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Immunogenicity of Covid-19 vaccine in pregnant and lactating women

Aug 12 | 2:00 PM

What is the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women? How is the cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants? What do the trials imply?Is it safe and advisable to take vaccine during pregnancy and immediately post partum? Let's understand all the concepts and standard guidelines, few exceptions if any for the same with Dr. Vaishali Joshi.

[Music] so a very good evening to one and all who are attending today's session it gives me great honor and pride to introduce a very very famous and renowned gynecologist dr vaishali yoshimam she's a senior obstetrician and gynecologist practicing at kokilaben hospital in mumbai she has more than 20 over 25 years of experience in the field of obstetrics and gynecology she has been also felicitated with the frcog degree by the royal college uk for 14 years of her contribution in the field of obstetrics and gynecology her work involves a mix of advanced laparoscopic and hysteroscopic surgeries she has a lot of training also to her laurels including training for diagnostic and treatment training for pre-cancerous lesions she has done more than 250 laparoscopic surgeries including complex surgeries for endometriosis and tuber ovarian masses uh today we are very honored to have you man with us and today she will enlighten us on the topic of immunogenicity of kovid 19 vaccines especially in pregnant and lactating women i welcome you ma'am to this wonderful session over to you ma'am thank you molina and thank you matrix uh i think kavanagh actually contacted me with this topic i uh i actually said this is the topic uh need of the hour and let's not waste time and i should start with my presentation okay okay so uh let's talk about what is immunogenicity because when i i myself is a gynecologist i am not a um immunologist or from public uh public epidemic i think uh since we're addressing large platform of multi specialities um this is a basic i think but i mean immunogenicity is the ability of a foreign substance to provoke an immune response in the host so uh it is very important when we are planning to uh particularly in preventive medicine um and as you we all know because of the way the kovind 19 um virus structure it is a very complex subject um particularly in kovind 19 vaccine so uh it why because it income for encompasses the efficacy of the vaccine the types of immune response are the vaccine generates and the uh duration of the immune response so uh let's go to the next topic uh next slide the challenges in uh sarah's kobi 2 uh immunogenicity so relatively it is a new virus with changing mutations as we know already we have uh been on um this recent variant the beta variant coming up no precise definition of effective immune response after natural infection then us human and self-mediated immune immune responses are also very essential for uh developing uh protection against this infection lack of there is a lack of global standards of temperatures and there is no definite value for a protective immune response so these are the real challenges for the um for the kobe 19 immunogenicity so being a gynecologist and looking at the today's topic let's now concentrate on pregnancy so as we know uh you know our human immune system the two types of uh immune responses the first one is a production of numeral antibodies and second one is cell mediated um in response particularly in pregnancy uh it is very important because the uh immune response is change in pregnancy and party and mostly after any viremia or after viral infection so the antibodies which are uh typically produced are iga antibodies but because of the large molecular size of the igm antibodies it cannot cross the placenta so it was of no value in protection of unburned fetus uh but it is definitely important because it is secreted and present in the breast milk the igg antibodies has a a smaller molecular volume size and hence it can be uh it can have a transplacental uh transmission of giving facilitate the are uh associated in brace gland and the uh the ducts lining uh it it is mostly important in a uh exclusively breastfed newborns and ah and it it can be used as a first line of defense from exposure uh exposure to the viral particles coming to the same mediated immune response in pregnancy it is uh is still quite complex and not clearly understood uh the first trimester where the immunological process is going on against the implanted embryo and developing fetus there is a pro-inflammatory response created by the immune system which now then changes to anti-inflammatory type in second and third trimester so um what is a pathophysiology of a covalent infection in pregnancy and lactation so ah as we all know and it has been said that pregnancy is a immunocompromised state in in spite of that till now there has not been shown that there is a increased risk of kobe 19 infection in pregnancy so uh post infection definitely uh there is an increased probiotic leading to virus infected and cytokines storm particularly in third trimester and which can give rise to release of pro inflammatory cytokines in the phytomaternal surface and the disruption of this protective anti-inflammatory environment on uh which is maintained by the natural desire natural pillar cells can be the cause of a freedom labor and may be sudden cause of uh