useful in in terms of uh saying that although children were mostly asymptomatic there were symptoms in normal children that is cough and fever and pharyngitis as well as other respiratory symptoms and it says that children rarely needed admission to incentive care units and yet this series had three percent i don't consider that to be rare so uh although children do not seem to have a lot of serious disease as to adults and of course uh particularly the the elderly yet they are not uh uh protected completely against serious sars2 disease uh next slide uh so here is uh another review of the uh situation uh and uh it does point out that again that although they looked at quite a large group of children uh 7 480 uh again about two percent of the children were admitted to pediatric intensive care and um there was very low mortality 0.08 percent but nevertheless a dead child is not a happy thing and [Music] so that again children are not totally immune uh and interestingly a higher proportion of newborns was severely ill 12 percent with dyspnea so um again that perhaps might be an argument to vaccinating pregnant women in order to pass their antibodies to the fetus but but again my overall point is the um that that infection in children is not totally asymptomatic and my last slide in this regard is the next one uh and um so here there was a series of over 1 000 children uh 14 were asymptomatic in this series uh but among those that were ill whereas 36 were mild 46 were moderate and 2.1 were severe with 1.2 percent being critically ill so these reviews are consistent in that about one or two percent of uh children are having significant disease and if you think about other infections in childhood for homophobic influenza meningitis for example um that that incidence would not be out of line so uh my point being that if one is vaccinating against let's say homophilus that this might also be an indication for um vaccination of children so my last slide is the one that i want to linger on uh and that is the the overall point about why i think eventually once there's enough vaccine that children should be vaccinated and the first point is the one that i've made repetitively now that although i'm sorry i use the word rare but i don't think it's rare although uncommon serious disease does occur in children uh that is covet 19 disease does occur in children um second children when they become infected excrete virus and therefore they could be the agent to infect parents teachers and other children and of course this is an argument that applies to other vaccines as well that is justifying a vaccination in children a third point is that inasmuch as infection in children is often asymptomatic as in other young people we have no way of knowing who's infected which child is infected and which child therefore is uh capable of infecting uh other people um and then uh on the condition that vaccines against source 2 do give long-lasting immunity or at least priming for an accelerated response to the virus the child will still be resistant after growing up and that is an important point because uh as we cannot count on universal vaccination of adults vaccination of children will eventually result in an uh immune population uh just as is the case with other uh agents for for which we vaccinate so in summary my argument is that if we are if assuming that sars2 virus becomes a permanent threat that we are going to have to include children in our plans for vaccination in order to maintain control of the epidemic to protect people who who are likely to have serious disease such as grandparents but also to protect the children themselves and i would also add it's not on this slide but in thinking about this at least in the u.s the possibility of making vaccination against sars2 mandatory is an important point because of course that's what we do with other vaccines in childhood the argument being that that is the best way to protect our innocent children and by the way also to protect the population at large so now i admit that this is an early statement that we do not yet know which vaccines would be the optimal vaccines for children and there are other aspects of the disease that we're just learning about but looking ahead and i think we should always do that looking ahead i do believe that children should eventually be vaccinated and i will stop there thank you black and very helpful remarks ahead of time dr hopkins it's a little hard to hear you turn up my microphone here uh thank you for your remarks dr plotkin that was very helpful we're running a bit ahead of time do any of the members of the committee have a question or comment for dr plotkin before we move forward uh bob it's tim cook i do please tim but it's not it's not related to the uh question about pregnancy and children so uh it it i hope i'm not barging in on other people's questions that may be um but one of our charges and let me uh here i'll show my screen um sorry one of the charges that nvac has from the uh from the ash is to make recommendations on what lessons were learned from covid19 vaccine development and how we can use these in the future to promote innovation and shorten timelines so doctor plotaken it's great to have you back at nvac again and uh i wondered if you know you've been at this a long time and whether you had thoughts on you know what lessons will be learned and i know it's it's these would be the early lessons so far and there's a lot more lessons to be learned about how we can innovate more around vaccine development in the future but if you could share any thoughts we'd really appreciate it well so thank you for those questions which are big yeah uh big questions um i you know uh what's has struck me about this experience uh are basically two things uh one that um fortunately and in part because of financing by the federal government all hands are on deck that is to say all of the platforms that are used to develop vaccines including of course the newer ones are being used to develop uh this fact the vaccines against stars too and uh that that is that is great i mean that shows that uh given an emergency on the scientific community can respond rapidly and in the event of of another disease i'll come back to that that um that the the industry so to speak and academia uh will will respond um that is assuming that they get enough uh support financial support uh from the government um uh although not not not every organization has needed that but most most uh most have um the the the second point is one that goes back a bit um in 19 i'm sorry in 2015 i believe it was i wrote an article with jeremy ferrar from the welcome uh uh trust uh and um uh well anyway i wrote an article that in the new england journal that proposed the development of an organization to