O&G Forum

OBSTETRICS & GYNAECOLOGY FORUM 2021 | ISSUE 2 | 19 C M S A The Colleges of Medicine of South Africa NPC Nonprofit Com pany (Reg No.1955/000003/08) Nonprofit Organ isation (Reg. No. 009-874 NPO) Vat No. 4210273191 The CMSA is opposed to all forms of discrimination JOHANNESBURG OFFICE EXAMINATIONS & CREDENTIALS 27 Rhodes Avenue, PARKTOWN WEST, 2193 Tel: +27 11 726 7037 ; Fax: +27 11 726 4036 Website : General: www.cmsa.co.za Academic.Registrar@cmsa.co.za College of Ob stetricians and Gynaecologi sts of South Africa – Recommendations for COVID -19 vaccination in pregnancy INTRODUCTION Pregnant and lact ating w omen were excluded fr om initial COV ID -19 v accine trials; thus dat a to gui de vaccine decision-making are l acking. I n t he largest US st udy c omparing pregnant and non -pregnant women, pregnant wom en were significantly more likely to req uire intensive care and mechanical ventilation than non - pregnant women of the same age. 1 Bl ack women experienced a disproportionally higher number of deat hs. Preliminary dat a from the S outh African O bstetric Survey Systems s uggests t hat majority of COVI D -positive pregnant w omen w ere di agnosed in the third trimester of pregnancy. 1 One in six pregnant w omen admitt ed to hospit al required admission t o the i ntensive care unit, while one in sixteen w omen died. Clinical trials ev aluati ng the s afety and efficacy of COVID-19 vaccines in pregnancy are underway and planned. As of March 22, 2021 more than 60 000 pregnant w omen hav e been registered on the US/CDC V -saf e Registry Monitoring Sys tem. 2 Animal studies using the M oder na, P fizer -Biotec h and J &J/Janssen CO VID -19 vacci nes befor e or during pregnancy found no saf ety concerns . The M oder na and Pfizer -Biotec h vacci nes ar e mRNA vaccines t hat do not c ont ain a live virus. Additi onally, mRNA vaccines do not int eract with a person’s DNA or caus e genetic changes, as it does not ent er the nucl eus of t he c ell. The J &J/Janssen vaccine is a viral v ector vacci ne using a modifi ed version of a vec tor. Thus far, no adverse pregnancy outcom es have been reported when the same viral vec tor was used in other vaccines and administ ered to pregnant w omen i n all trimesters of pregnancy. A recent st udy by Gray et al ev aluating the mRNA COVID -19 vac cine respons e in pregnancy and lact ation, enrolled 84 pregnant and lactating women. 3 Elev en (13%) women rec eived the first vacci ne dose in t he fir st trimester, 39 (46%) in the sec ond trimester and 34 (40%) in t he third trimes ter. The aut hors concluded that COVID -19 mRNA vaccines generated robust hum oral immunity in pregnant and lac tating women with immunogenicity and reactogenicity similar t o t hat obs erved in non-pregnant women. Vacci ne-induced immune r esponses were significantly greater t han the respons e to natural inf ection. Imm une transf er to neonates occurred via the pl acenta and breastmilk. Adv erse eff ects ev aluated in t his st udy incl uded the ri sks of pr eterm birth, rat es of pre -ecl ampsia and growth r estriction. T here w ere no cases of pre -eclampsia or growth restriction in women receiving t he vacci ne during pregnancy. One cas e of preterm birth w as reported. RECOMMENDATIONS COVID-19 v accination is strongly enc ouraged f or non-pregnant w omen c ontemplating pregnancy. COVID -19 vacci nes using the mRNA or viral v ect or t echnology s hould be of fered to all pregnant women aft er 14 w eeks gestation. Pregnant women wit h c o-morbidities s uch as di abetes and hy pertension in pregnancy should be prioritized for vaccinati on s hould v accine supplies be limited. Health care w orkers are encouraged to discuss t he risks and benefits of t he COVID -19 vacci nati on with t heir pati ents. These discus sions s hould incl ude t