intrauterine fatal day a transplacental transmission of uh kovin 19 um has been almost negligible there has been a a large uh reported data in which the maximum uh incidence is between 2.6 to 5 percent and in the breast milk there is no evidence of transmission of 19 infection in the breast now coming to the uh what should be why we should be talking about vaccine uh vaccination in pregnancy so i have already covered the reason one antenatal uh vaccination is because of the generation of igg antibodies which can give rise to passive immunity to the uh fetus and obviously and to protect the mother the protection of mother through the induction of cell mediated and human immunity and passive protection of greatest standard protocol of vaccine use in pregnancy usually whenever same is introduced each has to go through robust data usually generated after phase three trial um so uh that is one of the most essential recommendation for any vaccine so uh till now so far recently use vaccines like inactivated vaccine which we use like tetanus or diphtheria so the earth oxide vaccines are completely safe while the white the vector uh viral vector vaccine uh is also seem to be safe and we've been using for last many years particularly the flu vaccine or ebola vaccine they are supposed to be safe in pregnancy now uh what are the types of 19 vaccines available globally so there are uh different platforms through which the kovin-19 vaccines are have been delivered so nucleic acid vaccine that is dna plasma plasmid or mrna vaccine that is bio intake kaiser modern and covaxy viral vector vaccine is oxford uh estrogenica coefficients jensen and inactivated vaccine which is cyanovac and coronavac so uh because the us fda along with who has granted emergence under emergency use authorization of above vaccines after phase two and small phase three trials as a response to pandemi so this time so this is just a diagrammatic representation of a different uh kobi 19 vaccines now the mechanisms of vaccine so uh it's important to understand and uh the mechanism i think everybody uh being the all medicals everybody is aware so mrna vaccine rna vaccine nuclear mrn nucleoside coding for s protein peptides induces host production of spy protein peptides using the native cellular translation mechanism expression of the spike protein outside the cellular surface and hence the production of srs uh co uh protein specific antibodies while vector viral vector vaccine the adenovirus uh vector serves only to deliver or as a medium the spike dna into the host cell the host cells then produce the spike protein and this elicits protective immune response the adenovirus vector has been modified so that it cannot uh replicate and the spy protein is not expressed on the adenovirus itself so this is very important that it doesn't replicate so uh i think uh that's this much information i think is certain but there is a need for vaccination so as we know that when we kill the patients taken in pregnancy almost 80 percent patients are either a symptomatic or mild to moderate symptomatic um with the delta virus variant going on which is very highly transpace transmissible infectious and there has been a severe um uh outcome particularly uh in pregnancy in third trimester um in unvaccinated unvaccinated pregnant woman so that is the reason that there is a need of globally for us as a professional to uh give right information to the patient and decrease the vaccine resist uh uptake hesitancy so there are uh these uh the findings which have been there in the uh around the uk uh oss that is united kingdom obstetrics surveillance system data which is actually published last year 20 uh has consistently shown the the most vulnerable stage in pregnancy for a poor maternal outcome is third trimester and immediate postpartum we need to also prevent and reduce potentially transmission to the vulnerable household members particularly young children who cannot be vaccinated so uh this has been uh uh uh the recent study which has published in uh ah ajog in may 19. the maternal and perinatal outcome of pregnant woman with src is going to infection uh at the time of birth in england a national cohort study by um course study so in that they they have it is a population-based course study 3442 080 women of whom 3527 had laboratory confirmed infections and uh and uh out of them uh the uh the uh uh sar is kovi to infection at the time of birth is associated with higher rates of fetal death preterm birth pre-eclampsia and emergency scissoring this is this is why it is the need of height now we talk about some intervention we have because there is no phase three clinical time um we have to get updated and be up to date with the available safety data so uh with regarding copy 19 vaccine most of the data i'm afraid to say is is for a mrna vaccine because it is mostly coming from us and um uh so the v safe ob19 vaccine pregnancy registry has shown that this is i think it has been published recently on 9th of august on cdc website and i was saying because of uh because this these vaccines are not uh haven't had a complete phase 3 clinical trial is always better to be updated with the safety available data so the recent uh data which is available about the safeties we said kobe 19 vaccine registry uh regular registry um so more than 130 000 pregnant women have been vaccinated mainly with mrna vaccines such as pfizer biontech and moderna have not raised any safety concerns