deal with emerging infections to develop vaccines against emerging infections and that was because of the ebola experience and fortunately that idea which wasn't really that brilliant but it it took off and now we have sepi the coalition for epidemic preparedness and innovation they are financing some of the vaccines for against uh kovit uh and they are financing development of vaccines against many other uh infections that for which there's no commercial interest uh i think we have to pursue that in the future uh if you look at all of the agents which are now in animals some of which are obviously capable of jumping to humans such as sars2 we could start vaccine development now uh assuming that kind of there's enough financial support and we now have an organization that could handle that so my my second perception if you will is that we have a way now to try to deal with emerging infections at an early point before they become a pandemic such as sars2 and we should take advantage of of of that opportunity so i've tried to answer your question as much as i can yeah thank you dr pluck and i think that's definitely one of the lessons learned in here and how to use the partnerships like sepi to be able to combat these different emerging infections as as quickly as we can i also think it's a great opportunity to have so many different vaccine platforms and particularly new platforms like mrna and some of the recombinant live virals go at the same you know the same target at the same time and i can't help but think we're going to learn a tremendous amount how about which platforms are good for either getting there quickly or or getting there cheaply or you know being stored at reasonable temperatures and all of that so i think it'll be very interesting you know i do think that the u.s government has to think hard about their ability to handle this um i i i don't i'm not saying that the federal response was poor definitely was not poor but i think it was somewhat disorganized at the beginning and so again my emphasis is being ready for this type of event now when you think about it there's been uh ebola zika uh sars2 and others and and they've been recent you know that's not going back to the to the 1918 influenza these are our recent events chikungunya and we should be able to deal with these um in a better way than we have been okay well thanks so much i'll stop there and uh sorry if i've intruded on some questions about pregnancy and and children but thank you dr plotkin bob uh this is cody meisner asked a question cody i think daniel i think daniel looks like he was uh up before you and then i'll put you next thank you um thank you uh bob and thank you cody for being patient um and thank you dr plotkin for your wonderful comments i think we all are thinking that it's important to be vaccinating children pregnant females at some point but also that we are wanting to be very careful about when um and the sort of general concept i think is we need to have plenty of safety data in the adults first before we really contemplate this in a big way in these special populations but i just wondered if i could ask for more granularity in your opinion on the timing of it i think what we are um thinking is that certainly uh after eu a as a minimum on some vaccine but i'm just wondering what you would think about starting clinical trials in these populations bridging trials in kids and in pregnant females starting as soon as possible after eua is given or if you wait until there's actual official licensure of the vaccine well thank you for the for uh thank you for that question oops we can hear you yeah thank you thank you i don't know what's what's happening here but thank you for that question and i entirely agree that trials should be started now because you we have i think already at least with with several of the vaccines sufficient evidence of safety in adults so i i think we have um the right to start vaccinating children so that we have the clinical data at the after all of the other populations have been vaccinated if i understand correctly by the middle of 2021 all of the target populations will have been offered vaccination so we should start soon in children so that we have clinical data by let's say the second half of 2021 and can then decide whether to push ahead or not thank you i think cody will probably follow up on that thank you dan and uh thank you dr platkin uh it's always uh an educational experience to hear your comments uh i i would like to ask you um what your thoughts are about the mrna vaccines that is it seems quite interesting that both vaccines came up with efficacy rates that are pretty similar of 95 and it seems to me we should interpret that as reassuring that in fact these vaccines are going to be effective at least in the short term and do you have any thoughts about how durable that immunity might be and thinking uh in comparison that the conventional coronaviruses which we've all known about uh uh for many years it tends the immunity tends to wane and do you think it might be uh different with this virus so cody that's a a good question and i can only give a very partial answer because the the the two main things we don't know yet are uh can we prevent mucosal replication of the virus with the uh vaccines and how long will our protection last or to put it another way what is the correlate of protection how much neutral assuming it's neutralizing antibody how much neutralizing antibody does one need actually the mrna vaccines have been so effective that the data from them is probably not going to allow much in the way of a conclusion about that but the data with the um the astrazeneca uh adenovirus vaccine should allow us to determine whether uh or what the level of neutralizing antibody is that is protective uh i assume i hope i'm right i assume that there are specimens available to measure neutralization after vaccination and then to look at who got infected and who didn't so all i can say about the mrna vaccines is there is evidence of b cell memory uh but again we don't know yet what level of antibody is necessary but it's of course as you know it's complicated it could be that having memory would allow a animistic response to occur at the time of exposure uh and therefore uh protection to occur even though um antibodies have waned but there was there are so many factors that we we need to know with this disease has a relatively short incubation period and unfortunately for as a generalization with vaccines those with short incubation periods cannot rely on memory so you know i don't know the answer to your question and i can only know after we have more data and incidentally if i can you know ring a bell uh that's one of the arguments for human challenges to determine what is the duration of