he lac k of s afety dat a f or pregnancy and breastf eeding women, t he strong immune res ponse conferred t o mothers following v accination, t he benefits of immune transf er t o t he neonat e and t hat there are no known risks associ ated with ot her non -live vacci nes given i n pregnancy. REFERENCES 1. Maswime S. Global Research on Covid-19 and Pregnancy. Discovery Webinar. Youtube.com/watch?v=GwYUSxCL2sg. Accessed 29 March 2021 2. V-safe COVID-19 Vaccine Pregnancy Registry. www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafepregnancyregistry.html . Acc essed 29 March 2021 3. Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young B et al. COVID-19 vaccine response in pregnant and lactating women: a cohort study, AJOG 2021, doi: https://doi.org/10.1016/j.ajog.2021.03.023 . Signed _________________________ ______________________ Prof P Soma-Pillay Pro f H Botha (President ) (Hono rary Secr etary ) 30 March 2021 C M S A The Colleges of Medicine of South Africa NPC Nonp rofit Comp any (Reg No.1955/000003/08) Nonpro fit Organis ation (Reg. No. 009-874 NPO) Vat No. 4210273191 The CMSA is opposed to all forms of discrimination JOHANNESBURG OFFICE EXAMINATIONS & CREDENTIALS 27 Rhodes Avenue, PARKTOWN WEST, 2193 Tel: +27 11 726 7037 ; Fax: +27 11 726 4036 Website : Gener l: www.cmsa.co.za Academic.Registrar@cmsa.co.za College f Ob tetricians and Gynaecologi sts of South Africa – Recommendatio s for COVID -19 vaccination in pregnancy INTRODUCTION Pregnant an lact ating w omen were excluded fr om initial COV ID -19 v accine trials; thus dat a to gui de vaccine decision-making are l acking. I n t he largest US st udy c omparing pregnant and n n -pregnant women, pregnant wom en were sign ficantly mo e likely to req uire intensive care a d mechanical ventilation than non - pregnant women of the sam age. 1 Bl ack w men experienced a disproportionally higher number of d at hs. Preliminary dat a from the S outh African O b tetric Survey Systems s uggests t hat m jority of COVI D -positive pregnant w omen w ere di agnosed in the third trimest r of pregnancy. 1 On in six pregnant w omen admitt ed hospit al required admission t o the i ntensive car unit, while one in sixteen w omen died. Clinical trials ev aluati ng the s afety and efficacy of COVID-19 vaccines in pregnancy are underway and planned. As of March 22, 2021 more than 60 000 pregnant w omen hav e been registered on the US/CDC V -saf e Registry Monitor Sys tem. 2 Animal studies using the M oder na, P fizer -Biotec h and J &J/Janssen CO VID -19 vacci nes befor e or during p egnancy found no saf ety concerns . The M oder na and Pfizer -Biotec vacci nes ar e mRNA vaccines t hat do ot c ont ain a live virus. Additi onally, mRNA vacci e do not int eract with a person’ DNA or caus e genetic changes, as it do s not ent er the nucl us of t h c ell. The J &J/Janssen vaccine is a viral v ector vacci ne using a modifi ed version of a vec tor. Th s far, no advers pr gnancy outcom s have been rep rted when the same viral vec tor was used in other vacci es and administ ered to pregnant w omen i n all trimesters of pregnancy. A recent st udy by Gray et al ev luating the mRNA COVID -19 vac cine respons e in pregnancy and lact ation, enrolled 84 pregna t and lactating women. 