so far and as you can see uh the latest uh latest updates this website on 9th of august is actually they had a recent uh analysis of the data so far and there has been it has been shown there is no increased risk of spontaneous abortion less than 20 weeks of pregnancy in the recipients of the vaccine the public health of health scotland also has reported that 4000 pregnant women have received a van will may have no important no serious pregnancy related adversity uh and jcbi that a joint committee for vaccination and immunization in uk advises that it is preferable for heiser mine tech or modern mrna vaccines to be offered to the pregnant woman in uk wherever it is available now um what are what so this is a safety data so uh what are the adverse effects of the vaccine so uh they are almost similar to a non-pregnant uh woman uh the most common are minor local reactions like redness swelling pain at the injection sites and mild systematic uh systemic adverse effects like fever are in 10 to 20 percent uh patients which may last for a day or two fatigue headache maldivia occasional uh loose emotions the rare ones uh are have been reported and i think that has also raised a lot of concern particularly in pregnant population and uh under viral victor um delivering vaccine so with astrazeneca it has been reported vaccine induced thrombosis and thrombocytopenia so vitp 5 to 20 days or 28 days though the pregnancy increases the risk of coagulability there is no evidence that the pregnant or postpartum women are at a higher risk of vitt than non-pregnant woman so uh it is also been reported with a j jensen vaccine uh with the other rare side effect uh can adverse effect is myocarditis and pericarditis particularly seen rarely with physic and modena so uh since we were talking about the adverse effects uh there has been a uh there has been some um uh thing going on on the net about the recent uh the recent cdc uh website uh summary um is uh this report the preliminary findings of mrna kovi 19 vaccine safety which was published in um june 21 so uh the preliminary report did not show obvious safety signals among the pregnant women who have received mrna uh kobe 19. so probably that has also given rise to little bit of vaccine uh resistance in the general population and maybe in some professionals but we need to understand the last sentence the whatever the calculated portion of adverse pregnancy and net outcomes in vaccinated against coen 19 had a completed pregnancy the sa has a similar risk of incidence reported in the studies involving pregnant women who that were uh conducted before kovi 19 pandemic that means the whatever the adverse uh neonatal outcome effects and pregnancy uh uh pregnancy adverse pregnancy outcome like miscarriage small for gestational age uh pre number the incidences were similar to the pre kovid era so there has not a significant increase uh now coming so the we have talked about the mrna vaccine now viral vector vaccine the safety data the only data which is available is the animal data pregnant and lactating female rabbits did not demonstrate adverse effects on the female reproductive system or fatal development there is no human data available yet but safety surveillance system in public health sector should be used to collect uh the data for the viral vector vaccine but systems like uh uk oss or uk uh teratollargy informing system or cdc's vsa v19 vaccine pregnancy registry similar type vaccine priors have been done in the past particularly large scale ebola vaccination trial using similar vaccine uh delivery method uh given in all trimester in the past and there has no reported any adverse pregnancy outcomes so uh we uh um so i i think that is one of the another positive uh safety data we can take and apply to viral vector vaccines uh now since the topic itself is immunogenicity so we also need to understand that doing this intervention of uh giving vaccine taking a uh uh raise how is it beneficial so what is the latest data says about immunogenicity uh for mrna vaccine uh immunogenic uh so as you can see the immunogenicity our data is uh this is also a recent data one published in may 2021 by college uh collier and natal so it has been a cohort study they have studied 103 women who have received copin 19 mrna vaccine and 30 of them were pregnant and 16 of them were breastfeeding so they have shown that the vaccine elicited binding and neutralizing antibodies in core blood and breast milk and it also actually triggered a better cell mediated uh t a foreign helper cell response um in the pregnant and lactating woman so uh the second study is immune response to vaccination against uh against uh chromatin in breastfeeding health in healthcare workers so it was also published in june 21 they studied 30 group of 32 healthcare worker and the strongest results is with the rise of a rising immunoglobulin shield and iga uh which was seen seven days plus or minus three days after second dose uh now another study as you can see um which was published a little earlier now um the the latest one is uh uh this kobe 19 vaccine response in pregnancy and lack in lactating woman is a cohort study uh this there has been uh they have studied 131 uh pregnant women uh 84 by pregnant 31 were lactating and 16 were non-pregnant so coming 19 vaccine generated robust humoral humidity in pregnant and lactating woman with immunogenicity and reactogenicity similar to those observed in non pregnant women