immunity after vaccination in in vaccinated people uh it is it is a key question there's no doubt about that thank you dr plotkin thank you you always teach us i don't think i've ever heard you speak where i haven't learned at least two or three new things uh thank you for your input today sir i thank you very much and i i assume it's safe for me to just to close off right yes sir yes sir okay thank you bye-bye bye-bye our next uh endeavor is a panel on approaches to including pregnant women in covet 19 clinical trials we have four speakers and also have a couple of other experts that will be on the line to help with answering questions we're going to start with dr sasha ellington from cdc dr ellington is an epidemiologist at cdc and co-lead on the covet 19 response pregnancy and infant linked outcomes team she'll be followed by dr ruth faden from johns hopkins dr faden is the philip franklin wagley professor of biomedical ethics and the founding director of the johns hopkins vermont institute next will be dr jeff roberts from food and drug administration where he's associate director for scientific affairs in the office of vaccines research and review then dr linda eckert from the university of washington and representing the american college of ob gyn she's professor of ob gyn at the university of washington and then dr dana mini dellum from cdc will be on the line to answer questions she's the co-lead of the vaccine task force in covet 19 response and dr t odayubu from cdc who's medical officer in the cdc covet 19 response i want to thank all of you for your participation in our committee meeting and to help us with our deliberations i'll now turn the floor over to dr ellington hi can you hear me i hear you dr ellington um good afternoon everybody i'm sasha ellington i'm an epidemiologist with the pregnancy and infant lead outcomes team on cdc's covid19 response i'm going to provide a brief update on the epidemiology of covert 19 in pregnancy and cdc's surveillance activities uh next slide please so to start with a very brief background it is well established that there are physiologic changes in pregnancy that could increase the risk of severe respiratory viral illness in pregnant women and these include but are not limited to increased heart rate and oxygen consumption decreased lung capacity and the shift away from cell mediated immunity severe disease has been associated with other viral respiratory infections during pregnancy such as with influenza next slide a living systematic review and meta-analysis published in september synthesizes the literature on copenhagen and pregnancy fairly well the review has sought to identify risk factors for severe coping 19 illness during pregnancy and delivery and to report on the adverse outcomes among mothers and infants differences in clinical manifestations of the disease and pregnant versus stimul similarly aged non-pregnant women with cover 19 were detected specifically fever and myalgia were less common among pregnant women although based on a limited number of studies included for meta-analysis authors reported an increased likelihood of admission to intensive care unit and a need for invasive ventilation among pregnant women compared with non-pregnant women with coca-19 these associations were stronger when comparing pregnant women with covered 19 to pregnant women without coping 19 especially for admission to the intensive care unit mortality due to copic 19 was low among pregnant women the study also showed that pregnant women might have a higher odds of preterm birth and that neonates born to women with coca-19 may have a higher odds of admission to a neonatal intensive care unit lastly findings from the systematic review showed that risk factors for severe cobit 19 during pregnancy included older maternal age high body mass index and underlying medical conditions like chronic hypertension and pre-existing diabetes next slide please now i'm going to review several recent cdc analyses and publications in late september a pair of mmwr reports were released which examined outcomes among hospitalized pregnant women the first report on the left side of this slide is from the covet 19 associated hospitalization surveillance network or covadnet which conducts population-based surveillance for a laboratory confirmed code 19 associated hospitalizations in 14 states and it encompasses 99 counties from march 1st to august 22nd among nearly 600 hospitalized pregnant women with covert 19 just under half were symptomatic among the symptomatic women 16 were admitted to intensive care and 8 required invasive mechanical ventilation among completed pregnancies 99 resulted in live birth and 1 in pregnancy loss a pregnant woman who delivered a live birth during october 19 associated hospitalization the proportion of pre-term deliveries was 13 this was approximately three times higher among symptomatic women at 23 percent than among those who did not report symptoms at 8 percent a second mmwr report was an analysis by the vaccine safety data link which is a collaboration between cdc immunization safety office and nine us healthcare organizations serving more than 12 million people each year during march 1st through may 30th of this year as part of the vsd or vaccine safety data link surveillance of covert 19 hospitalizations 105 hospitalized pregnant women with covert 19 were identified of these 41 percent were hospitalized for treatment of their covenanting illness three out of 10 pregnant women admitted for coca-19 without a pregnancy related reason required intensive care and one pregnant woman died from covert 19.
Among 93 women who delivered uh stillbirths occurred in three percent or three uh of the pregnancies and 97 were live births among live births 12 were preterm in this study preterm delivery and stillbirth rates were higher among women with coping 19 regardless of symptoms and compared to background rates in the vsd catchment area during the same time period next slide please so next time i'll discuss a couple of analyses and publications that came out in early november on november 2nd in october we analyzed cdc's national covid19 case surveillance data to assess if pregnancy was associated with severe illness from cobit 19. this was an update from an analysis that we had previously done from january 22nd to october 3rd cdc received reports of approximately 1.3 million women aged 15 to 44 years with laboratory confirmed stars kobe 2 infection data on pregnancy status were available for approximately 460 000 of these women and among these women 7 or about 30 000 were reported as pregnant 77 of pregnant women were reported as symptomatic while 89 of non-pregnant women were reported as symptomatic next slide please we assessed four outcomes in this analysis icu admission receipt