3 El v en (13%) women rec eiv d the first vacci ne dose in t he fir st trimester, 39 (46%) in the sec ond trimes er and 34 (40%) in t he third trimes er. The aut hors concluded that COVID -19 mRNA vaccines generated robust hum oral immu ity in pregnant and lac tating women with immunogenicity and reactogenicity similar t o t hat obs erved in non-pr gnant women. Vacci ne-induced immune r esponses were ignificantly gre ter t han the respons e to natural inf ection. Imm une transf er to neonates occurred via the pl acenta and breastmilk. Adv erse eff ects ev aluated in t his st udy ncl uded the ri sks of pr eterm birth, rat es of pre -ecl ampsia and growth r estriction. T here w e e n cases of pre -eclampsia or growth restrictio in women receiving t he vacci ne during pregnancy. One cas e of preterm birth w as reported. RECOMMENDATIONS COVID-19 v accinati is stro gly enc ouraged f or non- eg t w omen c ontemplating pregnancy. COVID -19 vacci nes using the mRNA or viral v ect or t echnology s hould b of fered to all pregnant women aft er 14 w eeks gestation. Pregnant women wit h c o-morbidities s uch as di abetes and hy pertension in pregnancy should be prioritized for vaccinat on s hould v accine supplie be limited. H alth care w orkers are encouraged to discuss t he risks and benefits of t he COVID -19 vacci nati on with t heir pati ents. These discus sion s hould incl ude t he lac k of s afety dat a f or preg ancy and breastf eeding wom n, t h strong i mune res ponse conferred t o mothers following v accination, t he b nefits of immune transf er t o t he eo at e and t hat th re are no know r sks ssoci ated with ot her non -live vacci nes given i n pregnancy. REFERENCES 1. Maswime S. Global Res arch on Covid-19 and Pregnancy. Discovery Webinar. Youtube.com/watch?v=GwYUSxCL2sg. Accessed 29 March 2021 2. V-sa fe COVID-19 Vacci e Pregnancy Registry. www.cdc.gov/coronavirus/2019-ncov/va ccin / afety/vs fepregnancyregistry.html . Accessed 29 March 2021 3. Gray KJ, ordt EA, Atyeo C, Deriso E, Akinwunmi B, You g B et al. COVID-19 vaccin response in pregnant and lactating women: a cohort study, AJOG 021, doi: https://doi.org/10.1016/j.ajog.2021.03.023 . Signed ________________ _________________ Prof P Soma-Pillay Pro f H Botha (President ) (Hono rary Secr etary ) 30 March 2021 O&G Forum 2021; 31: 19 RECOMMENDATION C M S A The Colleges of Medicine of South Africa NPC Nonprofit Company (Reg No.1955/000003/08) Nonprofit Organisation (Reg. No. 009-874 NPO) Vat No. 4210273191 JOHANNESBURG OFFICE EXAMINATIONS & CREDENTIALS 27 Rhodes Avenue, PARKTOWN WEST, 2193 Tel: +27 11 726 7037 ; Fax: +27 11 726 4036 Web site : General: ww w.cmsa.co.za Academic.Registrar@cmsa.co.za Co l l eg e o f Ob st et r i c i an s an d Gyn a eco l o g i st s o f So u t h A f r i c a – R e commen d at i o n s f o r COV I D - 1 9 vac ci n at i o n i n p r eg n an cy I NTRODUCT I ON P r egn an t and l ac t at i n g w omen w er e ex c l u de d f r om i ni t i al COV I D - 19 v ac c i ne t r i al s ; t h us dat a t o gui de v ac c i n e dec i s i on - mak i n g ar e l ac k i ng . I n t he l ar g es t US s t udy c ompar i n g p r egna nt a nd no n - pr e gna nt w omen , pr eg na nt w om en w s i gni f i c a nt l y mor e l i k el y t o r eq u r i nt e ns i v e c ar e an d mec h ani c al v e nt i l at i o n t h an non - pr eg na nt w omen of t h e s a e a ge . 1 B l ac k w ome n ex p er i enc e d a di s pr o por t i o nal l y hi gh er number of d eat hs . P r el i m i nar y d at a f r om t h e S ou t h A f r i c an O bs t e t r i c Sur v ey Sy s t ems s ugg es t s t ha t maj or i t y o f COV I D - pos i t i v e pr e gn ant w omen w er e di ag nos e d i n t h e t hi r d t r i mes t er of pr e gna nc y . 1 On e i n s i x pr eg nan t w omen a dm i t t ed t o h os pi t al r e qui r e d adm i s s i o n t o t h e i nt e ns i v e c ar e u ni t , w hi l e o ne i n s i x t e en w omen di e d. C l i ni c al t r i al s ev al uat i ng t h e s af e t y a nd e f f i c ac y of COV I D - 1 9 v a c c i nes i n pr e gn anc y ar e u nd er w ay a nd pl a nn ed . As of Mar c h 22 , 2 02 1 m r e t h a 6 0 0 00 pr eg nt w omen hav e bee n r gi s t er e d on t he US / CDC V - s af e R e gi s r y M ni t or i ng Sy s t em . 