so vaccine induced immune response was significantly greater than the response to natural infection and immune transfer to neonate occur via placenta and breast milk so uh this information can give us a more confidence to uh uh to tell patients and recommend uh and counsel pa uh pregnant patients for our vaccination over 19 vaccination now um i think uh since we know the importance and why it should be given is there any role beneath um so that we have a base response immunogenicity uh reaction which will be ideal for the pregnant woman and for the uh newborn baby and a fetus so uh updated uh so the recent data shows the pregnant woman are more likely to become seriously this i think i have already covered uh more likely to become seriously unveiled needing ico care compared to non-pregnant even particularly in third trimester the risk of premature delivery almost increases to two to three times um after 28 weeks of uh gestation if they uh they catch kobe 19 uh infection and there is a a small but slightly increased risk of intratrying fetal death uh because of the infection so the recommendations are is to have the vaccine before the trimester bearing in mind that it takes time for immunity to develop and protection is higher after the second dose of vaccine uh support 19 vaccines can be given at any time in pregnancy particularly in a high risk woman of getting infected with the uh with the uh with the kobe 19. but uh for example in following circumstances healthcare worker or frontline worker community high or increasingly exposed uh to people outside a household difficulty in complying with social distancing in a living in a crowded household so in a low risk situation uh uh delay vaccination until 12 weeks can be uh recommended so women who have had a first dose of vaccine before getting pregnant because nowadays we are seeing lot of uh patients like that uh should complete the course of the same vaccine um in even if meaning including if they had their first dose of oxford astrazeneca vaccine in scheduled time now timing of vaccination in postpartum and lactation so immediate postpartum like any general non-pregnant population it can be given lactation is very important uh there is no known risk of uh in giving available kobe 19 vaccine to breastfeeding women this is recommended by uh jcbvi uh in december 20 uh so there has been few concerns about giving a vaccination in lactating woman ah there should not be because there is a low likelihood of trans placental transfer of mrna vaccine active compounds and vaccine is not like a vaccine and the mrna does not enter the nucleus of the sale of the vaccinated individual and is degraded quickly it is biologically and clinically unlikely to cause risk to breastfeeding child and child receiving you express human men so this is actually a statement uh on unicef uh website who said interim recommendation so woman should not stop breastfeeding in order to vaccinate against kobe 19 and even after vaccination of coping 19 she should continue breastfeeding uh now coming to our own uh current practice and own uh the country so uh foxy ministry of health health and family welfare have been very uh proactive and uh putting up a guidance on the website so as we know uh since the vaccine is offered over age of 18 out of 69 percent of eligible population uh to be vaccinated 48 percent are women so it's so important for us to carry on this campaign uh rightly and to the grassroots available vaccines we have are inactivated mrna vaccine that is co-vaccine and non-replicating vectors since uh it's kovichin the modena and uh jensen they are just have been granted permission but they are not available in our practice yet so voluntary acceptance of vaccine in pregnant and lactating woman have been stressed uh counseling and risk assessment is important in making informed choice by the targeted population so uh there has been a a published tool to obtain uh informed consent i've given the um the site address from where you can download and proxy actually have done a consent format as well for the vaccine now it's very important when we do take a consent or when we counsel one has to individualize uh the counseling uh so the risk factors for developing complications of after copy 19 infection during pregnancy uh also need to be taken into consideration and these are the patients uh have been stressed upon for the uptake of vaccine first one is advanced maternal age high body mass index and pregnant women with certain high risk conditions like pre-existing diabetes organ transplant recipients chronic respiratory conditions homozygous sickle cell disease um the congenital are acquired heart disease so um i think i'm coming i know it's been uh it's uh it's i am really looking forward for an interactive thing uh but i just am coming to my last slide so we after taking in all this information it is really important for us to act in balance so uh what is a global perspective on coving 19 vaccination in pregnancy as you can see all the international bodies like a seog uh a figo uh royal college of obstetrician and gynecologist foxy who all are endorsing um and asking for um for the vaccination in pregnant and lactating woman and uh in in current wave of highly infectious data variant threat worldwide benefits of vaccination outweighs the risk theoretical risk of vaccine that has been a cdc's recent statement so uh it's very important how do we make our patient understand so