of mechanical or invasive ventilation receipt of extracoreal membrane oxygenation or ecmo and death we restricted the analysis to women who had symptoms of covid19 this was to help ensure that reports of the four outcomes of interest among pregnant women were related to coping 19 rather than a pregnancy associated complication among ace an asymptomatic woman after adjusting for age race ethnicity and presence of pre-existing conditions pregnant women were three times more likely to be admitted to the icu compared to non-pregnant women 2.9 times more likely to have received invasive ventilation 2.4 times more likely to have received ecmo and 74 more likely to have died next slide please so weekly cdc updates the number of pregnant women with lab confirmed copic 19 based on the national case surveillance data as of last week we reported 40 406 left confirmed cases of covert 19 among pregnant women and 54 deaths and then this was updated as of yesterday as well and we are now reporting 42 268 cases and 55 deaths the website also provides cases by selected demographics age race ethnicities and indicators for the severe illness outcomes that i previously mentioned next slide please so in addition to the national case surveillance data we are collecting birth and infant outcomes data among pregnant women with lab confirmed cobig 19 through cdc's surveillance for emerging threats to mothers and babies network or set net setnet was adapted from the u.s zika pregnancy and infant registry and was designed to serve as a preparedness network that could be leveraged should a new threat emerge so it has now been adapted to include covid19 the map on the left shows the 16 jurisdictions that contributed data on pregnant women with confirmed coping 19 to set net as of october 14 2020 and were included in a recent published analysis and as of um october there were 5 252 pregnant women with a confirmed lab confirmed copig 19 reported to set net pregnancy outcome was known for 84 of these women or 4 42 women of those with known pregnancy outcomes and with data on trimester infection 85 percent of infections occurred in third trimester 15 in the second and less than one percent in the third trimester of pregnancy uh next slide please among the 4 42 women with stars kobe 2 infection and pregnancy with a known pregnancy outcome 9 had asymptomatic infection 52 had reported symptoms and 39 were missing data on symptom status among the 3912 live births with data on gestational age reported to set net 12.9 percent of infants were born preterm this is higher than the national estimate of 10.2 percent in 2019 suggesting that women with code 19 during pregnancy might be at risk for preterm delivery next slide please so following this for first publication of birth and infant outcomes from um copic 19 set net data we launched a monthly reporting webpage as of november 19th we are reporting 5775 completed pregnancies from 17 jurisdictions among four thousand seven hundred and forty live foreign infants within with the information after gestational age twelve point one percent were born pre-term um we are continuing to update this weight this page and additional data analyses as we continue to monitor this outbreak and pandemic next slide please i think uh the next slide i uh let me see i have one more slide in my set but perhaps um it's not consistent so i will say that we have um we in addition to public health surveillance cdc is supporting um multiple investigations including sierra prevalence and cohort studies to better understand the impact of covert 19 during pregnancy on both the mother and infant data collected as part of these efforts can't help i think we just lost the audio on dr ellington dr ellington you are muted uh can you hear me now now i hear you again okay i'm sorry is there an is there a next slide no not for your presentation it doesn't look like okay uh maybe maybe it got lost so i just um so the key takeaway points um from the presentation are um that based on the current data we have pregnant peop uh pregnant people are at increased risk of severe illness from covert 19 compared to non-pregnant people the data also suggests that preterm birth is higher than expected among pregnant people and pregnancy loss um specifically stillbirth has been observed with some evidence that this may be higher than expected although there are limited data we're continuing to monitor illness severity and evaluate birth and infant outcomes among pregnant women occult at 19.
thank you thank you dr ellington our next speaker is dr ruth faden from johns hopkins dr faden are you on okay can you hear me now i hear you dr faden you have your flower okay thank you i don't know if i've got video but that's not important as long as the slides are showing so thank you for this opportunity uh to present to and back um could i have the we're really grateful for it can i have the next slide please this is just an acknowledgement slide i have no conflicts of interest our uh this work is supported by a grant from the welcome trust our project is called the cover project and you can see here my co-investigators and colleagues on that project next slide please i am going to skip this entirely because we just said an excellent and much more authoritative presentation that i could give about the rest of pregnant women and to their offspring from covid19 disease that dr ellington just provided so let's just assume we've all listened to tentatively to what she has to say and of course we have more authoritative voices coming after me so let's just assume that pregnant women are indeed it's more likely to have severe outcomes and that some pregnant women are probably at elevated risk within the group of pregnant women because of something about them in addition to their pregnancy could i have the next slide please so the work that uh our cover project is doing now builds on the work of a previous group called the prevent working group that released the prevent guidance in 2019 this is the work of an interdisciplinary international team of experts across a range of disciplines that were brought together in the wake of the zika crisis to address how best to advance the interests of pregnant women and their offspring in the development and deployment of vaccines for emerging and re-emerging diseases with particular eye on the equity gap the gap in evidence available for pregnant women and other population groups next slide please that group made 22 recommendations the prevent group did grouped into three areas preparedness r d and vaccine delivery next slide please uh we were working with a certain vision of the world which i'd like to share it's kind of nice to envision where you want to get to and where we want to get to and where we hope that we are making progress