2 Ani mal s t u di es us i g t h e M oder na, P f i z r - B i ot ec h an d J &J / J a ns s e CO V I D - 19 v ac c i nes b ef or e or dur i ng pr eg na nc y f o un d n o s af et y c o nc er ns . T he M oder na and P f i z er - B i ot ec h v ac c i nes ar e mRNA v ac c i nes t ha t do not c ont ai n a l i v e v i r us . Addi t i on al l y , mRNA v ac c i nes do no t i nt er ac t w i t h a p er s on’ s DNA or c aus e g en et i c c h an ges , as i t do es n ot ent er t h e nuc l eus of t he c el l . T he J &J / J a ns s e n v ac c i ne i s a v i r al v ec t or v ac c i ne us i ng a modi f i ed v er s i on of a v ec t or . T h us f ar , no a dv er s e pr eg na nc y o ut c om es h av e b ee n r ep or t e d w he n t h e s ame v i r al v ec t or w as us ed i n ot h er v ac c i n es a nd adm i ni s t er ed t o pr e gna nt w omen i n al l t r i mes t er s of pr eg na nc y . A r ec e nt s t udy by G r ay e l ev al u at i ng t h e mRNA COV I D - 1 9 v ac c i n r es p o s i n pr gna c y an d l ac t at i o n, e nr ol l d 84 pr e gn ant an d l ac t a t i ng w ome n. 3 E l ev en ( 1 3%) w omen r ec ei v e d t he f i r s t v ac c i ne d os e i n t he f i r s t t r i mes t er , 39 ( 46%) i n t h e s ec ond t r i mes t er an d 3 4 ( 40%) i n t he t hi r d t r i mes t er . T he aut hor s c o nc l u ded t h at COV I D - 1 9 mRNA v ac c i nes g en er at e d r b us t hum or al i mmuni t y i n pr e gn ant and l ac t at i n g w omen w i t h i mmuno ge ni c i t y an d r eac t o ge ni c i t y s i m i l ar t o t ha t o bs er v ed i n n on - pr e gn ant w o men. Vac c i ne - i nd uc e d i mmun e r es p ons es w er e s i gni f i c an t l y gr ea t er t han t h e r es p ons e t o na t ur al i nf ec t i o n. I mm une t r ans f er t o ne on at es oc c ur r ed v i a t h e pl ac e nt a and br eas t m i l k . Adv er s e ef f ec t s ev al ua t e d i n t hi s s t udy i nc l ude d t h e r i s k s of pr et er m bi r t h, r at es of pr e - ec l amps i a and gr ow t h r es t i c t i on. T her w r e n o c as es of pr e - l amps i a r gr ow t h r es r i c t i o n i w ome n r ec i v i n g t he v ac c i ne dur i ng pr e gna nc y . On e c as e o f pr e t er m bi r t h w as r ep or t e d. RECOMMENDAT I ONS COV I D - 19 v ac c i na t i on i s s t r o ngl y enc our a ge d f or n on - pr e gn ant w omen c on t empl a t i ng pr e gn anc y . COV I D - 1 9 v ac c i nes us i ng t h e mRNA or v i r al v ec t or t ec hn ol o gy s ho ul d be of f er e d t o al l pr e gn ant w ome n af t er 1 4 w eek s g es t a t i on. P r egn an t w ome n w i t h c o - mor bi di t i es s uc h as di abe t es a nd hy per t e ns i on i n pr e gn anc y s h oul d b e pr i or i t i z ed f or v ac c i nat i on s ho ul d v ac c i ne s u ppl i es be l i m i t e d. H e al t h c ar e w or k e r s ar e e nc o ur ag ed t o di s c us s t he r i s k s an d b en ef i t s of t he COV I D - 1 9 v ac c i nat i on w i t h t hei r pat i ent s . T h es e di s c us s i ons s ho ul d i nc l ud e t he l ac k of s af e t y dat a f or pr egn anc y a nd br e as t f ee di ng w omen , t he s t r on g i mmun e r es po n s e c o nf er r e d t o m o t h er s f ol l ow i n g v ac c i na t i on, t he ben ef i t s of i mmune t r ans f er t o t he n eo nat e and t hat t h er ar e no k now n r i s k s as s oc i at e d w i t h ot her no n - l i v e v ac c i nes gi v en i n pr e gn anc y . REFERENCES 1. Maswime S. Global Research on Covid-19 and Pregnancy. Discovery Webinar. Youtube.com/watch?v=GwYUSxCL2sg. Accessed 29 March 2021 2. V-safe COVID-19 Vaccine Pregnancy Registry. www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafepregnancyregistry.html . Accessed 29 March 2021 3. Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young B et al. COVID-19 vaccine response in pregnant and lactating women: a cohort study, AJOG 2021, doi: https://doi.org/10.1016/j.ajog.2021.03.023 . S i gne d _________________________ ______________________ Prof P Soma-Pi l l ay Pro f H Botha (Pres i dent ) (Hono rary Secr etary ) 30 March 2021