it's important it is the key is in our hand so we have to have that power communication power of counseling giving correct information to the patient in their own language and that giving special information reflect that will give them empower the patient to make the informed choices and decrease vaccine hesitancy and i think this is the only way forward this is maybe the best gift of fetus in the form of perfection um i think thank you very much for your patience listening and i think we should be open to take questions and answer for a wonderful session i think it was very very detailed and especially we noticed that there is a lot of under confidence as far as vaccinating pregnant and lactating women is concerned because there is so much of haziness concerning the immunogenicity how it is going to affect these mothers what are the side effects and so on but a lot of things have been cleared and thank you so much ma'am we have a lot of questions from our audience uh and we'll if there are any specific guidelines for those who are planning pregnancy in a couple of months any mandatory gap to be kept between the vaccination and the session and the pregnancy planning um the recent guidelines if you visit rcog website fertility can also affect the abortion rate or anything so there is one can definitely go ahead and take the vaccine irrespective of their fertility treatment but if somebody is planning to go for a for ivf treatment and things like that then it makes a sense to complete your two dosage and then you can go and go for the further treatment but uh meaning because you have to take vaccine uh or because you don't have to interrupt your or postpone your dose of vaccine if you are in between you understand me so you can carry on with your schedule yes that is true ma'am and um i hope that answers rishabh spoke sushila sanju is asking whether uh after taking the first dose of the covet vaccine if the patient gets pregnant shall we continue the pregnancy or is it a reason to get abortion done no so uh all the websites meaning all the international bodies are for more than a year are telling a vaccine is not the reason for termination of pregnancy so if a woman has taken a vaccine before a pre-pregnancy she should take her second scheduled dose whenever it comes irrespective of her trimester of pregnancy uh it's very important that she finishes her uh vaccination uh scheduled properly that will give her the best protection and nowadays in such kind of a situation this is like information we all as a professional need to give it to them yes that is very true ma'am in question um meaning that i cannot i cannot hear you in bitcoin there is one very interesting question but the current vaccines which are available are protective against the alpha beta uh and the e2 strains and a31 stains and so on but now we are all concerned about this new delta strain and the kappa strain in the lambda stream so how much is the cross protection offered from these new variants see remember i don't know i think my initial uh slides were little bit dry but i did address these issues that why the immunogenicity of kovid 19 vaccine is important and why it is complex because of these different mutations coming on so it's very difficult to gauge how effective this vaccine is going to be against these new variants coming but at least having vaccinated will you give you little protection than uh no protection that's what meaning this is a common sense i don't have any kind of evidence for that but we have seen that with the delta variant the uh uh the the uh kovi shield menastras seneca and uh uh pfizer they do uh the efficacy may not be like what they have proclaimed that 80 percent or 85 percent it is reduced to maybe 65 to 60 67 to 70 percent and there is some uh protection so that may probably protect you from the severe illnesses um i i think and then uh there and we we have a scope for having boosters so you know that uh that's what the pfizer and the the companies which are meaning mrna uh they are planning to uh offer that uh in near future so i think uh this saga i hope uh should end but probably looking at it we may have to think long term about all these boosters thing it probably like influenza every year we uh the vulnerable population have to take uh flu shots so that may be a reality yes um that is taking the vaccine will put you in a better position to fight the infection and we must take it irrespective of being concerned about the strains which are arising uh because otherwise uh we will be probably hit with the strain earlier than we would expect somehow is asking if the mother is covered positive then is it possible that the baby will also be affected see uh i think even that i have covered say the transplacental transfer of infection or we call it as a vertical transmission of the virus is almost negligible there has been some studies and data coming from china uh which was published kind of uh last year which has shown the actual uh uh viremia in the cod blood is very minimal and two point almost just two point six to four to five percent and these uh even if they get affected the complete uh cure is there and so actually in last six to nine months data we are quoting that the risk of that happening is almost negligible particularly after covet 19 uh infection uh in pregnancy at the time of delivery so the main risk may be later on when they mothers are breastfeeding so that this may be there and