towards is a world in which pregnant people are not unjustifiably excluded from participating in vaccine studies a world in which pregnant women and their offspring benefit from advances in vaccine technologies and are not left behind as new vaccine products are developed and also a world in which pregnant pregnant people have access to safe and effective vaccines to protect them and their offspring in real time against emerging and re-emerging pathogenic threats that's our hope now please go on to the next slide thank you we quickly well i wouldn't say so quickly but we fairly quickly came to a shorthand way of expressing the diagnosis of the problem when we came to call this the presumption of occlusion it's kind of a vicious self-perpetuating cycle in which pregnant women are precluded from the evaluative designed research work in the development of news that new vaccines because of ethical concerns because of concerns about reliability and frankly because a kind of inertia had set in in which pregnant women were just not considered or thought about in the development of r d the r d of vaccines with the notable exception of maternal immunizations where the vaccines are developed specifically for the target group of pregnant women but excluding that excluding that set aside for maternal immunization pregnancy targeted vaccines pregnant women have been by and large excluded from r d for vaccine development for emerging and re-emerging infections the lack of data from the research phase has resulted in a lack of evidence which then has resulted in exclusion or delay of pregnant women from rollout and programmatic delivery programs and that then itself becomes another source of lack of information or data so you get this perpetuated cycle of exclusion and evidence gaps that perpetuates itself from research to to program to research to program over and over again and we end up with just nowhere near the information we should have on products and platforms next slide please our prescription and in a nutshell is to shift the presumption from a presumption of exclusion to a presumption of inclusion the idea here is that we should strive in all cases for the appropriate and we can talk about more we can talk more about what that means but the appropriate inclusion of pregnant women in the research phase of development of new vaccines for emerging and re-emerging threats the appropriate inclusion as early as possible then results in better evidence about safety and immunogenicity which then allows for the appropriate inclusion of pregnant women in vaccine campaigns which then allows for enhanced evidence for use in future outbreaks and what you get is instead of a pernicious vicious cycle if you like you get a virtuous cycle in which greater knowledge about platforms adjuvants and vaccine technologies then go on to inform future research and future use and take us closer to that envisioned positive future next slide please i want to pause here on one particular step on the way to the inclusion of attempts to evaluate candidate vaccines with pregnant people and that is the necessity from a regulatory point of view of conducting dart studies non-clinical studies before regulatory authorities will generally permit pregnant people to be included in any way in the evaluation of an investigational vaccine one of our major recommendations was that dart studies be initiated ideally right after the end of phase one evaluation of a candidate as it moves on a promising candidate from phase one to phase two so that we would have the data in hand or flee favorable dart data as soon as it becomes appropriate to expand our evaluative investigation to pregnant women next slide please this is borrowed and i apologize for the tiny tiny text here but i'll decode it for you it's borrowed and updated from a slide that dr oliver presented i think last month and basically if i can draw your attention although i think i do need to decode it to uh the dart row for the leading candidates those that are closest to eu authorization what you could see if you could see here is that none of the drug developers have thus far reported any uh dart data they all indicate that dart studies are underway of the two candidate vaccines that are of immediate interest moderna is saying that it will be reporting dart data in the first quarter of 2021 you may have more accurate information than we do on this point or more up-to-date information but that would be fairly soon and the pfizer biontech developers are saying that the dart data are being collected but have not given an indication of as far as we know at least that we can find of when that data will be available the az vaccine with oxford has reported anyway that they plan to release start data by the end of quarter 4 2020 so that would be super soon but you know so far no data have been no dart data have been reported next slide please so as we work our way through the questions of whether or under what conditions which is the way we would rather phrase it under what conditions is it acceptable to begin evaluating an investigational vaccine directly in pregnant women and similarly when is it acceptable to offer pregnant men pregnant women a cova 19 vaccine as part of a public health vaccination program we're obviously in a context in which we are balancing the prospect of benefit against the risk next slide please among the factors that need to be taken into account in making this risk benefit assessment specific to pregnancy are the prospects for vaccine protection the risk of harm from infection from community acquired infection the likelihood of infection the risk of harm from vaccination and the availability and alternatives the availability of alternative preventives and treatments next slide please just to make this a little bit more particular to pregnancy at least right now with respect to both pfizer and moderna it appears as if and i'm clearly i'm saying this to the you know to the relevant experts and authorities here but it does look as if we have a prospect of a very efficacious vaccine so the prospect of vaccine protection is high uh the risk of harm from infection we have heard dr ellington describe so i won't review that here the risk of harm from vaccination is the black box and so where considerable discussion and analysis and thinking is happening right now both in terms of what theoretically might be possible and what could be learned quickly from dart studies if anything and from other kinds of investigation these other two factors likelihood of infection and availability of alternative preventives and treatments very much co-travel and here the main point i want to make is an obvious one but it bears repeating and that is that pregnant women are not one homogeneous group of people pregnant