Pregnant women should be informed about benefits, risks and likely side-effects of COVID-19 vaccine to help them make an informed decision on taking the jab, the Union Health Ministry said on Friday as it allowed their inoculation.
The ministry released an ‘Operational Guidance for COVID-19 Vaccination of Pregnant Women’.
Experts have suggested that the COVID-19 vaccine may be offered to the pregnant women if no contraindications exist, it said.
The intent is to weigh risk versus benefit on individualised basis so that a pregnant woman can take an informed decision.
“The full impact of COVID-19 disease on pregnancy outcomes for mother and foetus as well as for newborn is still unclear. Therefore, pregnant women require special considerations and systematic reporting of adverse events following immunization (AEFI),” the guidance document said.
Obstetrician and gynaecologist, pediatrician or neonatologist to be included in AEFI committees.
All serious and severe adverse events following vaccination of pregnant women should be reported immediately, it stated.
The investigation of all such cases to be expedited. Cytopathological examination of aborted/ perinatal death if any occurring in vaccinated women may be done, the document said.
“The adverse event and the pregnancy outcome must be noted on the ANC/MCH card. Pregnancy registry can be used to track such cases and to determine pregnancy outcome. All antenatal, post-natal and other relevant clinical records must be sought for and collected during investigation and gathered from the treating physician,” it said.
Causality assessment of all adverse events following vaccination of pregnant women to be expedited.
During vaccination, the vaccinator or medical officer must consider the fact that women in reproductive age group might be unaware of the pregnancy at the time of vaccination.
Therefore, the vaccinator must inform her for immediate reporting of AEFI, if any. In such cases, women will need to report immediately to the vaccinator or nearest health facility, the document said.
States would undertake an orientation of programme managers at district, block and sub-block levels and other stakeholders.
The document also contains a fact-sheet to guide the medical officers for counselling pregnant women, according to which pregnancy does not increase the risk to COVID-19 infection, but current evidence indicate that pregnant women are at an increased risk for severe illness from COVID-19 compared to non-pregnant women in case they get infected.
Additionally, pregnant women with COVID-19 are at increased risk for pre-term birth and might have an increased risk of other adverse pregnancy outcomes, including higher chances of neonatal morbidity.
Most pregnant women will be asymptomatic or have mild disease, but their health may deteriorate rapidly and that might affect the foetal outcome. It is important that they take all precautions to protect themselves from acquiring COVID-19, including taking vaccination.
The WHO recommends vaccination in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks, such as pregnant women at high risk of exposure to COVID-19 and pregnant women with comorbidities that place them in a high-risk group for severe COVID-19 disease.
It is, therefore, advised that a pregnant woman should take COVID-19 vaccine, the document said.
The fact sheet further mentions that although most (more than 90 per cent) infected pregnant women recover without need for hospitalisation, rapid deterioration in health may occur in a few.
Symptomatic pregnant women appear to be at increased risk of severe disease and death.
Compared with pregnant women without COVID-19, those with symptomatic COVID-19 are at increased risk of adverse pregnancy outcomes, including admission to the ICU, iatrogenic pre-term birth, pre-eclampsia-like symptoms, Caesarean section and death.
On how does COVID-19 infection of pregnant women affect the baby, the document said most (over 95 per cent) of newborns of positive mothers have been in good condition at birth.
However, COVID-19 in pregnancy increases the chances of pre-term birth, increasing the possibility of hospitalization for the neonate and in some cases even death.
Risk factors for developing complication after infection during pregnancy are: Pre-existing co-morbidities, advanced maternal age, and high body mass index.
Pregnant women with certain high-risk conditions have greater risk of severe illness from COVID-19 such as pre-existing medical conditions e.g. Diabetes, Organ transplant recipients, chronic respiratory conditions like COPD, Asthma, Cystic Fibrosis and homozygous sickle cell disease among others.
In case a woman has been infected with COVID-19 infection during the current pregnancy, then she should be vaccinated soon after the delivery, the document stated.
On side effects of vaccines that can either harm the pregnant women or her foetus, the fact-sheet stated the available jabs are safe and vaccination protects pregnant women against COVID-19 illness/disease like other individuals.
Based on current knowledge, experts believe that COVID-19 vaccines are unlikely to pose a risk to the pregnant person or foetus.
Like any medicine a vaccine may have side-effects which are normally mild. After getting the vaccine, she can get mild fever, pain at injection site, or feel un-well for 1-3 days. The long-term adverse effects and safety of vaccine for foetus and child is not established yet.
On any specific contraindications for vaccination in pregnancy, the fact-sheet stated as for the general population, pregnant women should avoid vaccination in conditions such as anaphylactic or allergic reaction to the previous dose of COVID-19 vaccine, anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items, etc.