that is the reason this data is that two point six to five percent is not very reliable whether those uh newborns have gone got it through the cord or umbilical meaning trans placental or they have acquired later on so i would say it's really negligible yes that is also when shivangi mehta is asking if a patient is pregnant with twins in her third trimester and she gets infected with govinda then after how long is she advised to take the vaccine for three months three to four months so i think after that you of she can take vaccine at any time yes also questions regarding guidelines of vaccination in uh high-risk patients whether they have gestational diabetes pih or other high-risk pregnancies but i think madam you have covered that in the lecture itself that the foxy has given a blanket guidelines and high-risk patients should all the more take it yes that's right absolutely right yes uh also um there is one question that i are there any exceptional circumstances from which the patient should not take the vaccine okay so uh only when you uh the uh it has been said that the vaccine should be avoided if somebody has a uh history of a severe allergic reaction uh to any medicines and things like that so these are the patients who should avoid vaccination otherwise sorry there is no need to uh avoid vaccination because it is relatively safe and the rare side effects whatever i have mentioned they are very rare so i think that answers your question for questions about um which vaccine is superior or inferior to the other and what are the preferences as far as the vaccines are concerned i think you have already addressed it man but you could just reinforce it because there are at least two to three questions just for this yeah i know uh see because the safety data and the robust safety data which is there on the nate and in our uh uh literature so far is as i've mentioned is particularly on a mrna vaccine okay the pfizer by uh faizaban tech and moderna so which is unfortunately in our current practice is not available for our population so uh the only thing which we have similar to uh mrna is co-vaccine and uh the covicien even it at least coverage we have some data because of astrazeneca uh uh vaccine which is the kind of similar sister concern so ah so there is nothing like which is better and which is less i feel that whichever is available you locally you should go ahead and take it uh looking at the uh other risk factor and where in stage of pregnancy you are uh it may be advisable to suggest a particular type because as we said about the immune response immunogenicity it's always better to meaning better to complete two dosage to have a maximum uh advantage of yourself and to the unknown on unknown baby uh the uh the protection against the poor 19. so you should at what stage pregnancy you are and depending on that you can take a call because as you know obviously on our centralized common app you will not be able to take it within four weeks you have to wait for 84 days um compared to that uh the sputnik v you can take it within three to four weeks the vaccine within four weeks so i think it's important to get uh vaccinated that is what is important also my one more thing and there are some people meaning i see patients so there are people who have different uh needs like somebody wants to travel abroad one could settle abroad so again that puts a lot of constraints on your choices that's true ma'am third one i also have one question uh we all know that kovid is essentially um immune response especially the systemic info involvement that it has it's mainly modulating your immune system and a lot of inflammation occurs in the body so um what according to you is the role of mesenchymal stem cell therapy for subsiding this immuno modulation and for this uh immune response so how long do you think how far are we as far as stem cell therapy is concerned which could be applied for its treatment sense and therapy non-pregnancy it can be but still i would say it is still a research way i know we have been doing so many things in cove treatment which has been uh trial and error and uh this thing but i would be a bit skeptical to do all those things in pregnant women you know today we are having such a long discussion about just a vaccine safety which has been there in the market for last now from uh last eight nine months so just imagine how much uh uh eyes eyebrows will be raised if we uh talk about this i really don't have any uh i have not read about it thank you um all the audiences man all of them are thanking you for a great insight into this burning topic uh and uh ma'am we bring an end to the question and answer session now i think we have covered most of the questions and the rest of them you have already covered it in your session in detail

BEING ATTENDED BY

Dr. Darius Justus & 870 others

SPEAKERS

dr. Molina Patel

Dr. Molina Patel

Consultant Obstetrician & Gynecologist, Akanksha Hospital, Anand

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dr. Vaishali Joshi

Dr. Vaishali Joshi

Senior Obstetrician and Gynaecologist at Kokilaben Hospital, Mumbai

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dr. Molina Patel

Dr. Molina Patel

Consultant Obstetrician & Gynecologist, Akank...

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dr. Vaishali Joshi

Dr. Vaishali Joshi

Senior Obstetrician and Gynaecologist at Koki...

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