women obviously vary in terms of the likelihood that they could become infected the likelihood that they would become seriously ill if they became infected and the extent to which they are positioned to be able to avail themselves of opportunities to reduce their risk of infection through for example physical distancing and some combination of sheltering and so here just to underscore the point for pregnant women who are able to work from home or who do not work outside the home and who live in housing that does not put them in close quarters with many people who must work outside the home the alternative of essentially sheltering until the pregnancy is completely as a possibility for pregnant women who live in crowded housing conditions multiple multi-generational or multi-numbers of people in small spaces in compact communities who must work outside the home either because of financial necessity professional duty or both but the prospect of being able to shelter themselves from risk of infection just evaporates and i don't need to say but maybe i should that the conditions i've just described disproportionately are the case for women who are low income from for women of color from poor communities and for disadvantaged groups generally with respect to the availability of alternative treatments i just want to flag although this is not the right group to to think about this uh i'd say it's not your remit that there are interesting ethics questions about whether if pregnant women are not afforded opportunity to protect themselves with vaccine for some period of time when other people who are otherwise like them are it raises the question of whether they should be at the top of the queue for treatments should they become infected and ill with covid19 disease and that raises the question for example about what we know um say about certain of the newer treatments in pregnancy next slide please one other point i want to underscore is at each stage of decision making about whether or how to expose or offer the opportunity to be exposed to pregnant uh two cobia 19 vaccine for a pregnant woman or pregnant women it's very important that the right people be around the table so we have been pushing all the way through that experts in maternal and perinatal health in pediatrics and in research ethics and in public health ethics when it comes to the deployment decision as well as people who are in positions to speak for pregnant people directly or representationally be involved in that decision next slide please and with that i thank you and look forward to the conversation thank you dr faden uh our next speaker is dr jeff roberts from fda dr roberts you have the floor good afternoon can you hear me okay yes you're loud and clear right so it's good to be with you this afternoon i'm going to give an update that's organized based on the the topics that we covered in the guidance for industry that we issued in june around clinical development of the copic vaccines generally and in that guidance document we address pregnancy uh in in several times according to several different topics so i will i will talk about an update according to those different topics it's a nice segue from what ruth was raising earlier about developmental and reproductive toxicology studies or dart studies this was a strong recommendation in our guidance document that these studies be done as quickly as possible i can tell you as an update that they are nearing completion but they will almost certainly not be ready to be reviewed and labeled in time for the labeling that you will see in association with an emergency use authorization or eua should there be one um we're very close and those labels will almost certainly be updated to include those data when they become available but they will not almost certainly not be available at the time of initial e-way so another area we addressed in our guidance document was just to encourage all the sponsors during their pre-clinical studies to follow all pregnant women and document outcomes in the infants um as you know a pregnancy has been a country i mean a um an exclusion criteria in these trials women were tested for pregnancy before being vaccinated each time in those programs despite those measures women are frequently vaccinated very early or they're vaccinated very early in pregnancy and we get a few pregnancies like that in in these large pre-licensure trials that's inevitable we know that very well from the large trials that were done in hpv that has happened again to a small degree in these trials but there are very few pregnancies to um data to review and most of those pregnancies are not yet completed so we don't we're not going to have data on that either in this early phase of eua and or licensure um now another topic that we raise in our guidance document is that um we recommend it to the sponsors that they uh both consider including women in the trials who are not actively avoiding pregnancy and we recommended that they conduct specific studies in pregnant women now these are really two different undertakings and they give you different sets of data and in the first case it models what we're likely to see in for example a nationwide program that includes healthcare workers because um there will be inevitable uh inadvertent vaccinations that occur in pregnancy but before women were and knew that they were pregnant um and and so we still think it's important if possible to to remove that exclusion criteria in pre-licensure trials and to start to get those sorts of data in the latter case of vaccinating conducting studies specifically in pregnancy uh are typically done once women already know they're pregnant um they are sometimes targeted to a specific trimester like the second or third trimester and they give you an entirely different set of safety data so we think that both of those are still very important but in both cases dart study data we feel are necessary to support the safety of initiating those those types of studies um so we don't yet have those dart data and those studies have not been initiated yet so the other thing we talk about in the guidance is the importance of evaluating the safety posts post eua or post licensure through pregnancy registry studies or other types of study designs and all of those approaches are areas of active discussions internally and externally so what i thought i would do finally is to talk about labeling a little bit um it has been an area of confusion um essentially since we've started talking about maternal immunization uh from a regulatory perspective many years ago um so in some cases some vaccines are contraindicated they have a warning on the front page of the label under contraindications that indicate that the vaccine should not be used during pregnancy um in in most cases those are live attenuated viruses um that are the basis of the vaccine and those viruses are um for example in the case of mmr known to be teratogenic with respect to the wild-type virus so those types of associations and data that support contraindications in pregnancy uh are are the case in in for some vaccines but if we in the absence of of those types of data or those concerns those safety signals then the vaccine is generally not contraindicated and we don't consider uh use and pregnancy to be quote unquote off label which you'll you'll hear talked about quite a bit because the indication for use is inclusive of a population in that age range both males and females so that is not considered to be off-label use so it's important to to really understand that basic perspective and then i think we can start to talk about what uh the contrasts are between our approach and the approach of other groups like the acip but one that i think is really important and that we may want to talk about we've already had some discussion some questions externally about the approach that the uk's regulatory authority mhra took in labeling with respect to pregnancy and breastfeeding in that label they recommend against both pregnancy and breastfeeding and even recommend testing prior to administration in the vaccine our labels generally and i would say now almost across the board do not include recommendations and there's a good reason for that that recommendations uh can change based on new data and uh our labels are generally reserved for um displaying uh the data that we that has been submitted to us and agreed upon with the manufacturer as being adequate to support the benefit risk perspective for use in any given population so we generally do not include recommendations in our label and i can tell you that almost certainly we are going to stick with that and our labels will will not include recommendations with respect to use in pregnancy or breastfeeding so we will label the data that we have in hand as we get it so i think that is enough for now for me in terms of an update and uh want to leave time for discussion if if people have questions so thank you thank you dr roberts next will be dr linda eckert from the university of washington representing acog dr eckert you have the floor i think you're muted please great thank you thank you very much for this participation in this panel which has just been excellent so far i'm talking representing the american college of obstetrics and gynecology or acog next slide please and just a little brief background about acog it's a non-profit membership organization that contains 95 percent of board certified ob gyns in this country and of course we are a major source of ambulatory care for women and do attend 85 percent of deliveries in the united states next slide please so acog in 2010 convened an immunization expert work group as ob gyns were called to become vaccinators more commonly with increasing products being used in our patient population and over the years this group has expanded to include a range of infectious disease and emerging infection public health preparedness guidance the members of the acog immunization and infectious disease expert group are recognized experts in infectious diseases and the immunization and have had various uh roles both nationally and internationally and are well represented as liaisons across the sphere of immunization work um and this work group has been integral to acog's response to covet 19 as it was to the response to zika next slide please acog has worked extremely hard on kova 19 response efforts there's been four independent work groups that have focused on ethics gyn ob and telehealth there's been practice advisories there's been very frequent updates of frequently asked questions for clinicians and patients next slide and the acog group is working currently on recommendations for use of cova 19 vaccines these development the development of these vaccine recommendations for pregnant women is being led by the acog immunization expert work group and also will be reviewed by different work groups within acog as well and the last meeting that we had as a large group was on november 16th where we had a very robust discussion about these recommendations but i would say that there's nearly weekly calls updates uh very frequent emails trying to stay abreast of things that are happening in this rapidly evolving space next slide so acog was asked by acip to make a comment and um the the acog considerations that went into the acip comment word the idea that we've talked about here that pregnant patients are at increased risk of severe severe illness as we know they have not been included but that they do make up a significant portion of the top priority groups including as dr faden spoke to the idea that many pregnant patients are also the same people that have faced increased risk due to systemic barriers within the health care system and we of course also acknowledge that these mrna vaccines are new and we don't have a background of historical data on safety and efficacy to fall back on next slide but in light of those things and taking them still into consideration the acog statement that we presented at acip was that pregnant and lactating individuals who otherwise fit the criteria for inclusion in the high priority population should not be excluded from receiving a vaccine now clearly this is before an eua is stated and if the eua is silent or permissive for pregnancy uh we would continue to hold this position um also that the decision to vaccinate a pregnant patient should be based on the respitific conversation with the patient and the clinical care team and again i think dr faden had a really wonderful slide about all those different risk benefit components the other thing i would like to add is that acog does feel that we would like to try to disconnect pregnancy and lactation these are almost always stated together in the same sentence but they actually have a very different we would consider risk profile and so that would be another point for discussion next slide and so with that i will stop and allow other panelists to speak and look forward to the discussion thank you thank you dr eckert um at this point uh i think dr uh mini dellman and dr odobayo are just are available for questions so i will open up the floor to any members of the committee with questions or comments you would either unmute yourself or announce yourself on the chat i will be happy to recognize you bob uh cody meisner here if please go ahead two questions thank you i have a question for ruth saden and for uh jeff roberts um and thank you all for very uh interesting presentations so dr faden um this spring there was a publication regarding vaccination with novartis's nanoparticle vaccine in pregnant women to protect against rsv the idea being that a woman would boost her immunity antibodies would be passed on to the baby and in fact uh it didn't reach the primary endpoint but the results were really quite promising uh oh yeah guidos uh nova backs uh not novartis um and i know that novavax is working on a um a a sars cov2 vaccine uh it'll be a a protein and it seems to me that that would make sense um to use that in pregnant women since we already have some preliminary data about a safety vaccine the safety of that vaccine and then the second question i'll just put out there because jeff robert for jeff robertson and for anyone else um one concern that's been expressed with these messenger rna vaccines uh during pregnancy particularly in the first trimester um is could that rna somehow become uh incorporated into the dna of the fetus when there is so much cell replication going on we don't ordinarily think of an rna dependent dna polymerase being around but what happens if there's a retrovirus is that is that just a a completely unlikely scenario over if you are muted you need to come off music so we can hear you ruth you're on mute please okay there you go yeah there you go you hear me hear your name okay great so i should go ahead please so all right so thank you dr maynard and let me just distinguish my expertise from those of others so i'm going to leave it to gita and others uh both on the committee and in the panel to address the question of whether the novadex vaccine if there's reason to think because of past experience uh prior use of a similar platform that it is is a safer vaccine for pregnant women than sydney mrna vaccines but what i will say is the following from an ethics point of view from the standpoint of the interests of pregnant women right now those that are currently pregnant will want an answer especially if they are in high risk of infection context will want a an answer uh to the question of whether they're able to take permitted to make a decision to take the vaccine that's on offer now and the vaccine that is on offer presumably i don't want to get ahead of dr roberts in the fda but let's just envision you're a pregnant person and it's you know december 28th and the fda has taken its decision and your health system has started to it's one of the four areas that's going to get vaccine early it's going to roll out and you're the beginning of your third trimester and you're working in the health system and the people around you are similar in similar risk and they want it they're getting vaccinated and the ethics sort of fairness question is what should be permitted with respect to that those pregnant workers we can't tell them wait for the novovax vaccine to come out because they won't be pregnant anymore so the issue that we're facing in the near term is a very specific one which is uh how to address the the claims of the pregnant people who are right now concerned about whether they should be offered a vaccine whether they should make that decision or not i'm not giving you the answer i'm just saying that it may be that in several months time we will have a good vaccine from the standpoint comparatively for pregnant women that the consensus of the people who are expert on the technical questions agree is better than some of the others but for right now that's not where we're that's right not right now what we're facing so we don't have an immediate near-term technical fix to the to the ethics challenge so i'll just pick it up there with respect to the the other question that that cody asked and i think it's a good one and and it's one amongst many theoretical concerns that we've thought about um what what i'll say is that it at least at least for for us internally there is some degree of of reassurance in that bmrna products are not um entirely new in terms of clinical development programs some that technology has gone forward to one degree or another in several different clinical development programs zika is a good example um so we have some safety data in humans prior to even embarking on the copic vaccine studies and in some of those previous programs we even do have some darts data that can be used to evaluate uh to some degree that that specific question you asked cody and i would say that at least for us so far those data have been reassuring with respect to that question thank you gita would you like to make a comment yeah thanks bob so i just want to say to one one point about cody's question about the novovax vaccine platform which is the baculovirus uh expression vector so the only issue is that in the in those studies so while it's true that we have data quite frankly on many many pregnant women that received that vaccine keep in mind that was an alum aggregated vaccine the covent vaccine with novovax now is actually a proprietary m matrix adjuvant and that is something that as you know we've had lots and lots of discussions about adjuvants in even in pediatric vaccines and also in pregnant women we have not yet yet so far licensed or approved of any products the only adjuvant and vaccine experience we really have in pregnancy would have been back from h1n1 probably with um and len would probably know this data better than me but maybe with aso3 um or with one of the uh null vaccine h1n1 vaccines in the eu or in europe at the time so i i think it would be great if we could use data that we have from other locations but i'm not sure we're necessarily going to be able to just pick one over the other um and to kind of reiterate ruth's points and the things that dr um that both ruth faden and linda eckert pointed out is that i think from the ethical standpoint all of this information is something that an adult woman who happens to be pregnant should i think still be offered the opportunity can to consider i'll stop there thanks thank you gita um lynn also posted the comment that protein vaccines like hpv have a strong history of safety experience in pregnant women also are there any other questions or comments from members of the committee any comments that dr minnie delmon or dr odaybo would like to make i know it's been a robust uh discussion and as you heard from others we are awaiting the ua and then acip will um you know discuss this at one of their upcoming meetings thanks certainly thank you all right well we have reached our time of uh a break we're going to take a break now from 2 45 to 3 p.m eastern time at which time we'll return for a discussion on vaccine safety systems and coveted 19.
thank you all for your participation in this december 4th meeting to address our charge from the secretary and we'll be back on in 15 minutes promptly thank you produced by the u.s department of health and human services at taxpayer expense.
